<p>On 19&nbsp;September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)&nbsp;adopted a positive opinion,&nbsp;recommending the granting of marketing authorization&nbsp;for&nbsp;two aflibercept biosimilars:&nbsp;&nbsp;Sandoz’s Afqlir and Samsung Bioepis’s Opuviz.&nbsp;These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.</p>

<p>The US Food and Drug Administration (FDA) granted approval for two&nbsp;biosimilars, Formycon’s FYB202/Otulfi (ustekinumab-aauz) and Samsung Bioepis’ Soliris biosimilar, Epysqli (eculizumab-aagh), on 27 September and 22 July 2024, respectively. FYB202/Otulfi, a biosimilar referencing&nbsp;Johnson &amp; Johnson’s Stelara, while Epysqli is a biosimilar referencing Alexion’s Soliris.</p>

<p> <b>BIOSIMILAR RED TAPE ELIMINATION ACT (S2305):</b><br /> <b><i>Weakening FDA Regulatory Standards for Biosimilars, Undermining Physician Confidence and Jeopardizing Patient Health</i></b><br /><b>31 October 2024&nbsp;|&nbsp;</b><b><a href="https://youtu.be/X6-dYZ7fjhM" target="_blank">WATCH REPLAY</a></b></p>

<p>In May 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) announced that it will trial new timelines for variation applications&nbsp;of registered pharmaceutical products and natural health supplements (TMHS).</p>

<p>The European Commission (EC) granted marketing authorization for<b>&nbsp;</b>three ustekinumab biosimilars<b>:&nbsp;</b>Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s&nbsp;Otulfi on 25 September 2024.</p>

Some 180 women were prescribed valproate, a medicine used to treat epilepsy and bipolar disorder, during their pregnancy within a 2.5 year interval, NHS data has revealed.

Researchers around the world are working at record speed to find the best ways to treat and prevent COVID-19, from investigating the possibility of repurposing existing drugs to searching for novel therapies against the virus.

Community pharmacies able to administer up to 400 COVID-19 vaccines per week can now apply to become designated vaccination sites, NHS England has said.

A new type of drug that targets chemotherapy directly to cancer cells reduces the risk of death from the most common type of bladder cancer by 30%, a phase III trial in the New England Journal of Medicine has suggested.

By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Ever wondered what goes into diligencing a new idea, program, company, or platform? While each diligence is unique and every investor will have

The post Deconstructing the Diligence Process: An Approach to Vetting New Product Theses appeared first on LifeSciVC.

By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC In the last decade, our industry has made great strides in combating cancer by harnessing the body’s own immune system. As it was

The post Neuro-Immunology: The Promise Of A Differentiated Approach To Neurodegenerative Disease appeared first on LifeSciVC.

By Jonathan Montagu, CEO of HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC HotSpot’s trip to Barcelona for the recent European Society of Medical Oncology (ESMO) Annual Meeting was no ‘European Vacation,’ but it was certainly

The post ESMO Reflections: Glimmers of Hope with the Next Wave of I-O Therapies? appeared first on LifeSciVC.

“Children are not small adults.” We invoke this saying, in a vague and hand-wavy manner, whenever we talk about the need to study drugs in pediatric populations. It’s an interesting idea, but it really cries out for further elaboration. If they’re not small adults, what are they? Are pediatric efficacy and safety totally uncorrelated with adult efficacy and safety? Or are children actually kind of like small adults in certain important ways?

Pediatric post-marketing studies have been completed for over 200 compounds in the years since BPCA (2002, offering a reward of 6 months extra market exclusivity/patent life to any drug conducting requested pediatric studies) and PREA (2007, giving FDA power to require pediatric studies) were enacted. I think it is fair to say that at this point, it would be nice to have some sort of comprehensive idea of how FDA views the risks associated with treating children with medications tested only on adults. Are they in general less efficacious? More? Is PK in children predictable from adult studies a reasonable percentage of the time, or does it need to be recharacterized with every drug?

Essentially, my point is that BPCA/PREA is a pretty crude tool: it is both too broad in setting what is basically a single standard for all new adult medications, and too vague as to what exactly that standard is.

In fact, a 2008 published review from FDA staffers and a 2012 Institute of Medicine report both show one clear trend: in a significant majority of cases, pediatric studies resulted in validating the adult medication in children, mostly with predictable dose and formulation adjustments (77 of 108 compounds (71%) in the FDA review, and 27 of 45 (60%) in the IOM review, had label changes that simply reflected that use of the drug was acceptable in younger patients).

So, it seems, most of the time, children are in fact not terribly unlike small adults.

But it’s also true that the percentages of studies that show lack of efficacy, or bring to light a new safety issue with the drug’s use in children, is well above zero. There is some extremely important information here.

To paraphrase John Wanamaker: we know that half our PREA studies are a waste of time; we just don’t know which half.

This would seem to me to be the highest regulatory priority – to be able to predict which new drugs will work as expected in children, and which may truly require further study. After a couple hundred compounds have gone through this process, we really ought to be better positioned to understand how certain pharmacological properties might increase or decrease the risks of drugs behaving differently than expected in children. Unfortunately, neither the FDA nor the IOM papers venture any hypotheses about this – both end up providing long lists of examples of certain points, but not providing any explanatory mechanisms that might enable us to engage in some predictive risk assessment.

While FDASIA did not advance PREA in terms of more rigorously defining the scope of pediatric requirements (or, better yet, requiring FDA to do so), it did address one lingering concern by requiring that FDA publish non-compliance letters for sponsors that do not meet their commitments. (PREA, like FDAAA, is a bit plagued by lingering suspicions that it’s widely ignored by industry.)

The first batch of letters and responses has been published, and it offers some early insights into the problems engendered by the nebulous nature of PREA and its implementation.

These examples, unfortunately, are still a bit opaque – we will need to wait on the FDA responses to the sponsors to see if some of the counter-claims are deemed credible. In addition, there are a few references to prior deferral requests, but the details of the request (and rationales for the subsequent FDA denials) do not appear to be publicly available. You can read FDA’s take on the new postings on their blog, or in the predictably excellent coverage from Alec Gaffney at RAPS.

Looking through the first 4 drugs publicly identified for noncompliance, the clear trend is that there is no trend. All these PREA requirements have been missed for dramatically different reasons.

Here’s a quick rundown of the drugs at issue – and, more interestingly, the sponsor responses:

1. Renvela - Genzyme (full response)

Genzyme appears to be laying responsibility for the delay firmly at FDA’s feet here, basically claiming that FDA continued to pile on new requirements over time:

Genzyme’s correspondence with the FDA regarding pediatric plans and design of this study began in 2006 and included a face to face meeting with FDA in May 2009. Genzyme submitted 8 revisions of the pediatric study design based on feedback from FDA including that received in 4 General Advice Letters. The Advice Letter dated February 17, 2011  contained further recommendations on the study design, yet still required the final clinical study report  by December 31, 2011.

This highlights one of PREA’s real problems: the requirements as specified in most drug approval letters are not specific enough to fully dictate the study protocol. Instead, there is a lot of back and forth between the sponsor and FDA, and it seems that FDA does not always fully account for their own contribution to delays in getting studies started.

2. Hectorol - Genzyme (full response)

In this one, Genzyme blames the FDA not for too much feedback, but for none at all:

On December 22, 2010, Genzyme submitted a revised pediatric development plan (Serial No. 212) which was intended to address FDA feedback and concerns that had been received to date. This submission included proposed protocol HECT05310. [...] At this time, Genzyme has not received feedback from the FDA on the protocol included in the December 22, 2010 submission.

If this is true, it appears extremely embarrassing for FDA. Have they really not provided feedback in over 2.5 years, and yet still sending noncompliance letters to the sponsor? It will be very interesting to see an FDA response to this.

3. Cleviprex – The Medicines Company (full response)

This is the only case where the pharma company appears to be clearly trying to game the system a bit. According to their response:

Recognizing that, due to circumstances beyond the company’s control, the pediatric assessment could not be completed by the due date, The Medicines Company notified FDA in September 2010, and sought an extension. At that time, it was FDA’s view that no extensions were available. Following the passage of FDASIA, which specifically authorizes deferral extensions, the company again sought a deferral extension in December 2012. 

So, after hearing that they had to move forward in 2010, the company promptly waited 2 years to ask for another extension. During that time, the letter seems to imply that they did not try to move the study forward at all, preferring to roll the dice and wait for changing laws to help them get out from under the obligation.

4. Twinject/Adrenaclick – Amedra (full response)

The details of this one are heavily redacted, but it may also be a bit of gamesmanship from the sponsor. After purchasing the injectors, Amedra asked for a deferral. When the deferral was denied, they simply asked for the requirements to be waived altogether. That seems backwards, but perhaps there's a good reason for that.

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It is a surprisingly common peril among analysts: we don’t have the data to answer the question we’re interested in, so we answer a related question where we do have data. Unfortunately, the new answer turns out to shed no light on the original interesting question.

This is sometimes referred to as the Streetlight Effect – a phenomenon aptly illustrated by Mutt and Jeff over half a century ago:

This is the situation that the Tufts Center for the Study of Drug Development seems to have gotten itself into in its latest "Impact Report".  It’s worth walking through the process of how an interesting question ends up in an uninteresting answer.

So, here’s an interesting question:

My company owns a drug that may be approvable through FDA’s 505(b)(2) pathway. What is the estimated time and cost difference between pursuing 505(b)(2) approval and conventional approval?

That’s "interesting", I suppose I should add, for a certain subset of folks working in drug development and commercialization. It’s only interesting to that peculiar niche, but for those people I suspect it’s extremely interesting - because it is a real situation that a drug company may find itself in, and there are concrete consequences to the decision.

Unfortunately, this is also a really difficult question to answer. As phrased, you'd almost need a randomized trial to answer it. Let’s create a version which is less interesting but easier to answer:

What are the overall development time and cost differences between drugs seeking approval via 505(b)(2) and conventional pathways?

This is much easier to answer, as pharmaceutical companies could look back on development times and costs of all their compounds, and directly compare the different types. It is, however, a much less useful question. Many new drugs are simply not eligible for 505(b)(2) approval. If those drugs

Extreme qualitative differences of 505(b)(2) drugs. Source: Thomson Reuters analysis via RAPS

are substantially different in any way (riskier, more novel, etc.), then they will change the comparison in highly non-useful ways. In fact, in 2014, only 1 drug classified as a New Molecular Entity (NME) went through 505(b)(2) approval, versus 32 that went through conventional approval. And in fact, there are many qualities that set 505(b)(2) drugs apart.

So we’re likely to get a lot of confounding factors in our comparison, and it’s unclear how the answer would (or should) guide us if we were truly trying to decide which route to take for a particular new drug. It might help us if we were trying to evaluate a large-scale shift to prioritizing 505(b)(2) eligible drugs, however.

Unfortunately, even this question is apparently too difficult to answer. Instead, the Tufts CSDD chose to ask and answer yet another variant:

What is the difference in time that it takes the FDA for its internal review process between 505(b)(2) and conventionally-approved drugs?

This question has the supreme virtue of being answerable. In fact, I believe that all of the data you’d need is contained within the approval letter that FDA posts publishes for each new approved drug.

But at the same time, it isn’t a particularly interesting question anymore. The promise of the 505(b)(2) pathway is that it should reduce total development time and cost, but on both those dimensions, the report appears to fall flat.

• Cost: This analysis says nothing about reduced costs – those savings would mostly come in the form of fewer clinical trials, and this focuses entirely on the FDA review process.
• Time: FDA review and approval is only a fraction of a drug’s journey from patent to market. In fact, it often takes up less than 10% of the time from initial IND to approval. So any differences in approval times will likely easily be overshadowed by differences in time spent in development. 

But even more fundamentally, the problem here is that this study gives the appearance of providing an answer to our original question, but in fact is entirely uninformative in this regard. The accompanying press release states:

The 505(b)(2) approval pathway for new drug applications in the United States, aimed at avoiding unnecessary duplication of studies performed on a previously approved drug, has not led to shorter approval times.

This is more than a bit misleading. The 505(b)(2) statute does not in any way address approval timelines – that’s not it’s intent. So showing that it hasn’t led to shorter approval times is less of an insight than it is a natural consequence of the law as written.

Most importantly, showing that 505(b)(2) drugs had a longer average approval time than conventionally-approved drugs in no way should be interpreted as adding any evidence to the idea that those drugs were slowed down by the 505(b)(2) process itself. Because 505(b)(2) drugs are qualitatively different from other new molecules, this study can’t claim that they would have been developed faster had their owners initially chosen to go the route of conventional approval. In fact, such a decision might have resulted in both increased time in trials and increased approval time.

This study simply is not designed to provide an answer to the truly interesting underlying question.

[Disclosure: the above review is based entirely on a CSDD press release and summary page. The actual report costs $125, which is well in excess of this blog’s expense limit. It is entirely possible that the report itself contains more-informative insights, and I’ll happily update that post if that should come to my attention.]

Sudan's civil war has displaced 10 million citizens. Here are profiles of two young people from the most vulnerable groups: an unaccompanied minor caring for twin brothers, a woman who was raped.

Nearly every day since she was a child, Alex Leow, a psychiatrist and computer scientist at the University of Illinois Chicago, has played the piano. Some days she plays well, and other days her tempo lags and her fingers hit the wrong keys. Over the years, she noticed a pattern: How well she plays depends on her mood. A bad mood or lack of sleep almost always leads to sluggish, mistake-prone music.

In 2015, Leow realized that a similar pattern might be true for typing. She wondered if she could help people with psychiatric conditions track their moods by collecting data about their typing style from their phones. She decided to turn her idea into an app.

After conducting a pilot study, in 2018 Leow launched BiAffect, a research app that aims to understand mood-related symptoms of bipolar disorder through keyboard dynamics and sensor data from users’ smartphones. Now in use by more than 2,700 people who have volunteered their data to the project, the app tracks typing speed and accuracy by swapping the phone’s onscreen keyboard with its own nearly identical one.

The software then generates feedback for users, such as a graph displaying hourly keyboard activity. Researchers get access to the donated data from users’ phones, which they use to develop and test machine learning algorithms that interpret data for clinical use. One of the things Leow’s team has observed: When people are manic—a state of being overly excited that accompanies bipolar disorder—they type “ferociously fast,” says Leow.

Compared to a healthy user [top], a person experiencing symptoms of bipolar disorder [middle] or depression [bottom] may use their phone more than usual and late at night. BiAffect measures phone usage and orientation to help track those symptoms. BiAffect

BiAffect is one of the few mental-health apps that take a passive approach to collecting data from a phone to make inferences about users’ mental states. (Leow suspects that fewer than a dozen are currently available to consumers.) These apps run in the background on smartphones, collecting different sets of data not only on typing but also on the user’s movements, screen time, call and text frequency, and GPS location to monitor social activity and sleep patterns. If an app detects an abrupt change in behavior, indicating a potentially hazardous shift in mental state, it could be set up to alert the user, a caretaker, or a physician.

Such apps can’t legally claim to treat or diagnose disease, at least in the United States. Nevertheless, many researchers and people with mental illness have been using them as tools to track signs of depression, schizophrenia, anxiety, and bipolar disorder. “There’s tremendous, immediate clinical value in helping people feel better today by integrating these signals into mental-health care,” says John Torous, director of digital psychiatry at Beth Israel Deaconess Medical Center, in Boston. Globally, one in 8 people live with a mental illness, including 40 million with bipolar disorder.

These apps differ from most of the more than 10,000 mental-health and mood apps available, which typically ask users to actively log how they’re feeling, help users connect to providers, or encourage mindfulness. The popular apps Daylio and Moodnotes, for example, require journaling or rating symptoms. This approach requires more of the user’s time and may make these apps less appealing for long-term use. A 2019 study found that among 22 mood-tracking apps, the median user-retention rate was just 6.1 percent at 30 days of use.

App developers are trying to avoid the pitfalls of previous smartphone-psychiatry startups, some of which oversold their capabilities before validating their technologies.

But despite years of research on passive mental-health apps, their success is far from guaranteed. App developers are trying to avoid the pitfalls of previous smartphone psychiatry startups, some of which oversold their capabilities before validating their technologies. For example, Mindstrong was an early startup with an app that tracked taps, swipes, and keystrokes to identify digital biomarkers of cognitive function. The company raised US $160 million in funding from investors, including $100 million in 2020 alone, and went bankrupt in February 2023.

Mindstrong may have folded because the company was operating on a different timeline from the research, according to an analysis by the health-care news website Stat. The slow, methodical pace of science did not match the startup’s need to return profits to its investors quickly, the report found. Mindstrong also struggled to figure out the marketplace and find enough customers willing to pay for the service. “We were first out of the blocks trying to figure this out,” says Thomas Insel, a psychiatrist who cofounded Mindstrong.

Now that the field has completed a “hype cycle,” Torous says, app developers are focused on conducting the research needed to prove their apps can actually help people. “We’re beginning to put the burden of proof more on those developers and startups, as well as academic teams,” he says. Passive mental-health apps need to prove they can reliably parse the data they’re collecting, while also addressing serious privacy concerns.

Passive sensing catches mood swings early

A crucial component of managing psychiatric illness is tracking changes in mental states that can lead to more severe episodes of the disease. Bipolar disorder, for example, causes intense swings in mood, from extreme highs during periods of mania to extreme lows during periods of depression. Between 30 and 50 percent of people with bipolar disorder will attempt suicide at least once in their lives. Catching early signs of a mood swing can enable people to take countermeasures or seek help before things get bad.

But detecting those changes early is hard, especially for people with mental illness. Observations by other people, such as family members, can be subjective, and doctor and counselor sessions are too infrequent.

That’s where apps come in. Algorithms can be trained to spot subtle deviations from a person’s normal routine that might indicate a change in mood—an objective measure based on data, like a diabetic tracking blood sugar. “The ability to think objectively about my own thinking is really key,” says retired U.S. major general Gregg Martin, who has bipolar disorder and is an advisor for BiAffect.

The data from passive sensing apps could also be useful to doctors who want to see objective data on their patients in between office visits, or for people transitioning from inpatient to outpatient settings. These apps are “providing a service that doesn’t exist,” says Colin Depp, a clinical psychologist and professor at the University of California, San Diego. Providers can’t observe their patients around the clock, he says, but smartphone data can help close the gap.

Depp and his team have developed an app that uses GPS data and microphone-based sensing to determine the frequency of conversations and make inferences about a person’s social interactions and isolation. The app also tracks “location entropy,” a metric of how much a user moves around outside of routine locations. When someone is depressed and mostly stays home, location entropy decreases.

Depp’s team initially developed the app, called CBT2go, as a way to test the effectiveness of cognitive behavioral therapy in between therapy sessions. The app can now intervene in real time with people experiencing depressive or psychotic symptoms. This feature helps people identify when they feel lonely or agitated so they can apply coping skills they’ve learned in therapy. “When people walk out of the therapist’s office or log off, then they kind of forget all that,” Depp says.

Another passive mental-health-app developer, Ellipsis Health in San Francisco, uses software that takes voice samples collected during telehealth calls to gauge a person’s level of depression, anxiety, and stress symptoms. For each set of symptoms, deep-learning models analyze the person’s words, rhythms, and inflections to generate a score. The scores indicate the severity of the person’s mental distress, and are based on the same scales used in standard clinical evaluations, says Michael Aratow, cofounder and chief medical officer at Ellipsis.

Aratow says the software works for people of all demographics, without needing to first capture baseline measures of an individual’s voice and speech patterns. “We’ve trained the models in the most difficult use cases,” he says. The company offers its platform, including an app for collecting the voice data, through health-care providers, health systems, and employers; it’s not directly available to consumers.

In the case of BiAffect, the app can be downloaded for free by the public. Leow and her team are using the app as a research tool in clinical trials sponsored by the U.S. National Institutes of Health. These studies aim to validate whether the app can reliably monitor mood disorders, and determine whether it could also track suicide risk in menstruating women and cognition in people with multiple sclerosis.

BiAffect’s software tracks behaviors like hitting the backspace key frequently, which suggests more errors, and an increase in typing “@” symbols and hashtags, which suggest more social media use. The app combines this typing data with information from the phone’s accelerometer to determine how the user is oriented and moving—for example, whether the user is likely lying down in bed—which yields more clues about mood.

Ellipsis Health analyzes audio captured during telehealth visits to assign scores for depression, anxiety, and stress.Ellipsis Health

The makers of BiAffect and Ellipsis Health don’t claim their apps can treat or diagnose disease. If app developers want to make those claims and sell their product in the United States, they would first have to get regulatory approval from the U.S. Food and Drug Administration. Getting that approval requires rigorous and large-scale clinical trials that most app makers don’t have the resources to conduct.

Digital-health software depends on quality clinical data

The sensing techniques upon which passive apps rely—measuring typing dynamics, movement, voice acoustics, and the like—are well established. But the algorithms used to analyze the data collected by the sensors are still being honed and validated. That process will require considerably more high-quality research among real patient populations.

Greg Mably

For example, clinical studies that include control or placebo groups are crucial and have been lacking in the past. Without control groups, companies can say their technology is effective “compared to nothing,” says Torous at Beth Israel.

Torous and his team aim to build software that is backed by this kind of quality evidence. With participants’ consent, their app, called mindLAMP, passively collects data from their screen time and their phone’s GPS and accelerometer for research use. It’s also customizable for different diseases, including schizophrenia and bipolar disorder. “It’s a great starting point. But to bring it into the medical context, there’s a lot of important steps that we’re now in the middle of,” says Torous. Those steps include conducting clinical trials with control groups and testing the technology in different patient populations, he says.

How the data is collected can make a big difference in the quality of the research. For example, the rate of sampling—how often a data point is collected—matters and must be calibrated for the behavior being studied. What’s more, data pulled from real-world environments tends to be “dirty,” with inaccuracies collected by faulty sensors or inconsistencies in how phone sensors initially process data. It takes more work to make sense of this data, says Casey Bennett, an assistant professor and chair of health informatics at DePaul University, in Chicago, who uses BiAffect data in his research.

One approach to addressing errors is to integrate multiple sources of data to fill in the gaps—like combining accelerometer and typing data. In another approach, the BiAffect team is working to correlate real-world information with cleaner lab data collected in a controlled environment where researchers can more easily tell when errors are introduced.

Who participates in the studies matters too. If participants are limited to a particular geographic area or demographic, it’s unclear whether the results can be applied to the broader population. For example, a night-shift worker will have different activity patterns from those with nine-to-five jobs, and a city dweller may have a different lifestyle from residents of rural areas.

After the research is done, app developers must figure out a way to integrate their products into real-world medical contexts. One looming question is when and how to intervene when a change in mood is detected. These apps should always be used in concert with a professional and not as a replacement for one, says Torous. Otherwise, the app’s assessments could be dangerous and distressing to users, he says.

When mood tracking feels like surveillance

No matter how well these passive mood-tracking apps work, gaining trust from potential users may be the biggest stumbling block. Mood tracking could easily feel like surveillance. That’s particularly true for people with bipolar or psychotic disorders, where paranoia is part of the illness.

Keris Myrick, a mental-health advocate, says she finds passive mental-health apps “both cool and creepy.” Myrick, who is vice president of partnerships and innovation at the mental-health-advocacy organization Inseparable, has used a range of apps to support her mental health as a person with schizophrenia. But when she tested one passive sensing app, she opted to use a dummy phone. “I didn’t feel safe with an app company having access to all of that information on my personal phone,” Myrick says. While she was curious to see if her subjective experience matched the app’s objective measurements, the creepiness factor prevented her from using the app enough to find out.

Keris Myrick, a mental-health advocate, says she finds passive mental-health apps “both cool and creepy.”

Beyond users’ perception, maintaining true digital privacy is crucial. “Digital footprints are pretty sticky these days,” says Katie Shilton, an associate professor at the University of Maryland focused on social-data science. It’s important to be transparent about who has access to personal information and what they can do with it, she says.

“Once a diagnosis is established, once you are labeled as something, that can affect algorithms in other places in your life,” Shilton says. She cites the misuse of personal data in the Cambridge Analytica scandal, in which the consulting firm collected information from Facebook to target political advertising. Without strong privacy policies, companies producing mental-health apps could similarly sell user data—and they may be particularly motivated to do so if an app is free to use.

Conversations about regulating mental-health apps have been ongoing for over a decade, but a Wild West–style lack of regulation persists in the United States, says Bennett of DePaul University. For example, there aren’t yet protections in place to keep insurance companies or employers from penalizing users based on data collected. “If there aren’t legal protections, somebody is going to take this technology and use it for nefarious purposes,” he says.

Some of these concerns may be mediated by confining all the analysis to a user’s phone, rather than collecting data in a central repository. But decisions about privacy policies and data structures are still up to individual app developers.

Leow and the BiAffect team are currently working on a new internal version of their app that incorporates natural-language processing and generative AI extensions to analyze users’ speech. The team is considering commercializing this new version in the future, but only following extensive work with industry partners to ensure strict privacy safeguards are in place. “I really see this as something that people could eventually use,” Leow says. But she acknowledges that researchers’ goals don’t always align with the desires of the people who might use these tools. “It is so important to think about what the users actually want.”

This article appears in the July 2024 print issue as “The Shrink in Your Pocket.”

A Barcelona-based startup called Inbrain Neuroelectronics has produced a novel brain implant made of graphene and is gearing up for its first in-human test this summer.

The technology is a type of brain-computer interface. BCIs have garnered interest because they record signals from the brain and transmit them to a computer for analysis. They have been used for medical diagnostics, as communication devices for people who can’t speak, and to control external equipment, including robotic limbs. But Inbrain intends to transform its BCI technology into a therapeutic tool for patients with neurological issues such as Parkinson’s disease.

Because Inbrain’s chip is made of graphene, the neural interface has some interesting properties, including the ability to be used to both record from and stimulate the brain. That bidirectionality comes from addressing a key problem with the metallic chips typically used in BCI technology: Faradaic reactions. Faradaic reactions are a particular type of electrochemical processes that occurs between a metal electrode and an electrolyte solution. As it so happens, neural tissue is largely composed of aqueous electrolytes. Over time, these Faradaic reactions reduce the effectiveness of the metallic chips.

That’s why Inbrain replaced the metals typically used in such chips with graphene, a material with great electrical conductivity. “Metals have Faraday reactions that actually make all the electrons interact with each other, degrading their effectiveness...for transmitting signals back to the brain,” said Carolina Aguilar, CEO and cofounder of Inbrain.

Because graphene is essentially carbon and not a metal, Aguilar says the chip can inject 200 times as much charge without creating a Faradic reaction. As a result, the material is stable over the millions of pulses of stimulation required of a therapeutic tool. While Inbrain is not yet testing the chip for brain stimulation, the company expects to reach that goal in due time.

The graphene-based chip is produced on a wafer using traditional semiconductor technology, according to Aguilar. At clean-room facilities, Inbrain fabricates a 10-micrometer-thick chip. The chip consists of what Aguilar terms “graphene dots” (not to be confused with graphene quantum dots) that range in size from 25 to 300 micrometers. “This micrometer scale allows us to get that unique resolution on the decoding of the signals from the brain, and also provides us with the micrometric stimulation or modulation of the brain,” added Aguilar.

Testing the Graphene-Based BCI

The first test of the platform in a human patient will soon be performed at the University of Manchester, in England, where it will serve as an interface during the resection of a brain tumor. When resecting a tumor, surgeons must ensure that they don’t damage areas like the brain’s language centers so the patient isn’t impaired after the surgery. “The chip is positioned during the tumor resection so that it can read, at a very high resolution, the signals that tell the surgeon where there is a tumor and where there is not a tumor,” says Aguilar. That should enable the surgeons to extract the tumor with micrometric precision while preserving functional areas like speech and cognition.

Aguilar added, “We have taken this approach for our first human test because it is a very reliable and quick path to prove the safety of graphene, but also demonstrate the potential of what it can do in comparison to metal technology that is used today.”

Aguilar stresses that the Inbrain team has already tested the graphene-based chip’s biocompatibility. “We have been working for the last three years in biocompatibility through various safety studies in large animals,” said Aguilar. “So now we can have these green lights to prove an additional level of safety with humans.”

While this test of the chip at Manchester is aimed at aiding in brain tumor surgery, the same technology could eventually be used to help Parkinson’s patients. Toward this aim, Inbrain’s system was granted Breakthrough Device Designation last September from the U.S. Food & Drug Administration as an adjunctive therapy for treating Parkinson’s disease. “For Parkinson’s treatment, we have been working on different preclinical studies that have shown reasonable proof of superiority versus current commercial technology in the [reduction] of Parkinson’s disease symptoms,” said Aguilar.

For treating Parkinson’s, Inbrain’s chip connects with the nigrostriatal pathway in the brain that is critical for movements. The chip will first decode the intention message from the brain that triggers a step or the lifting of the arm—something that a typical BCI can do. But Inbrain’s chip, with its micrometric precision, can also decode pathological biomarkers related to Parkinson’s symptoms, such as tremors, rigidity, and freezing of the gait.

By determining these biomarkers with great precision, Inbrain’s technology can determine how well a patient’s current drug regimen is working. In this first iteration of the Inbrain chip, it doesn’t treat the symptoms of Parkinson’s directly, but instead makes it possible to better target and reduce the amount of drugs that are used in treatment.

“Parkinson’s patients take huge amounts of drugs that have to be changed over time just to keep up with the growing resistance patients develop to the power of the drug,” said Aguilar. “We can reduce it at least 50 percent and hopefully in the future more as our devices become precise.”

UPDATE 31 OCTOBER 2024: No. 1 no longer. The would-have-been groundbreaking study published in Nature Communications by Amit Goyal et al. claiming the world’s highest-performing high-temperature superconducting wires yet has been retracted by the authors.

The journal’s editorial statement that now accompanies the paper says that after publication, an error in the calculation of the reported performance was identified. All of the study’s authors agreed with the retraction.

The researchers were first alerted to the issue by Evgeny Talantsev at the Mikheev Institute of Metal Physics in Ekaterinburg, Russia, and Jeffery Tallon at the Victoria University of Wellington in New Zealand. In a 2015 study, the two researchers had suggested upper limits for thin-film superconductors, and Tallon notes follow-up papers showed these limits held for more than 100 known superconductors. “The Goyal paper claimed current densities 2.5 times higher, so it was immediately obvious to us that there was a problem here,” he says.

Upon request, Goyal and his colleagues “very kindly agreed to release their raw data and did so quickly,” Tallon says. He and Talantsev discovered a mistake in the conversion of magnetization units.

“Most people who had been in the game for a long time would be fully conversant with the units conversion because the instruments all deliver magnetic data in [centimeter-gram-second] gaussian units, so they always have to be converted to [the International System of Units],” Tallon says. “It has always been a little tricky, but students are asked to take great care and check their numbers against other reports to see if they agree.”

In a statement, Goyal notes he and his colleagues “intend to continue to push the field forward” by continuing to explore ways to enhance wire performance using nanostructural modifications. —Charles Q. Choi

Original article from 17 August, 2024 follows:

Superconductors have for decades spurred dreams of extraordinary technological breakthroughs, but many practical applications for them have remained out of reach. Now a new study reveals what may be the world’s highest-performing high-temperature superconducting wires yet, ones that carry 50 percent as much current as the previous record-holder. Scientists add this advance was achieved without increased costs or complexity to how superconducting wires are currently made.

Superconductors conduct electricity with zero resistance. Classic superconductors work only at super-cold temperatures below 30 degrees Kelvin. In contrast, high-temperature superconductors can operate at temperatures above 77 K, which means they can be cooled to superconductivity using comparatively inexpensive and less burdensome cryogenics built around liquid nitrogen coolant.

Regular electrical conductors all resist electron flow to some degree, resulting in wasted energy. The fact that superconductors conduct electricity without dissipating energy has long lead to dreams of significantly more efficient power grids. In addition, the way in which rivers of electric currents course through them means superconductors can serve as powerful electromagnets, for applications such as maglev trains, better MRI scanners for medicine, doubling the amount of power generated from wind turbines, and nuclear fusion power plants.

“Today, companies around the world are fabricating kilometer-long, high-temperature superconductor wires,” says Amit Goyal, SUNY Distinguished Professor and SUNY Empire Innovation Professor at the University of Buffalo in New York.

However, many large-scale applications for superconductors may stay fantasies until researchers can find a way to fabricate high-temperature superconducting wires in a more cost-effective manner.

In the new research, scientists have created wires that have set new records for the amount of current they can carry at temperatures ranging from 5 K to 77 K. Moreover, fabrication of the new wires requires processes no more complex or costly than those currently used to make high-temperature superconducting wires.

“The performance we have reported in 0.2-micron-thick wires is similar to wires almost 10 times thicker,” Goyal says.

At 4.2 K, the new wires carried 190 million amps per square centimeter without any externally applied magnetic field. This is some 50 percent better than results reported in 2022 and a full 100 percent better than ones detailed in 2021, Goyal and his colleagues note. At 20 K and under an externally applied magnetic field of 20 tesla—the kind of conditions envisioned for fusion applications—the new wires may carry about 9.3 million amps per square centimeter, roughly 5 times greater than present-day commercial high-temperature superconductor wires, they add.

Another factor key to the success of commercial high-temperature superconductor wires is pinning force—the ability to keep magnetic vortices pinned in place within the superconductors that could otherwise interfere with electron flow. (So in that sense higher pinning force values are better here—more conducive to the range of applications expected for such high-capacity, high-temperature superconductors.) The new wires showed record-setting pinning forces of more than 6.4 trillion newtons at 4.3 K under a 7 tesla magnetic field. This is more than twice as much as results previously reported in 2022.

The new wires are based on rare-earth barium copper oxide (REBCO). The wires use nanometer-sized columns of insulating, non-superconducting barium zirconate at nanometer-scale spacings within the superconductor that can help pin down magnetic vortices, allowing for higher supercurrents.

The researchers made these gains after a few years spent optimizing deposition processes, Goyal says. “We feel that high-temperature superconductor wire performance can still be significantly improved,” he adds. “We have several paths to get to better performance and will continue to explore these routes.”

Based on these results, high-temperature superconductor wire manufacturers “will hopefully further optimize their deposition conditions to improve the performance of their wires,” Goyal says. “Some companies may be able to do this in a short time.”

The hope is that superconductor companies will be able to significantly improve performance without too many changes to present-day manufacturing processes. “If high-temperature superconductor wire manufacturers can even just double the performance of commercial high-temperature superconductor wires while keeping capital equipment costs the same, it could make a transformative impact to the large-scale applications of superconductors,” Goyal says.

The scientists detailed their findings on 7 August in the journal Nature Communications.

This story was updated on 19 August 2024 to correct Amit Goyal’s title and affiliation.

Neuralink’s visual prosthesis Blindsight has been designated a breakthrough device by the U.S. Food and Drug Administration, which potentially sets the technology on a fast track to approval.

In confirming the news, an FDA spokesperson emphasized that the designation does not mean that Blindsight is yet considered safe or effective. Technologies in the program have potential to improve the current standard of care and are novel compared to what’s available on the market, but the devices still have to go through full clinical trials before seeking FDA approval.

Still, the announcement is a sign that Neuralink is moving closer to testing Blindsight in human patients. The company is recruiting people with vision loss for studies in the United States, Canada, and the United Kingdom.

Visual prostheses work by capturing visual information with a video camera, typically attached to glasses or a headset. Then a processor converts the data to an electrical signal that can be relayed to the nervous system. Retinal implants have been a common approach, with electrodes feeding the signal to nerves in the retina, at the back of the eye, from where it travels on to the brain. But Blindsight uses a brain implant to send the signal directly to neurons in the visual cortex.

In recent years, other companies developing artificial vision prosthetics have reached clinical research trials or beyond, only to struggle financially, leaving patients without support. Some of these technologies live on with new backing: Second Sight’s Orion cortical implant project is now in a clinical trial with Cortigent, and Pixium Vision’s Prima system is now owned by Science, with ex-Neuralink founder Max Hodak at the helm. No company has yet commercialized a visual prosthetic that uses a brain implant.

Elon Musk’s Claims About Blindsight

Very little information about Blindsight is publicly available. As of this writing, there is no official Blindsight page on the Neuralink website, and Neuralink did not respond to requests for comment. It’s also unclear how exactly Blindsight relates to a brain-computer interface that Neuralink has already implanted in two people with paralysis, who use their devices to control computer cursors.

Experts who spoke with IEEE Spectrum felt that, if judged against the strong claims made by Neuralink’s billionaire co-founder Elon Musk, Blindsight will almost certainly disappoint. However, some were still open to the possibility that Neuralink could successfully bring a device to market that can help people with vision loss, albeit with less dramatic effects on their sense of sight. While Musk’s personal fortune could help Blindsight weather difficulties that would end other projects, experts did not feel it was a guarantee of success.

After Neuralink announced on X (formerly Twitter) that Blindsight had received the breakthrough device designation, Musk wrote:

The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see.

Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.

To set expectations correctly, the vision will be at first be [sic] low resolution, like Atari graphics, but eventually it has the potential be [sic] better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths, like Geordi La Forge.

Musk included a picture of La Forge, a character from the science-fiction franchise Star Trek who wears a vision-enhancing visor.

Experts Puncture the Blindsight Hype

“[Musk] will build the best cortical implant we can build with current technology. It will not produce anything like normal vision. [Yet] it might produce vision that can transform the lives of blind people,” said Ione Fine, a computational neuroscientist at the University of Washington, who has written about the potential limitations of cortical implants, given the complexity of the human visual system. Fine previously worked for the company Second Sight.

A successful visual prosthetic might more realistically be thought of as assistive technology than a cure for blindness. “At best, we’re talking about something that’s augmentative to a cane and a guide dog; not something that replaces a cane and a guide dog,” said Philip Troyk, a biomedical engineer at the Illinois Institute of Technology.

Restoring natural vision is beyond the reach of today’s technology. But among Musks recent claims, Troyk says that a form of infrared sensing is plausible and has already been tested with one of his patients, who used it for help locating people within a room. That patient has a 400-electrode device implanted in the visual cortex as part of a collaborative research effort called the Intracortical Visual Prosthesis Project (ICVP). By comparison, Blindsight may have more than 1,000 electrodes, if it’s a similar device to Neuralink’s brain-computer interface.

Experts say they’d like more information about Neuralink’s visual prosthetic. “I’m leery about the fact that they are very superficial in their description of the devices,” said Gislin Dagnelie, a vision scientist at Johns Hopkins University who has been involved in multiple clinical trials for vision prosthetics, including a Second Sight retinal implant, and who is currently collaborating on the ICVP. “There’s no clear evaluation or pre-clinical work that has been published,” says Dagnelie. “It’s all based on: ‘Trust us, we’re Neuralink.’”

In the short term, too much hype could mislead clinical trial participants. It could also degrade interest in small but meaningful advancements in visual prosthetics. “Some of the [Neuralink] technology is exciting, and has potential,” said Troyk. “The way the messaging is being done detracts from that, potentially.”

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.

The post ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer appeared first on MedCity News.

Top challenges impacting specialty pharmacy outcomes, and how health systems may achieve efficiencies and enhance performance for optimal outcomes.

The post An Integrated Approach to Optimizing Specialty Pharmacy and Accelerating Performance appeared first on MedCity News.

By adopting a contingent workforce model and investing in the right data tools to power better informed decision-making and talent strategy, healthcare organizations can begin to address staffing challenges and turn their talent goals into reality. 

The post Closing Staffing Gaps in Healthcare by Utilizing Diverse Pipelines of Contingent Talent appeared first on MedCity News.

As radiopharmaceuticals enter a new phase, industry leaders must rethink external services and internal capabilities to master the complexities of delivering advanced therapies.

The post Unlocking the Future of Radioligand Therapy: From Discovery to Delivering at Scale appeared first on MedCity News.

Neurogene’s Rett syndrome gene therapy has preliminary data supporting safety and efficacy of the one-time treatment. But a late-breaking report of a serious complication in a patient who received the high dose sent shares of the biotech downward.

The post Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors appeared first on MedCity News.

The Pew Charitable Trusts today commended Michigan Governor Gretchen Whitmer (D), state Senate Majority Leader Mike Shirkey (R), and Lee Chatfield (R)—whose term as state House Speaker ended last month—for passing and signing a bipartisan package of bills aimed at protecting public safety while reducing the number of people in county jails.

2020 was a difficult year for dental providers as the COVID-19 pandemic swept across the country. When stay-at-home orders went into effect in the spring, dental offices closed their doors to all but emergency patients.

In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications related to cancer immunotherapy and is set to launch in July 2016. According to the USPTO, this initiative: aims to cut the time it takes to...… Continue Reading

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1]  The en banc opinion...… Continue Reading

 This paper presents the essential information that you need to get started with ODS Graphics in SAS 9.4.

You have just a few more days to submit your paper proposal for the 2017 SAS® Global Forum in Orlando on April 2–5. The call for papers ends and registration begins October 3.

Singapore's food culture is legendary, with staples such as chicken rice, bak chor mee, laksa, and roti prata feeding generations of locals and visitors alike. But there's one thing they all have in common — carbs! In carb-crazy Singapore, sticking to a keto diet might seem like a gone case and borderline sacrilegious, but trust me, it's doable. I've been through it, and I'm here to share my tips on how you can enjoy our local food scene while staying keto. What is keto? In case you blur about what a ketogenic (keto) diet is, it's all about cutting carbs and eating more fat. Yup, you read that right — more fat. Sounds shiok, right? The goal is to push your body into ketosis, where instead of burning carbs for energy, it burns fat. Hello, weight loss! Beyond that, keto helps you avoid those pesky post-meal sugar crashes — you know, the ones that make want to toh after a heavy meal. My keto experience I first tried keto as a teen, thinking it was just about cutting out rice, bread, and noodles. Wrong! Keto is stricter than that. To stay in ketosis, you've got to limit your carbs to just 20-50g a day.

Life can sometimes feel like a never-ending cycle of stress and decisions. That's usually my weekdays in a nutshell: chasing deadlines, making tough calls, and hopping between meetings. When your brain feels like it's on overdrive, it's time to hit pause. Engaging in some therapeutic activities can give your mind the breather it desperately needs. The good news? They don't have to be complicated or time-consuming. Here are some that can work wonders for your mental clarity and overall well-being. Step outside for a walk Walking is one of the simplest ways to clear your mind. It's amazing what a little fresh air at your nearby PCN can do. Just stepping outside and getting those legs moving can shift your perspective in a matter of minutes — and burn a few calories too! Disconnect from your phone and enjoy the sights and sounds of the great outdoors. I find that a 30-min walk and a change of environment works wonders for me, helping me rationally dissect my worries, such as my crushing feelings of inadequacy at work.

Monday blues were non-existent at the Singapore Indoor Stadium yesterday (Nov 11) as fans of Blackpink's Lisa strolled into the venue in their Y2K-style outfits inspired by the Thai singer's Rockstar music video. Singapore was the first stop for the 27-year-old's first solo fan-meet tour and needless to say, the excitement could be felt, and heard. Once the lights turned off and Lisa appeared, the screams were deafening. The show started with a bang, fittingly with her self-titled hit song Lalisa. Usually at fan-meets of K-pop idols, the special effects are kept to a minimum unlike concerts. PHOTO: UnUsUaL Entertainment But at Lisa's, the performances were elevated with bursts of pyrotechnics and visual effects. After the first song, she sat down for a few interactive segments. During Welcome Lisa, she tried local delicacies like kaya toast and chicken rice.

WASHINGTON — Donald Trump is expected to take a slew of executive actions on his first day as president to ramp up immigration enforcement and roll back signature Biden legal entry programs, a sweeping effort that will be led by incoming "border czar" Tom Homan and other Republican immigration hardliners, three sources familiar with the matter told Reuters. The executive actions would give federal immigration officers more latitude to arrest people with no criminal records, surge troops to the US-Mexico border and restart construction of the border wall, the sources said. Homan, who served as acting director of US Immigration and Customs Enforcement from 2017-2018 under Trump, will bring a deep understanding of the US immigration system after a four-decade career that took him from a frontline Border Patrol agent to head of the agency that arrests and deports immigrants in the US illegally.

SEOUL - South Korea's military said it will hold a three-day joint exercise with the United States and Japan starting on Wednesday (Nov 13), featuring fighter jets and marine patrol aircraft as well as the US nuclear-powered aircraft carrier USS George Washington. The Freedom Edge exercise is a response to what the South Korean military said were threats from North Korea, which recently conducted an intercontinental ballistic missile test, drawing condemnation from Seoul, Tokyo and Washington. It also comes as the US State Department said North Korean troops have started engaging in combat operations in Russia's war with Ukraine. The exercise will include South Korean and Japanese fighter jets and maritime patrol aircraft, as well as the USS George Washington, Seoul's Joint Chiefs of Staff (JCS) said in a statement. The trilateral exercise follows a first round held earlier this year after the leaders of the three countries agreed at a summit in 2023 to hold annual training drills. Pyongyang has long condemned joint drills between South Korea and the United States, calling them a rehearsal for invasion.

SINGAPORE – The police are investigating deepfake nude photos of Singapore Sports School (SSP) students that were created and spread by other students. In response to queries from The Straits Times, school principal Ong Kim Soon said SSP is “aware of the incident involving the creation and sharing of deepfake photos by our student-athletes”. “The school does not condone such harmful behaviour,” he said, adding that it has launched an investigation and lodged a police report. The police, in response to queries from ST, confirmed that a report was lodged and investigations are ongoing. A reader who identified himself as a parent of a victim had alerted ST in an e-mail on Nov 12 about the deepfake nude images that were being circulated. “Many parents of affected female students in Singapore Sports School are making police reports about deepfake nude photos of their daughters generated by male students from the school,” the parent said. When contacted, the parent said that female teachers were also targeted, and that the school has offered affected students counselling.

JAKARTA — Indonesia said on Monday (Nov 11) it does not recognise China's claims over the South China Sea despite signing a joint maritime development deal with Beijing, as some analysts warned the agreement risked compromising the country's sovereign rights. Beijing has long clashed with its Southeast Asian neighbours over territory in the South China Sea, which it claims sovereignty over in almost its entirety via a "nine-dash line" on its maps that cuts into the exclusive economic zones (EEZ) of several countries. Joint agreements with China in the strategic waterway have for years been sensitive, with some claimant states wary of entering into deals they fear could be interpreted as legitimising Beijing's vast claims. An arbitral tribunal in 2016 said the Chinese claim, based on its old maps, has no basis under international law, a decision China refuses to recognise. A joint statement issued at the weekend during Indonesian President Prabowo Subianto's visit to Beijing mentioned the two countries had "reached important common understanding on joint development in areas of overlapping claims".

In July 2024, internet personality Bobby Saputra posted a video of himself living it up at what appeared to be the star-studded, ultra-lavish wedding of Radhika Merchant and Anant Ambani, the youngest child of Indian billionaire and Asia's richest man, Mukesh Ambani. The video featured clips of Saputra dancing, feasting and soaking up the "completely crazy" celebrations. He gushes in the voiceover: "It was like watching a Bollywood production." The video quickly went viral, racking up 6.6 million views on Instagram, 5.1 million on TikTok, and another 2.2 million on YouTube. Thousands left comments, including some celebrities who claimed they spotted him there. Except… he never set foot in the party. As it turns out, he had pieced together clips from a wedding he attended a few months prior — complete with him in full Indian attire, dancing with friends — and spliced in shots from the Ambani wedding that he found online. The result? Social media magic.

KOLKATA — A court in the eastern state of West Bengal began the trial on Monday (Nov 11) of a police volunteer accused of raping and murdering a doctor at a government hospital in August, a case that sparked outrage over the lack of safety for women in India. The woman's body was found in a classroom at the R.G. Kar Medical College and Hospital in the state capital Kolkata on Aug 9, the federal police said. They also said they had arrested a police volunteer, Sanjay Roy, for the crime.

I have had a long-standing interest in South Africa, and in 1995 briefly contemplated moving there to work. The country had just had its first multi-racial election, and the great Nelson Mandela had been elected President. I was deeply curious to see, at first-hand, what the land and its people would make of their hard [...]

In one of the first books I read, the writer had posed the question: ‘Who was the greatest all-rounder in the history of cricket?’, before providing this answer: ‘He was a left-arm bowler and a right-hand batsman, who was born in the village of Kirkheaton’. I now forget the title of the book, but remember [...]

I saw Christopher Nolan’s Oppenheimer earlier this week. The main character in the film, J. Robert Oppenheimer, was a physicist whose family was Jewish, and who worked for many years at the Institute of Advanced Studies in Princeton. In these respects he was akin to Albert Einstein, who makes several appearances in the movie itself. [...]

My first editor, Rukun Advani, once described himself as ‘a composite hybrid of the Indian and the Anglo-European’, who sought to reconcile ‘within himself those varying cultural influences which chauvinistic nationalists could only see as contradictions.’ This self-characterization I might avow as my own. One mark of the Anglo-European in me is that, unlike members [...]

The climate crisis has brought human ill-treatment of nature forcibly to our attention, though of course India’s environmental problems are by no means the product of global warming alone. The staggeringly high rates of air pollution in the cities of Northern India, the ongoing devastation of the Himalaya by carelessly planned roads and dams, the [...]

In recent years, a stream of books and articles have appeared seeking to analyse the theory and practice of Hindutva. They have sought to alternatively explain, critique, or justify the rising influence of the BJP and the RSS. Some have focused on organizational questions, on the building of social networks on the ground and how [...]

The Indian socialist tradition is now moribund, but there was a time when it had a profound and mostly salutary influence on politics and society. Yet few people now know of its past vigour and dynamism. The Congress, the Communists, the regional parties, the Ambedkarites, and (especially in recent years) the Jana Sangh and the [...]

An Indian I greatly admire is the social worker and pioneer of the Chipko movement, Chandi Prasad Bhatt. My first meeting with him, when I was in my early twenties, had an transformative impact on my life. I have met him many times since; each encounter providing fresh insights into the moral, political and environmental [...]

Last month I spent several stimulating days in Mizoram. I had some knowledge of the state’s political history, met numerous Mizos in the course of my life, but never visited the state before. I flew first to Guwahati, where I caught up with some old friends, gloried in my sightings of the Brahmaputra, and spoke [...]

In about a week’s time we shall mark the sixtieth anniversary of the death of India’s first Prime Minister, Jawaharlal Nehru. This column focuses on one key aspect of Nehru’s political career, his collaboration with Vallabhbhai Patel. These two men worked shoulder-to-shoulder during the freedom struggle and in the early years of Independence. They had [...]

Pakistan's National Security Adviser to the Prime Minister, Mahmud Ali Durrani, on the 2008 bombing of the Indian Embassy in Kabul