Objective responses seen in 29% of patients with locally advanced basal cell carcinoma (BCC)

US-based drugmaker Mylan and partner India-based biologicals specialist Biocon have announced the launch of their pegfilgrastim biosimilar, Fulphila, in Australia. The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

An online educational course has been published by Medscape in collaboration with the Association of Diabetes Care & Education Specialist.

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 28 April 2020 the launch of their pegfilgrastim biosimilar, Fulphila, in Canada. This is the second biosimilar from the pair to be launched in the country.

The likelihood of an effective vaccine being developed and scaled up in less than 12 months is unrealistic, suggests GlobalData analyst.

Sanofiâs insulin aspart biosimilar receives positive opinion from the EMAâs CHMP.

The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading →

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading →

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

Posted by Roger Bate A new research paper in Health Affairs suggests that the use of compulsory licenses may not lead to cost savings, when compared with voluntary negotiations. Compulsory licensing (CL) allows low-income countries to break innovator patents and accelerate cheap alternatives, either produced locally or imported. In some cases the price cuts of CL can be substantial, notably in Thailand, where key medicines dropped to about 10% of the original price. But researchers (in [...]

Posted by Roger Bate My op-ed with Dinesh Thakur in The Hill today highlights the recent recommendation by Europe's chief drug regulator to suspend 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization. We urge U.S. Federal regulators to follow Europe’s lead and move to rescind market approval for these drugs while conducting their own investigation. You can read the op-ed here [...]

Posted by Roger BateThe World Health Organization just posted its new report on inferior medicines (http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_33-en.pdf). It is called the member state mechanism (MSM) report on Substandard/spurious/falsely-labelled/falsified/counterfeit medical products - SSFFC for short. This report is the culmination of multiple meetings of health bureaucrats to finalize how to combat inferior medicines. Or rather that is what one hoped for when the SSFFC process began [...]

by Lucas Waldron and Nadia Sussman

Many people across the country experienced COVID-19 symptoms but could not get a test to confirm if they actually had the virus. Now some are looking to a different kind of coronavirus test for answers.

Antibody tests are meant to recognize a past infection. Many of these have hit the market in recent weeks and are being offered at local clinics. Officials have touted the tests as crucial for reopening the economy and developing public health strategies to contain the virus.

But there are still questions about how accurate they are. And even with a very good test, it's possible to test positive for antibodies even when you don't actually have them. Watch our new video to learn why.

by Derek Willis

In an April report that warns of the risks of fraud in mail-in voting, a conservative legal group significantly inflated a key statistic, a ProPublica analysis found. The Public Interest Legal Foundation reported that more than 1 million ballots sent out to voters in 2018 were returned as undeliverable. Taken at face value, that would represent a 91% increase over the number of undeliverable mail ballots in 2016, a sign that a vote-by-mail system would be a “catastrophe” for elections, the group argued.

However, after ProPublica provided evidence to PILF that it had in fact doubled the official government numbers, the organization corrected its figure. The number of undeliverable mail ballots dropped slightly from 2016 to 2018.

The PILF report said that one in five mail ballots issued between 2012 and 2018, a total of 28.3 million, were not returned by voters and were “missing,” which, according to the organization, creates an opportunity for fraud. In a May 1 tweet that included a link to coverage of the report, President Donald Trump wrote: “Don’t allow RIGGED ELECTIONS.”

PILF regularly sues state and local election officials to force them to purge some voters from registration rolls, including those it claims have duplicate registrations from another state or who are dead. It is headed by J. Christian Adams, a former Justice Department attorney who was a member of the Trump administration’s disbanded commission on election integrity.

The report describes as “missing” all mail ballots that were delivered to a valid address but not returned to be counted. In a statement accompanying the report, Adams said that unaccounted-for ballots “represent 28 million opportunities for someone to cheat.” In particular, the organization argues that the number of unreturned ballots would grow if more states adopt voting by mail.

Experts who study voting and use the same data PILF used in the report, which is from the Election Administration and Voting Survey produced by the federal Election Assistance Commission, say that it’s wrong to describe unreturned ballots as missing.

“Election officials ‘know’ what happened to those ballots,” said Paul Gronke, a professor at Reed College, who is the director of the Early Voting Information Center, a research group based there. “They were received by eligible citizens and not filled out. Where are they now? Most likely, in landfills,” Gronke said by email.

A recent RealClear Politics article based on the PILF report suggested that an increase in voting by mail this year could make the kind of fraud uncovered in North Carolina’s 9th Congressional District in 2018 more likely. In that case, a political consultant to a Republican candidate was indicted on charges of absentee ballot fraud for overseeing a paid ballot collection operation. “The potential to affect elections by chasing down unused mail-in ballots and make sure they get counted — using methods that may or may not be legal — is great,” the article argues.

PILF’s report was mentioned in other news outlets including the Grand Junction Sentinel in Colorado, “PBS NewsHour” and the New York Post. The Washington Times repeated the inaccurate claim of 1 million undeliverable mail ballots.

In a statement, the National Vote at Home Institute, an advocacy group, challenged the characterization of the 28.3 million ballots as missing. Of those ballots, 12 million were mailed by election officials in Colorado, Oregon and Washington, which by law send a mail-in ballot to every registered voter, roughly 30% of which are not returned for any given election. “Conflating voters choosing not to cast their ballots with ‘missing’ ballots is a fundamental flaw,” the statement reads.

In an interview, Logan Churchwell, the communications director for PILF, acknowledged the error in the number of undelivered ballots, but defended the report’s conclusions, saying that it showed potential vulnerabilities in the voting system. “Election officials send these ballots out in the mail, and for them to say ‘I have no idea what happened after that’ speaks more to the investments they haven’t made to track them,” he said in a telephone interview.

But 36 states have adopted processes where voters and local officials can track the status of mail ballots through delivery, much like they can track packages delivered to a home. Churchwell said there are other explanations why mail ballots are not returned and that state and local election officials could report more information about the status of mail ballots. “If you know a ballot got to a house, you can credibly say that ballot’s status is not unknown,” he said.

The EAVS data has been published after every general election since 2004, although not every local jurisdiction provides complete responses to its questions.

In the data, election officials are asked to provide the number of mail ballots sent to voters, the number returned to be counted and the number of ballots returned as undeliverable by the U.S. Postal Service, which provides specific ballot-tracking services. The survey also asks for the number of ballots that are turned in or invalidated by voters who chose to cast their ballots in person. It asks officials to report the number of ballots that do not fit into any of those categories, or are “otherwise unable to be tracked by your office.”

Gronke described the last category as “a placeholder for elections officials to put numbers so that the whole column adds up,” and said that there was no evidence to support calling those ballots a pathway to large-scale voter fraud.

Numerous academic studies have shown that cases of voter fraud are extremely rare, although they do occur, and that fraud in mail voting seems to occur more often than with in-person voting.

by Alice Wilder, WNYC

Presidential lawyer and former New York City Mayor Rudy Giuliani has largely fallen out of the public eye since his starring role in President Donald Trump’s impeachment. But Giuliani hasn’t gone silent.

Instead, he’s in his home, doing a call-in radio show and a podcast — “Common Sense” — during which he has repeatedly gone on bigoted rants about China and its government.

“They have no morals,” he said on his April 28 radio show. “They’re amoral in the sense that human life means something in Western civilization, it means a lot. Human life doesn’t mean the same thing to them.”

Giuliani has also speculated that the spread of the coronavirus may be a plot by the Chinese government.

For example, Giuliani has raised the possibility that China purposely released the virus from a biological lab in Wuhan. “We have to say accidentally,” Giuliani said in a recent radio broadcast. “But I don’t think as responsible investigators we can rule out that it wasn’t done deliberately.”

Experts say there’s no public evidence the virus came from the lab. Amid a reported White House push, U.S. intelligence agencies have said they are investigating the origins of the virus.

Giuliani is also fixated on the idea that the Chinese government sent sick people overseas. In an April 27 episode of his podcast, he said that China allowed “over a million people from Wuhan travel to us, to the United States, to England to France to Italy to Germany.” He added, “I hope the people there have the same reaction we have to the value of human life and the loss of human life.”

“When they found out about this terrible virus that escaped, assuming they didn’t do it on purpose,” Giuliani said a day later on his radio show, “they were going to make sure the West suffered as much if not more than they did and jumped on top of an opportunity, it’s not a big assumption to make. And there isn’t a contrary explanation.”

The New York Times found that thousands, not millions, of people flew internationally out of Wuhan.

Asked about his comments, Giuliani did not respond.

The comments by Giuliani have come as discrimination against Asian Americans has spiked. And they reinforce the White House’s emerging push to blame China for the pandemic.

Giuliani has said he’s spoken to the president a number of times about the coronavirus. Two days after Giuliani said he was sure the virus came from the Wuhan lab, Trump said he has evidence of the same. (The president declined to give the evidence, saying it’s secret.)

Giuliani appears to have found a receptive wider audience too. An advertising executive at 77 WABC, which airs Giuliani’s radio show, said “feedback has been amazing” and online listening has “skyrocketed.”

The station’s parent company, Red Apple Media, did not respond to a request for comment.

In an April 23 radio show, Giuliani interviewed Gordon Chang, a conservative pundit who frequently predicts the collapse of the Chinese government. Chang said if China released the virus accidentally — for which, again, there’s no evidence — it then decided to create a global pandemic. “I think what Xi Jinping did was he decided he was going to spread the virus so that he would level the playing field so that China would not be in such a hole,” Chang said, referring to China’s president.

“Wow,” Giuliani responded. “So he saw an opportunity, if that theory is correct, and it wasn’t a bioweapon to start with, he saw an opportunity that was sort of accidentally presented to him, and then he took advantage of it. It was opportunistic.”

Chang acknowledged, “We can’t know what was in Xi Jinping’s mind for sure.” But then he went on, “It looks more like they were deliberate and malicious and that means Mr. Mayor ... this is a crime against all of humanity.”

Giuliani ended the interview by inviting Chang to be a guest on his other show, the podcast.

Giuliani has also said he’d use his access to help guests on his show move ahead with exploratory treatments. Talking with one pharmaceutical executive on his show in late March, Giuliani told his guest, “I’ll use whatever my yelling and screaming can do to do it faster, to help you.”

As the Times reported, the executive’s company received initial trial approval from the Food and Drug Administration soon after. (The FDA has said the application was subject to “internal scientific review.” And Giuliani has said he has no business connection to the company.)

“I don’t lobby the government,” Giuliani emailed in response to a request for comment. “I do hope, however, that they and others are successful.”

Giuliani appears to have strong feelings about the government’s process for approving drugs.

In an April 23 broadcast, Mark, a pharmacist from New Jersey, called in to report on his “informal study” of the patients who have used a drug cocktail that includes hydroxychloroquine — the anti-malaria drug that Trump long has touted.

Giuliani was excited when Mark reported that none of his patients had been hospitalized: “Why doesn’t this count with all these geniuses in Washington? The double blind study and the triple blind study and this study and that study, we don’t have time for that, we’ve got to go to people like Mark in New Jersey!”

In fact, the FDA has warned against widespread use of the drug, noting that it can cause heart problems.

The discussions with his listeners, though, often come back to China.

One caller to Giuliani’s radio show, identifying himself as “George from Bay Ridge,” went on a rant against Chinese people, likening them to serial killers with “no conscience” who are attempting to take over businesses all over the world.

Giuliani responded, “George, I’ve been getting complaints about this for a long time.” He added: “It almost reminds me of the Mafia. You know, they say, if you do business with America it’s one thing. If you do business with China you don’t realize, all of a sudden you start owing them too much and they believe they own you.”

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by ProPublica

The Pulitzer Board announced Monday that two series published by ProPublica were awarded Pulitzer Prizes. “Lawless,” a ProPublica Local Reporting Network project by the Anchorage Daily News that revealed how indigenous people in Alaska are denied public safety services, was awarded the prize for public service. “Disaster in the Pacific,” an investigation on the staggering leadership failures that led to deadly accidents in the Navy and Marines, won a national reporting prize. The two designations are ProPublica’s 6th Pulitzer win in 12 years and the first Pulitzer awarded to a Local Reporting Network partner.

Led by Daily News reporter Kyle Hopkins, “Lawless” was the first comprehensive investigation to lay bare Alaska’s failing, two-tiered justice system in which Native villages are denied access to first responders. In much of rural Alaska, villages can only be reached by plane, and calling 911 to report an emergency often means waiting hours or days for help to arrive.

The series evolved from a string of stories that Hopkins reported in 2018 for the Daily News, recounting horrific incidents of sexual assault in Alaska — which has the nation’s highest rate of sexual violence — and policing failures that have allowed offenders to continue the abuse with impunity. To fully investigate issues of lawlessness and sexual assault in the most remote communities in the U.S., the Daily News applied to participate in ProPublica’s Local Reporting Network. The program partners with newsrooms across the country, paying the salary and a stipend for benefits for local reporters who spend a year tackling big investigative stories that are crucial to their communities. Participating reporters work with a ProPublica senior editor and receive support, including from ProPublica’s data, research and engagement teams.

The collaboration’s first story, based on more than 750 public records requests and interviews, found that one in three rural Alaska communities has no local law enforcement of any kind. These indigenous communities are also among the country’s most vulnerable, with the highest rates of sexual assault, suicide and domestic violence. The series’ second major installment found that dozens of Alaska communities, desperate for police of any kind, hired officers convicted of felonies, domestic violence, assault and other offenses that would make them ineligible to work in law enforcement or even as security guards anywhere else in the country.

Next, Hopkins revealed how the state’s 40-year-old Village Public Safety Officer Program, designed to recruit villagers to work as life-saving first responders, has failed by every measure. Alaska had quietly denied funding for basic recruitment and equipment costs for these unarmed village officers while publicly claiming to prioritize public safety spending. “Lawless” also exposed how the Alaska State Troopers agency, created to protect Alaska Native villages, instead patrols mostly white suburbs surrounding cities on the road system like Wasilla. The series ended with a list of six practical solutions to Alaska’s law enforcement crisis, based on interviews with experts, village leaders, the Alaska congressional delegation and sexual assault survivors.

The Daily News and ProPublica faced a number of challenges in reporting the series. The first: No one knew which remote Alaska villages had police officers of any kind. So they built the first-ever statewide policing database by drawing on payroll, arrest and hiring records from communities spread across the state. They also contacted every village city government, sovereign tribal administrator and Alaska Native corporation in the state — more than 600 organizations.

The vastness of the state and the fact that 80% of communities aren’t on the road system posed another challenge. Journalists flew hundreds of miles, sleeping on the floors of schoolhouse libraries and riding in sleds and on snowmobiles. To aid the reporting, they also held a community meeting in Kotzebue, Alaska, where a 10-year-old girl had been raped and murdered in 2018, providing residents, advocates, tribal leaders and law enforcement their first chance for a public discussion on sexual violence. Throughout the year the reporters spoke to more than 300 people across the state.

Following publication of the first major story, U.S. Attorney General William Barr visited the state and declared the lack of law enforcement in rural Alaska to be a federal emergency. The declaration led the Department of Justice to promise more than $52 million in federal funding for public safety in Alaska villages. The U.S. Attorney’s Office in Anchorage announced the hiring of additional rural prosecutors, while Gov. Mike Dunleavy said the state will post 15 additional state troopers in rural Alaska. In addition, the Alaska Police Standards Council has proposed changing state regulations that govern the hiring and screening of village police officers, and Alaska legislators proposed legislation that would increase pay for VPSOs and overhaul funding of the program.

The Daily News’ Loren Holmes, Bill Roth, Marc Lester, David Hulen, Anne Raup, Vicky Ho, Alex Demarban, Jeff Parrott, Michelle Theriault Boots, Tess Williams, Tegan Hanlon, Zaz Hollander, Annie Zak, Shady Grove Oliver and Kevin Powell, as well as ProPublica’s Charles Ornstein, Adriana Gallardo, Alex Mierjeski, Beena Raghavendran, Nadia Sussman, Lylla Younes, Agnel Philip, Setareh Baig and David Sleight also contributed to the series.

“The ProPublica Local Reporting Network was started to give local newsrooms across America the resources and support they need to execute investigative journalism that digs deep and holds power to account,” Ornstein, a ProPublica deputy managing editor, said. “This powerful collaboration with the Anchorage Daily News investigation does exactly that, going far beyond reporting on isolated incidents to provide meticulous research and context on how the justice system has failed Alaska’s most remote and vulnerable communities. Most importantly, it has been a force for real change.”

In their “Disaster in the Pacific” series, ProPublica reporters T. Christian Miller, Megan Rose and Robert Faturechi centered on three deadly accidents in the Navy and Marines in 2017 and 2018. They exposed America’s vaunted 7th Fleet as being in crisis with broken ships and planes, poor training for and multiple warnings ignored by its commanders. The costs: 17 dead sailors in crashes involving Navy warships, and six Marines killed in a training accident.

The back-to-back accidents in 2017 and 2018 gained initial attention from Congress and the national media, but they had been told an incomplete, misleading and dangerous story of half-truths and cover-ups. ProPublica’s series provided the first full accounting of culpability, tracing responsibility to the highest uniformed and civilian ranks of the Navy. The reporting team spent 18 months on the investigation, obtaining more than 13,000 pages of confidential Navy records and interviewing hundreds of officials up and down the chain-of-command.

The first article in the series, “Fight the Ship,” reconstructed a 2017 crash involving the USS Fitzgerald, one of the deadliest accidents in the history of the Navy. The story showed that the accident was entirely preventable, and that the Navy’s senior leadership had endangered the warship by sending a shorthanded and undertrained crew to sea with outdated and poorly maintained equipment. To show readers what happened, ProPublica hired designer Xaquín G.V. Working with investigations producer Lucas Waldron, Xaquín used geodata on the ships’ locations, mapped the path of each vessel and created a graphic that simulated the crash, down to the moment the Fitzgerald was sent spinning out of control, rotating 360 degrees. The team also collected radar images, ship blueprints, hand-drawn images made by surviving sailors and video taken inside the ship, which allowed them to portray the disaster from the perspective of the sailors onboard.

A second story, “Years of Warnings, Then Death and Disaster,” detailed how the fatal crash of the USS Fitzgerald, and of the USS McCain weeks later, were the result of a congressional gutting of the Navy and the Navy’s prioritization of building new ships. Top Navy officials gave urgent, repeated warnings to Navy Secretary Ray Mabus about the deadly risks facing its fleet, including being short of sailors, sailors poorly trained and worked to exhaustion, warships physically coming apart, and ships routinely failing tests to see if they were prepared to handle warfighting duties. They were ignored, told to be quiet or even ordered to resign.

Another story captured the Marine Corps multiple failures that were responsible for the deaths of six men in a nighttime training exercise 15,000 feet above the Pacific — an accident that senior leaders had been warned was possible, even likely. ProPublica created an animated short documentary, using a combination of an on-camera interview, 3D animation, 2D illustration and atmospheric footage to bring the excruciating hours of a needless tragedy to light. Through extensive interviews with eyewitnesses, the team reconstructed the moments leading up to the crash, the crash itself and the botched search and rescue effort.

The series also illuminated how the Navy’s reckless management of the 7th Fleet was measured not only in fatalities, but also in the hurt and shame of the rank-and-file sailors whom the Navy blamed and prosecuted for the accidents. The Navy’s prosecution of Navy Cmdr. Bryce Benson for what were clearly systemic shortcomings, traceable all the way to the Pentagon, left many of its own furious and demoralized.

Weeks after the first story’s publication, the House Armed Services Committee convened a panel to challenge senior Navy leaders over their claims that they had been fully truthful about its failings and its efforts at reform. The reporting forced the Navy to admit to Congress that its claims about its rate of progress on reform were misleading. In light of ProPublica’s reporting on the improper role that the Navy’s top commander played in the prosecution of Benson, one of captains on the USS Fitzgerald, the Navy dropped all criminal charges. U.S. and NATO Navy commands throughout the world have ordered sailors and officers to read the ProPublica accounts as part of training and education.

Joseph Sexton, Tracy Weber, Agnes Chang, Katie Campbell, Joe Singer, Kengo Tsutsumi, Ruth Baron, David Sleight, Sisi Wei, Claire Perlman, Joshua Hunt and Nate Schweber also contributed to this series.

“The Navy actively blocked reporting at every step, with communications officers attempting to dissuade officials from conducting interviews with ProPublica and leaking positive stories to competing media outlets in an attempt to front-run our stories,” ProPublica Managing Editor Robin Fields said. “The military even threatened that we could be criminally prosecuted for publishing the material we obtained. This tour de force of investigative journalism is a testament to the unflinching tenacity of the reporters and the innovation of ProPublica’s data, graphics, research and design teams. Their essential work laid bare the avoidance of responsibility by the military’s most senior leaders.”

SECOND UPDATE: On July 8, 2019, the judge issued an order setting aside the CMS rule. The full opinion is available here.

UPDATE: On July 8, 2019, the judge in this suit is due to provide a ruling on whether the rule will take effect on July 9. The judge might issue a stay on the rule's implementation. For more details, see this report from MM&M.

On June 14, 2019, Amgen, Merck, Lilly, and the Association of National Advertisers filed a complaint challenging the CMS rule requiring TV ads to include drug pricing information.

Here's a link to the original complaint: https://drive.google.com/file/d/1w5I5kvuYIedGaFGOYzl_VtzZEDFGA7vQ/view

If there is no action on this complaint, the rule will go into effect on July 9.

Pharmacies dispensed approximately 35% more prescriptions in March 2020, compared with the previous month, according to a survey by the National Pharmacy Association.

To read the whole article click on the headline

The latest information about the novel coronavirus identified in Wuhan, China, and advice on how pharmacists can help concerned patients and the public.

To read the whole article click on the headline

All the most important developments in the COVID-19 pandemic for pharmacists and their teams, as they happen.

To read the whole article click on the headline

March 4, 2020 — The U.S. Supreme Court delivered a surprise on March 2 when it announced it will hear a challenge to the constitutionality of the Affordable Care Act (ACA) next term, leap-frogging over the process that was playing out in lower courts. Oral arguments have not yet been scheduled, but are likely to […]

March 16, 2020 – Amid rising concerns over “Novel Coronavirus Disease 2019” (COVID-19), the Food and Drug Administration and the Federal Trade Commission took action last week against seven companies for selling fraudulent COVID-19 products. The regulators sent Warning Letters to the companies because these products “are unapproved drugs that pose significant risks to patient […]

March 23, 2020 – As the United States grapples with the COVID-19 outbreak and its ongoing fallout, there is another pressing issue that is crucial to the American public: ensuring safe and fair elections between now and Nov. 3. “The Coalition believes it is important for all Americans to be active in the political process […]

April 20, 2020 – With additional changes to the regulations still in administrative review and businesses grappling with pressing COVID-19 issues, a group of nearly 100 advertising trade associations, organizations and companies asked California Attorney General Xavier Becerra (D) to delay the July 1 enforcement date for the California Consumer Protection Act (CCPA). But it […]

Temple University researchers discovered that boosting levels of a protein called Lin28 in injured spinal cords of mice prompts the regrowth of axons and repairs communication between the brain and body. They believe the discovery could be used to develop new treatments for both spinal cord and optic nerve injuries.

Sanofi and Regeneron’s Dupixent has become a popular treatment for atopic dermatitis and asthma. Now, a research team in Japan has discovered that IL-4 and its receptor—which Dupixent inhibits—could be promising targets for treating the eye disease age-related macular degeneration.

The dietary supplement industry as a whole is enjoying booming sales as consumer stock up on products to support optimum health. But an industry strategist warns that that sales bump is likely to be ephemeral, and brands that are not strategizing vigorously now may be caught out in the near future.

Researchers working with a group of postmenopausal women found that a technology using casein to encapsulate calcium nanoparticles reduced GI issues compared with more conventional calcium carbonate or calcium citrate supplements.

Consumers are turning to dietary supplements in record numbers, but the industry must deliver on the results the products are promising if the industry is to convert them to long term customers, says Steve Mister.

Combining exercise with a bacterial strain isolated from an Olympic weightlifting gold medalist may synergistically increase endurance compared to training or the probiotic alone, suggests data from a mouse study.

I saw the Breakthrough Prizes announced this weekend and was excited to learn about the interesting scientists on the list, including Jennifer Doudna who many of us in life science recognize for her CRISPR/Cas9 work. I’ll start out saying that I am glad to see a group of such influential people (Sergey Brin and Anne Wojcicki, Mark

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for...… Continue Reading

It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […]

If the worst thing that happens to me during this global pandemic is that I have to buy new pants, I will weep with gratitude.

Newsom said earlier this week that bookstores, florists and others can reopen for curbside pickup Friday, unless barred by tougher local restrictions.

The good news: The state is far better prepared to meet this challenge than it was a decade ago. The bad news: It will need help from the feds, and a lot of it.

Film critic Justin Chang hosted a live discussion of 'The Avengers,' the first film Times readers chose in the Ultimate Summer Movie Showdown series.

The idea that old people are worth something because they contribute significantly to society puts us on a slippery slope.

Building a wardrobe of fashionable face masks doesn't make me insensitive to the grave consequences of coronavirus.

LAX and many airlines are now requiring face coverings to avoid coronavirus spread. TSA agents will don them too.

Carson Meyer, daughter of an NBCUniversal executive and sister of jewelry designer Jennifer Meyer, is reaching parents-to-be virtually in the COVID-19 age.

With the economy in free fall and deaths still rising from the coronavirus crisis, President Trump argued Friday that voters shouldn't hold him responsible.

Gov. Gavin Newsom's administration sent letters to Modoc, Sutter and Yuba counties warning that the areas could be ineligible for disaster funding unless they adhere to the state's coronavirus reopening plan.