Climate activists won against Shell in 2021 when a Dutch court commanded the oil giant to reduce its carbon emissions by 45 percent by the end of 2030. Three years later, Shell managed to win its appeal against this ruling. In the court's view, Shell doesn’t have a “social standard of care” to curtail emissions, the BBC reports.

The 2021 ruling was noteworthy, as it was the first time a court made a private company obey the 2015 Paris Agreement in addition to Dutch law. However, the appeals court judge said that while Shell had an obligation to reduce emissions, a 45 percent cut could not be established as there is no universally accepted amount. Shell’s statement says it’s planning to reduce its products’ carbon intensity by a comparatively paltry 15 to 20 percent by 2030 compared to a 2016 baseline.

The 2021 ruling would only be effective in the Netherlands as well. Shell wouldn’t have been legally obligated to follow the lower court's ruling for its operations outside Dutch territory. Now even that small gain is off the table for now.

The activists, who are largely associated with Milieudefensie (the Dutch branch of Friends of the Earth), issued a statement promising to continue the fight against climate change. “Large polluters are powerful. But united, we as people have the power to change them,” said Donald Pols, Director of Milieudefensie. They’re now trying to take the case to the Supreme Court, but getting a final verdict will likely take years.

This article originally appeared on Engadget at https://www.engadget.com/science/shell-wins-appeal-in-dutch-court-after-three-year-battle-against-green-groups-165543894.html?src=rss

Apple has a history of eye-popping price tags, but the company is reaching new heights with a product that isn't even a gadget. After Apple Music unveiled a list of the 100 best albums of all time earlier this year, the streaming service is releasing a companion coffee table book. You can grab one of the 1,500 copies for a cool $450.

I find these endeavors to rank and quantify art hilarious, because music is subjective and personal by nature. But people do love to debate their own artistic opinions, so if that's your jam there's plenty to dig into with Apple Music's assessment. (And before you ask, the top spot was claimed by The Miseducation of Lauryn Hill.) This particular countdown was assembled by "Apple Music’s team of experts alongside an exclusive group of artists including Maren Morris, Pharrell Williams, J Balvin, Charli XCX, Mark Hoppus, Honey Dijon and Nia Archives, as well as songwriters, producers and industry professionals," according to the book listing.

I'm sure this limited-run hardcover will be very beautiful, and maybe the liner notes analyzing each entry are deeply insightful. But I also wonder who would bother to buy it. If you are one of those 1,500 people who wants one, the book is due to start shipping in January.

This article originally appeared on Engadget at https://www.engadget.com/entertainment/music/the-coffee-table-book-of-apple-musics-best-100-albums-will-set-you-back-450-193018825.html?src=rss

The initial buzz for Apple’s mixed-reality headset has died down, but new apps and experiences are still arriving for consumers who plunked down $3,500. The UK broadcaster Channel 4 just dropped a dedicated streaming app for the headset, which lets users watch stuff in “ground-breaking cinema-style.”

Channel 4 is the first UK broadcaster to take this step. The app leverages the tech inside the headset to overlay streaming content on the real world, which allows for a “full-screen viewing experience” of stuff like The Great British Bake Off and Taskmaster, in addition to multi-screen view.

Speaking of Taskmaster, the broadcaster also announced an environment based on the comedy game show. Environments on the AVP transform the world around the user, so people can watch Taskmaster while sitting in a room inspired by Taskmaster (cue that Xzibit Yo Dawg meme.) Other streaming apps have their own environments. Paramount+ offers one based on SpongeBob Squarepants and Disney+ now includes one set in Iceland.

This app doesn’t feature access to the recently-released Taskmaster VR experience. That one’s still tied to Steam VR and Meta Quest. By most accounts, it’s a pretty bad game, so the Vision Pro isn’t missing much.

This article originally appeared on Engadget at https://www.engadget.com/ar-vr/channel-4-in-the-uk-now-has-a-dedicated-app-for-apple-vision-pro-200027166.html?src=rss

Apple is rumored to be working on a new smart home product. Mark Gurman at Bloomberg reported that the company is developing a wall-mounted display for controlling appliances, interacting with Siri and videoconferencing. The tablet is said to look "like a square iPad" with "a roughly 6-inch screen." It would have a camera at the top as well as internal speakers and a built-in rechargeable battery. His sources said this smart home display could be officially announced as soon as March following three years in development.

This description sounds a lot like the Google Home Hub, which came out in 2018, or the Echo Show, which is already up to its eighth iteration. If Apple wants to be a serious competitor in this smart home space, it'll have to prove to customers that it has something to offer that these more established brands and products don't.

Right now, the only distinguishing feature is likely Apple Intelligence, which finally began rolling out to users in late October, and the upcoming App Intents system for controlling software programs with AI. But Apple may be looking farther ahead toward something more extravagant than just a smart device control panel. Gurman reported that Apple is already working on a version with a robotic arm that could move the tablet around. It should be interesting to see exactly what Apple does formally launch and when.

This article originally appeared on Engadget at https://www.engadget.com/home/smart-home/apple-could-launch-a-smart-home-control-center-next-year-222136073.html?src=rss

THE reasons behind a decision to release a secret expletive-laden recording of former Chief Justice Tim Carmody are almost as juicy as the tape is expected to be.

New Delhi (AFP) Nov 5, 2024
The toxic smog season in India's capital has just begun, but those unable to escape cancer-causing poisonous fumes say the hazardous impact on health is already taking its toll. New Delhi regularly ranks among the world's most polluted capitals, with a melange of factory and vehicle emissions exacerbated by agricultural fires blanketing the city each winter, stretching from mid-October until

New Delhi (AFP) Nov 8, 2024
India's capital unveiled plans Friday to fly special drones to clear pollution from its smog-choked skies - a plan derided by experts as another "band-aid" solution to a public health crisis. New Delhi and the surrounding metropolitan area, home to more than 30 million people, consistently tops world rankings for air pollution in winter. The smog is blamed for thousands of premature de

Bill MacDonnell's paintings are on display at the Military Museums in Calgary through Remembrance Day and into 2025.

Toy giant Mattel says it "deeply" regrets an error on the packaging of its Wicked movie-themed dolls, which mistakenly links toy buyers to a pornographic website.

Une ado qui aurait été enlevée de force par ses propres frères était en panique et criait d’appeler le 911, selon un témoin appelé au procès.

The national chief of the Assembly of First Nations says the International Criminal Court should investigate the disappearance of Indigenous children from Canadian residential schools.

A phone app that allows people to videochat in groups of up to eight has become a huge hit.

UPDATE: EDDIE McGuire has the backing of the Collingwood board to remain president after accepting his apology for his explosive radio comments about Caroline Wilson.

Le chanteur Zach Bryan aurait demandé à son ex-copine Brianna LaPaglia de ne pas parler de leur relation en lui offrant 12 millions de dollars.

APPLE could be set to make its biggest new product announcement since the iPhone, with the company believed to be working on a game changer.

KOROROIT MP Marlene Kairouz will become Victoria’s new minister for consumer affairs, gambling and liquor regulation.

A court throws out a ruling that the gas and oil giant cut its greenhouse gas emissions.

The ex-senator launches a last-ditch bid against a bankruptcy ruling, hoping to regain the seat he officially lost yesterday.

Public Sector Enterprises Selection Board (PSEB) is seeking qualified candidates for the post of managing director at the Karnataka Antibiotics & Pharmaceuticals Limited (KAPL) in Bengaluru. The candidate will be

Raising deep concern over the partnership between Swiggy Instamart and PharmEasy for a rapid drug delivery model, the All India Organization of Chemists and Druggists (AIOCD) has apprised the Drug Controller

The Department of Pharmaceuticals (DoP) has upheld the retail price fixation of National Pharmaceutical Pricing Authority (NPPA) for Mumbai─based Aristo Pharmaceuticals for its multivitamin tablets with

The Subject Expert Committee (SEC), which advises the national drug regulator on approval of new drugs and clinical trials, has recommended grant of market authorisation for Dr Reddy's Laboratories' Siponimod

The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for

TekniPlex Healthcare is set to unveil its strongest-ever reinforced paper for medical device packaging applications at Pack Expo 2024, 3-6 November in Chicago.

Olivia Friett, editor of Medical Plastics News takes a look at the current regulatory landscape.

Joe Anderson, product and promotional marketing manager at Harland, explores the role of surface preparation in the application of hydrophilic and hydrophobic coatings.

Bormioli Pharma has announced a partnership with Chiesi, an international, research-focused biopharmaceutical company (Chiesi Group), to supply Carbon Capture PET bottles.

The Martian new year arrives with the Red Planet’s vernal equinox. Explaining why requires a deep dive into celestial mechanics and Earth’s calendrical history

Outside groups often offer their solutions for climate adaptation in Africa. But the best people to manage the climate crisis are the people in those communities themselves. For climate adaptation to succeed in Africa, let communities and local leaders show the way

Today’s guest post comes from Timothy Nielsen, Vice President of Customer Success at AssistRx.

Timothy discusses the affordability and patient journey challenges of specialty-lite products for patients, manufacturers, and health care providers. He explains how AssistRx's Advanced Access Anywhere (AAA) solution streamlines processes for specialty-lite products and facilitates enrollment via a digital hub.

To learn more, register for AssistRx's free webinar on October 8: Meet Your Patients Where They Are & Gain Visibility: Even at Retail.

Read on for Timothy’s insights.
Read more »

Today’s guest post comes from Angie Franks, Chief Executive Officer of Kalderos.

Angie discusses how the Maximum Fair Price provision of the Inflation Reduction Act of 2022 will challenge providers, pharmacies, and manufacturers. She explains how Kalderos’ Truzo platform could reduce duplicate claims and address compliance issues.

To learn more, register for Kalderos’ October 25 webinar Cracking the MFP Code: How Flexible Technology Helps You Navigate an Evolving Landscape.

Read on for Angie’s insights.
Read more »

A new survey of plan sponsors sheds light on their satisfaction with transparency at large and small pharmacy benefit managers (PBMs).

As you will see, clients remain slightly more satisfied with the perceived transparency of smaller PBMs compared with the Big Three PBMs—CVS Caremark, Express Scripts, and Optum Rx.

However, plan sponsors are dissatisfied with transparency about how both large and small PBMs make money. Smaller PBMs have an edge, but it’s narrower than you might think.

Perhaps PBMs’ clients are unable or unwilling to negotiate better deals, write more effective contracts, and switch to more satisfying relationships. Or maybe they don’t mind the current system, despite the challenges for patients. Some argue that transparency could swoop down to solve this problem. Riddle me this: Should we watch what plan sponsors say, or what they do?

Read on to see what you think of my arguments below. Then, click here to share your thoughts with the Drug Channels community.
Read more »

Today’s guest post comes from Shabbir Ahmed, Chief Commercial Officer at CareMetx.

Shabbir explains the barriers that providers face when dealing with branded portals for multiple products. He then maintains that patients can access new therapies more quickly when the manufacturer relies on a brand-agnostic hub connected to a large network of providers and integrated with the systems those providers use daily.

To learn more, download CareMetx’s new 2024 Patient Services Report: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage.

Read on for Shabbir’s insights.
Read more »

Here on Drug Channels, we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall.

Novel transparency information reveals that this good news doesn’t always translate into savings. Below, we rely on a unique data set from Turquoise Health to examine how much four national commercial health plans—Aetna, Anthem, Cigna, and UnitedHealthcare—paid hospitals for Avastin and its two most significant biosimilar competitors.

As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars. What’s more, plans can pay hospitals more for a biosimilar than for the higher-cost reference product. The U.S. drug channel system is warping hospitals’ incentives to adopt biosimilars, while simultaneously raising costs for commercial plans.

The namesake of my alma mater once said: “Sunlight is said to be the best of disinfectants.” What would happen if we disinfected the entire channel?
Read more »

The U.S. Food and Drug Administration posted a video:

What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

The U.S. Food and Drug Administration posted a video:

What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

The U.S. Food and Drug Administration posted a video:

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

The U.S. Food and Drug Administration posted a video:

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

The U.S. Food and Drug Administration posted a video:

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

The U.S. Food and Drug Administration posted a video:

Quizás sepa que la FDA es responsable de aprobar los medicamentos nuevos, como medicamentos de receta, genéricos, biosimilares y de venta libre, y de garantizar que esos medicamentos sean seguros, de alta calidad y funcionen como se supone que deben hacerlo. Pero nuestro trabajo no termina ahí. Continuamos monitoreando la seguridad y calidad de los medicamentos aprobados en los años venideros. Aprenda más sobre nuestro papel en la regulación de estos medicamentos.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

The U.S. Food and Drug Administration posted a video:

La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546

The U.S. Food and Drug Administration posted a video:

Quizás sepa que la FDA es responsable de aprobar los medicamentos nuevos, como medicamentos de receta, genéricos, biosimilares y de venta libre, y de garantizar que esos medicamentos sean seguros, de alta calidad y funcionen como se supone que deben hacerlo. Pero nuestro trabajo no termina ahí. Continuamos monitoreando la seguridad y calidad de los medicamentos aprobados en los años venideros. Aprenda más sobre nuestro papel en la regulación de estos medicamentos.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

The U.S. Food and Drug Administration posted a video:

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

The U.S. Food and Drug Administration posted a video:

La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Disclosure: I sit on the Planning Committee for the FDLI Ad-Promo conference. This is an unpaid, volunteer position. The contents of this post were not discussed with or influenced by any member of the FDLI staff.

This post provides some of the highlights from FDLI's ad-promo conference. An on-demand version of the conference presentations is available on-demand at: https://www.fdli.org/2023/11/advertising-promotion-for-medical-products-conference-on-demand/

The Food and Drug Law Institute's (FDLI) Advertising & Promotion for Medical Products conference wrapped up last week. I attended the conference and also moderated a panel on data privacy and concerns about the use of health data for the targeting of advertising.

The first day kicked off with a fireside chat with Arun Rao from the Department of Justice (DOJ), Lauren Roth from the Food & Drug Administration (FDA), and Serena Viswanathan from the Federal Trade Commission (FTC), led by Christine Simmon of FDLI.

FDA and FTC both noted their recent guidance updates. For FDA, that means the new Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers Guidance for Industry (SIUU) and the newly finalized Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements. 

FTC has also been busy, providing updated guidance on endorsements, reviews and testimonials, and a distinct Health Products Compliance Guidance.

DOJ, FDA, and FTC also mentioned the extent to which they are still very much digging out from the backlog created by the pandemic. More than three years after COVID-19 first came to our shores, its effects are very much still being felt.

Rao also mentioned a new policy from DOJ to create a safe harbor for self-reported disclosures made in connection with a merger or acquisition. Under this new policy, companies that learn of wrongdoing at a company they have acquired can be protected from later liability if they report the wrongdoing to DOJ within six months of closing the merger or acquisition. This is as Rao described it a "very big juicy carrot" to encourage self-reporting of wrongdoing, and it also ramps up the need for effective due diligence during the M&A to ensure that all wrongdoing is uncovered and can be reported.

One final point mentioned by Roth is the importance to FDA of combatting misinformation about medical products. Commissioner Califf has repeatedly warned about the need to combat misinformation, and it is not a stretch to see FDA's SIUU guidance as one small step in that direction. By providing further guidance about exactly how sponsors can share truthful, not misleading information about unapproved uses, FDA is enabling efforts to get good information from the people who should be seen as the most reliable source of that information, the product's sponsors.

The next session of the day included an update from OPDP, APLB, CDRH, and CVM related to advertising and promotion.

Katie Gray from OPDP gave a detailed presentation on the Recorlev enforcement action from earlier this year and an overview of the SIUU guidance. Lisa Stockbridge from APLB provided a reminder on reminder advertising, indicating that this well-established category of communication continues to cause firms difficulties. Debra Wolf of CDRH emphasized that although there has not been a significant amount of publicly available enforcement actions from CDRH, the Agency continues to have many private communications with firms about their marketing efforts.

The next plenary session covered scientific exchange and pre-approval communications. Elisabethann Wright of Cooley provided particular insight into the EU's approach, which of course varies widely by country, and has been especially active on platforms such as LinkedIn. Of note is the extremely active role played by the industry's own associations in not merely promulgating guidance and establishing codes of conduct but in regularly enforcing violations of those codes against member companies.

After lunch, the first set of breakout sessions occurred including the panel I moderated on data privacy. I found the discussion very lively and enjoyed hearing from Elisa Jillson from the FTC, Lyra Correa from HHS's Office of Civil Rights, and Nancy Perkins from Arnold & Porter. I have previously opined that the 2020s will be most known for its focus on privacy, and while the cookie-less future we keep hearing about gets pushed back once again, there's growing awareness and concern about how much deeply personal information has been given up and on how companies are using (or misusing) that data.

Simultaneous sessions looked at the recently finalized guidance from the FDA on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements while another session looked more into the promotion of veterinary products. Because I was leading another session, I couldn't attend either, but I'm looking forward to using that link provided earlier to view the recordings. 

The afternoon plenary sessions resumed with a look at FTC's role in enforcement of healthcare advertising and closed out with a session on that perennial chestnut of social media usage.

Day two of the conference kicked off with an enlightening discussion of so-called CFL (Consistent with FDA-Labeling) claims. Torrey Cope of Sidley Austin provided an insightful look not just at FDA's enforcement post-guidance for claims that failed to meet the CFL standard, but also for taking the time to examine the nature and wording around the acceptance by FDA of so-called Real-World Evidence (RWE) in the context of product approvals. RWE is not the sole source of CFL claims, but Cope was able to provide some valuable lessons.

The afternoon's breakout sessions included one on artificial intelligence (which I attended), promotional challenges in rare disease treatments, and navigating accelerated approval promotion.

The closing session focused on other avenues for enforcement, including of course, the Better Business Bureau National Advertising Division's (NAD), as well as general counsel to general counsel complaint letters, filing complaints with the FDA, and perhaps even bringing a Lanham Act case.

The NAD's finding against Novartis earlier this year was of course a hot topic. But it is worth noting that in a more recent case, Viiv simply declined to participate in the NAD process. NAD referred the matter to FDA and FTC noting that decision, but as of the writing of this post, no further action by the government has been seen.

Alan Minsk of Arnall Golden Gregory noted the importance of determining your goal when looking at the appropriate path. If your goal is get a competitor in trouble then you really need to rely on the government or the courts, but if your goal is primarily to just get the company to stop the use of misleading promotion, then NAD or a direct complaint letter might be a far more cost-effective solution.

Overall, the conference was a huge success, though my opinion should be viewed as biased because I sit on the conference planning committee. FDA is definitely digging itself out from the pandemic backlog. I fully expect we'll see more from the Agency, as a very active 2023 has already demonstrated.

The proposed American Privacy Rights Act (APRA) has taken its first step U.S. House legislative process with several issue disagreements becoming more evident. On May 23, the U.S. House Committee on Energy and Commerce Subcommittee on Data, Innovation and Commerce approved the updated APRA, advancing the bill to full committee consideration. Just prior to the […]