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May 1, 2024 Big Pharma Toxic Exposures

Toxic Exposures

Johnson & Johnson to Pay $6.5 Billion to Resolve Nearly All Talc Ovarian Cancer Lawsuits in U.S. + More

The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.

Johnson & Johnson to Pay $6.5 Billion to Resolve Nearly All Talc Ovarian Cancer Lawsuits in U.S.

CNBC reported:

Johnson & Johnson on Wednesday said it plans to pay $6.5 billion over 25 years to settle nearly all of the thousands of lawsuits in the U.S. claiming its talc-based products caused ovarian cancer, pending approval of the claimants.

Those cases have for decades caused financial and public relations trouble for J&J, which contends that its now-discontinued talc baby powder and other talc products are safe for consumers. About 99% of the talc-related lawsuits filed against J&J and its subsidiaries stem from ovarian cancer.

The deal, pending approval by claimants, would allow J&J to resolve the lawsuits through a third bankruptcy filing of a subsidiary company, LTL Management. Courts have rebuffed J&J’s two previous efforts to resolve the lawsuits through the bankruptcy of that subsidiary, which was created to absorb the company’s talc liabilities.

Litigation has resulted in some large verdicts for claimants. That includes a roughly $2 billion award in favor of 22 women who blamed their ovarian cancer on asbestos in J&J’s talc products.

Pfizer Takes Top Spot in Docs’ Vaccine Ranking by ‘Huge Margin’

Fierce Pharma reported:

Physicians are unequivocal about who is the big kahuna in the vaccine industry. Asked to rank vaccine manufacturers on five metrics, physicians produced a leaderboard that reads Pfizer, yawning gap, Merck.

ZoomRx generated the ranking by asking 50 physicians to name the top vaccine manufacturers in five areas: reputation, innovation, patient centricity, promotions and HCP centricity. The doctors ranked 13 vaccine manufacturers, but the same name kept appearing toward the top of their lists, regardless of the metric being assessed.

Around 80% of respondents ranked Pfizer as one of the top three companies in every category. Merck came closest to keeping pace with Pfizer but was still a long way back. The closest Merck got to Pfizer was in the innovation and patient-centricity categories, where the front-runner had a 23 percentage point lead over second place.

Pfizer’s rivals for the COVID-19, RSV and pneumococcal markets feature in the chasing pack. Merck came in second on four of the five metrics, only slipping to third place behind Moderna on the reputation rank. Moderna and GSK fought for third place across the other categories. Sanofi was fifth on all the metrics.

Do Our Flu Antivirals Work on H5N1? — Infectious Disease Physicians Weigh In

MedPage Today reported:

With avian influenza A (H5N1) infecting more mammals than ever before — including U.S. dairy cattle — infectious disease experts are paying close attention to whether current influenza antivirals would be effective should H5N1 adapt to humans.

All influenza viruses have extremely similar internal mechanisms for reproduction, William Schaffner, MD, of Vanderbilt University Medical Center in Nashville, Tennessee, and a spokesperson for the Infectious Diseases Society of America (IDSA), told MedPage Today. So if an antiviral works against one strain, it will also work on other strains, he said.

This includes neuraminidase inhibitors, such as oseltamivir (Tamiflu), zanamivir (Relenza), and peramivir (Rapivab), as well as the polymerase inhibitor baloxavir (Xofluza). While neuraminidase inhibitors interfere with the enzyme that allows a virus to cleave itself off an infected cell in order to spread, polymerase inhibitors interfere with replication at the level of messenger RNA.

The CDC is working in the lab “to better characterize the virus from the human case in Texas,” and the agency “completed susceptibility testing for the most common class of influenza antiviral medications that are used for seasonal influenza,” a spokesperson for the CDC’s Center for Global Health told MedPage Today.

Weight-Loss Drug Drives Eli Lilly to Raise 2024 Sales Forecast by $2 Billion

Reuters reported:

Explosive demand and increased manufacturing capacity for Eli Lilly‘s (LLY.N) weight-loss drug Zepbound drove the company to raise its annual sales forecast by $2 billion on Tuesday, lifting its shares nearly 5%.

Lilly said it expects significant production increases in the second half of the year for its obesity treatment and related diabetes drug Mounjaro, for which most doses are in shortage due to high demand.

Skyrocketing demand for Mounjaro and Zepbound, both chemically known as tirzepatide, has propelled the Indianapolis-based drugmaker’s market value above $700 billion — surpassing that of Tesla (TSLA.O) and Walmart (WMT.N).

Pharma’s Reputation Falls for First Time Since 2018 as Pandemic-Era Halo Slips

Fierce Pharma reported:

Pharma’s pandemic-era halo is slipping. After tracking a surge in the industry’s reputation, PatientView found patient groups soured on drugmakers somewhat last year to send pharma’s standing to its lowest level since 2020.

The good news for the pharma industry is that its reputation remains at a near-record high, according to a PatientView survey that collected the views of more than 2,500 patient groups around the turn of the year. PatientView said 57% of the respondents believe the industry has a good or excellent corporate reputation. From 2014 to 2019, the figure never exceeded 46%.

Pharma’s reputation continued to improve in some countries in 2023, with the proportion of good and excellent responses from groups in the Netherlands, Denmark, Taiwan, Sweden and the U.K. increasing by more than 10 percentage points. But the gains were offset by the curdling of views elsewhere.

The proportion of good and excellent responses from U.S. patient groups fell by 8 percentage points in 2023, slipping from 65% to 57%. PatientView saw the biggest u-turns in Finland and Ireland, where the proportion of good and excellent responses cratered by 29% and 28%, respectively. Both countries went from having well above to well below average views of the industry’s reputation.

First Trial Over Zantac Cancer Claims Set to Begin in Chicago

Reuters reported:

The first trial over claims that blockbuster heartburn drug Zantac, once sold by GSK (GSK.L) and other companies, causes cancer is set to begin this week in Chicago. GSK and Boehringer Ingelheim are the only defendants in the trial, after other companies settled.

The plaintiff, 89-year-old Illinois resident Angela Valadez, alleges in her lawsuit that she developed colorectal cancer as a result of taking over-the-counter Zantac and generic versions of it from 1995 to 2014. Like other plaintiffs suing over the drug, she says its active ingredient, ranitidine, as it ages turns into a cancer-causing substance called NDMA.

Her case is one of tens of thousands against GSK, Boehringer Ingelheim and other companies including Pfizer (PFE.N) and Sanofi (SASY.PA), which have worried investors in recent years. It will offer the first test of whether the cancer claims will persuade a jury since all cases previously set for trial were settled or were dropped.

FTC Challenges ‘Junk’ Patents Held by 10 Drugmakers, Including for Novo Nordisk’s Ozempic

CNBC reported:

The Federal Trade Commission on Tuesday said it is challenging hundreds of alleged “junk” patents held by pharmaceutical companies for 20 brand-name drugs, including Novo Nordisk’s blockbuster drugs Ozempic, Saxenda and Victoza.

The FTC issued letters to 10 companies, warning them that certain drug patents were improperly listed. These companies include Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Covis Pharma, GlaxoSmithKline, Novartis, Teva Pharmaceutical, and Amphastar Pharmaceuticals, as well as some of their subsidiaries.

Most top-selling medications are protected by dozens of patents covering various ingredients, manufacturing processes, and intellectual property. Generic drugmakers can only launch cheaper versions of a branded drug if the patents have expired or are successfully challenged in court.

“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” FTC Chair Lina Khan said in a release. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need.”

Philips Agrees to Pay $1.1 Billion Settlement After Wide-Ranging CPAP Machine Recall

USA TODAY reported:

Medical device company Philips reached a settlement Monday to shell out $1.1 billion to cover hundreds of personal injury lawsuits linked to its respiration and sleep apnea machines.

The manufacturer has recalled more than 15 million breathing devices since 2021, primarily due to health hazards caused by the breakdown of foam materials that users could inhale, according to the Food and Drug Administration.

Philips did not admit any fault as part of the settlement and did not admit any liability for any of the reported injuries. However, the company said in a statement that the settlement was made to “end the uncertainty associated with litigation in the U.S.”

This personal injury settlement comes after several other hits to Philips Respironics’ pockets in recent years. In September of last year, Philips agreed to a $445 million tentative economic loss settlement to compensate users who had to replace their devices. In April, the company also agreed to a consent decree that halted production in the U.S.

U.S. FDA Grants Full Approval for Pfizer’s Cervical Cancer Drug

Reuters reported:

The U.S. Food and Drug Administration (FDA) granted full approval for Pfizer‘s (PFE.N) drug for treating cervical cancer patients whose disease had progressed on or after chemotherapy, the agency said on Monday.

The treatment, Tivdak — an antibody-drug conjugate co-developed by Genmab A/S (GMAB.CO), and Seagen — received the FDA’s accelerated approval for the same indication in 2021.

It was added to Pfizer’s oncology portfolio last year through a $43 billion deal to acquire Seagen, along with other targeted cancer therapies.

J&J, Bristol Myers Lose Challenges to U.S. Drug Price Negotiation Program

Reuters reported:

A U.S. judge on Monday rejected a challenge by Bristol Myers Squibb (BMY.N) and Johnson & Johnson (JNJ.N) to a law requiring them to negotiate the prices of their blockbuster blood clot prevention drugs with the U.S government’s Medicare health insurance program or pay heavy penalties.

U.S. District Judge Zahid Quraishi in Trenton, New Jersey, became the fourth federal judge to uphold the program, one of Democratic President Joe Biden’s signature initiatives, against drug industry challenges, rejecting their argument that it was an illegal taking of their property.

The drugmakers did not immediately respond to requests for comment, though Bristol Myers has already filed a notice in court that it was appealing the ruling. Drugmakers have argued that it is not feasible to withdraw from Medicare because it represents nearly half the U.S. prescription drug market.

Blood thinners Eliquis from Bristol Myers and J&J’s Xarelto were among the 10 drugs chosen last August for the first round of negotiations under the program, which was part of the 2022 Inflation Reduction Act. Biden and other supporters said the negotiated prices, to go into effect in 2026, will bring down prescription drug costs.

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