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Johnson & Johnson to Pay $8.9 Billion to Settle Talc Cancer Claims

CNBC reported:

Johnson & Johnson on Tuesday said it will pay $8.9 billion over the next 25 years to settle allegations that the company’s baby powder and other talc products caused cancer.

The company announced the proposed settlement in a securities filing. J&J’s subsidiary LTL Management also refiled for Chapter 11 bankruptcy protection after its first attempt was thwarted, the filing said.

More than 60,000 claimants have committed to support the proposed resolution, which would require approval in bankruptcy court, the filing added.

World Making ‘Huge Mistake’ Not Funding New TB Vaccines — Gates

Reuters reported:

A lack of funding could delay late-stage trials of the first new vaccine against tuberculosis for more than a century, warned Bill Gates, whose foundation is backing the development of the shot.

The Microsoft co-founder turned philanthropist said there was a raft of promising innovations in the fight against TB, the world’s biggest infectious disease killer, but that more funding was essential.

The Bill and Melinda Gates Foundation is the largest funder of the battle against TB, he said, and the work on the M72/AS01 vaccine, originally developed by GSK (GSK.L) and the Gates-backed non-profit Aeras, is now being led by the Bill and Melinda Gates Medical Research Institute.

Gates said a plan for phase III trials for the vaccine would likely be announced later this year. But he called on governments and other philanthropists to step up to help fund the trials, as well as other TB innovations. He estimated that the vaccine trial would cost $700-800m to “prove it out.”

Anti-Nausea Drug Bendectin Linked to Increased Colorectal Cancer Risks: Study

AboutLawsuits.com reported:

A new study suggests that side effects of a drug commonly prescribed to treat pregnancy nausea during the 1960s and 1970s may be responsible for increased rates of colorectal cancer among a generation of children exposed before their birth.

In a report published last month in the journal JNCI Cancer Spectrum, researchers examined the association between colorectal cancer and Bendectin, which was removed from the market in 1983.

Bendectin was commonly used among pregnant women to treat nausea and vomiting, containing the active pharmaceutical ingredient dicyclomine, which is an antispasmodic originally created to treat irritable bowel syndrome. The same ingredient was also linked to birth defects caused by thalidomide during the same time period, which led to the manufacturer eventually removing dicyclomine from Bendectin’s formula.

Overall, 5% of children born to mothers who used Bendectin developed colorectal cancer. The risk of colorectal cancer was 3.5 times higher among children whose mothers used Bendectin than those who did not.

Bayer Defeats Merck in Lawsuit Over Talc Liabilities

Reuters reported:

A Delaware judge on Monday dismissed Merck & Co’s (MRK.N) lawsuit seeking to hold Bayer AG (BAYGn.DE) responsible for more talc-related liabilities stemming from its $14.2 billion purchase of Merck’s consumer care business in 2014.

Vice Chancellor Nathan Cook of the Delaware Chancery Court said the purchase agreement “clearly and unambiguously” left Merck liable for claims related to products, including Dr. Scholl’s foot powder, sold before the transaction closed.

The companies face potentially billions of dollars of liability from lawsuits by consumers alleging that asbestos contained in talc-based products such as Dr. Scholl’s caused cancer.

Why Cheaper Insulin Today Risks Higher Costs Later

Bloomberg reported:

After years of complaints about runaway drug costs, pharmaceutical companies are finally reducing the price of insulin. On March 1, Eli Lilly & Co. slashed some versions by 70%. Two weeks later, Novo Nordisk A/S and Sanofi SA responded with similar cuts. Just as important for diabetics, who often pay hundreds of dollars monthly for the vital medication, Lilly and Sanofi instituted new policies aimed at capping copays — what patients must shell out at the pharmacy counter — to $35 per month for many versions.

While all this is undeniably great news for people with diabetes, industry watchers say that in the long run, limits on out-of-pocket payments risk propping up insulin prices, not cutting them. The changes threaten to tamp down competition from new, cheaper alternatives known as biosimilars, keeping insurance premiums high and preventing the rivals from gaining traction, according to Robin Feldman, a law professor at the University of California College of the Law at San Francisco. “It looks like a gift to the patient, but the costs to the plan, not to mention the healthcare system, are carefully camouflaged,” she says.

Kasia Lipska, an endocrinologist and associate professor at the Yale School of Medicine, says the price reductions and caps on out-of-pocket costs are “long overdue.” But ultimately “these steps are defensive on the part of drug manufacturers,” she says. “They are trying to stay in the market and to hold on to the monopoly they have on insulin.”

Camber Recalls Pneumonia Drug, Citing Possible Microbial Contamination

Fierce Pharma reported:

Camber Pharmaceuticals issued a voluntary recall of one lot of atovaquone oral suspension used to treat a form of pneumonia. The recall is due to the potential for microbial contamination of Bacillus cereus.

In a filing posted on the FDA’s website, the company said the recall covers lot #E220182 of atovaquone, USP 750mg/5mL, at the consumer level. The drugs were packaged in 210 milliliters HDPE bottles with an expiration date of December 2023. The recalled lot was distributed to wholesalers, distributors, retail pharmacies and mail-order pharmacies nationwide.

Those most at risk for such microbial contamination are immunocompromised patients. The contamination of B. cereus can cause life-threatening infections such as endocarditis and necrotizing soft tissue infections.

Gilead Details Promising Early COVID Antiviral Data, Setting Up Larger Studies

Reuters reported:

Gilead Sciences Inc (GILD.O) on Tuesday unveiled data from the first human study of its experimental oral COVID-19 antiviral, saying the results in healthy volunteers cleared the way for two large Phase III trials of the drug that have begun enrolling patients.

The drug, obeldesivir and previously known as GS-5245, is designed to keep the coronavirus that causes COVID from replicating in the body and overwhelming a patient’s immune system. Once metabolized, it works in the same way as Gilead’s older intravenous COVID treatment Veklury (remdesivir), which targets virus replication through inhibition of the viral RNA polymerase.

The most common laboratory abnormality was grade 2 creatinine clearance decrease, which can be an indication of impaired kidney function and occurred in 31% of treated participants and 25% of placebo participants.

Pandemic Saw Rise in Opioid Prescriptions Given After Childbirth

U.S. News & World Report reported:

New mothers who gave birth early in the pandemic filled far more opioid prescriptions than American women did previously, raising concerns about the potential for narcotic misuse.

About 38% of more than 460,000 women who gave birth from July 2018 through December 2020 were prescribed opioids for postpartum pain management, according to the University of Georgia study.

But there was a nearly 3 percentage point increase in the number of opioid prescriptions filled after March 2020 — when a national emergency was declared in the United States — than before the health crisis began.

The opioids these mothers were prescribed were also higher strength, the researchers noted. The findings were especially concerning because opioid overdose deaths increased during the pandemic, surpassing 100,000 deaths annually, the study authors said.

Sanofi, BARDA Break Ground on Another Flu Vaccine Plant at PA Campus

Fierce Pharma reported:

Sanofi and the Biomedical Advanced Research and Development Authority (BARDA) are expanding their capacity to manufacture flu shots. They are breaking ground on a two-story formulation and filling facility at the company’s sprawling campus in Swiftwater, Pennsylvania.

This is the third major manufacturing investment for BARDA at the site as part of a contract signed in 2019 to increase domestic production capabilities for pandemic flu vaccines. The contract supports the clinical development of an adjuvanted recombinant pandemic influenza vaccine that uses the same technology as Sanofi’s recombinant quadrivalent flu shot. It also expands Swiftwater’s site capacity to include these technologies in addition to the current egg-based platform capability.

The purpose of the contract is to expand preparedness by leveraging the new recombinant, protein-based technology to deliver a pandemic vaccine. BARDA is part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.

The Swiftwater campus includes more than 60 buildings on 500 acres in the Pocono Mountains. Sanofi produces vaccines for seven other diseases there. Sanofi is the world’s largest producer of seasonal flu vaccines, providing more than 250 million shots to 120 countries annually.