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After Johnson & Johnson Loses Again in Bankruptcy Case, It’s Game on for Talc Lawsuits

Fierce Pharma reported:

After Johnson & Johnson’s initial victory in its attempt to resolve talc lawsuits through a bankruptcy ploy, little has gone the way of the pharma giant.

Friday, J&J took another courtroom defeat as the U.S. Court of Appeals for the 3rd Circuit rejected its bid to delay an order dismissing the bankruptcy. The company had hoped for a stay, pending an appeal with the Supreme Court. The decision allows more than 38,000 cases pending against J&J to proceed in court.

J&J is attempting to use the so-called Texas two-step strategy, in which a company facing a mountain of personal-injury asbestos lawsuits creates a firm to funnel the claims and declares it bankrupt.

J&J faces claims that its talcum products — including its iconic baby powder — cause cancer. The company has maintained that the products are safe and free of asbestos. J&J removed its baby powder from shelves in North America in 2020 and is stopping its sales worldwide this year. Instead, the company has shifted to a cornstarch version.

FDA Finds Dirty Equipment, Dozens of Other Issues at Eye Drops Factory Linked to Deadly Outbreak

CBS News reported:

Federal inspectors found dozens of issues at an eye drops manufacturer now linked to a fatal outbreak of drug-resistant bacteria, inspection records released by the Food and Drug Administration show, ranging from dirty equipment and clothing to missing safeguards and procedures.

The FDA’s findings were detailed in citations issued to Indian manufacturer Global Pharma Healthcare Pvt Ltd after an inspection from February 20 through March 2. This appears to have been the company’s first visit from the FDA to their plant in India: no other inspections are on record for the site.

That inspection came in the wake of a swelling multistate outbreak of rare and extensively drug-resistant bacteria that was linked to eye drops manufactured by the firm, which had been branded as EzriCare and Delsam Pharma.

Dozens of people have been infected in the outbreak, which has included at least eight reports of vision loss and three deaths, the Centers for Disease Control and Prevention says. All of the “artificial tears” eye drops made by the company linked to the outbreak have since been recalled.

U.S. FDA Identifies Recall of Getinge’s Heart Devices as Most Serious

Reuters reported:

The U.S. health regulator on Friday classified the recall of Getinge AB’s (GETIb.ST) heart devices as its most serious type as their use may cause grave injuries or death due to the risk of unexpected shutdowns.

An estimated 4,502 devices were recalled by the Swedish medical equipment maker’s unit, Datascope, in the country in January, according to the U.S. Food and Drug Administration (FDA). A communication loss between certain chips may result in an unexpected shutdown of the devices, which are designed to help the heart pump more blood, the agency said.

Unexpected pump shutdown and any interruption to therapy could lead to unstable blood flow, and organ damage, including death, especially for critically ill people.

Earlier in March, the FDA had classified the recall of an estimated 2,300 of these devices as most serious due to a different issue. Getinge had also recalled 4,454 units initiated back in December due to another issue.

Why Experts Worry the ‘Magic’ in New Weight Loss Medications Carries a Dark Side

USA TODAY reported:

Drugs such as Ozempic, Wegovy and Mounjaro can help someone lose 15% to 20% of their body weight — as much as 60 pounds for someone who started at 300 — far more than previously possible without surgery. But some doctors, psychologists and eating disorder experts worry these new medications, originally developed to treat diabetes, could become a problem long-term.

Common side effects of these so-called GLP-1 receptor agonists — nausea, diarrhea, vomiting and constipation — can be significant. Nearly half of the people with diabetes quit an earlier generation of the medications within a year, one real-world study showed, and 70% within two years.

Most people are likely to regain lost weight if they don’t keep taking the drugs for life and the psychological toll of that rebound could be damaging, psychologists predict.

And people may not realize how much the companies making these $1,000-a-month medications are working behind the scenes to convince them they need the appetite-suppressing drugs.

The Tragic, Preventable Reasons Syphilis Is Surging Among U.S. Infants

The Washington Post reported:

A decade ago, the United States stood on the brink of eliminating the scourge of babies born with syphilis. Now, cases are surging, a phenomenon that is underscoring deep inequities in the nation’s healthcare system and reviving concerns about a disease easily controlled with routine antibiotics.

Syphilis, a bacterial infection that primarily spreads through sexual contact, can be passed from mother to child through the placenta. Congenital syphilis resulted in 188 stillbirths and 23 infant deaths in 2021, according to CDC data, and can cause organ damage, profound fetal anemia and long-term complications for surviving babies.

When a pregnant woman tests positive for syphilis, the only recommended treatment to prevent a congenital case — Bicillin L-A — can be hard to come by. Pfizer is the only manufacturer, and there’s no generic version.

It’s so expensive that pharmacies and private health providers often don’t stock it, making it difficult to immediately start providing treatment. Public health departments are the most likely to have the shots on hand.

BioNTech, DualityBio to Develop Cancer Treatment Drugs in Over $1.5-Billion Deal

Reuters reported:

Germany’s BioNTech (22UAy.DE) said on Monday that it signed a deal with Chinese biotech company DualityBio to co-develop and commercialize two cancer antibody drug candidates.

DualityBio will receive upfront payments totaling $170 million and will be eligible to receive development, regulatory and commercial milestone payments of potentially more than $1.5 billion, as well as single-digit to double-digit tiered royalties, the companies said in a joint statement.

DualityBio will retain commercial rights for Mainland China, the Hong Kong Special Administrative Region and the Macau Special Administrative Region, while BioNTech will hold commercial rights in the rest of the world. However, DualityBio has the option to co-commercialize one of the two product candidates, DB-1311, in the United States, the companies said.

DualityBio’s lead candidate, DB-1303, has received Fast Track designation from the U.S. Food and Drug Administration (FDA), which aims to speed up the development and testing of new drugs and is currently in the second of three phases of clinical development.

Exclusive: U.S. to Build $300 Million Database to Fuel Alzheimer’s Research

Reuters reported:

The U.S. National Institute on Aging (NIA) is funding a 6-year, up to $300 million project to build a massive Alzheimer’s research database that can track the health of Americans for decades and enable researchers to gain new insights into brain-wasting disease.

The NIA, part of the government’s National Institutes of Health (NIH), aims to build a data platform capable of housing long-term health information on 70% to 90% of the U.S. population, officials told Reuters of the grant, which had not been previously reported.

The platform will draw on data from medical records, insurance claims, pharmacies, mobile devices, sensors and various government agencies, they said.

Alzheimer’s research has been galvanized by Leqembi, a new treatment from Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) that slows the advance of the disease in early-stage patients. Once built, the platform could also track patients after they receive treatments such as Leqembi, which won accelerated U.S. approval in January, and is widely expected to receive traditional FDA approval by July 6.

ADHD Med Prescriptions Spiked Early in Pandemic

U.S. News & World Report reported:

Prescriptions for attention deficit hyperactivity disorder (ADHD) medications spiked during the COVID-19 pandemic, a new government report shows. The trend may reflect both greater awareness among adults of ADHD symptoms and increased stress driving people to get the care they need.

The study, published on March 31 in the CDC publication Morbidity and Mortality Weekly Report, noted that prescriptions filled for stimulant medication increased to 4.1% in 2021 from 3.6% in 2016 among those enrolled in employer-sponsored insurance.

The increase was even more pronounced in certain age groups: Among adolescent and adult females ages 15 to 44 and males ages 25 to 44, prescriptions grew 10% from 2020 to 2021. They also rose nearly 20% among females in an even narrower age range, 20 to 24.

The medications tracked in the analysis were stimulants sold under the brands Dexedrine and Adderall, methamphetamine under the brand Desoxyn, and methylphenidate, known as Ritalin.

5 FDA Decisions to Watch in the Second Quarter

BioPharma Dive reported:

Over the next three months, the Food and Drug Administration could approve the first vaccines for an elusive virus, the first gene therapy for a deadly neuromuscular disorder and a new treatment for a genetic form of ALS.

Each decision is important in its own right, but each could also have broader implications for the biotech and pharmaceutical sector.

Respiratory syncytial virus, or RSV, has bedeviled researchers for years and the fact that vaccines are now in reach represents a scientific step forward that could buoy other efforts. Sarepta Therapeutics’ gene therapy for Duchenne is the culmination of a long biotech journey and the FDA’s verdict on it will be suggestive of broader agency views on similar therapies. An approval for Biogen’s drug tofersen, meanwhile, could set a precedent that other developers of ALS medicines seek to follow.

Complications With AGGA and Similar Appliances Draw FDA Safety Evaluation

AboutLawsuits.com reported:

The U.S. Food and Drug Administration (FDA) confirmed this week that it has launched a safety investigation to evaluate recent reports of complications with the Anterior Growth Guidance Appliance (AGGA) and similar dental appliances, which were never officially approved by the agency and have been linked to reports of tooth damage, bone loss and other problems.

The FDA safety communication about the AGGA appliance was issued on March 30, confirming recent reports that federal regulators were evaluating the device.

In addition to reviewing reports of complications with AGGA, the agency also indicates that it is evaluating similar devices, including the Fixed Anterior Growth Guidance Appliance (FAGGA), the Anterior Remodeling Appliance (ARA), the Fixed Anterior Remodeling Appliance (FARA), the Osseo-Restoration Appliance (ORA) and Fixed Osseo-Restoration Appliance (FORA).