J&J offers US$ 8.9 bn to resolve talc lawsuits; Global Pharma violated safety norms, says FDA

By PharmaCompass

2023-04-06

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Johnson & Johnson has proposed to pay US$ 8.9 billion over the next 25 years to settle thousands of lawsuits that allege its talc products caused cancer.

Details of the final trial have revealed that Pfizer’s experimental respiratory syncytial virus (RSV) vaccine was 82 percent effective in preventing severe infections in infants when given to expecting mothers in the second half of their pregnancy.

In regulatory news, the US Food and Drug Administration (FDA) has found several violations at Global Pharma’s manufacturing site near Chennai (India). The drugmaker’s EzriCare Artificial Tears Eye Drop had been linked to 68 cases of eye infection in the US. The agency has also issued a Form 483 with 10 observations to Lupin’s manufacturing facility at Pithampur (India).

In M&A news, Sartorius said it will acquire French company Polyplus for €2.4 billion (US$ 2.6 billion) to bolster its cell and gene therapy operations. And BioNTech has inked a deal with China’s DualityBio to jointly develop and market two cancer drug candidates.

In drug approvals, FDA has granted accelerated approval to Seagen and Astellas Pharma’s Padcev in combination with Merck’s Keytruda as a first-line treatment for adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

A combination of AstraZeneca’s cancer drugs, Imfinzi and Lynparza, have achieved success in a late-stage trial for patients with advanced epithelial ovarian cancer. And, Europe has increased the fee payable to the European Medicines Agency (EMA) for all applications due to inflation.

J&J offers to pay US$ 8.9 billion to settle thousands of talc lawsuits

Johnson & Johnson (J&J) has proposed to pay US$ 8.9 billion over the next 25 years to settle more than 60,000 lawsuits that allege its baby powder and talc products caused cancer. If a bankruptcy court and a large majority of plaintiffs approve the moves, it would become the largest product liability settlement in bankruptcy history.

J&J’s subsidiary, LTL Management, has filed for Chapter 11 bankruptcy protection for a second time in New Jersey with the intention of presenting a reorganization plan that includes the proposed settlement to a judge by May 14. J&J had spun off LTL Management in October 2021 to funnel talc lawsuits. The subsidiary had earlier filed for bankruptcy using the ‘Texas-two step’ to manage the talc claims, but an appeals court had shot down the plan.

FDA finds violations at Global Pharma’s eye drops plant in India; issues Form 483

FDA has found several violations in manufacturing processes and sterilization methods used by India-based Global Pharma for its EzriCare Artificial Tears Eye Drop, which has been linked to 68 cases of eye infection in the US, including eight cases of vision loss and three deaths. The agency conducted a surprise inspection at the company’s manufacturing site in Thiruporur, near Chennai (India), from February 20 through March 2 and issued a Form 483.

The violations mentioned in FDA’s 14-page report include skipping vital tests to check for microbial growth in the drug, not testing active pharmaceutical ingredients and packaging material to ensure sterility, and failing to maintain an aseptic, pathogen-free environment at its plant.

Global Pharma had voluntarily recalled all its eye drops on the US market in February after the FDA issued a warning saying a highly drug-resistant bacteria, Pseudomonas aeruginosa, had been found in the eye drops.

Lupin’s India facility hit by FDA’s Form 483: FDA has issued a Form 483 with 10 observations to Lupin’s Unit-2 manufacturing facility at Pithampur (India). The agency had conducted an inspection from March 21 to 29. The Indian drugmaker has received several Form 483s in the recent past.

Camber recalls pneumonia med due to bacterial infection: Camber Pharmaceuticals, a subsidiary of India-based Hetero Drugs , has recalled one lot of its pneumonia medicine – Atovaquone Oral Suspension – due to potential Bacillus cereus contamination that can lead to life-threatening infections such as endocarditis and necrotizing soft tissue infections.

Sartorius to acquire French company Polyplus for US$ 2.6 billion

German pharmaceutical and laboratory equipment supplier Sartorius will acquire French company Polyplus for €2.4 billion (US$ 2.6 billion) from private investors to bolster its cell and gene therapy operations. Polyplus produces materials and components that are essential in creating viral vectors used in cell and gene therapies, including DNA/RNA reagents and plasmid DNA. The deal, to be completed through Sartorius’ French division Stedim Biotech, is expected to be finalized in the third quarter of 2023.

BioNTech, DualityBio join hands to develop cancer drugs: BioNTech has inked a deal with China’s DualityBio to jointly develop and market two cancer drug candidates. Under the agreement, DualityBio will receive US$ 170 million upfront and will be eligible for a potential US$ 1.5 billion in milestone payments, along with royalties. The partners will develop the two antibody-drug conjugates (ADCs) as a combination therapy for solid tumors.

Seagen’s Padcev, Merck's Keytruda combo bags FDA nod for bladder cancer

FDA has granted accelerated approval to Seagen and Astellas Pharma’s Padcev in combination with Merck’s Keytruda as a first-line treatment for adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. This marks the first time an anti-PD-1 therapy has been approved in combination with an ADC for such patients in the US.

Final trial data shows 82 percent efficacy in infants for Pfizer’s maternal RSV vaccine

Pfizer’s experimental respiratory syncytial virus (RSV) vaccine was found to be 82 percent effective in preventing severe infections in infants when administered to expectant mothers in the second part of their pregnancy, according to final results from a trial reported in the New England Journal of Medicine. It was also 69.4 percent effective in preventing severe infections in the first 180 days, but failed to reduce non-severe illness in infants.

Final data from a second trial showed that the vaccine was about 67 percent effective in preventing RSV-associated lower respiratory tract illness in older adults with two or more symptoms and 86 percent effective for people with three or more symptoms. The agency is expected to decide on the vaccine’s approval for older adults by May and for pregnant women by August.

Astra’s drug combo succeeds in late-stage ovarian cancer trial: A combination of AstraZeneca’s cancer drugs — Imfinzi and Lynparza — has met its main goal in a late-stage trial for patients with advanced epithelial ovarian cancer. The two drugs, along with the current standard of care — chemotherapy and bevacizumab — improved progression-free survival in newly diagnosed patients with advanced ovarian cancer without certain mutations.

Europe raises fee payable to EMA by over 10 percent due to inflation

The European Commission has increased the fees payable to the EMA for all applications except pharmacovigilance procedures in line with last year’s 10.4 percent inflation rate in the European Union. The revised fee schedule will come into effect on April 1.

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