FDA Releases Almost 50 Product-Specific Guidances to Aid Generics Makers
The FDA has issued nearly 50 draft product-specific guidances (PSG) meant to help accelerate generic drug development by industry sponsors. Source: Drug Industry Daily
J&J Wins $465 Million Opioid Verdict Reversal in Oklahoma
In a stunning decision, Oklahoma’s supreme court has reversed a $465 million verdict against Johnson & Johnson (J&J), regarding allegations the drugmaker contributed to the state’s public health crisis by…
Bristol Myers Squibb Teases Positive Phase 3 Data for Opdivo in NSCLC
Bristol Myers Squibb (BMS) unveiled positive interim results from its phase 3 CheckMate trial, showing that Opdivo (nivolumab) plus chemotherapy significantly improved event-free survival in patients with resectable IB-IIIA nonsmall-cell…
GSK Touts Positive Phase 3 Data for Anemia-Linked CKD Drug
GlaxoSmithKline’s (GSK) daprodustat increased or maintained hemoglobin levels in patients with anemia due to chronic kidney disease (CKD) across five phase 3 studies, says a new analysis. Source: Drug Industry…
Liquidia Scores Tentative OK for Dry Powder Inhaled Treprostinil
Liquidia has grabbed tentative FDA approval for Yutrepia, the first inhalation powder form of treprostinil, a vasodilator used in other forms to treat pulmonary hypertension. Source: Drug Industry Daily
Regeneron’s COVID-19 Antibody Cocktail Shows 8-Month Preventative Protection
A single dose of Regeneron’s COVID-19 antibody cocktail, REGEN-COV, slashed the risk of contracting the coronavirus by 81.6 percent up to eight months after treatment in a phase 3 trial.…
Indian Generics Maker Settles with Plaintiffs in U.S. Price-Fixing Case
Two U.S. subsidiaries of Indian generics company Sun Pharmaceutical Industries have reached settlements totaling $85 million with plaintiffs in the companies’ drug-pricing antitrust litigation, said Sun in a statement. Source:…
Two Federal Judges Render Opposite Rulings in 340B Cases, Making Matters Murkier
Can the federal government force drugmakers to participate in the controversial 340B drug discount program, punishing them with fines if they don’t? Source: Drug Industry Daily
FDA Observes Lapses in Lot Failure Investigations at Miyoshi America
Miyoshi America didn’t investigate associated lots that may have been linked with specific drug product lot failures, among other lapses observed by FDA investigators during a recent inspection of the…
The U.S. Has a Booming — and Dangerous — Off-the-Books Stem Cell Business
More than 2,750 clinics in the U.S. offer a bewildering array of unauthorized stem cell types hawked for indications ranging from pain to erectile dysfunction to cures for COVID-19 to…
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