Less than a month after issuing warning letters to a China-based manufacturer of plastic syringes for various quality and branding violations, the FDA is suggesting U.S. providers and consumers avoid…
Over the past week, the FDA published a request for comments on a meeting to discuss user fee financial transparency and efficiency. Source: Drug Industry Daily
The FDA is hamstrung from truly mitigating impending drug supply shortages because the agency can’t get a consistently transparent view into drug manufacturers’ operations, FDA Commissioner Robert Califf told the…
The number of ongoing and active U.S. drug shortages peaked at 323 during the fourth quarter of 2023 — and 48 new medicines have been added to the list so…
Members of Parliament adopted their proposals to revamp EU pharmaceutical legislation aimed at fostering innovation and enhancing the security of supply, accessibility and affordability of medicines. Source: Drug Industry Daily
Biosimilar sales appear generally strong, despite market struggles for Hadlima, Samsung Bioepis’ biosimilar challenger for AbbVie’s Humira (adalimumab), and other Humira challengers, according to the company’s first quarter biosimilar market…
Cipla, the third largest pharmaceutical company in India, received a Form 483 after an FDA inspection March 28-April 4 reported failures in cleaning and maintenance to prevent contamination as well…
The Department of Justice (DOJ) filed a complaint under the False Claims Act (FCA) against Regeneron Pharmaceuticals alleging that the company knowingly submitted average sales price (ASP) reports to CMS…
A new chapter emerged this week in the contentious issue of patent thickets, a web of overlapping patents filed on a single existing product to create barriers to competition and…
Despite the introduction of eight Humira (adalimumab) biosimilars last year, AbbVie is still holding on to its gargantuan 96 percent market share, largely because pharmacy benefit managers (PBM) are suppressing…