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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 House Committee on Oversight and Accountability during a nearly five-hour hearing on Thursday. Read More
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 far this year — with last year’s figure marking the highest number since the University of Utah Drug Information Service started tracking this data in 2001. Read More
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. Read More
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 report. Read More
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 as failures to investigate out of specification product. Read More
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 that resulted in inflated Medicare reimbursements to the company. Read More
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 extend effective patent life. Read More
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 biosimilar competition, according to two new reports. Read More
A drug manufacturing facility with ungowned, barefoot employees received an FDA Warning Letter that cited “insanitary conditions” in the production of sterile ophthalmic drug products, and was among the manufacturers cited in a recent FDA consumer warning on the risk of contaminated eye drops. Read More