Drug Shortages Reached All Time High Last Year, Says Report
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…
EU Parliament Adopts Position on Pharma Reform Data and Environmental Protection
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
Strong Biosimilar Performance Increases Market Share, Decreases Prices, Report Says
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…
Cleaning and Maintenance Failures Cited in Cipla Form 483
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…
DOJ Files Against Regeneron for Inflated Drug Price Reporting
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…
FDA Rethinking Automatic 30-Month Stay in Patent Thickets After Endo Sues
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…
PBMs Suppressing Humira Biosimilars Sales, Causing Low Market Share, Report Finds
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…
Philips CPAP, BiPAP, Ventilators Restricted From Production Under Consent Decree
A consent decree of permanent injunction against Philips Respironics restricting the production and sale of new CPAP and BiPAP machines and mechanical ventilators at three U.S. facilities has been entered…
Barefoot Employees, Fabricated Test Results Earn Eye Drop Manufacturer an FDA Warning Letter
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…
Support Wanes on FDA Proposal Regulating LDTs as Medical Devices
Three industry groups responding to a Senate committee’s March 14 RFI distributed to stakeholders showed no support for the FDA’s plan to regulate laboratory developed tests. Source: Drug Industry Daily
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