A Florida manufacturer of over-the-counter drug products had high microbial counts in water it used for manufacturing among other significant violations of current good manufacturing practice, according to an FDA…
Warnings of international crime targeting the yet-to-be-approved COVID-19 vaccines are getting louder, with the international police agency Interpol issuing an Orange Notice, which warns of an “imminent threat to public…
By the end of 2022, drug, device and biologic product sponsors that are required to submit a risk evaluation and mitigation strategy (REMS) will have to do so electronically, the…
The FDA is working on a report tied to a two-day meeting held in December to discuss its pilot program on pharmaceutical supply chain interoperability, as well as other efforts…
In a Thursday hearing of a congressional committee, two members of the Sackler family and Purdue Pharma’s current president and CEO, Craig Landau, dutifully expressed sorrow for the role played…
The FDA’s vaccines advisory committee voted almost unanimously on Thursday in favor of Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine, with all but one abstaining member supporting clearance, and…
With COVID-19 cases surging across Europe, EC President Ursula von der Leyen announced yesterday that EU countries will start vaccinations with the two-dose Pfizer/BioNTech vaccine on Dec. 27. Source: Drug…
GlaxoSmithKline has received FDA approval for Benlysta (belimumab) to treat active lupus nephritis, a serious inflammation of the kidneys that appears in about four in 10 patients with the most…
Novartis has agreed to buy Cambridge, Mass.-based Cadent Therapeutics for a possible $770 million, expanding its pipeline of treatments for cognitive and mood disorders. Source: Drug Industry Daily
COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could…