In the latest FDA blow to Biocon Biologics, a July inspection of its insulin production facility in Johor, Malaysia, has been classified by the agency as “Official Action Indicated” (OAI),…
The European Commission (EC) has unconditionally approved Pfizer’s $43 billion acquisition of Seagen, concluding that the transaction would not raise competition concerns in the EU, Iceland, Liechtenstein and Norway. Source:…
Eli Lilly has filed lawsuits against 11 online pharmacies that are importing, selling and distributing products purported to contain the active ingredient Lilly’s blockbuster glucagon-like peptide-1 (GLP-1) receptor agonist Mounjaro…
Over the past week, the FDA issued final guidances on testing for methanol in alcohol, premarket notification for magnetic resonance diagnostic devices, patient remote monitoring devices, benefit-risk assessments for new…
In this edition of Quick Notes, we cover a pharmaceutical ingredient cartel, fake Ozempic pens and new transparency rules for the European Medicines Agency clinical trial information system. Source: Drug…
After an FDA advisory committee voted overwhelmingly against its ALS drug NurOwn, BrainStorm Cell Therapeutics announced that it is withdrawing the BLA for the drug so that it can conduct…
The FDA has deemed Hamilton Medical’s recall of certain of its ventilators as class I, the most serious type of recall, as a potential leak could cause the machine to…
The FDA smacked Samsung Biologics for using technology to support application submission testing that had inadequate data integrity controls, among other lapses, following an inspection of its Incheon, South Korea,…
It’s rare, but it turns out a company seeking approval for a new indication can find success in the wake of an FDA Complete Response Letter (CRL) as is the…
The FDA has issued a new final guidance intended to facilitate the development and assessment of regenerative medicine therapy (RMT) products CBER regulates through identifying and recognizing voluntary consensus standards…