Generic drug makers are responsible for providing sufficient information in their abbreviated new drug applications (ANDA) to show that the generic drug’s active ingredient is the same as that of…
Neurotech Pharmaceuticals has announced positive phase 3 topline results from two trials evaluating its NT-501 eye treatment for patients with macular telangiectasia type 2 (MacTel). Source: Drug Industry Daily
In the ongoing saga of the Pasteur Act — a thus-far unsuccessful bill introduced in 2020 to encourage new treatments for fighting drug-resistant pathogens — a group of academics and…
GSK’s Blenrep (belantamab mafodotin), an antibody-drug conjugate that won accelerated approval in 2020, has failed its required confirmatory study as a treatment for relapsed or refractory multiple myeloma (RRMM), missing…
In the latest twist in an ongoing patent case with far-reaching implications, the U.S. Supreme Court will consider Amgen’s petition seeking review of an appeals court decision that invalidated the…
Before filing for an orphan medicinal product designation, says the European Medicines Agency (EMA) in a new guidance, sponsors should request a pre-submission meeting to discuss the prevalence of the…
The FDA has adopted the final version of an International Conference for Harmonisation (ICH) guidance on the validation of bioanalytical methods and studies. Source: Drug Industry Daily
New 24-month data will delay the FDA’s decision for Apellis Pharmaceuticals’ investigational therapy for the rare eye disease geographic atrophy (GA) until February, but — according to the company —…
The Centers for Disease Control and Prevention (CDC) has revamped its recommendations for prescribing opioids, nixing controversial dose and duration limits from 2016 that critics say hurt patients who needed…
AbbVie has filed a complaint against several generics producers — including Teva Pharmaceuticals and Novartis’ Sandoz unit — alleging the companies infringed on patents for its endometriosis drug Orilissa (elagolix)…