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In this edition of Quick Notes, we review recent FDA drug approvals of Jaypirca for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma, Ogsiveo for desmoid tumors who require systemic treatment, Fabhalta an oral monotherapy for the treatment of PNH and a priority review voucher award for Genzyme. Read More
Two cell-based gene therapies to treat sickle cell disease — Casgevy (exagamglogene autotemcel or exa-cel) and Lyfgenia (lovotibeglogene autotemcel or lovo-cel) — received FDA approval Friday, marking the first treatments to provide potential life-long elimination of severe disease symptoms. Read More
The FDA has released two draft guidances with interim policies addressing the FDA’s efforts to finalize bulk drug lists for compounders subject to 503A regulations and for compounders using bulk substances under 503B regulations. Read More
As action dates for two groundbreaking sickle cell gene therapies loom, U.S. Senator Bill Cassidy, MD (R-LA), is raising questions about the cost, and how these extremely expensive, but life-changing, treatments will be paid for and allocated. Read More
As the comment period closed Wednesday on a trio of FDA draft guidances covering data requirements for 510(k) device submissions, industry trade group AdvaMed expressed its clear concerns that the guidances exceeded the agency’s regulatory scope. Read More
AbbVie and Cerevel Therapeutics announced that AbbVie will buy Cerevel Therapeutics and its neuroscience pipeline of schizophrenia, Parkinson's disease, and mood disorder drugs that are in multiple clinical and preclinical stages for $8.7 billion. Read More
Medtronic notified EOFlow on Dec. 6 that it exercised its right to terminate its agreement to acquire the company based on multiple breaches, according to a Securities Exchange Commission Form 8-K. Read More
Drug containers contaminated with wood, cellulose, brass and steel as well as multiple corrective and preventive actions (CAPA) to address mold are among the reasons the FDA listed in its untitled letter to Novartis Pharmaceuticals over its biological product Kymriah (tisagenlecleucel). Read More
The FDA has updated its eSTAR online medical device 510(k) application submission process — which became mandatory as of Oct. 1 — to include additional submission types. Read More
Cordis’s recall of Infiniti angiographic catheters for lack of sterilization has been identified by the FDA as a Class I recall, the most serious type of recall as use of these devices may cause serious injuries or death. Read More
After agreeing to a voluntary plan to help lower drug prices in the UK, the Association of the British Pharmaceutical Industry (ABPI) has issued a statement today accusing the UK government and England’s National Health Service (NHS) of sending mixed messages to life science companies. Read More
Upcoming events in the coming weeks and months include two FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on overcoming common clinical trial challenges, supplier quality agreements and FDA inspections. Read More