We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
After suffering the setback of a complete response letter (CRL) concerning its contract manufacturing plant, Regeneron has bounced back with FDA approval of two drugs — Eylea HD (aflibercept 8 mg) and Veopoz (pozelimab-bbfg). Read More
After numerous setbacks, Ipsen has won FDA approval for Sohonos (palovarotene), the first treatment for fibrodysplasia ossificans progressiva (FOP), a disease that causes connective tissue — muscle, tendons and ligaments — to gradually turn to bone. Read More
This first European Edition of Quick Notes includes a PDUFA date extension for a chikungunya vaccine candidate, NICE approved AI technologies for radiotherapy treatment therapies, Novartis cited for claims made on an Entresto podcast and comments on the EU proposal for compulsory licensing. Read More
Quick Notes
Today’s Quick Notes include a drug shortages survey conducted by the American Society of Health-System Pharmacists, an AARP analysis of drug price increases and a request for comments from the FDA on the development of a technology and software assessment that examines the feasibility of dispensers to meet new requirements. Read More
The latest FDA drug approvals include traditional approval of pralsetinib for metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, a monoclonal antibody for infants and children at severe risk of respiratory syncytial virus (RSV), the first treatment for people two years of age and older with the viral skin infection molluscum contagiosum, and a treatment for an eyelid disease called Demodex blepharitis. Read More
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended 14 medicines for market authorization during its July meeting including GSK’s Apretude (cabotegravir) for HIV, seven cancer treatments and a drug for relapsing multiple sclerosis. Read More
New FDA drug approvals in June include new gene therapies for ambulatory Duchenne Muscular Dystrophy and hemophilia A, a treatment for pediatric growth hormone deficiency and the first ever cell therapy for a severe form of type 1 diabetes. Additionally, the FDA approved a new device for skin repigmentation in patients with vitiligo. Read More
Amneal Pharmaceuticals’ recent complete response letter (CRL) for its investigational Parkinson’s extended-release drug IPX203 didn’t identify any issues with efficacy or manufacturing — just the safety of one of the two ingredients in the NDA. Read More