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RSS FeedPosted by Michael Wonder on 30 Mar 2020
FDA on signing of the COVID-19 Emergency Relief Bill, including landmark over-the-counter drug reform and user fee legislation
30 March 2020 - On Friday, the President signed into law a $2 trillion emergency relief bill that will continue ...
Posted by Michael Wonder on 30 Mar 2020
EMA to issue electronic certificates for medicines
30 March 2020 - EMA has implemented a new system to issue electronic certificates for human and veterinary medicines. ...
Posted by Michael Wonder on 30 Mar 2020
FDA approves durvalumab for extensive-stage small cell lung cancer
30 March 2020 - On 27 March 2020, the FDA approved durvalumab (Imfinzi, AstraZeneca) in combination with etoposide and either ...
Posted by Michael Wonder on 30 Mar 2020
Lilly's Taltz (ixekizumab) receives U.S. FDA approval for the treatment of paediatric patients with moderate to severe plaque psoriasis
30 March 2020 - Taltz is the first and only IL-17A antagonist approved to treat this population. ...
Posted by Michael Wonder on 30 Mar 2020
Mylan and Lupin announce positive CHMP opinion for Nepexto, biosimilar etanercept
27 March 2020 - Mylan and Lupin today announced that the EMA's CHMP has adopted a positive opinion recommending the ...
Posted by Michael Wonder on 29 Mar 2020
Infinity receives fast track designation for IPI-549 in combination with the checkpoint inhibitor Opdivo for the treatment of advanced urothelial cancer
25 March 2020 - Infinity Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for IPI-549 in ...
Posted by Michael Wonder on 29 Mar 2020
Pharma’s future blockbusters laid up with coronavirus
27 March 2020 - Normally a haven during downturns, pharmaceuticals will see forthcoming products delayed as pandemic disrupts or delays clinical ...
Posted by Michael Wonder on 29 Mar 2020
IntelGenx receives complete response letter from FDA for Rizaport NDA
27 March 2020 - IntelGenx today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 28 Mar 2020
Highlights from the 23-26 March 2020 CHMP meeting
27 March 2020 - Eight new medicines recommended for approval. ...
Posted by Michael Wonder on 28 Mar 2020
EMA advises continued use of medicines for hypertension, heart or kidney disease during COVID-19 pandemic
27 March 2020 - EMA is aware of recent media reports and publications which question whether some medicines, for instance ...
Posted by Michael Wonder on 28 Mar 2020
AveXis receives positive CHMP opinion for Zolgensma, the only gene therapy for spinal muscular atrophy
28 March 2020 - AveXis, a Novartis company, today announced that the CHMP of the EMA has adopted a positive ...
Posted by Michael Wonder on 28 Mar 2020
Novartis Cosentyx gains positive CHMP opinion for new indication in the axial spondyloarthritis spectrum
28 March 2020 - EMA CHMP positive opinion in non-radiographic axial spondyloarthritis (nr-axSpA) paves way for fourth indication in Europe, and ...
Posted by Michael Wonder on 28 Mar 2020
Bristol Myers Squibb receives positive CHMP opinion recommending approval of Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease
28 March 2020 - Bristol Myers Squibb today announced that the CHMP of the European Medicines Agency has adopted a ...
Posted by Michael Wonder on 27 Mar 2020
Sanofi receives positive CHMP opinion for Sarclisa (isatuximab) for the treatment of relapsed and refractory multiple myeloma
27 March 2020 - Positive CHMP opinion based on data from ICARIA-MM, the first randomised Phase 3 trial to evaluate an ...
Posted by Michael Wonder on 27 Mar 2020
Arvelle announces European Medicines Agency acceptance of the marketing authorisation application for cenobamate
26 March 2020 - The applocation seeks authorisation for the adjunctive treatment of focal-onset seizures in adult patients with epilepsy. ...