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RSS FeedPosted by Michael Wonder on 20 Nov 2019
European Commission approves two new regimens of Merck’s Keytruda (pembrolizumab) as first-line treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma
20 November 2019 - Approval based on significant overall survival findings from Phase 3 KEYNOTE-048 trial. ...
Posted by Michael Wonder on 20 Nov 2019
Alkermes submits new drug application to U.S. FDA for ALKS 3831 for treatment of schizophrenia and bipolar I disorder
19 November 2019 - Alkermes today announced that it has submitted a new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 20 Nov 2019
Newron receives FDA rare paediatric disease designation for sarizotan for the treatment of Rett syndrome
19 November 2019 - Newron announced today that the U.S. FDA has granted the rare paediatric disease designation for sarizotan, ...
Posted by Michael Wonder on 20 Nov 2019
Generic drug approvals soar, but patients still go without
19 November 2019 - Brand name makers’ patent action limits release of the lower-price medicines, hindering cost-control efforts. ...
Posted by Michael Wonder on 20 Nov 2019
Medexus granted priority review status for Gliolan by Health Canada
19 November 2019 - Medexus Pharmaceuticals today announced that Health Canada has granted priority review status for the new drug ...
Posted by Michael Wonder on 20 Nov 2019
Genmab announces European marketing authorization for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone in frontline multiple myeloma
19 November 2019 - Approval based on data from Phase III MAIA study. ...
Posted by Michael Wonder on 19 Nov 2019
Orphazyme receives breakthrough therapy designation for arimoclomol in Niemann-Pick disease Type C
19 November 2019 - Orphazyme today announces that the US FDA has granted breakthrough therapy designation for arimoclomol, an investigational drug ...
Posted by Michael Wonder on 19 Nov 2019
FDA accepts Samsung Bioepis’ BLA for SB8 bevacizumab biosimilar candidate
19 November 2019 - Samsung Bioepis today announced that the U.S. FDA has accepted for review the company’s biologics license ...
Posted by Michael Wonder on 19 Nov 2019
In a rare political move, prominent biotech venture capitalists speak out against Pelosi’s drug pricing bill
18 November 2019 - A group of top biotech venture capitalists are issuing a stark warning to Congress: They won’t ...
Posted by Michael Wonder on 19 Nov 2019
European Medicines Agency grants Orchard Therapeutics accelerated assessment of OTL-200 for patients with metachromatic leukodystrophy
18 November 2019 - Orchard Therapeutics today announced that the CHMP of the EMA has granted an accelerated assessment for OTL-200, ...
Posted by Michael Wonder on 18 Nov 2019
Levo Therapeutics receives fast track designation from FDA for intranasal carbetocin for the treatment of Prader-Willi syndrome
18 November 2019 - Levo Therapeutics announced today that the U.S. FDA has granted Fast Track designation for LV-101 (intranasal carbetocin) ...
Posted by Michael Wonder on 18 Nov 2019
Seelos Therapeutics receives FDA fast track designation for intranasal racemic ketamine (SLS-002)
18 November 2019 - Seelos Therapeutics today announced the U.S. FDA has granted fast track designation to its new, investigational intranasal ...
Posted by Michael Wonder on 18 Nov 2019
National MS Society responds to price of new Biogen/Alkermes MS medication Vumerity
13 November 2019 - The FDA recently approved a new medication for relapsing MS, Vumerity, by Biogen and Alkermes. ...
Posted by Michael Wonder on 18 Nov 2019
FDA approves Pfizer's biosimilar, Abrilada (adalimumab-afzb) for multiple inflammatory conditions
18 November 2019 - Pfizer today announced the United States FDA has approved Abrilada (adalimumab-afzb), as a biosimilar to Humira ...
Posted by Michael Wonder on 18 Nov 2019
Statement from Sarah Yim, acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product
15 November 2019 - Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. ...