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RSS FeedPosted by Michael Wonder on 18 Dec 2020
Novaremed receives fast track designation from the FDA for NRD135S.E1 for the treatment of painful diabetic peripheral neuropathy
18 December 2020 - Novaremed announced today that it has received fast track designation from the U.S. FDA for the development ...
Posted by Michael Wonder on 18 Dec 2020
Novo Nordisk files for EU regulatory approval of once weekly semaglutide 2.4 mg for weight management
18 December 2020 - Novo Nordisk today announced the submission of a marketing authorisation application to the EMA for subcutaneous semaglutide ...
Posted by Michael Wonder on 18 Dec 2020
Blueprint Medicines submits supplemental new drug application to FDA for Ayvakit (avapritinib) for the treatment of advanced systemic mastocytosis
17 December 2020 - Blueprint Medicines today announced the submission of a supplemental new drug application to the U.S. Food FDA ...
Posted by Michael Wonder on 18 Dec 2020
Sandoz Canada receives authorisation from Health Canada to launch new biosimilar Hyrimoz (adalimumab)
17 December 2020 - Hyrimoz approved for use in all same indications as reference medicine* including rheumatology, gastro-enterology and dermatology. ...
Posted by Michael Wonder on 17 Dec 2020
FDA approves Amgen's Riabni (rituximab-arrx), a biosimilar to Rituxan (rituximab)
17 December 2020 - Fifth FDA Approval From Amgen's Biosimilars Portfolio. ...
Posted by Michael Wonder on 17 Dec 2020
Novartis investigational oral therapy iptacopan (LNP023) receives FDA breakthrough therapy designation for PNH and rare paediatric disease designation for C3G
16 December 2020 - Iptacopan is in development for paroxysmal nocturnal haemoglobinuria, as well as C3 glomerulopathy and several other ...
Posted by Michael Wonder on 17 Dec 2020
Decibel Therapeutics announces DB-020 has been granted fast track designation by the U.S. FDA
17 December 2020 - Decibel Therapeutics today announced that their clinical product candidate, DB-020, has been granted fast track designation ...
Posted by Michael Wonder on 17 Dec 2020
Hospitals discover a surprise in their vaccine deliveries: extra doses
16 December 2020 - Pharmacists have found that they can squeeze an additional dose from some of the glass vials that ...
Posted by Michael Wonder on 17 Dec 2020
FDA updates list of off-patent, off-exclusivity drugs without an approved generic
17 December 2020 - Today, the U.S. FDA published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved ...
Posted by Michael Wonder on 17 Dec 2020
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for locally advanced unresectable or metastatic oesophageal and gastro-esophageal junction cancer
17 December 2020 - Application based on overall survival and progression-free survival data comparing Keytruda plus chemotherapy to chemotherapy alone from ...
Posted by Michael Wonder on 17 Dec 2020
FDA grants RMAT designation for Cook MyoSite’s investigational autologous muscle derived cells for urinary sphincter repair
17 December 2020 - Cook MyoSite today announced that the U.S. FDA has granted the regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 17 Dec 2020
FDA approves GSK’s Benlysta as the first medicine for adult patients with active lupus nephritis in the US
17 December 2020 - Approval builds on nearly 10 years of experience in lupus. ...
Posted by Michael Wonder on 17 Dec 2020
Kite’s Tecartus (KTE-X19) granted conditional marketing authorisation for the treatment of relapsed or refractory mantle cell lymphoma in Europe
16 December 2020 - 93% of patients in ZUMA-2 pivotal trial responded to single infusion of Tecartus. ...
Posted by Michael Wonder on 17 Dec 2020
Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine
17 December 2020 - Over the last few weeks, EMA has made good progress on the assessment of the marketing authorisation ...
Posted by Michael Wonder on 17 Dec 2020
MacroGenics announces FDA approval of Margenza for patients with pretreated metastatic HER2 positive breast cancer
16 December 2020 - Product launch anticipated in March of 2021. ...