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RSS FeedPosted by Michael Wonder on 08 Mar 2021
NICE approves life changing gene therapy for treating spinal muscular atrophy
8 March 2021 - A new and potentially curative one-off gene therapy for babies with the rare genetic disorder spinal muscular ...
Posted by Michael Wonder on 09 Mar 2021
Request for proposals - supply of adalimumab
9 March 2021 - PHARMAC invites proposals for the supply of adalimumab in New Zealand. ...
Posted by Michael Wonder on 09 Mar 2021
AltruBio’s neihulizumab granted fast track designation by the FDA for steroid refractory acute graft versus host disease
8 March 2021 - AltruBio announced today that the U.S. FDA granted fast track designation for its immune checkpoint regulator, ...
Posted by Michael Wonder on 09 Mar 2021
Sesen Bio submits marketing authorisation application to the European Medicines Agency for Vicineum
8 March 2021 - Potential approval in Europe anticipated in early 2022. ...
Posted by Michael Wonder on 08 Mar 2021
U.S. FDA grants fast track designation to three Passage Bio gene therapy candidates targeting rare CNS disorders
8 March 2021 - FDA designation will facilitate development and expedited review of company’s lead gene therapy product candidates for ...
Posted by Michael Wonder on 08 Mar 2021
Women report worse side effects after a COVID-19 vaccine
8 March 2021 - Men and women tend to respond differently to many kinds of vaccines. That’s probably because of a ...
Posted by Michael Wonder on 08 Mar 2021
Italy's block on AstraZeneca COVID-19 vaccines prompts warning against 'vaccine protectionism' from Australian Government
9 March 2021 - The Australian Government says it wants to build a "coalition of countries" to pressure the European Union ...
Posted by Michael Wonder on 08 Mar 2021
World's most expensive drug given the green light in Scotland
8 March 2021 - A medicine known as the most expensive in the world has been approved to treat a rare ...
Posted by Michael Wonder on 08 Mar 2021
SMC - March 2021 decisions
8 March 2021 - Medicines which can be used to treat a rare genetic disease in children and some cancer ...
Posted by Michael Wonder on 08 Mar 2021
Health Canada approves Keytruda (pembrolizumab) as first-line treatment for adults with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
8 March 2021 - Approval based on significant progression-free survival findings from Phase 3 KEYNOTE-177 trial. ...
Posted by Michael Wonder on 08 Mar 2021
Pacific pharmacists want inclusion on PHARMAC review
6 March 2021 - The President of the Pacific Pharmacists’Association, Kasey Brown, says a review of New Zealand’s drug buying ...
Posted by Michael Wonder on 08 Mar 2021
Viatris and Kindeva Drug Delivery announce FDA tentative approval of the first abbreviated new drug application generic version of Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol
8 March 2021 - Milestone reinforces Viatris' commitment to complex products and innovative solutions to help increase patient access ...
Posted by Michael Wonder on 08 Mar 2021
BioMarin announces FDA regenerative medicine advanced therapy designation granted to valoctocogene roxaparvovec, investigational gene therapy for haemophilia A
8 March 2021 - RMAT designation granted by FDA during bleeding disorders awareness month. ...
Posted by Michael Wonder on 08 Mar 2021
Genentech provides update on Tecentriq U.S. indication in prior-platinum treated metastatic bladder cancer
7 March 2021 - Genentech today announced that the company is voluntarily withdrawing the U.S. indication for Tecentriq (atezolizumab) in prior-platinum ...
Posted by Michael Wonder on 08 Mar 2021
Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and priority review of NDA for Korsuva injection in haemodialysis patients with moderate to severe pruritus
8 March 2021 - FDA has set Prescription Drug User Fee Act target action date of 23 August 2021. ...