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 ...

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Request for proposals - supply of adalimumab

9 March 2021 - PHARMAC invites proposals for the supply of adalimumab in New Zealand. ...

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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, ...

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Sesen Bio submits marketing authorisation application to the European Medicines Agency for Vicineum

8 March 2021 - Potential approval in Europe anticipated in early 2022. ...

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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 ...

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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 ...

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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 ...

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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 ...

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SMC - March 2021 decisions

8 March 2021 - Medicines which can be used to treat a rare genetic disease in children and some cancer ...

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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. ...

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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 ...

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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 ...

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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. ...

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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 ...

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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. ...

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