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RSS FeedPosted by Michael Wonder on 19 Feb 2020
U.S. FDA accepts Karyopharm’s supplemental new drug application for Xpovio (selinexor) as a treatment for patients with relapsed or refractory diffuse large B cell lymphoma
19 February 2020 - Priority review granted; user fee goal date set for 23 June 2020. ...
Posted by Michael Wonder on 19 Feb 2020
FDA grants priority review to Genentech’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer
18 February 2020 - Genentech today announced that the U.S. FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 19 Feb 2020
Seattle Genetics and Astellas receive FDA breakthrough therapy designation for Padcev (enfortumab vedotin-ejfv) in combination with pembrolizumab in first-line advanced bladder cancer
19 February 2020 - Breakthrough therapy designation based on initial results from Phase 1b/2 EV-103 clinical trial. ...
Posted by Michael Wonder on 19 Feb 2020
Frustration as life-saving EpiPens sit in warehouses, pharmacists out of stock
19 February 2020 - The peak body for Australians with severe allergies is calling on pharmacists to stock up on ...
Posted by Michael Wonder on 19 Feb 2020
Merck receives complete response letter from the US FDA for supplemental biologics license applications for Keytruda (pembrolizumab) six-week dosing schedule
18 February 2020 - Merck today announced that the U.S. FDA has issued a complete response letter regarding Merck’s supplemental biologics ...
Posted by Michael Wonder on 19 Feb 2020
Understanding the role of comparative clinical studies in the development of oncology biosimilars
14 February 2020 - Biosimilars have the potential to broaden patient access to biologics and provide cost savings for health care ...
Posted by Michael Wonder on 19 Feb 2020
European Commission approves Vyndaqel, the first treatment in the EU for transthyretin amyloid cardiomyopathy (ATTR-CM)
19 February 2020 - Vyndaqel is the only EC-approved medicine proven to reduce mortality and frequency of cardiovascular-related hospitalisations in adults ...
Posted by Michael Wonder on 19 Feb 2020
Medical device application processing times
19 February 2020 - Australia's regulatory framework for therapeutic goods is undergoing a number of changes in response to the Review ...
Posted by Michael Wonder on 18 Feb 2020
Paying clinical trial participants: legal risks and mitigation strategies
18 February 2020 - Offering remuneration to participants in cancer trials can promote recruitment and retention. ...
Posted by Michael Wonder on 18 Feb 2020
Horizon Therapeutics announces U.S. FDA approval of new dosage form for Procysbi (cysteamine bitartrate) delayed-release oral granules
18 February 2020 - Oral granules in packets provide an additional, tear-open option for people living with cystinosis. ...
Posted by Michael Wonder on 18 Feb 2020
ALX Oncology’s ALX148 receives two fast track designations from FDA for the treatment of patients with head and neck squamous cell carcinoma and patients with gastric or gastro-esophageal junction adenocarcinoma
18 February 2020 - ALX Oncology today announced that the U.S. FDA has granted two fast track designations for its lead ...
Posted by Michael Wonder on 18 Feb 2020
FDA accepts BioCryst’s NDA for oral, once daily berotralstat (BCX7353) to prevent HAE attacks
18 February 2020 - PDUFA date is 3 December 2020. ...
Posted by Michael Wonder on 18 Feb 2020
FDA calls states’ bluffs on drug importation
18 February 2020 - For decades, critics of the U.S. drug pricing system have advocated importing drugs from Canada as ...
Posted by Michael Wonder on 18 Feb 2020
Novartis receives EC approval for Beovu, a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide
17 February 2020 - Beovu (brolucizumab) is the only anti-VEGF treatment approved in Europe for wet AMD that offers the option ...
Posted by Michael Wonder on 18 Feb 2020
Randomised clinical trials of artificial intelligence
17 February 2020 - As patient data are increasingly captured digitally, the opportunities to deploy artificial intelligence, especially machine learning, ...