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RSS FeedPosted by Michael Wonder on 16 Feb 2020
After a new version of a decades-old drug gets orphan status, the price suddenly skyrockets
12 February 2020 - For years, hospitals and clinics have used an injectable medicine called dehydrated alcohol to treat such ...
Posted by Michael Wonder on 16 Feb 2020
RWE: cost and time savings entice sponsors as pitfalls linger
14 February 2020 - The New England Journal of Medicine published an article earlier this week raising questions about the ...
Posted by Michael Wonder on 15 Feb 2020
FDA approves Agile Therapeutics' Twirla (levonorgestrel and ethinyl estradiol) transdermal system – a new weekly contraceptive patch delivering a 30 mcg daily dose of oestrogen and 120 mcg daily dose of progestin
14 February 2020 - Twirla is a new non-daily, non-invasive contraceptive approved in the U.S. ...
Posted by Michael Wonder on 14 Feb 2020
FDA approves three drugs for non-prescription use through Rx-to-OTC switch process
14 February 2020 - The U.S. FDA today approved three drugs for nonprescription, or over-the-counter (OTC), use through a process called ...
Posted by Michael Wonder on 14 Feb 2020
Epizyme announces FDA acceptance of new drug application for filing with priority review for Tazverik (tazemetostat) for the treatment of follicular lymphoma
14 February 2020 - Approval would expand Tazverik label into second indication. ...
Posted by Michael Wonder on 14 Feb 2020
Seattle Genetics announces FDA filing acceptance for priority review of tucatinib new drug application for patients with locally advanced or metastatic HER2-positive breast cancer
13 February 2020 - FDA Action Date is 20 August 2020; Application under FDA’s real-time oncology review and Orbis pilot programs. ...
Posted by Michael Wonder on 14 Feb 2020
Internal FDA emails reveal how price, Sanders’s pressure played a role in competitor’s approval, Catalyst claims
13 February 2020 - A series of partially redacted internal emails from the US FDA, released as part of a ...
Posted by Michael Wonder on 14 Feb 2020
FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market
13 February 2020 - Potential risk of cancer outweighs the benefits. ...
Posted by Michael Wonder on 13 Feb 2020
Diurnal Group’s new drug application accepted by the US FDA
13 February 2020 - Diurnal Group announced on Thursday that the US FDA accepted its new drug application for review. ...
Posted by Michael Wonder on 13 Feb 2020
FDA grants Soligenix fast track designation for RiVax in the prevention of ricin poisoning
13 February 2020 - Soligenix announced today that its RiVax (heat stable ricin toxin vaccine) development program for prevention of ricin ...
Posted by Michael Wonder on 13 Feb 2020
U.S. FDA accepts for priority review Bristol-Myers Squibb’s biologics license application for lisocabtagene maraleucel (liso-cel) for adult patients with relapsed or refractory large B cell lymphoma
13 February 2020 - Application based on results from the TRANSCEND NHL 001 trial, the largest study of CD19-directed CAR T ...
Posted by Michael Wonder on 13 Feb 2020
NDA accepted for filing by the FDA for antisense oligonucleotide viltolarsen
7 February 2020 - Nippon Shinyaku announced today that the U.S. FDA has accepted the filing of our new drug ...
Posted by Michael Wonder on 13 Feb 2020
The magic of randomisation versus the myth of real world evidence
12 February 2020 - Non-randomised observational analyses have been promoted as alternatives to randomised clinical trials. ...
Posted by Michael Wonder on 13 Feb 2020
Deciphera Pharmaceuticals announces U.S. FDA acceptance of new drug application and priority review for ripretinib in patients with advanced gastro-intestinal stromal tumour
12 February 2020 - FDA grants priority review and sets PDUFA date of 13 August 2020. ...
Posted by Michael Wonder on 12 Feb 2020
FibroGen announces U.S. FDA acceptance of new drug application for roxadustat for the treatment of anaemia of chronic kidney disease
11 February 2020 - FibroGen, Inc. (NASDAQ:FGEN) today announced that the U.S. Food and Drug Administration (FDA) has completed its filing ...