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RSS FeedPosted by Michael Wonder on 15 Jan 2020
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) in first-line non-small cell lung cancer
15 January 2020 - Application based on results from Part 1 of Phase 3 CheckMate-227 study. ...
Posted by Michael Wonder on 15 Jan 2020
Reform at the FDA—in need of reform
14 January 2020 - On 23 December 2016, the US FDA announced the approval of nusinersen, the first drug for the ...
Posted by Michael Wonder on 15 Jan 2020
FDA approval and regulation of pharmaceuticals, 1983-2018
14 January 2020 - How has the regulation of prescription drugs evolved from the 1980s to 2018, and what trends have ...
Posted by Michael Wonder on 14 Jan 2020
Roche aims to 'underwhelm' on SMA drug price to challenge rivals
14 January 2020 - Swiss drug maker Roche plans to price its oral spinal muscular atrophy drug risdiplam aggressively to challenge ...
Posted by Michael Wonder on 14 Jan 2020
FDA approves drugs faster than ever but relies on weaker evidence, researchers find
14 January 2020 - The FDA has gotten faster at approving new prescription drugs over the past four decades, but ...
Posted by Michael Wonder on 14 Jan 2020
Basket cases: how real-world testing for drugs approved based on basket trials might lead to false diagnoses, patient risks, and squandered resources
14 January 2020 - Basket trials, studies designed to assess the safety and efficacy of therapeutics targeted to a specific molecular ...
Posted by Michael Wonder on 14 Jan 2020
Chiasma announces FDA acceptance of Mycapssa new drug application resubmission
13 January 2020 - FDA sets PDUFA date of 26 June 2020. ...
Posted by Michael Wonder on 14 Jan 2020
Incidental imaging findings in clinical trials
13 January 2020 - Clinical trial end points are outcome measures used to assess the efficacy and safety of an ...
Posted by Michael Wonder on 14 Jan 2020
PTC Therapeutics provides corporate update
13 January 2020 - PTC-AADC MAA submitted; BLA now expected to be submitted in 2Q 2020. ...
Posted by Michael Wonder on 14 Jan 2020
Ultragenyx and Kyowa Kirin announce submission of supplemental biologics license application to U.S. FDA for Crysvita (burosumab) for tumour-induced osteomalacia
13 January 2020 - Ultragenyx and Kyowa Kirin today announced that they submitted a supplemental biologics license application to the U.S. ...
Posted by Michael Wonder on 13 Jan 2020
Imago receives fast track designation from U.S. FDA for bomedemstat for treatment of essential thrombocythemia
13 January 2020 - Imago BioScience today announced that the U.S. FDA has granted fast track designation for the development ...
Posted by Michael Wonder on 13 Jan 2020
Neurelis announces FDA approval for seizure rescue treatment Valtoco (diazepam nasal spray) that incorporates the science of Intravail for consistent and reliable absoption
13 January 2020 - Valtoco is the first nasal spray approved by the FDA as a rescue treatment for people with ...
Posted by Michael Wonder on 13 Jan 2020
Lynparza regulatory submission granted priority review in the US for first-line maintenance treatment with bevacizumab in advanced ovarian cancer
13 January 2020 - Submission based on Phase III PAOLA-1 trial for patients with advanced ovarian cancer regardless of biomarker ...
Posted by Michael Wonder on 13 Jan 2020
Aquestive Therapeutics receives FDA response to Citizen’s Petition
12 January 2020 - Aquestive Therapeutics today reported that the U.S. FDA issued a response letter dated 10 January 2020 denying ...
Posted by Michael Wonder on 12 Jan 2020
The FDA is in trouble. Here’s how to fix it.
11 January 2020 - Some New Year’s resolutions for the incoming boss. ...