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RSS FeedPosted by Michael Wonder on 23 Jun 2018
Voyager Therapeutics announces FDA regenerative medicine advanced therapy designation granted for VY-AADC for the treatment of Parkinson’s Disease
21 June 2018 - Voyager Therapeutics today announced that the U.S. FDA granted regenerative medicine advanced therapy designation for Voyager’s VY-AADC ...
Posted by Michael Wonder on 23 Jun 2018
HTX-011 for post-operative pain management receives breakthrough therapy designation from FDA
21 June 2018 - Heron Therapeutics today announced that HTX-011 for post-operative pain management has received breakthrough therapy designation from the ...
Posted by Michael Wonder on 22 Jun 2018
FDA announces program to enhance early communications with biological product developers
22 June 2018 - The FDA’s new INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) meeting program was created ...
Posted by Michael Wonder on 22 Jun 2018
FDA alerts health care professionals and oncology clinical investigators about an efficacy issue identified in clinical trials for some patients taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as monotherapy to treat urothelial cancer with low expression of PD-L1
20 June 2018 - The FDA is restricting the use of Keytruda and Tecentriq for patients with locally advanced or ...
Posted by Michael Wonder on 21 Jun 2018
White House proposes a narrowing of FDA’s mission — and a new name
21 June 2018 - The Trump administration has proposed a fundamental change to the mission of the FDA, one that ...
Posted by Michael Wonder on 21 Jun 2018
FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies
21 June 2018 - Today, the agency withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September ...
Posted by Michael Wonder on 21 Jun 2018
U.S. FDA accepts application for Opdivo plus low-dose Yervoy for treatment of first-line non-small cell lung cancer in patients with tumour mutational burden ≥10 mut/Mb
21 June 2018 - First-ever application for an I-O/I-O combination in lung cancer to be accepted. ...
Posted by Michael Wonder on 21 Jun 2018
Shire announces FDA approval for label expansion of Cinryze (C1 esterase inhibitor [human]) for prevention of attacks in paediatric hereditary angioedema patients
21 June 2018 - Shire is the only drug developer to complete a paediatric study for the prophylactic treatment of hereditary ...
Posted by Michael Wonder on 21 Jun 2018
Acurx's lead antibiotic product candidate, ACX-362E for Clostridium difficile infection
20 June 2018 - Acurx Pharmaceuticals today announced that the U.S. FDA has designated the Company's lead antibiotic product candidate, ACX-362E, ...
Posted by Michael Wonder on 21 Jun 2018
The ‘right to try’ could cost dying patients a fortune
21 June 2018 - Small biotech considers giving access under new U.S. law. ...
Posted by Michael Wonder on 21 Jun 2018
Health Canada approves Taltz (ixekizumab) for treatment of active psoriatic arthritis
20 June 2018 - The approval of Taltz is based on the Phase 3 clinical trials that demonstrated efficacy on both ...
Posted by Michael Wonder on 20 Jun 2018
Finding cancer patients is the pharma industry’s unlikely challenge
20 June 2018 - Doctors will need to test 100 patients to find one candidate. ...
Posted by Michael Wonder on 20 Jun 2018
Budget matters: infrastructure to support robust generic drug competition
18 June 2018 - The FDA launched its Drug Competition Action Plan more than a year ago, with the aim of ...
Posted by Michael Wonder on 20 Jun 2018
Health Canada approves Amgen's Repatha (evolocumab) to reduce the risk of cardiovascular events in adults with atherosclerotic cardiovascular disease
19 June 2018 - New indication supports Amgen's commitment to reduce the risk of recurrent cardiovascular events faced by heart attack ...
Posted by Michael Wonder on 20 Jun 2018
Amgen receives European Commission approval to add overall survival data to Blincyto (blinatumomab) label
19 June 2018 - Blinctyo is the first-and-only approved bispecific CD19-directed CD3 T cell engager (BiTE) immunotherapy. ...