Blog
RSS FeedPosted 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FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies
21 June 2018 - Today, the agency withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September ...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 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
Novartis receives FDA approval for inclusion of new evidence that Cosentyx inhibits progression of joint structural damage in psoriatic arthritis
19 June 2018 - New prescribing information to include data demonstrating Cosentyx (secukinumab) slows progression of joint structural damage associated with ...
Posted by Michael Wonder on 20 Jun 2018
Caladrius receives FDA regenerative medicine advanced therapy designation for CD34+ cell therapy for treating refractory angina
19 June 2018 - Caladrius Biosciences announces today that the U.S. FDA has granted regenerative medicine advanced therapy designation to the ...
Posted by Michael Wonder on 20 Jun 2018
Alexion submits application for priority review and approval of ALXN1210 as a treatment for patients with paroxysmal nocturnal haemoglobinuria in the U.S.
19 June 2018 - Submission in the European Union on track for mid-year and in Japan for the second half of ...
Posted by Michael Wonder on 19 Jun 2018
Statement from deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products
19 June 2018 - Among the biggest challenges health care providers and patients face are shortages of medically necessary medications. ...