Blog
RSS FeedPosted by Michael Wonder on 03 Feb 2017
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) in previously treated locally advanced or metastatic urothelial carcinoma, a type of bladder cancer
2 February 2017 - Approval based on CheckMate-275, in which Opdivo demonstrated an objective response rate of 19.6% (95% CI: 15.1-24.9; ...
Posted by Michael Wonder on 02 Feb 2017
Teva confirms generic Victoza patent challenge in the United States
2 February 2017 - Teva Pharmaceuticals today announced that it has filed an abbreviated new drug application with the U.S. ...
Posted by Michael Wonder on 02 Feb 2017
Trump pledges to gut FDA: which regulations need to go?
1 February 2017 - With an executive order and comments from President Donald Trump yesterday calling for a massive overhaul ...
Posted by Michael Wonder on 02 Feb 2017
U.S. FDA grants priority review to AbbVie for its investigational regimen of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in all major genotypes
2 February 2017 - The priority designation shortens the regulatory review period from the standard 10 months to six months ...
Posted by Michael Wonder on 02 Feb 2017
OptiNose announces FDA acceptance for filing of the new drug application for OPN-375
31 January 2017 - FDA sets user fee goal date in September 2017. ...
Posted by Michael Wonder on 02 Feb 2017
Drug development challenges for small biopharmaceutical companies
1 February 2017 - Small biopharmaceutical companies are becoming increasingly important as drivers of innovation in drug development. ...
Posted by Michael Wonder on 01 Feb 2017
Trump wants to blow up the FDA. The drug industry? Not so much
1 February 2017 - President Donald Trump wants to remake the FDA. ...
Posted by Michael Wonder on 01 Feb 2017
Can a butterfly cause a typhoon? Just ask Innate Immunotherapeutics
1 February 2017 - Can the flutter of a butterfly in South America, or in this case Oceania, really cause ...
Posted by Michael Wonder on 31 Jan 2017
Tom Price, Steve Mnuchin nominations blocked by Democratic boycott
31 January 2017 - Republicans delayed indefinitely planned Senate committee votes on President Donald Trump’s picks to be Health and ...
Posted by Michael Wonder on 31 Jan 2017
Trump order on regulations could create hurdles for FDA, Cures Act
31 January 2017 - President Trump on Monday signed an executive order directing federal agencies to cut two regulations for ...
Posted by Michael Wonder on 30 Jan 2017
Teva announces FDA approval of two new RespiClick maintenance inhalers for the treatment of asthma
30 January 2017 - Approvals expand portfolio of respiratory medicines delivered in RespiClick inhaler designed to eliminate the need for hand-breath ...
Posted by Michael Wonder on 29 Jan 2017
Sunovion’s Latuda (lurasidone hydrochloride) receives FDA approval to treat adolescents with schizophrenia
28 January 2017 - First treatment approved in five years for adolescents aged 13-17 years with schizophrenia. ...
Posted by Michael Wonder on 26 Jan 2017
U.S. FDA approves 72 mcg dose of Linzess (linaclotide) for adults with chronic idiopathic constipation
26 January 2017 - New dosage strength expected to be available in first quarter of 2017. ...
Posted by Michael Wonder on 26 Jan 2017
Narcan (naloxone hydrochloride) 2 mg nasal spray approved by FDA
25 January 2017 - Adapt Pharma to provide 2 mg as an additional dosing option for naloxone nasal spray ...
Posted by Michael Wonder on 25 Jan 2017
AbbVie initiates phase 2 clinical trial programs for ABBV-8E12, an investigational anti-tau antibody, in early Alzheimer's disease and progressive supranuclear palsy
25 February 2017 - ABBV-8E12 granted fast track designation from the U.S. FDA for progressive supranuclear palsy. ...