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RSS FeedPosted by Michael Wonder on 06 Feb 2017
Intarcia announces FDA filing acceptance of new drug application for ITCA 650 for the treatment of type 2 diabetes
3 February 2017 - Intarcia Therapeutics announced today that the U.S. FDA has accepted for active review its new drug ...
Posted by Michael Wonder on 06 Feb 2017
Charleston Laboratories and Daiichi Sankyo receive complete response letter from FDA for new drug application for CL-108 (hydrocodone, acetaminophen, promethazine) tablets for oral use
3 February 2017 - Charleston Laboratories and Daiichi Sankyo confirmed today that the U.S. FDA has issued a complete response ...
Posted by Michael Wonder on 04 Feb 2017
Symbicort granted paediatric exclusivity in the US
26 January 2017 - AstraZeneca today announced that on 25 January 2017 the US FDA granted six months of paediatric ...
Posted by Michael Wonder on 04 Feb 2017
Intellipharmaceutics announces FDA acceptance for filing of NDA for Rexista (oxycodone hydrochloride extended release), an abuse deterrent opioid analgesic for the treatment of moderate to severe pain
2 February 2017 - Intellipharmaceutics International today announced that the U.S. FDA has accepted for filing the company's previously-announced new ...
Posted by Michael Wonder on 03 Feb 2017
U.S. House panel to take up bill to spur generic drug development
2 February 2017 - A U.S. House of Representatives subcommittee will take up bipartisan legislation next week to foster generic ...
Posted 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 01 Feb 2017
Pharmaceutical patent challenges: company strategies and litigation outcomes
31 January 2017 - The pharmaceutical industry has experienced a large number of patent challenges in recent years. ...
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 ...