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RSS FeedPosted by Michael Wonder on 08 Feb 2017
Lilly's Trulicity (dulaglutide) label updated to include use in combination with basal insulin for adults with type 2 diabetes
8 February 2017 - The label for Eli Lilly and Company's once-weekly Trulicity (dulaglutide) is now updated to include use ...
Posted by Michael Wonder on 08 Feb 2017
FDA approves Amgen's Parsabiv (etelcalcetide), first new treatment in more than a decade for secondary hyperparathyroidism in adult patients on hemodialysis
7 February 2017 - Intravenous administration puts delivery in hands of health care provider. ...
Posted by Michael Wonder on 08 Feb 2017
FDA grants fast track designation to Angionetics' Generx product candidate, a one-time gene therapy for coronary heart disease
7 February 2017 - Angionetics today reported that the FDA has granted fast track designation for the Phase 3 clinical ...
Posted by Michael Wonder on 08 Feb 2017
Flexion Therapeutics announces new drug application for Zilretta (FX006) accepted by U.S. Food and Drug Administration
7 February 2017 - FDA reviewing Zilretta as potential new treatment for osteoarthritis of the knee. ...
Posted by Michael Wonder on 07 Feb 2017
Privatised pharmaceutical innovation vs access to essential medicines: a global framework for equitable sharing of benefits
7 February 2017 - The effect of the current privatized model of pharmaceutical innovation on the development and affordability of lifesaving ...
Posted by Michael Wonder on 07 Feb 2017
Promotion of drugs for off-label uses: the US Food and Drug Administration at a crossroads
7 February 2017 - Since 1962, the US FDA has required companies to establish, with adequate and well-controlled clinical trials, ...
Posted by Michael Wonder on 07 Feb 2017
Perrigo confirms patent challenge for generic version of Onexton Gel
7 February 2017 - Perrigo announced that it has filed an abbreviated new drug application with the U.S. FDA for clindamycin, ...
Posted by Michael Wonder on 06 Feb 2017
Trump’s F.D.A. pick could undo decades of drug safeguards
5 February 2017 - President Trump’s vow to overhaul the Food and Drug Administration could bring major changes in policy, ...
Posted 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
FDA accepts two sBLAs for Merck’s Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer in cisplatin-ineligible first-line and second-line post-platinum failure treatment settings
3 February 2017 - Keytruda also receives breakthrough therapy designation for second-line treatment based on KEYNOTE-045, which includes primary endpoints ...
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; ...