We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The Supreme Court wasted no time in acting on the precedent it set last week in its Copaxone ruling, sending several patent cases, including one Hatch-Waxman dispute, back to the appellate level. Read More
A new report finds growing support among pharma executives for the FDA to evaluate drug candidates on both their clinical and economic effectiveness, with 43 percent of drug company execs supporting the concept compared with 14 percent in 2010.
Read More
The FDA emphasized flexibility in a Monday final guidance that attempts to harmonize U.S. and International Conference on Harmonisation drug photosafety testing requirements. Read More
The European Medicines Agency has officially launched an electronic database for the safety reports all drugmakers are required to periodically submit on approved therapies. Read More
In a 46-page draft guidance released Monday, the FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality regulations and implement streamlined quality systems. Read More
The FDA has given a Teva subsidiary the first greenlight for a generic Nexium in a snub to Ranbaxy, which is suing the agency after having its ANDA first-filer status on the therapy revoked over GMP violations at its India plants. Read More
Antares Pharma received an FDA complete response letter for labeling issues and minor deficiencies in its ANDA for sumatriptan injection USP, the company said in a Monday SEC filing. Read More
NPS Pharma plans to make Natpara available for some patients with hypoparathyroidism in the second quarter of this year, following FDA approval late Friday. Read More
UK healthcare cost watchdogs confirmed Friday that Bayer’s Xarelto is cost-effective for preventing blood clots in patients who have had heart attacks. Read More
Mylan has been awarded another $13.7 million in supplemental damages from GlaxoSmithKline in an ongoing lawsuit against the brandmaker that accuses it of violating a 2007 contract over exclusivity rights to generic antidepressant Paxil. Read More