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The FDA barred beleaguered drugmaker Ipca Laboratories from shipping drugs to the U.S because of good manufacturing practice violations — the 27th time the agency has cracked down on GMP violations at Indian drug facilities in the last two years. Read More
Actavis will become the UK’s largest generics supplier, once its roughly $461 million acquisition of Auden Mckenzie closes in the first quarter of this year. Read More
The White House released a joint statement by President Barack Obama and Indian Prime Minister Narenda Modi pledging to negotiate a harmonized approach to intellectual property protections and establish standard definitions for what is patentable. Read More
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.
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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In a 46-page draft guidance released Monday, the FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality regulations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