FDAnews Drug Daily Bulletin

Congress is pointing a finger at the FDA for spurring the increase in drug shortages through stepped up enforcement actions, despite the agency’s efforts to mitigate the trend.

The European Medicines Agency (EMA) has updated its draft guideline on clinical investigations of venous thromboembolism (VTE) products, adding new definitions for bleeding events and secondary endpoints to consider for clinical trials.

The FDA should work with other regulatory bodies, especially the European Medicines Agency (EMA), to create a single marketing application that would be accepted by multiple regulators, drug industry insiders urge.

Merck is making its first move into one of the hotter corners of biotech, by forming a partnership to make “smart bomb” antibody drugs with San Diego-based Ambrx.

Merck’s patent for the allergy drug Nasonex isn’t infringed by Apotex, a federal judge ruled.

Piramal Healthcare is in talks to buy U.S. contract drug manufacturer Cambridge Major Laboratories for around $200 million, a person with direct knowledge of the development said.

The organization representing the pharmaceutical industry has claimed that patients are not getting access to new medicines.

Takeda said it will stop distributing 13 Pfizer drugs it now sells in Japan at the end of this year and Pfizer itself will begin selling them from 2013.

Bostonians have long lamented the flight of young technical talent, smarting over Facebook, which decamped in 2004 from a Harvard dorm room to Silicon Valley, and a long-list of other would-be Zuckerbergs blinded by the California sunshine and drawn by the buzz, community and money of the Bay Area.