Multinational biopharmaceutical companies will see the door to China swing open wider this year if the country’s new leadership delivers on promises made in November to let market forces dominate.
2014 could usher in the year of the crowd for biopharma start-ups, depending on how long it takes the SEC to finalize its crowdfunding rule and what the final rule looks like.
The SEC is asking companies and investors to put on their thinking caps for some brainstorming next year on ways to simplify securities disclosure requirements to improve their effectiveness and minimize duplication.
U.S. drug pricing continues under attack on a number of fronts as lawmakers and payers look for ways to trim health care costs as part of the overall deficit battle.
Frustrated by years of study but no FDA rule requiring effective patient medication information (PMI) for prescription drugs, a Senate committee threatened to use the power of the purse to force some changes to protect patients from drug labeling mistakes.
A new spending framework constructed by congressional budget negotiators would provide some relief from across-the-board sequestration cuts, but it does nothing to protect FDA and Patent and Trademark Office (PTO) user fees from those cuts.
Although the U.S. is several years behind Europe in how it treats allergies, it may be about to catch up. The FDA’s Allergenic Products Advisory Committee (APAC) is slated this week to look at the first sublingual allergy tablets to come down the pike in the U.S.
Despite being haunted by the progressive multifocal leukoencephalopathy (PML) specter raised by natalizumab, Takeda Pharmaceutical Co. Ltd.’s Entyvio got strong support Monday from two advisory committees that weren’t overly concerned by trials that missed some endpoints.
