Transgene SA was riding high Thursday after releasing top-line preliminary data from a Phase IIb/III study of TG4010, an immunotherapy being developed for non-small-cell lung cancer (NSCLC).

With an eye on the bottom line, the Centers for Medicare & Medicaid Services (CMS) is proposing a Part D rule change that would tip the formulary scale in favor of generics and, in time, biosimilars.

The FTC is set to butt into the biosimilar debate next month with a workshop on the potential competitive impacts of proposed naming schemes and state regulations.

Congress’ top priority when it heads back to Washington next week is to churn out an omnibus spending bill to keep the government running after Jan. 15, when the current continuing resolution expires.

In one of its last precedential opinions of 2013, the U.S. Court of Appeals for the Federal Circuit overturned a Patent and Trademark Office (PTO) decision Monday and gave it a reading lesson in obviousness and prior art.

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.