The FDA declined to approve Intellipharmaceutics International ‘s long-acting opioid painkiller in its current form.
The U.S. FDA issued a Complete Response Letter calling for additional clinical data to evaluate the safety of Janssen’s rheumatoid arthritis drug sirukumab.
Pfizer launched a six-person biotech startup, SpringWorks Therapeutics, with a $103 million Series A financing. Joining Pfizer in funding the company was Bain Capital Life Sciences, Bain Capital Double Impact, OrbiMed and LifeArc, formerly known as MRC Technology.
PureTech subsidiary Gelesis is moving closer to filing for regulatory approval of its obesity treatment Gelesis100 after results of the latest study, the company said.
U.S. senators made a last-ditch effort to secure support for the latest Republican attempt to repeal former President Barack Obama’s signature healthcare law, releasing revised legislation to appeal to undecided senators.
Roche immunotherapy Tecentriq won European Union approval for treating advanced lung and bladder cancer, the Swiss drugmaker said.
A Native American tribe holding patents for drugmaker Allergan Plc moved to dismiss a case brought by generic drug company Mylan NV challenging the patents.
Versartis Inc. said the company’s experimental human growth hormone somavaratan failed to meet endpoints in a critical Phase III trial.
Japan will weigh the concerns of U.S. drug firms in its efforts to complete by year-end a drastic revision of its drug-pricing system, aimed at reining in medical spending and cutting the public burden, the health minister said.
Federal lawmakers are concerned that a recent cyberattack on pharma giant Merck & Co. could lead to numerous problems. including a drug shortage.