Johnson & Johnson’s small molecule FGFR kinase inhibitor is now indicated for patients with susceptible FGFR3 mutations who progressed after at least one line of systemic therapy.

Amgen

The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.

Gilead

The company announced today that the trial failed to show that it significantly improved survival for previously treated patients with advanced non-small cell lung cancer.

BioNTech

BioNTech and its partner Duality Biologics said they initiated a late-stage trial testing their precision drug against a certain type of breast cancer, taking on a rival partnership between AstraZeneca, and Daiichi Sankyo.

Wegovy, Novo Nordisk

The European Union’s drug regulator will this week consider wider use of Novo Nordisk’s weight-loss drug Wegovy to include reducing the risk of strokes and heart attacks.

Eli Lilly

U.S. inspectors recently uncovered new manufacturing problems at an Eli Lilly (LLY.N) plant that has been under scrutiny by federal investigators, according to government records obtained by Reuters.

Sun Pharma first moved to acquire Taro in May 2007, at the time offering $454 million or $7.75 per share.

Gavel

“Would-be insider traders tempted by the prospect of easy money should know that the Southern District of New York is watching, we’ll catch you, and we’ll make sure you pay the price for violating the law,” stated Damian Williams, United States Attorney for the Southern District of New York.

pills, money

A legislative proposal, if passed into law, could cost the United States up to 1.2 million jobs and lead to more than 130 fewer FDA approvals over a 10-year period.

Capitol

The pharma companies may be served with subpoenas to appear before the Senate health committee to explain why their products are much more expensive in the U.S. than in other countries, according to chairman Sen. Bernie Sanders.