Tag Archive for: Merck

The FDA’s busy March continues with six target action dates remaining on the calendar. Over the next two weeks, the regulator will decide on investigational therapies for Duchenne muscular dystrophy, chronic kidney disease anemia, a rare metabolic disorder and more.

Merck said its blockbuster immunotherapy Keytruda, in combination with chemoradiotherapy, met the main goal of improving overall survival for newly diagnosed patients with a form of cervical cancer in a late-stage study.

Merck & Co said it plans to conduct clinical trials testing its human papillomavirus (HPV) vaccine Gardasil 9 to evaluate the efficacy and safety of a single-dose regimen compared to the approved three-dose regimen.

Despite a patent extension, Merck’s muscle relaxant reversal injection is now facing potential generic competition from Hikma Pharmaceuticals, which is seeking the FDA’s approval for a copycat version.

Merger and acquisition activity is on the rise after the biopharma industry moved on from the COVID-19 pandemic, while the role of AI in drug development is reaching new levels.

The Biden administration is sending drugmakers opening offers for the U.S. Medicare program’s first ever price negotiations on Thursday, the White House said in a statement.

The CEOs of J&J and Merck have finally committed to testifying before the Senate health committee regarding the high prices of drugs in the U.S. The hearing is set for Feb. 8.

The blockbuster immunotherapy secured separate late-stage victories as an adjuvant-setting treatment in renal cell carcinoma and muscle-invasive urothelial carcinoma.

Ahead of a Jan. 31 vote, Senate health committee chair Sen. Bernie Sanders on Thursday said he has the votes needed to subpoena the CEOs of Johnson & Johnson and Merck to testify on drug pricing.

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.