U.S. FDA staff members on Tuesday supported the use of Intercept Pharmaceuticals Inc.’s liver drug as a monotherapy in patients unresponsive to standard-of-care.

Gilead Sciences struck a $1.2 billion deal to acquire Cambridge, Mass.-based Nimbus Apollo Inc. for its Acetyl-CoA Carboxylase (ACC) inhibitor program.

U.S. regulators on Thursday approved a new once-daily pill for the liver-destroying hepatitis C virus made by Merck & Co Inc, which said it will sell the drug at a lower list price than its competitors. The list price for Zepatier will be $54,600 for a 12-week regimen, which Merck said it expects “to be […]

Massachusetts’ attorney general is studying whether the prices of Gilead Sciences Inc’s blockbuster treatments for hepatitis C violate state law, according to a letter the prosecutor sent to the California drugmaker. The letter from Attorney General Maura Healey to Gilead Chief Executive Officer John Martin, dated January 22, asked the biotechnology company to reconsider its […]

January 19, 2016By Mark Terry, BioSpace.com Breaking News Staff   Ardley, N.Y.-based Acorda Therapeutics, Inc. (ACOR) announced today that it plans to acquire Turku, Finland-based Biotie Therapies Corp. (BITI) for approximately $363 million. Acorda focuses on central nervous system disorders, such as multiple sclerosis (MS), spasticity related to MS, spinal cord injury (SCI), brain trauma […]

With the 2015 record-breaking biopharma merger-and-acquisition period about to come to an end, analysts are tuning their crystal balls to 2016. So far this year—not quite done yet—there has been $667.5 billion in healthcare mergers and acquisitions, according to Dealogic. Next year is likely to continue a trend that started, or at least accelerated, last […]

U.S. state Medicaid programs spent $1.3 billion before rebates in 2014 on Gilead Sciences’ new hepatitis C drugs to treat fewer than 2.4 percent of enrollees with the liver disease, according to a U.S. Senate investigation into pricing of the blockbuster medicines. In the latest salvo against high U.S. prices for important medicines, the 18-month […]

French biopharmaceutical company Genfit said on Monday it is to launch a phase 3 study of its treatment for liver disease NASH by year-end as part of an accelerated approval procedure which could allow it to be brought to market in 2019. Genfit shares rose 5 pct to 42.71 euros on the news. There is […]

Novato, Calif.-based Ultragenyx Pharmaceutical Inc. (RARE), announced today that it has inked a research and collaboration deal with San Diego-based Arcturus Therapeutics, Inc.   The two companies will work to identify and develop messenger RNA (mRNA) therapeutics for rare disease targets utilizing Arcturus’ UNA Oligomer chemistry and LUNAR nanoparticle delivery program. Ultragenyx will pay Arcturus […]

Raptor Pharmaceutical Corp lost more than a third of its market value after the company said it did not plan to develop its liver drug, which failed to meet the main goal in a second mid-stage study. The company’s shares plunged 35.5 percent to $7.61 in premarket trading on Monday. The study was testing the […]