An Esperion Therapeutics drug that pairs two cholesterol-lowering medicines in a single pill has been approved by the FDA, the second regulatory nod for the company in less than a week. The reglator’s decision covers the combination of Esperion’s bempedoic acid (Nexletol) and ezetimibe, an older generic drug for reducing levels of the “bad” form […]

Skyhawk Therapeutics has appointed Terry Connolly to serve as its chief operating officer. He had spent the past year as the Waltham, MA, company’s chief business officer. Before joining Skyhawk, Connolly held multiple roles at Celgene. Skyhawk is developing small molecule drugs that correct errors in RNA splicing. The company’s preclinical pipeline includes one program […]

At the end of the Brexit transition period, the UK will be charting its own course through the often choppy seas of medicines regulation. While it plans to retain the existing EU rules that have been transposed into domestic legislation, it also wants the freedom to tailor its regulations in areas like clinical trials, advanced […]

Veterinarians have a saying that a cat is not a small dog, says Invetx CEO Juergen Horn. Obviously, a dog of any size isn’t the same as a human. But Horn, a veterinarian, says there are enough similarities between the species to take the science behind biological drugs for people and apply it to animals. […]

The price of insulin, a life-saving treatment discovered a century ago, has been a flashpoint amid the broader drug pricing debate. The FDA is trying to tame high insulin prices by encouraging price competition. The FDA has historically regarded insulin as a drug. But insulin isn’t a chemical drug, it’s made from biological material. Under […]

Since a major restructuring at Five Prime Therapeutics in October that kicked off a wind-down of most of its research and preclinical efforts, the company has been looking to add to its partnerships portfolio. On Wednesday, South San Francisco-based Five Prime (NASDAQ: FPRX) said it inked one such new deal. The agreement, a license deal […]

Many companies are working to develop new drugs that target harmful proteins associated with neurodegenerative diseases. EnClear Therapies has raised a $10 million Series A round of financing from a syndicate of investors to advance a device that it says could help treat neurodegenerative diseases by filtering out such proteins from cerebral spinal fluid (CSF), […]

A year ago Five Prime Therapeutics cut a fifth of its workforce to save money as its worked to advance its clinical-stage drugs for solid tumor cancers. On Tuesday the company said one of those drugs, cabiralizumab, a Five Prime antibody that Bristol-Myers Squibb (NYSE: BMY) was testing in combination with its cancer immunotherapy nivolumab […]

A contraceptive patch developed by Agile Therapeutics was awarded FDA approval late Friday, clearing the way for a new birth control option to reach the market. The Agile (NASDAQ: AGRX) product, called Twirla, deliver delivers a combination of hormones via a proprietary skin patch applied once a week. It’s the first FDA approved product for the […]

Eisai is withdrawing weight-loss drug lorcaserin after a post-marketing study found a higher incidence of cancer in patients who took the medicine. The FDA said Thursday that its request for removal of the product from the market is voluntary, but Eisai has already started the process for doing so. The withdrawal follows an FDA alert […]

The RAS family of proteins are one of the hottest targets in cancer research despite being one of the hardest for drug hunters to hit. Revolution Medicines has raised $238 million in an IPO to finance development of therapies that it says can drug these molecules in a novel way. On Wednesday evening, Revolution priced […]

CRISPR, capacity, and consolidation powered the cell and gene therapy space in 2019, but a proactive focus on patient access topped Falcon Therapeutics CEO Susan Nichols’ annual roundup. In what has become one of the most anticipated presentations at the Phacilitate Leaders World Conference, Susan Nichols, CEO of private North Carolina-based cell therapy firm Falcon […]