FDA approval of Opill makes it the first oral contraceptive that may be used without a prescription. Clinicians say over-the-counter availability will lower barriers to access to a key component of reproductive healthcare.
Alkermes says separating cancer from its portfolio and pipeline of neuroscience products could put the company on a path to profitability. Meanwhile, the new cancer company would be an independent and publicly traded entity with a lead immunotherapy in pivotal testing for two types of cancer.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Jazz Pharmaceuticals is paying Zymeworks $50 million up front for rights to develop zanidatamab, a bispecific antibody cancer currently in two pivotal clinical trials. It’s the second bispecific antibody pact of the week, following Gilead Sciences’ deal to secure an option on a MacroGenics drug in early clinical development.
Mike Matson evaluated two earlier negative bits of information along with Thursday's revenue and earnings-per-share miss to conclude that Medtronic's stock, which has held up despite recent market swings, needs to be downgraded to a "hold" from a "buy".
Jazz Pharmaceuticals is licensing rights to a Werewolf Therapeutics cytokine therapy that’s on track to reach clinical testing next year. The deal gives Jazz a drug candidate that expands the company’s scope to immuno-oncology.
The clinical trial failure of Theravance Biopharma’s most advanced internal program, a drug for a rare blood pressure disorder, is leading to a companywide restructuring. Going forward, the biotech will focus on developing drugs for respiratory disorders.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The Theravance Biopharma drug is the lead program in an alliance with Johnson & Johnson subsidiary Janssen Biotech, which paid $100 million up front to develop the JAK inhibitor for intestinal diseases. Following the Phase 2 failure, Theravance said it will minimize spending on that program.
Mallinckrodt Pharmaceuticals received FDA approval for its engineered skin product, StrataGraft, a treatment for serious thermal burns. The product is the latest to be reviewed under a new designation for regenerative medicines.
The at-home testing startup plans to launch a broader virtual care offering after raising $150 million in funding. It plans to roll out virtual visits and offer prescription medications, in addition to building out its array of tests.
Alkermes antipsychotic drug Lybalvi now has FDA approval. Though the field of neuropsychiatric drugs is crowded with generic medications, Alkermes believes Lybalvi, designed to mitigate the weight gain side effect common with mood disorder drugs, could have an advantage.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Medtronic suffered a shocking setback back in 2014 when its Symplicity 3 pivotal trial failed to meet its primary endpoint of reducing blood pressure meaningfully. Now it is gearing up to present new data to the FDA.
The drug, Tepezza, is described as the first-ever drug treatment for thyroid eye disease, a debilitating disease usually treated with surgery.
After diabetes, Medtronic is looking to leverage AI through a distribution agreement with Viz.ai, which uses the technology to streamline stroke care.
The company initiated the voluntary recall of textured Biocell breast implants and tissue expanders after it received a warning from the FDA that they were linked to some cases of a type of T-cell lymphoma.
The rejection brings to an end an effort by the drugmaker and Native American tribe to invoke sovereign immunity to protect patents covering the dry-eye drug Restasis.