Some 300 biotech executives and industry leaders are objecting to the decision from a Texas federal judge to block the FDA’s approval of abortion drug mifepristone. The executives argue that the judicial interference will undermine the agency’s authority and endanger innovation in the industry.
In a classic “two steps forward, one step back” situation, just as Philips is aiming to wrap up the repair-and-replace program for the 5.5 million respiratory devices it began recalling two years ago, the company has had to double back and re-recall a slew of the already repaired machines.
A cell has to know what it is to do its job. New research from Trinity College Dublin has helped reveal just how cells establish their identities, which could have implications for developing more targeted cancer treatments.
Current diabetes risk assessments—including the American Diabetes Association’s 60-second risk test for Type 2 diabetes—typically take only a handful of basic, surface-level information into account: age, gender, race, family history and activity levels, among others.
German biotech Evotec is on high alert after a late-week cyberattack prompted the company to shut down its network.
Pear Therapeutics, which planted some of the earliest seeds that prescription smartphone apps could stand alongside prescription drugs, has failed to bear fruit. The company filed for Chapter 11 bankruptcy and announced it would lay off more than 90% of its employees as it seeks a buyer.
Almost 500 days have gone by since Molecular Templates disclosed the second of two cardiac adverse events in recipients of its CD38-directed cancer candidate. The biotech dialed down the dose at the start of 2022, and the trial has progressed uneventfully since then.
After Abbott warned users of its FreeStyle Libre diabetes monitoring hardware earlier this week of the possibility of dangerous battery issues—including swelling, overheating, sparking and catching fire—the FDA has dubbed the replacement efforts as a Class I recall.
Sernova, developer of a insulin-producing cell pouch implant to help treat diabetes, is fending off a proxy battle from a group of investors that says the company’s leadership has shown slow progress in clinical trials and presided over sliding stock value.
Takeda is moving away from early-stage R&D work in adeno-associated virus-based gene therapies and the rare hematology spaces, with an unknown number of employees set to “transition out” of the pharma.