Medical science has not yet convincingly duplicated the remarkable properties of cartilage, an omission that sustains an epidemic of life-altering knee replacement surgeries. Anthony Ratcliffe, CEO of Synthasome Inc., of Del Mar, Calif., said on a recent FDA webinar that companies might want to consider the lowly goat as the animal model of choice in preclinical studies of cartilage products because “the cost, ease of management, and the social aspects were all manageable” with goats.

The FDA has issued new risk classification orders for two series of products, including in vitro diagnostics for hepatitis C, two of which the agency down-regulated from class III to class II. However, blood lancets for multiple uses on more than one patient has been elevated from class I to class III, a change that has no impact on any products currently available on the U.S. market.

Even as antimicrobial resistance is expected to continue to grow, the development of much-needed novel antibiotics and antifungals remains trapped in a catch-22 in which funding is available for early stage research but not necessarily for the translational work necessary to bring the drugs to market.

New conditioning agents for hematopoietic stem cell transplant (HSCT) are in the works at a handful of companies, with Jasper Therapeutics Inc. ushering through the pipeline a candidate viewed by some on Wall Street as especially promising.

Stryker Corp.’s analyst day provided comfort to those concerned about the company’s ability to return to its strong pre-pandemic revenue and earnings growth after its lower than expected third-quarter earnings results. Management offered positive reports of fourth-quarter trends and a long-term strategy unfolding according to plan.

Pfizer Inc. scored a $5.29 billion deal with the U.S. government to provide 10 million courses of the company’s oral antiviral candidate Paxlovid (PF-07321332; ritonavir) for COVID-19, as Astrazeneca plc and Novavax Inc. also generated news in the space. Paxlovid, if approved or authorized, would be the first oral antiviral of its kind: a 3CL protease inhibitor specifically designed to combat SARS-CoV-2. New York-based Pfizer is seeking emergency use authorization (EUA) from the FDA. Rolling submissions have also commenced in several other countries, and the company continues to build its case for regulatory agencies around the world.

The Health Breach Notification Rule set forth by the U.S. Federal Trade Commission in 2009 was not initially directed toward health apps used strictly for non-medical uses, but the FTC has indicated it will enforce the rule for developers of these non-medical apps as well. The risk is substantial for these developers as the civil penalties for breaches can reach $44,000 per violation per day, which in the case of a mass breach could present a profound financial risk.

For brain surgeons, the shift is the sticking point. When a surgeon opens the cranium to remove a tumor, the brain moves as much as 1 cm, making much of the pre-operative mapping of the tumor essentially useless. While the bulk of a lesion can be identified by its density, the tendrils blend into the surrounding tissue – and taking excess margins means more brain damage. Designs for Vision Inc.’s bright idea, a headlamp that illuminates a fluorescing tumor with a laser light, makes brain surgery quicker, safer and more accurate.