Archive for November 2023

Namandje Bumpus, currently chief scientist for the FDA, will replace Janet Woodcock as principal deputy commissioner, FDA Commissioner Robert Califf announced Wednesday. Source: Drug Industry Daily

AbbVie and ImmunoGen today announced an agreement under which AbbVie will acquire ImmunoGen, and its flagship cancer therapy Elahere (mirvetuximab soravtansine-gynx) an antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer, accelerating AbbVie’s presence in the solid tumor space. Source: Drug Industry Daily

Kilitch Healthcare India received an FDA Form 483 citing lack of sterility, incomplete laboratory records and inadequate laboratory controls, inadequate validation of aseptic processes and unclean and insanitary buildings following an eight-day October inspection of its Mumbai, Maharashtra sterile drug manufacturing facility. Source: Drug Industry Daily

Despite overall enthusiasm for the use of multi-cancer diagnostic (MCD) tests, several members of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee raised concerns about the social and emotional risks the technology might carry. Source: Drug Industry Daily

Novo Nordisk has filed complaints against two Florida-based compounding pharmacies for marketing unapproved versions of its semaglutide products, claiming the products are weaker in strength than labeling indicates and may contain up to 33 percent impurities. Source: Drug Industry Daily

At an FDA advisory committee convened to gather insights on multi-cancer diagnostic (MCD) tests, the 10-member advisory panel veered off course when the topic of endpoints arose, voicing varying levels of support for mortality endpoints in trial design. Source: Drug Industry Daily

The FDA is proposing to classify for the first time certain wound dressings and liquid wound washes containing antimicrobials or other chemicals, an action that would also mean a premarket application (PMA) would be required for some of them. Source: Drug Industry Daily

Vivos Therapeutics achieved a first in obtaining FDA clearance of its removable oral appliance for severe obstructive sleep apnea — an alternative to continuous positive airway pressure (CPAP) or surgical implants — while Philips Respironics deals with potential overheating issues in its DreamStation 2 CPAP devices. Source: Drug Industry Daily

Upcoming events in the coming weeks and months include two FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common clinical trial challenges, supplier quality agreements and FDA inspections. Source: Drug Industry Daily

After receiving reports of T-cell malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapies, the agency has announced an investigation into the issue and is evaluating the need for regulatory action. Source: Drug Industry Daily