Here are the latest stories being discussed in biopharma today:
FDA Updates Gilead’s Labelling on CAR-T Tecartus with Warning Label for Secondary Cancer
Gilead had its CAR-T drug Tecartus updated by FDA to include a warning for secondary cancer. Novartis, Bristol Myers Squibb, and Johnson & Johnson were also requested by the FDA to add warnings to their currently marketed CAR-T therapies.
FDA Rejects Theratechnologies’ Lipodystrophy Drug for HIV Patients due to CMC Concerns
The FDA has issued a complete response letter to Theratechnologies, rejecting their more concentrated, lipodystrophy drug for HIV patients, Egrifta SV. Reasons cited for the rejection included chemistry, manufacturing and control issues.
Danco Warns SCOTUS of Potential Pharmaceutical Industry Instability due to Abortion Pill Restrictions
Danco Laboratories warned the Supreme Court on Tuesday that restrictive use of the abortion pill mifepristone could cause significant harm to women and potentially destabilize the pharmaceutical industry.
Pharma Companies to Keep Quiet on CMS’ Initial Rates
Pharma companies are expected to withhold information on the initial rate offerings from the Centers for Medicare & Medicaid Services. Despite being legally permitted to go public, the companies argue that they still view the price negotiation process as price setting, equating to undue government interference.
Auvi-q Recruits Brittany Mahomes for New Allergy Injector Campaign
Auvi-q has partnered with Brittany Mahomes to raise awareness for severe food allergies, detailing her own experiences and strategies to manage her infant and toddler’s reactions. She encourages caregivers to educate themselves on food allergy symptoms and always carry an Auvi-q epinephrine auto-injector.
Oncologists Seek More Treatment Options for Advanced Lung Cancer
The majority of oncologists are eager for more treatment options for advanced cases of non-small cell lung cancer (NSCLC), according to a new survey from the Cancer Research Institute and Regeneron. Most oncologists still feel the current treatment options are inadequate, with fewer than one in five rating the existing choices as “excellent.”
