Public Citizen’s request to place gabapentin on DEA’s controlled substances list may be a test case for how much weight FDA plans to give to broader public health impacts of drug approvals as opposed to the risk-benefit calculus for individual patients for whom a drug is labeled.

Lilly hopes to address immunology and pain indications with biotech’s LYTAC technology. Sunovion licenses European rights to Parkinson’s therapy Kynmobi to Bial.

CDER approves Bayer Healthcare’s azelastine 0.15% nasal antihistamine indicated for seasonal and perennial allergic rhinitis in adults and children 6 and older. Bayer says Astepro Allergy is first steroid-free antihistamine for allergies available OTC in the US and the first indicated for indoor and outdoor allergy relief.

News and views from day four of the BIO Digital annual meeting include the FDA's plans to use carrots not sticks to improve diversity and reflections on how the pandemic has strengthened biopharmaceutical supply chains.