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Latest From Arbor Pharmaceuticals, LLC

Gabapentin Petition Could Give FDA Opportunity to Revisit Tradeoffs In Opioid Oversight Debate

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.

Drug Safety Risk Management

Deal Watch: Lilly Teams Up With Lycia In Protein Degradation

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

Deal Watch Deals

OTC Allergy Switch Approved For Bayer In US

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.

Prescription To OTC Switch FDA

BIO 2021 Notebook: Biogen CEO On Corporate Responsibility

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. 

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