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The FDA issued a complete response letter (CRL) for Sanofi and Regeneron’s supplemental biologics license application (sBLA) for Dupixent (dupilumab) in chronic spontaneous urticaria (CSU) requesting additional efficacy data, the companies announced on Friday. Read More
In this edition of Quick Notes, we cover a pharmaceutical ingredient cartel, fake Ozempic pens and new transparency rules for the European Medicines Agency clinical trial information system. Read More
After an FDA advisory committee voted overwhelmingly against its ALS drug NurOwn, BrainStorm Cell Therapeutics announced that it is withdrawing the BLA for the drug so that it can conduct an additional phase 3 trial. Read More
It’s rare, but it turns out a company seeking approval for a new indication can find success in the wake of an FDA Complete Response Letter (CRL) as is the case for Ardelyx’s Xphozah (tenapanor). Read More
The FDA has issued a new final guidance intended to facilitate the development and assessment of regenerative medicine therapy (RMT) products CBER regulates through identifying and recognizing voluntary consensus standards (VCS). Read More
Seeking to better understand innovative clinical trial designs and approaches, CDER has asked stakeholders to share feedback on current barriers and opportunities around this topic. Read More
The FDA provides clarity for drugmakers in a final guidance on how the agency’s considerations about a drug’s risks and benefits factor into NDA and BLA premarket and postmarket decisions. Read More
The FDA handed out a fistful of approvals this week, including three for Merck’s juggernaut PD-1 blocker Keytruda, bringing the drug’s total indications to 36. Read More
CMS’s decision to allow coverage of positron emission tomography (PET) agents used to detect amyloid plaque deposits in the brain means patients suspected of having Alzheimer’s may now be covered for more than one PET scan per lifetime, and need not be in a clinical trial to receive the scan. Read More
The FDA’s new draft guidance provides recommendations on overall development programs for drugs to treat diabetic foot infections (DFI) as well as clinical trial designs. Read More