Amgen prevails in high-stakes drug case against Novartis (BioPharma Dive)
Alexion Completes Acquisition of Portola (BusinessWire)
Sarepta bags drug to fully unlock DMD gene therapy opportunity (Fierce Biotech)
Medtech
BARDA backs push for clinical-grade wearable to detect signs of COVID-19 (MedTech Dive)
EU Medical Device Regulation: What Should You Do During the Delay? (MD+DI)
UnitedHealthcare adds coverage of Tandem insulin pumps (MedTech Dive)
Kroger gets FDA authorization for at-home COVID test (Grocery Dive)
CMS proposes major market expansion in potential boost for Abbott's MitraClip (MedTechDive)
FTC settles false advertising suit against low-level light therapy marketer with $22 million judgment (Science-Based Medicine)
Qure.ai gets FDA clearance for its head CT scan product qER (Mobi Health News)
Sherlock, binx to develop point-of-care Covid-19 test using CRISPR technology (MedCity News)
Teva Branded Pharmaceutical Products R&D, Inc.; Withdrawal of Approval of a New Drug Application for ZECUITY (Federal Register) (FDA)
Chiesi Licenses Bioasis Tech to Tackle Brain Symptoms of Rare Diseases (Xconomy)
Government & Regulatory
Alexion Pharmaceuticals To Pay SEC $21M Over FCPA Claims (Law360)
Swift Pace Of Accelerated Approval Submissions Suggests Strong Constituency For US FDA Program (Pink Sheet)
Minnesota's Free Insulin Law Has 'Staggering' Implications, PhRMA Says (Pink Sheet)
US FDA Invites Warning Letter Follow-Up Inspection Alternative Proposals As Pandemic Persists (Pink Sheet)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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