Can Sanofi's top drug carry it through a pandemic? (BioPharmaDive)
Otsuka Files Japan NDA for Preventive Treatment of Migraines (PharmaJapan)
Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the Treatment of Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS) (Press)
AbbVie preps a challenge to a rival migraine drug from Biohaven, spelling out an upbeat set of PhIII data (Endpoints)
F-star's Eliot Forster maps a shortcut to Wall Street, bagging more cash to fuel oncology pipeline work (Endpoints)
The lead drug in Alexion’s $930M buyout deal last fall just flopped — adding injury to analysts’ M&A insults (Endpoints)
Medtech
Smith & Nephew falls short of expectations, citing COVID-19 headwinds (MedtechDive)
Boston Scientific sees sharp US recovery in Q2, CEO says 'procedures can't be deferred forever' (MedtechDive)
FDA approves Roche’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy (Press)
Government & Regulatory
FDA Warns Companies Illegally Selling Hangover Remedies (FDA)
Gilead Can’t Fend Off Antitrust Suit Over HIV Drug Pricing (Bloomberg)
HIV Drug Suit Against Gilead, BMS And Janssen Trimmed (Law360)
Pelosi huddles with chairmen on surprise billing but deal elusive (The Hill)
Seeking to battle high drug prices and the opioid crisis, two states ponder banning gifts to doctors (STAT)
Full Fed. Circ. Won't Rehear Actelion Spinoff's Patent Term Bid (Law360)
DEA Publishes Proposed Rulemaking Addressing Reporting of Thefts and Significant Losses of Controlled Substances (FDA Law Blog)
New York Chantix Case: Great on Preemption, Not So Hot on “Failure to Test.” (Drug & Device Law)
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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