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July 17, 2020
by Michael Mezher

Recon: EU in talks to secure COVID-19 vaccines; NICE backs Astellas’ Xospata

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Three more biotechs tumble onto Wall Street today, raising $475M as the IPO party rocks on (Endpoints)
  • CDC to recommend against retesting coronavirus patients before they end isolation (Politico)
  • The Latest: 3M files lawsuits for price gouging of N95 masks (AP)
  • Corbus Pharma is nearing the readout of a pivotal drug study. Here’s what you need to know (STAT)
  • 'Meaningless' FDA Certificates Are Used To Tout Dubious Face Masks (NPR)
  • Sens. Elizabeth Warren and Bernie Sanders slam Trump for giving Gilead ‘windfall’ deal for coronavirus drug (CNBC)
In Focus: International
  • EU in talks with Moderna, BioNtech, CureVac to secure possible COVID vaccines, sources say (Reuters)
  • EU Leaders Meet In Hopes Of Closing Divisions Over COVID-19 Relief Package (NPR)
  • Sanofi Considers US Biotech Targets Including Principia (Bloomberg)
  • UK builds up Covid-19 medicines stockpile in case of second wave (Financial Times)
  • NICE recommends Astellas’ Xospata for NHS use (PMLive)
  • In Coronavirus Vaccine Race, China Strays From the Official Paths (NYTimes)
  • Hong Kong Gives Nod to Asia’s Biggest Healthcare Listing in 2020 (Bloomberg) (Endpoints)
  • Japan Might Tap Coronavirus Emergency Reserve for Vaccines (PharmaJapan)
Coronavirus Pandemic
  • New Covid-19 study, despite flaws, adds to case against hydroxychloroquine (STAT)
  • India Coronavirus Cases Surge Past One Million (NYTimes)
  • Exclusive: White House Document Shows 18 States In Coronavirus “Red Zone” (Center for Public Integrity)
  • Operation Warp Speed doesn’t have the transparency it needs (STAT)
  • Hospitals’ recovery plans clash with new Covid infections (Politico)
  • Who took down the CDC’s coronavirus data? The agency itself. (Politico)
  • How HHS’s new hospital data reporting system will actually affect the U.S. Covid-19 response (STAT) (ProPublica)
  • UK MHRA Relies On Remote Drug GMP Inspections As COVID-19 Pandemic Grounds Inspectors (Pink Sheet)
  • CDC bans U.S. cruises through September, citing ‘ongoing’ coronavirus outbreaks on ships (CNBC)
  • 3 Quest COVID-19 assays get FDA OK for at-home collection via telehealth (MedtechDive)
  • BD sells 750K antigen tests to HHS as COVID-19 nursing home testing scales up (MedtechDive)
  • Coronavirus (COVID-19) Update: Daily Roundup July 16, 2020 (FDA)
Pharma & Biotech
  • Improving Clinical Trial Enrollment — In the Covid-19 Era and Beyond (NEJM)
  • Startup Spotlight: Glympse Bio hopes its test will show whether drugs are actually working (STAT)
  • As Amazon builds new health ventures, Haven struggles to gain ground (STAT)
  • AstraZeneca's Brilinta looks for label boost with trial win, priority review in stroke patients (Fierce)
  • AstraZeneca’s Farxiga scores another FDA fast-track designation (PMLive)
  • Merck, Bayer get FDA priority review for heart failure drug (PMLive)
  • In anticipation of PhIII trial results, Amicus pares down old debt with $400 million loan (Endpoints)
  • Eli Lilly’s mirikizumab joins the club beating up on Cosentyx as another head-to-head study leaves Novartis’ drug in the dust (Endpoints) (Press)
  • J&J-partnered MeiraGTx aims at Biogen with new eye gene therapy data (Endpoints)
  • Pharma's TV ad spending level sets in June, with AbbVie, Sanofi and Regeneron leading the way (Fierce)
  • A Jennifer Doudna-led team finds a new CRISPR enzyme in the giant viruses of a California mud bog (Endpoints)
  • BMS gets the ball rolling on liso-cel in Europe; BeiGene files China NDA for in-house PARP drug (Endpoints)
  • DoorDash partners with Walgreens to deliver over-the-counter drugs and other health products (CNBC)
  • Tony Kingsley takes over the reins at Scholar Rock; Idorsia taps pharma vet Patricia Torr for new US ops (Endpoints)
Medtech
  • J&J drops planned 510(k) for Verb-Auris general surgery robot, targets 2022 clinical trial start (MedtechDive)
  • FDA Gives Less Than 36 Hours’ Notice On Closure Of COVID-19 Hotline (MedtechInsight)
  • UK Health Care At The Crossroads As Medtechs Watch For Bill, Brexit And NHS Change (MedtechInight)
  • Ambu wins FDA clearance for single-use duodenoscope product (MedtechDive)
  • XACT Robotics nets FDA clearance for second-generation needle surgery system (Fierce)
  • Merck taps Novocure's cancer-fighting electric fields for new Keytruda combination study (Fierce)
Government & Regulatory
  • CVS Fined for Prescription Errors and Poor Staffing at Pharmacies (NYTimes)
  • Democrats use inspector general report to renew calls for Medicare chief's ouster (Politico)
  • How A Medicare Payment ‘Loophole’ Boosts Spending On Orencia, Cimza (Pink Sheet)
  • 9th Circ. Skeptical Calif. Pay-For-Delay Law Poses Danger (Law360)
  • Gilead Tries To Shake Antitrust Suit Over Expensive HIV Drugs (Law360)
  • Pfizer, Mylan Push To Pare Down EpiPen Class Action (Law360)
  • Covidien Asks 1st Circ. To Hand It Ex-Worker's Device Patents (Law360)
  • 6th Circ. Again Refuses To Boot Judge From Opioid MDL (Law360)
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.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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