Experts decry FDA’s halting of a high-profile Covid-19 study over approvals (STAT)
To Fight Covid-19, Don’t Neglect Immunity and Inflammation (NYTimes)
After shortages, Britain opens new protective equipment supply lines (Reuters)
Coronavirus (COVID-19) Update: Daily Roundup May 26, 2020 (FDA)
Pharma & Biotech
The Steps Drug Makers Must Take Now To Avoid A Post-COVID-19 Manufacturing Crisis (Pink Sheet)
COVID-19 Will Have Long Lasting Impact on Biopharma Manufacturing (GEN)
In latest cancer deal, Bristol Myers Squibb's new BD chief bets $65M in search for more targets like PARP (Endpoints)
For a post-Soliris world, Atlas-backed Q32 Bio outlines $46M next-gen complement play (Endpoints)
CRISPR: A New Break in the GPCR Drug Development Pipeline (GEN)
Dupixent clears PhIII trial in new disease as blockbuster looks to expand past Regeneron-Sanofi split (Endpoints)
GSK adds to its trove of positive data for multiple myeloma contender as rivals continue to command the spotlight (Endpoints)
GSK's asthma drug Nucala gets speedy review for rare blood disorder (Endpoints)
Bristol Myers Squibb finally gets in the frontline NSCLC game dominated by Merck, adding a second Opdivo/Yervoy-based option (Endpoints)
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting (FDA)
Novartis Kisqali® shows overall survival benefit in HR+/HER2- advanced breast cancer with consistent findings in patients with more aggressive disease (Press)
Bristol Myers Squibb Receives European Commission Approval for Zeposia (ozanimod) for the Treatment of Adult Patients with Relapsing Remitting Multiple Sclerosis with Active Disease (Press)
Medtech
FDA Breakthrough Devices Program nears 300 designations (MedtechDive)
AstraZeneca spins up new partnership with Propeller Health to add smart features to its Symbicort inhaler (Fierce)
Government & Regulatory
Suit Over 'Illegal' CBD Products Paused To Await FDA Rules (Law360)
Democratic Congressman Calls for Probe Into Former White House Official’s $3 Million Mask Deal (ProPublica)
Ex-biotech chief pleads guilty in college admissions scandal, faces a 10-month prison stretch in plea deal (Endpoints)
Patent Owners Would Get Better Shot At Quashing IPR Petitions Under USPTO Rule (Pink Sheet)
Recent Developments in Humira (adalimumab) Antitrust Suit (Big Molecule Watch)
Ninth Circuit Affirms Dismissal of Breast Implant Manufacturing Defect Claim (Drug & Device Law)
Mallinckrodt Wants More Cuts To Seizure Drug Price Suit (Law360)
Shkreli, Vyera Look To Duck Monopolization Claims (Law360)
High Court Won't Review GE, Teva Patent Appeals (Law360)
Drug Cos. Seek To Exit Chicago Opioid Case (Law360)
Pfizer, Mylan Can't Quickly Appeal EpiPen RICO Class Cert (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.
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