Recon: France, Italy and Belgium halt hydroxychloroquine use for COVID-19; Novavax buys Praha vaccines for $167M to boost capacity – Regulatory Focus

Posted 27 May 2020 | By Michael Mezher 

Recon: France, Italy and Belgium halt hydroxychloroquine use for COVID-19; Novavax buys Praha vaccines for $167M to boost capacity
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

  • Fauci: Hydroxychloroquine not effective against coronavirus (Politico)
  • Moderna execs have cashed out $89M in shares this year, as stock soared on vaccine hopes (STAT)
  • Trump administration to take action to cap insulin costs for seniors (Washington Post) (STAT) (NPR)
  • Quest Diagnostics launches coronavirus testing for employees returning to work (Reuters)
  • Novavax aims at make one billion COVID-19 vaccine doses after buying plant (Reuters)
  • Big Pharmacy Chains Also Fed the Opioid Epidemic, Court Filing Says (NYTimes)
  • Venture capital found its footing in biotech. Then came the virus. (BioPharmaDive)
  • Experts push for a ‘seal of approval’ to improve the quality of medicines (STAT)
  • Questions about COVID-19 test accuracy raised across the testing spectrum (NBC)
  • Finding, and Curing, Cancers May Be Another Casualty of Coronavirus (NYTimes)
  • Gilead pens $2B Arcus pact for immuno-oncology targets of the past and future (Fierce) (Endpoints)  (Press)

In Focus: International

  • A pharma effort to work with European officials to develop needed drugs is a ‘failure’ (STAT)
  • WHO expects hydroxychloroquine safety findings by mid-June (Reuters)
  • France, Italy, Belgium act to stop use of hydroxychloroquine for COVID-19 on safety fears (Reuters)
  • Drug wars: how AstraZeneca overtook GSK in UK pharma (Financial Times)
  • Roche, Novartis highlight intensifying rivalry in eye disease, MS (Reuters)
  • French consortium steps up plans for saliva-based COVID-19 screening test (Reuters)
  • Antibody drug tech firm AbCellera raises $105 million as it works on COVID-19 (Reuters) (Endpoints)
  • Sanofi CEO has $23B burning a hole in his pocket. Here are some hints on how he plans to spend it (Endpoints)
  • Vertex angers UK CF patients with a delay in submitting data for its newest therapy (STAT)
  • NICE approves Roche’s Tecentriq in TNBC after revising deal (PMLive)
  • NICE issues final guidance on NHS use of Bayer's Vitrakvi (PharmaTimes)

Coronavirus Pandemic

  • He experienced a severe reaction to Moderna’s Covid-19 vaccine candidate. He’s still a believer (STAT)
  • Coronavirus Vaccine Update, May 26 (In The Pipeline)
  • COVID-19 vaccine development (GAO)
  • 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)
  • HHS watchdog vows independence amid Trump actions (Politico)
  • 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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Source: https://www.raps.org/news-and-articles/news-articles/2020/5/recon-france-italy-and-belgium-halt-hydroxychloroq