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Regulatory Focus™ > News Articles > 2020 > 9 > Recon: FDA approves GSK's three-drug asthma inhaler; EMA extends review of BioMarin gene therapy

Recon: FDA approves GSK's three-drug asthma inhaler; EMA extends review of BioMarin gene therapy

Posted 10 September 2020 | By Michael Mezher 

Recon: FDA approves GSK's three-drug asthma inhaler; EMA extends review of BioMarin gene therapy

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Senior FDA career executives: We're following the science to protect public health in pandemic (USA Today)
  • The coronavirus pandemic underscores the need to bring drug manufacturing back to US (CNBC)
  • Several Covid-19 Vaccines Could Join Winner’s Circle (WSJ)
  • GSK's three-drug inhaler wins US nod for use in asthma patients (Reuters) (Endpoints)
  • Trump said he knew virus was deadly but still played down crisis: Woodward book (Reuters)
  • Senate polarized over next coronavirus aid package (Reuters)
  • Most Adults Wary of Taking Any Vaccine Approved Before the Election (KHN)
In Focus: International
  • AstraZeneca expects COVID vaccine result by year-end if trials resume (Reuters)
  • Serum Institute pauses India trials of AstraZeneca's COVID-19 vaccine (Reuters)
  • World must scale up clinical trials to address COVID-19, WHO says (Reuters)
  • UN's Guterres calls for $35 billion more for WHO COVID-19 program (Reuters)
  • EU review extended for BioMarin's gene therapy Valrox (PharmaTimes)
  • AstraZeneca's asthma drug succeeds late-stage study (Reuters)
  • China’s Baidu is in talks to raise up to $2 billion to launch a stand-alone biotech company (CNBC)
  • Germany Sets Direction Of Travel With New Biosimilar Guidelines (Pink Sheet)
Coronavirus Pandemic
  • ‘You can’t rush science’ — Merck CEO stresses need for careful approach to coronavirus vaccine (CNBC)
  • Scientists question ‘strange’ data in Russian coronavirus vaccine trial after ‘unlikely’ patterns (CNBC)
  • 8,000 jumbo jets needed to deliver coronavirus vaccines globally, IATA warns (CNBC)
  • Why the FDA authorized just one test to classify all Covid-19 plasma (Quartz)
  • ‘Hell has frozen over’: The pharmaceutical industry stands in for a politically impaired FDA (STAT)
  • The Pony Express? US Postal Service changes continue to slow down deliveries of mail-order prescriptions (STAT) (The Hill)
  • Exclusive: Ginkgo teams with unknown upstart in hunt for Covid-19 antibody (Endpoints)
  • Top FDA Officials Explain Standards For Take-Home COVID-19 Tests (MedtechInsight)
  • Key FDA Drug Inspection Challenges Amid COVID-19 (Law360)
Pharma & Biotech
  • FDA Delays Start of Sarepta’s Gene Therapy Trial. That Doesn’t Faze the Stock’s Bulls. (Barron's) (Endpoints)
  • Casma Therapeutics brings in another $50 million to target muscular dystrophy (STAT)
  • Korro Bio raises $90 million to fix mutations that cause diseases (STAT)
  • The Risks of the Prescribing Cascade (NYTimes)
  • Takeda reports PhIII failure for Ninlaro in multiple myeloma; AstraZeneca plots pivot to Nasdaq (Endpoints)
  • Upcoming market catalysts in Q4 2020 (Nature)
  • 23andMe’s next challenge: ensuring its customers can get drugs developed with their data (STAT)
  • MilliporeSigma Plans $65 Million Manufacturing Expansion (GEN)
  • Animal data in hand, Nessan Bermingham banks $91.5M for Atlas-backed RNA editing play (Endpoints)
  • Intra-Cellular's Caplyta could cruise toward blockbusterland with bipolar depression win: analyst (Fierce)
  • FL56+FL57= infinite possibilities? Flagship's hybrid startup takes machine learning in drug discovery to the next level — and Covid-19 offers a quick test (Endpoints)
  • Orasis Pharmaceuticals snags $30M to see its presbyopia treatment through to PhIII (Endpoints)
  • MiNA Therapeutics bags nearly $30M Series A to push activating mRNA tech through the clinic (Endpoints)
  • Recursion nabs $239M and an up to $1B partnership with Bayer as AI race heats up (Endpoints)
  • Codiak files for an IPO, again, this time shooting for a nine-digit raise (Endpoints)
  • Phase III migraine flop sends a small-cap biotech player into a deadly tailspin (Endpoints)
  • New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD) (Press)
Medtech
  • FDA aims to harmonize adverse event reporting with eMDR updates, makes patient problem codes public (MedtechDive)
  • Medtronic tricuspid valve replacement device wins FDA breakthrough status (MedtechDive)
  • The best TAVR device? Experts opine on when to use Boston Scientific, Edwards or Medtronic valve (MedtechDive)
  • Ultrasound ablation provided 'adequate' short-term control for prostate cancer patients, small study shows (MedtechDive)
Government & Regulatory
  • Rare Pediatric Disease Voucher Program Gains Temporary Extension From House Committee (Pink Sheet)
  • Mallinckrodt Pays Executives $5 Million in Bonuses Ahead of Possible Bankruptcy (WSJ)
  • GAO: FDA Could Better Communicate with Airlines to Encourage Voluntary Construction Inspections of Aircraft Galleys and Lavatories (GAO)
  • Hospitals urge HHS to step in on 340B fight with drugmakers (BioPharmaDive)
  • Drugmakers Want Zetia 'Shortcut' Cert. Short-Circuited (Law360)
  • Doctor Says FDA Made Wrong Call On Opioids In NY AG Suit (Law360)
  • House Committee Advances Medical Marijuana Research Bill (Law360)
  • AAM Renews Challenge to California’s Law Targeting Pharmaceutical Patent Infringement Settlements (Big Molecule Watch)
  • Snyders Heart Valve LLC v. St. Jude Medical, LLC (Fed. Cir. 2020) (Patent Docs)
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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