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Regulatory Focus™ > News Articles > 2020 > 7 > Recon: Novavax, Regeneron get nearly $2B in Operation Warp Speed funding; FDA puts Cellectis CAR-T t

Recon: Novavax, Regeneron get nearly $2B in Operation Warp Speed funding; FDA puts Cellectis CAR-T trial on hold after death

Posted 07 July 2020 | By Michael Mezher 

Recon: Novavax, Regeneron get nearly $2B in Operation Warp Speed funding; FDA puts Cellectis CAR-T trial on hold after death

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Moderna spars with US scientists over COVID-19 vaccine trials (Reuters)
  • FDA warns of false positives with BD coronavirus diagnostic (MedtechDive) (FDA)
  • US coronavirus response still crippled by lack of testing, Dr. Scott Gottlieb says (CNBC)
  • Death in Cellectis off-the-shelf CAR-T trial triggers FDA hold (Fierce) (STAT) (Endpoints)
  • US Will Pay $1.6 Billion to Novavax for Coronavirus Vaccine (NYTimes) (STAT)
  • Regeneron bags $450M deal with U.S. government for coronavirus antibody cocktail supply (Fierce) (Endpoints) (Reuters)
  • J&J sews up 5 years of coronavirus vaccine supply in $480M-plus deal with Emergent (Fierce)
  • Lobbyists tied to Trump represent more than a dozen companies working on Covid-19 (STAT)
In Focus: International
  • GSK’s anti-HIV drug better at preventing infection, trial finds (Financial Times)
  • GlaxoSmithKline pens COVID-19 vaccine pact with Medicago (Fierce) (Press)
  • Novartis banks EC approval for Enerzair Breezhaler (PharmaTimes) (Press)
  • Johnson & Johnson lowers the price of its TB drug in many poor countries, but is it enough? (STAT)
  • CureVac scores $85M loan to scale COVID-19 shot manufacturing at German site (Fierce)
Coronavirus Pandemic
  • Fauci on a COVID-19 vaccine: 'We will at least have an answer' in the winter whether it works (NBC)
  • Dr. Fauci says coronavirus immunity may be ‘finite,’ duration remains uncertain (CNBC)
  • US FDA’s Career Leaders Quietly Emerge As Effective Operators In COVID-19 Response (Pink Sheet)
  • A New Generation of Fast Coronavirus Tests Is Coming (NYTimes)
  • Coronavirus (COVID-19) Update: Daily Roundup July 6, 2020 (FDA)
Pharma & Biotech
  • A Shot to Protect Against HIV (NYTimes)
  • Patient Is Reported Free of HIV, but Scientists Urge Caution (NYTimes)
  • ‘It will consume your life’: 4 families take on rare diseases (NYTimes)
  • EMA fast-tracks review of AZ/Daiichi Sankyo’s HER2 drug (PMLive)
  • Biogen boosts gene therapy strategy with Harvard pact focused on inherited eye disease (Fierce)
  • Jonathan Sackler, joint owner of opioid maker Purdue Pharma, dies aged 65 (The Guardian)
  • Startup PBM Capital Rx, Walmart partner to shed light on specialty, mail-order drug prices (Fierce)
  • Proposed changes to lung cancer screening guidance could increase scans among Black patients, women (STAT)
  • Second PhIII study for Idorsia's sleep drug returns positive results, but also raises new questions (Endpoints)
  • Scientist Makes A Discovery That May Lead To New Drugs For Rare Brain Diseases (NPR)
  • India coronavirus: Life-saving Covid-19 drugs sold on Delhi black market (BBC)
  • Indian pharma compliance standards improving, regulatory risks here to stay: Ind-Ra (Economic Times)
  • AlloVir tests how much an antiviral biotech can reap in a pandemic stock market (Endpoints)
  • Boehringer Ingelheim ties the knot with Numab on new antibodies; Cabaletta inks pact with Artisan (Endpoints)
  • Flagship execs take a lesson from nature to master ‘gene writing,’ launching a star-studded biotech with big ambitions to cure disease (Endpoints)
  • Takeda’s post-merger deals continue as OTC subsidiary is prepared for sale (Endpoints)
  • Investors give ailing Unum a lease on life and a whole new suite of experimental cancer drugs (Endpoints)
  • RA Capital doubles down on Siddhartha Mukherjee's vision for a new cell engineering approach, leading Vor's $110M Series B (Endpoints)
  • EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer (Press)
  • 'If the public knew:' Ripple20 shows medical device software cyber weakness (MedtechDive)
  • FDA approves Abbott's Bluetooth-connected pacemaker, defibrillator implants (Fierce)
  • Propeller's digital inhaler tech to be co-prescribed with Novartis' new asthma med (Fierce)
  • Industry Publishes Key Proposals For Development Of Companion Diagnostic Guidance (MedtechInsight)
  • Dascena wins FDA beakthrough device designation for AI to predict kidney injury (MassDevice)
Government & Regulatory
  • Generics' Bid To Limit IP Loss 'Makes No Sense,' Judge Says (Law360)
  • Pharmacies Can't Slip Opioid Nuisance Claims, Counties Say (Law360)
  • How Therapeutic Formulations Affect Medical Device Patents (Law360)
  • Fed. Circ. Clears Amgen's Avastin Biosimilar In Notice Fight (Law360)
  • Sanofi Urges High Court To Expand Arthrex To All (Law360)
  • Immunex Corp. v. Sandoz Inc. (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.

Tags: US, worldwide

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