Regulatory Focus™ > News Articles > 2021 > 9 > Recon: UK launches trial of Grail blood test for 50 types of cancer; AbbVie hands Regenxbio $370M to

Recon: UK launches trial of Grail blood test for 50 types of cancer; AbbVie hands Regenxbio $370M to develop gene therapy

Posted 13 September 2021 | By Michael Mezher 

Recon: UK launches trial of Grail blood test for 50 types of cancer; AbbVie hands Regenxbio $370M to develop gene therapy

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA vaccine regulators argue against Covid-19 vaccine boosters in new international review (STAT) (Endpoints) (NYTimes) (Politico)
  • GOP Seethes at Biden Mandate, Even in States Requiring Other Vaccines (NYTimes)
  • Surgeon general: New vaccine policies neither illegal nor unusual (Politico)
  • Novavax expects to make available at least 2 bln COVID-19 vaccine doses in 2022 (Reuters)
  • Biden vaccine mandate will test US workplace regulator OSHA (Reuters)
  • FDA head Janet Woodcock raises patent-related concerns to PTO director (Endpoints) (Pink Sheet)
  • Centrist House Democrats Offer Rival Proposal on Cutting Prescription Drug Prices (WSJ)
  • Teva must face government's kickback claims over Copaxone – judge (Reuters)
  • Regenxbio to receive $370 mln upfront in gene therapy deal with AbbVie (Reuters)
  • Cancer drug indications remain on labels even after trials fail to confirm their benefits (STAT)
In Focus: International
  • Roche’s Controlling Family Rules Out Mega-Merger for Drugmaker (Bloomberg)
  • UK to offer Covid vaccines to 12 to 15-year-olds (FT)
  • Britain begins world's largest trial of blood test for 50 types of cancer (Reuters)
  • S.Africa's regulator approves Pfizer COVID-19 shot for children 12 and up (Reuters)
  • Everest to bring Canadian biotech's potential COVID shots to China, other markets (Reuters)
  • Valneva slumps as UK dumps €1.4bn order for COVID-19 jab (PharmaPhorum)
Coronavirus Pandemic
  • Biden to announce new COVID-19 steps ahead of U.N. meeting, surgeon general says (Reuters)
  • Australia buys additional 1 mln doses of Moderna's COVID-19 vaccine (Reuters)
  • Seriously ill COVID-19 patients double in vaccine pace-setter Singapore (Reuters)
Pharma & Biotech
  • A vaccine veteran steps away from the NIH, looking out toward the world (STAT)
  • Phony Diagnoses Hide High Rates of Drugging at Nursing Homes (NYTimes)
    Biogen trials for Alzheimer’s drug excluded much of the targeted patient pool, study finds (STAT)
  • FDA Continues Collaboration with Drug Compounders as Second Anniversary of Compounding Quality Center of Excellence Approaches (FDA)
  • Sanofi places new $1.9B bet even as its last sours; Sam Waksal's new biotech ideas; Cell therapy time for Roche; and more (Endpoints)
  • Exscientia tees up an IPO for its AI drug discovery platform, likely not willing to settle for just $100M (Endpoints)
  • AbbVie dives deeper into eye care, paying $370M cash — with a $1.4B sweetener — to partner on VEGF gene therapy (Endpoints)
  • On heels of one expansion, J&J will pour $176M into another boost for its manufacturing site in Ireland (Fierce)
  • After a decade at Facebook and Google, a tech exec tries his hand at drug development (STAT)
  • Biotech's 'founding father' and influential deal broker Fred Frank dies at 89 (Endpoints)
  • Bristol Myers rolls out 3-year data mesothelioma data for Opdivo/Yervoy in first look at ESMO slate (Endpoints)
  • Trans-Pacific power player Everest jumps on mRNA vaccine deal with Providence, paying $100M upfront to tap platform play (Endpoints)
  • Provention will wait for FDA to 'opine' on new data after teplizumab rejection, eyes Q4 for further talks (Fierce)
  • Bellus says its Merck cough rival passed a PhIIb test after earlier flop, but investors can't make up their minds (Endpoints)
Medtech
  • FDA slaps most serious classification on recall of potentially contaminated ultrasound gels (Fierce)
  • US Regulation Of Fat Transfer Devices Shifts To FDA Biologics Center (MedtechInsight)
  • Abbott, Quest, Quidel likely to benefit from Biden's COVID-19 testing push (MedtechDive)
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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