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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.
Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.