Recon: FDA places partial hold on Gilead blood cancer drug trials; Senators propose pandemic preparedness overhaul

ReconRecon | 26 January 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA hurries up a quick approval for the world's first TCR -- after a 14-year R&D trek (Endpoints) (Pharmaphorum)
  • In a setback, FDA orders Gilead to hit the brakes on their late-stage, $5B cancer play (Endpoints) (STAT) (Fierce) (BioPharma Dive)
  • Cortexyme switches direction, announces layoffs after FDA slaps hold on dark horse Alzheimer’s candidate (Endpoints)
  • FDA slams door to pivotal trial for bubble boy disease gene therapy as Mustang Bio runs into another hold (Endpoints)
  • Days after Gilead yanks PI3K drug, Incyte withdraws NDA for its own PI3K — saying confirmatory trials would take too long (Endpoints)
  • Key senators propose an overhaul of how the U.S. prepares for pandemics (STAT) (Bloomberg)
  • Republicans see political gold in Democrats' race-sensitive Covid drug guidance (Politico)
  • Insufficient progress is being made in reporting clinical trial results in the U.S. (STAT)
In Focus: International
  • Some European states plan to ease COVID curbs, others seek to tighten (Reuters)
  • German parliament debates compulsory vaccination as COVID surges (Reuters)
  • UK Venture Plans ‘Smart’ Randomized Trials To Speed Access To New Drugs (Pink Sheet)
  • Technology Transfer Deal Allows Brazil To Produce Vaxzevria Domestically (Pink Sheet)
  • DBV Pulls EU Peanut Allergy Patch Filing To Work On A Stronger Application  (Pink Sheet)
Coronavirus Pandemic
  • Scientists are monitoring a new omicron subvariant called BA.2 (The Hill)
  • U.S. has sent 400 mln COVID vaccine doses to 112 nations -White House (Reuters)
  • HHS secretary under fire for being 'invisible' leader during pandemic (The Hill)
  • CDC is asked to release race and gender data on long covid (Washington Post)
  • Covid Live Updates: Vaccination Gap Could Let Another Dangerous Variant Emerge, Experts Say (NYT)
  • New Research Hints at 4 Factors That May Increase Chances of Long Covid (NYT)
  • Wanted: Volunteers to catch COVID in the name of science (Reuters)
Pharma & Biotech
  • Well-connected, Gilead-backed biotech gets another stack of cash to pursue CAR-Ts for autoimmune disease (Endpoints)
  • J&J eyes “tuck-in deals” as consumer health spinoff nears (Pharmaphorum)
  • Small biotechs with big drug ambitions threaten to upend the traditional drug launch playbook (Endpoints)
  • CytoDyn fires embattled CEO as its growing chorus of critics gets louder (Endpoints)
  • As push to disrupt PD-(L)1 pricing heats up, Checkpoint trumpets a pivotal success (Endpoints)
  • A former FDA official on making the jump to health tech startups (STAT)
  • New J&J CEO Joaquin Duato promises an aggressive M&A hunt in quest to grow pharma sales (Endpoints)
  • Atomwise bulks up executive team with Boehringer, Moderna, BridgeBio alums (Fierce)
  • Sanofi claims high-rises neighboring its Toronto facility would pose 'national security' threat (Endpoints)
  • EU IVDR Amending Regulation Published And Staggered Grace Periods Now Official (MedTech Intelligence)
  • Further Transition Period Mooted As Eurasian Device System Comes Into Force To Little Fanfare (MedTech Intelligence)
  • Abbott’s Rapid Covid-19 Tests Boost Quarterly Sales Growth (WSJ) (Reuters)
  • Distalmotion’s Robotic Surgery Approach Attracts New Strategic Expertise And Funding (MedTech Intelligence)
  • Using the eyes as a window, AI predicts annual heart attack risk from retinal scans (Fierce)
Government, Regulatory & Legal
  • Pharma Chips Away at Discount Drugs While Battling HHS in Court (Bloomberg)
  • CBO report highlights rising cost of brand-name drugs in Medicare as Congress considers price negotiations (Endpoints)
  • Not cheaper by the dozen: Bristol Myers becomes the 12th pharma company to restrict 340B sales (Endpoints)
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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