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