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Recon: SEC, FTC investigating Aduhelm approval and marketing; Doctors and public health group mount campaign for Biden’s FDA pick

ReconRecon | 07 February 2022 |  By 

Recon: SEC, FTC investigating Aduhelm approval and marketing; Doctors and public health group mount campaign for Biden’s FDA pick

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Biogen says FTC, SEC probing Alzheimer's disease drug (Reuters) (Endpoints) (Fierce)
  • In a bid to save Biden’s FDA pick, doctors and public health groups are mounting a rare pressure campaign (STAT)
  • Pfizer's COVID cash pile opens opportunities for deals (Reuters)
  • Teva, Texas strike opioid settlement worth $225 million (Reuters)
  • Breaking with past comments, FDA's Richard Pazdur telegraphs rough road ahead for Lilly's China-developed cancer drug (Endpoints) (STAT)
  • Biden’s top science adviser bullied and demeaned subordinates, according to White House investigation (Politico) (WSJ)
  • After some lengthy delays, Sanofi gets the FDA's OK for a rare disease drug (Endpoints)
  • UCB races to regulators after $2.5B rare disease bet delivers data for attack on AstraZeneca and argenx (Fierce) (Endpoints)
  • Regeneron revenue beats estimates on strong sales of Eylea, COVID therapy (Reuters)
  • Pfizer’s $130M Lyme disease vaccine advances to phase 3 after 3rd shot shown to increase antibodies (Fierce)
  • How researchers can get a handle on the monkey shortage for tox studies: FDA explains (Endpoints)
In Focus: International
  • COVID disrupts health services in over 90% of countries -WHO (Reuters)
  • With thousands of jobs on the chopping block, 'nothing's off the table' at Sanofi. What's staying and what's going? (Endpoints)
  • France's Sanofi still sees COVID-19 phase 3 trial completed in first quarter (Reuters)
  • Innovent/Lilly’s Sintilimab, Developed In China, May Be Headed For Troubled US Waters (The Pink Sheet)
  • UK Regulator ‘Optimistic’ About EU Proposals For Northern Ireland Drug Supply (The Pink Sheet)
  • CANbridge, targeting gaps in AstraZeneca’s rare disease coverage, posts early-phase data on C5 inhibitor (Fierce)
  • UK’s CMA Issues £35m In Fines Over Prochlorperazine (The Pink Sheet)
  • India approves Sputnik Light COVID shot for unvaccinated - local manufacturer (Reuters)
  • South African regulator approves Sinopharm COVID vaccine (Reuters)
  • Approval of COVID vaccine made in South Africa could take 3 years, WHO says (Reuters)
  • Nigeria receives 2 million doses of J&J COVID vaccine from EU countries (Reuters)
Coronavirus Pandemic
  • Japan PM Kishida calls for doubling booster shots to 1 mln a day (Reuters)
  • US coronavirus cases are dropping. Other countries are breaking records. (Washington Post)
  • CDC: More vaccinated adults hospitalized with omicron, but fewer admitted to ICU (The Hill)
Pharma & Biotech
  • GSK finds American missed 37M routine vaccinations amid pandemic (Fierce)
  • FDA probes TG Therapeutics’ Ukoniq over potential for elevated death risks 1 year after drug’s approval (Fierce)
  • Arcellx raises $124M in Wall Street debut to bankroll study of multiple myeloma CAR-T (Fierce)
  • Endeavor snags $101M to go after Boehringer, Roche in lung scarring – and do some asset shopping (Fierce)
  • Takeda joins Novartis and Merck in $45M funding for Koneksa Health (Fierce)
  • Top 10 most anticipated drug launches of 2022 (Fierce)
  • Pharma’s cyber vulnerabilities run deeper than Merck’s ‘NotPetya’ attack: report (Fierce)
  • Sanofi ends 2 phase 1 cancer assets weeks after axing Sangamo deal (Fierce)
  • Bayer ends work on cough med that passed phase 2b weeks after FDA rejected Merck’s drug (Fierce)
  • Vanda's gastric drug flops in late-stage test, crashing the biotech's stock (Endpoints)
  • Vas Narasimhan and Severin Schwan each claimed pay packets worth $12M+ for 2021 (Endpoints)
  • Months after Tmunity ground to a halt on clinical hold, cell therapy pioneer Oz Azam is jumping to a stealth startup (Endpoints)
Medtech
  • Ambu scores FDA clearance for single-use gastroscope and touchscreen display (Fierce)
  • Roche partner recalls illegally imported rapid COVID-19 tests from US (MedTech Dive)
  • Procedure volatility, testing uncertainty & FDA delays: Medtech trends in 2022 (MedTech Dive)
Government, Regulatory & Legal
  • Philly, Pittsburgh DAs Lose Bid To Stop Opioid Settlement (Law360)
  • In a victory for medical journals, Pacira loses a libel lawsuit over ‘faulty scientific research’ allegations (STAT)
  • Inside J&J's secret plan to cap litigation payouts to cancer victims (Reuters)
  • In upholding Martin Shkreli's lifetime ban, judge rules any statement he makes about pharma could be a violation (Endpoints) (Reuters)
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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