Recon: PhRMA weighs legal options as US pricing reforms move through Congress; Europe to consider dose-sparing to increase monkeypox vaccine

| 11 August 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • The fight is on: As US pricing reform advances through Congress, pharma gears up for a brawl (Fierce) (Endpoints)
  • Pediatric Disincentive? Implications Of US Pricing Bill (Pink Sheet)
  • Amid Roche and Sanofi's oral SERD setbacks, Menarini gets speedy review at FDA (Endpoints)
  • Drugmakers Hunt for One Vaccine to Target All Covid Variants (Bloomberg)
  • Monkeypox vaccine maker voices concerns on US dose-splitting plan (Washington Post)
  • Monkeypox Emergency Clearance Excludes Siga’s Tpoxx Medicine (Bloomberg)
  • FDA declines to free MaaT’s microbiome drug from clinical hold (Fierce) (Endpoints) (Biospace)
  • Cutting Through The Confusion On US Biosimilar Interchangeability (The Pink Sheet)
  • US FDA says possible carcinogen found in some Merck diabetes drugs (Reuters)
In Focus: International
  • Europe to consider "dose-sparing" to increase monkeypox vaccine, WHO seeks trials (Reuters) (US News)
  • Spain asks EMA to allow 'dose-sparing' for monkeypox vaccine (Reuters)
  • EMA Tackles Delays With Scientific Advice Procedure (The Pink Sheet)
  • EMA issues warning of IVF drug shortage due to manufacturing issues (Endpoints)
  • Latin American Countries To Coordinate Purchase Of Monkeypox Vaccine (Pink Sheet)
  • French Increase Penalties On Firms Breaching Drug Supply Rules (The Pink Sheet)
  • 110,000 hens to be slaughtered after bird flu found on German farm (Reuters)
  • Aspen Setback Illustrates Need For Africa To Build Up Vaccines Market (The Pink Sheet)
  • Africa CDC in discussions with potential buyers for Aspen's COVID vaccines (Reuters)
  • Demand-constrained Covid vaccine market may push South Africa's Aspen to change its direction (Endpoints)
Pharma & Biotech
  • Biogen Expected to Cut Costs by $1B as Industry Braves Economic Instability (Biospace) (STAT)
  • Q2 ’22 was weakest quarter for biotech IPOs in more than 5 years (Fierce)
  • Band of biotechs cut pipeline prospects to focus cash on priority programs (Fierce)
  • Advent to sell Bioduro stake, eyes valuation over $1 bln – sources (Reuters) (Endpoints)
  • BMS bites at GentiBio’s next-gen regulatory T cells, betting $1.9B on 3 programs (Fierce)
  • Bristol Myers flashes a thumbs-up on pivotal push to expand Abecma's BCMA CAR-T market (Endpoints) (Fierce)
  • Pfizer launches rebate program for rare disease patients who have to stop taking Panzyga (Endpoints)
  • Fierce Biotech Layoff Tracker: Vedanta lets go of 20% of staff; Absci CEO reveals ‘workforce reduction’ (Fierce)
  • Just months after layoffs and pushing eye therapy, ProQR offloads eye portfolio in pivot to RNA-editing (Endpoints)
  • Citing 'challenging economic environment,' PhIII-ready microbiome biotech lays off 20% of staffers (Endpoints)
  • ‘Underfunded’ FDA falls short in ensuring medical devices protect against cyberattacks, experts say (Medtech Dive)
  • The FDA’s ‘breakthrough’ medical devices are finally hitting the market in numbers (STAT)
  • Insulet raises forecast as Omnipod 5 sales climb; Tandem expects tougher market in second half (Medtech Dive)
  • Class I Recall For Haimen Shengbang Viral Sampling Containers (MedTech Insight)
  • US CDC Teams Up With ACLA To Expand Monkeypox Testing (MedTech Insight)
  • As monkeypox cases increase, disease experts lament lack of testing access (Medtech Dive)
  • Cue Health plots next at-home tests while still raking in COVID profits for now (Fierce)
  • How We Can Use the FDA’s 2022 Diversity Guidance to Make Our Clinical Trials More Inclusive (Medtech Insight)
Government, Regulatory & Legal
  • Faced with thousands of opioid lawsuits, Endo says it will likely file for bankruptcy 'imminently' (Endpoints)
  • Facing Thousands of Zantac-Related Lawsuits, GSK and Sanofi See Mass Sell-Off of Shares  (Biospace)
  • GSK, Sanofi, Haleon slump on Zantac litigation concerns (Reuters)
  • Market reaction to Sanofi’s upcoming litigation over Zantac is ‘overblown,’ analysts say (Fierce)
  • Boston Scientific says it’s investigating allegations of anti-bribery law violations (Medtech Dive)
  • Surgalign Pays $2M To Resolve SEC Investigation (MedTech Insight)
  • Walgreens Fueled SF Opioid Epidemic, Judge Rules (Law360)
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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