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Recon: CMS head confirmed; EU seeks breach-of-contract fine from AZ

ReconRecon | 26 May 2021 |  By 

Recon: CMS head confirmed; EU seeks breach-of-contract fine from AZ

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Biden's CMS head confirmed, but FDA pick remains elusive (Axios/Yahoo)
  • BARDA Funding Freeze Risks Companies Abandoning COVID Therapeutic Work (Pink Sheet)
  • CDC: Half of US adults now vaccinated against COVID-19 (The Hill)
  • Pandemic creates 500-site backlog for FDA, despite decade of dwindling US inspections (Pharma Tech)
  • The Vaccine Rollout Is Changing How We Think about Prescription Meds (SciAm)
  • HHS commits $4.8B to COVID-19 testing for the uninsured (MedTech Dive)
In Focus: International
  • EU seeks large AstraZeneca fine for alleged contract breach (Reuters)
  • New Switzerland based hub for pathogen storage, sharing and analysis (BioPharma Reporter)
  • UK PM Johnson considered having COVID injection in early 2020, ex-adviser says (Reuters)
  • UK minister should have been fired over COVID, says Johnson's ex-adviser (Reuters)
  • German coronavirus incidence hits lowest level since October (Reuters)
  • Taiwan says China blocked deal with BioNTech for COVID-19 shots (Reuters)
  • Malaysia now has more Covid cases per million people than India (CNBC)
  • In ‘vaccine apartheid,’ Nepal is ground zero. It needs U.S. help (STAT)
  • India plans to study effectiveness of AstraZeneca, Bharat Biotech vaccines (Reuters)
  • A Critical Analysis of the Eurocentric Response to COVID-19: Data Colonialism (Harvard Law Blog)
  • Global Pharma Guidance Tracker – April 2021 (Pink Sheet)
  • Placing medical devices on the Swiss market after the EU MDR Date of Application (Emergo)
Coronavirus Pandemic
  • Op-Ed: Why Redfield Is Wrong on SARS-CoV-2 Origins (Medpage Today)
  • Belgium halts J&J COVID vaccine for under 41s after one dies (Reuters)
  • Russian regions begin vaccinating animals against COVID-19 - RIA (Reuters)
  • Is the Sputnik V vaccine too good to be true? Without the data, it’s hard to know (STAT)
  • Next wave of COVID vaccine developers could yet capture market share, with room for shares to run (Biocentury)
  • Top U.S. health official calls for 'transparent' new probe into origins of pandemic (NBC)
  • Is Herd Immunity With COVID-19 Realistic? (MedPage Today)
  • Microneedles May Alleviate Shots' Pain, Help With Global Vaccine Distribution (NPR)
  • Zydus Cadila, Taiwan's TLC ink pact to market black fungus drug in India Economic Times)
  • UK pharmaceutical firm Vectura agrees to £958m takeover deal (Guardian)
Pharma & Biotech
  • Provention Bio, in need of AdComm's support for diabetes drug, may have what it needs to satisfy the FDA (Fierce)
  • ‘Inaccuracies’ push FDA to reverse Trump-era termination of its Unapproved Drugs Initiative (Endpoints)
  • In a tentative sign of transparency, more leading U.S. universities are reporting clinical trial results (STAT)
  • UK Regulator Reviews AstraZeneca’s Planned $39 Billion Purchase of Alexion Pharmaceuticals (FDA News)
  • Could US FDA User Fee Bill Include The Long-Sought 505(b)(2) Pathway For Biosimilars? (Pink Sheet)
  • FDA Grants Scholar Rock Fast Track Designation for SMA Therapy (Global Genes)
  • FDA accepts BLA for ublituximab + Ukoniq in leukemia and lymphoma indications (Pharmaletter)
  • FDA sets back Travere's plans for kidney disease drug approval (Fierce) (Endpoints)
  • GSK-backed Lyell Immunopharma, fresh off a near $500M cash injection, guns for a $150M IPO (Fierce)
  • Abivax’s ABX464 shows ‘impressive’ efficacy in severe ulcerative colitis patients (Pharma Times)
  • ASCO readouts offer early hints of efficacy for 4-1BB antibodies (Biocentury)
  • Larimar Therapeutics slapped with FDA clinical hold, forced to halt $95M cash raise (Fierce)
  • Eight bets in, Spain's Ysios officially ties a bow around €216M fund (Endpoints) (Fierce)
  • Deal Watch: Roche To Try Pieris’s Anticalins In Respiratory, Ophthalmic Indications (Pink Sheet)
  • IP Waiver Talks Hinge On Use Of Big Pharma's Trade Secrets (Law360)
  • Three years after pivoting out of disaster, Vectura gets a $1.4B private equity buyout (Endpoints)
  • PureTech's video game for ADHD gets big Series D financing (Endpoints)
  • Alzheimer’s trials increasingly sponsored by public sector (Biocentury)
  • EpyGenix: Fishing for best in class in epilepsy (Biocentury)
  • Apellis and Sobi Report Positive Results from Empaveli Study in Treatment Naïve Patients with PNH (Global Genes)
  • ICER to review the role of health insurers in determining patient access to prescription drugs (PMLive)
  • Biotech flipper John Edwards joins Verseau as CEO after overseeing Tilos from birth to Merck buy (Fierce)
  • Comments To The FDA: Opioid Dosing Based On Milligram Morphine Equivalents Is Unscientific (ACSH)
Medtech
  • Hello Heart raises $45M as it charts a broader expansion (MedCity News)
  • What Medtech CEOs Expect from the Second Half of the Year (MedTech Dive)
  • Emboline's New Financing Moves the Needle for Embolic Protection Device (MD+DI)
Government & Regulatory
  • Coronavirus Regulations: A State-By-State Week In Review (Law360)
  • FDA Warns OTC Drugmaker in India for GMP Violations (FDA News)
  • When FDA Makes You An Offer You Can’t Refuse (FDA Law Blog)
  • AMAG Escapes Suit Over Preterm Birth Drug's Effectiveness (Law360)
  • 8th Circ. Won't Revive Mentor Breast Implant Suit (Law360)
  • Actavis Inks $1.1M Deal In ADHD Medication Antitrust Suit (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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Tags: biologics, devices, EMA, EU, FDA, MDR, medical, oncology, pharmaceuticals, US

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