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September 7, 2023
by Jason Scott

Recon: Astellas drops lawsuit over Medicare pricing negotiations; Pfizer, Valneva see positive results in Lyme vaccine booster study

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Astellas withdraws lawsuit after evading Medicare drug price negotiations (STAT) (Reuters)
  • Why the drug industry’s opaque warnings on price negotiations fall short (STAT)
  • What could fix cancer clinical trials’ longstanding diversity problem? (STAT)
  • Pfizer, Valneva say 'positive' result for Lyme disease vaccine candidate booster (Reuters)
  • ANDA Submissions Lagging As FY 2023 Nears Its End (Pink Sheet)
  • J&J shutters PhIII trial for pulmonary hypertension drug, blocking its expanded use as patent expiry looms (Endpoints)
  • FDA Rejects AstraZeneca’s Ultomiris Label Expansion in NMOSD (BioSpace)
  • Moderna Says Updated COVID-19 Vaccine is Effective Against Newer Variants (BioSpace)
In Focus: International
  • South Africa was forced into ‘one-sided’ deals with Covid-19 vaccine suppliers, contracts reveal (STAT)
  • Britain's Superdrug says Wegovy received is "very small fraction" of waiting list (Reuters)
  • In boon for scientists, U.K. strikes deal to join E.U. Horizon research program (STAT)
  • UK Considers US -Style Payment Reporting Obligations For Pharma Firms (Pink Sheet)
  • EU Health Data Access Proposal Should Not Include Opt-Out Model, Pharma Says (Pink Sheet)
  • Bristol Myers Squibb’s Camzyos gets NICE recommendation (Pharma Times)
  • EC Plans New Structures For Manufacturers Of High-Risk IVDs Soon (MedTech Insight)
Pharma & Biotech
  • Biogen names Jane Grogan as head of research (The Pharma Letter)
  • Novo Nordisk teams up with Harvard, Broad Institute on diabetes and cardiac fibrosis (Fierce Biotech)
  • Former Google AI expert raises $100mn for biotech start-up (Financial Times)
  • FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters (FDA Law Blog)
  • Cancer care appears brighter as off-the-shelf CAR-T advances (STAT)
  • AstraZeneca CEO Pascal Soriot proposes a novel fix to the drug pricing law’s alleged cancer problem (STAT)
  • What a viral study criticizing cancer screening gets very, very wrong (STAT)
  • Insulet shares slump on concerns of sales hit from new diabetes drugs (Reuters)
  • Alnylam's gene-silencing drug cuts blood pressure in mid-stage trial (Reuters)
    Seagen teams up with protein degradation specialist to make a new kind of antibody conjugate, paying $60M upfront (Endpoints)
  • Ultra-Rare Tumors: Public-Private Partnership Eyed To Boost Drug Development (Pink Sheet)
  • Ariceum doses first patient with satoreotide (Pharma Times)
  • Neuroplast spinal cord injury study milestone (Pharma Times)
  • Abbott Buys Bigfoot Biomedical – But What Lurks In The Forest? (MedTech Insight)
  • Roche Sees Return on $310M Investment with Alnylam’s Phase II Hypertension Win (BioSpace)
  • BMS Accused by HMO of Patent Fraud to Allegedly Sustain Pomalyst Monopoly (BioSpace)
  • Feeder Programs First Step in Bringing More Diversity to Pharma (BioSpace)
  • Nimbus Secures $210M in Private Funding on Heels of $4B Takeda Deal (BioSpace)
Medtech
  • IBM notifies J&J unit Janssen CarePath's customers of unauthorized data access (Reuters)
  • Philips settles one category of U.S. claims over respirator recall (Reuters)
  • Synchron brain-computer interface implanted in first 6 US patients (MedTech Dive)
  • Cue Health board pressured by investor to review strategy, cut costs (MedTech Dive)
  • Vitestro begins blood-drawing device study (Pharma Times)
  • Medtronic Faces Class-Action Lawsuit Over Alleged Patient Data Sharing From MiniMed, InPen Diabetes Devices (MedTech Insight)
Government, Regulatory & Legal
  • In Case You Missed It: News On Consent Decrees, Medicare’s ‘Small Biotech Exception’ And More (Pink Sheet)
  • HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises Questions (FDA Law Blog)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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