Recon: Pharma loses bid to stop states from importing drugs from Canada; EU approves AstraZeneca’s Forxiga for chronic heart failure

ReconRecon | 07 February 2023 |  By 

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

In Focus: US
  • Biden to push for universal insulin price cap in State of the Union (Politico)
  • The Medicine Is a Miracle, but Only if You Can Afford It (NYTimes)
  • A Technicality Could Keep RSV Shots From Kids in Need (KHN)
  • Kidney dialysis-related infection rates higher in U.S. minorities -report (Reuters)
  • Pharma loses a court battle in its bid to block states from importing drugs from Canada (STAT)
  • Chinese DNA giant’s U.S. affiliate looks to rival Illumina, touting $100 genome and high-power sequencers (STAT)
  • Senators probe telehealth companies for tracking and monetizing sensitive health data (STAT)
  • Former Sen. Richard Burr to join health care practice at law and lobbying firm (STAT)
  • Takeda snags expanded pediatric approval for rare genetic disorder drug (Endpoints)
In Focus: International
  • Angry at Vertex pricing of cystic fibrosis drugs, families in four countries seek to override patents (STAT) (Fierce) (NYTimes)
  • AstraZeneca’s Forxiga approved in EU for chronic heart failure (Pharmafile)
  • Takeda’s dengue vaccine receives MHRA approval for those aged four years and older (PMLive)
  • Farming, pharmaceutical and health pollution fuelling rise in superbugs, UN warns (The Guardian)
  • UK health system, under strain, lays out medtech strategy (MedtechDive)
  • GSK's India unit posts 9% rise in Q3 profit as input costs slump (Reuters)
  • Activist investor rallies Bayer shareholders as pressure on CEO mounts -sources (Reuters)
  • Australian biotech touts a positive mid-stage data readout — with old Shire drug (Endpoints)
Pharma & Biotech
  • Unjustifiable Delays In Generic Competition? Biopharma Contends There Is No Problem (Pink Sheet)
  • Danaher Said to Be Interested in Life Sciences Firm Catalent (Bloomberg)
  • A longtime tracker on pharma R&D productivity takes a post-pandemic plunge back to a bleak reality (Endpoints)
  • Aduhelm Shows Need For More FDA Transparency On Approval Decisions, Surrogate Endpoints, Critics Say (Pink Sheet)
  • Lundbeck shares spike after positive mid-term profit guidance (Reuters)
  • Aldeyra’s sights set on November PDUFA; Synbio startup scores cash (Endpoints)
  • Arrowhead confirms J&J’s plan to dial back hepatitis B drug research (BioPharmaDive)
  • Rocket, putting regulatory roadblocks in its rearview, receives show of confidence in gene therapy from FDA (Fierce)
  • Orexo, leveraging drug delivery tech, seeks FDA approval of nasal high-dose opioid rescue medicine (Fierce)
  • Roche says its C5 inhibitor aced PhIII head-to-head trials with AstraZeneca’s Soliris (Endpoints)
  • Blood stem cell therapy maker Garuda nabs $62M (Endpoints)
  • RefleXion overcomes 'unprecedented hurdles' to land FDA nod for biology-guided radiotherapy tech (Fierce)
  • Diagnostic firms turn to restructuring in bid to preserve cash: Goldman (MedtechDive)
  • EU Opening Pandora’s Box With Data Act, Warns Medical Imaging Body COCIR (MedtechInsight)
Government, Regulatory & Legal
  • PTAB Again Axes Cochlear Implant IP After Vidal Remand (Law360)
  • Sanofi responds to patent spat with Amgen as Supreme Court arguments set for March (Endpoints)
  • DC appeals court revives case accusing pharmas of financing terror attacks (Endpoints)
  • Centene warns of hit to fast-growing Medicare Advantage business next year (Reuters)
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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