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