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Abbott Enters US PFA Market With Volt, Gets Clearance For Heart Delivery Device In Premature Babies
Abbott, which secured CE Mark approval earlier this year, is hopeful that Volt, which can integrate with a 3D mapping system, will bring an edge over competitors. It also won FDA approval and CE mark for a heart device for premature babies, the Piccolo Delivery System.
Medtech Insight - December 26, 2025
MiniMed Files for IPO, Bets On New Pumps And CGMs Amid Simplera Delays
MiniMed flagged launch-related challenges in its IPO filing, saying production of its Simplera CGM is scaling more slowly than expected due to underperformance in initial high-volume automated manufacturing.
Medtech Insight - December 26, 2025
Effective Engagement With The FDA During Recalls Starts With Effective Communication, Expert Says
During webinar hosted by Sedgwick, regulatory experts discussed how firms can optimize engagement with FDA, especially when it comes to communicating recalls and corrective actions.
HBW Insight - December 26, 2025
Executives On The Move: Replicate Bioscience Gets A New Chief Business Officer From Pfizer
Recent moves in the industry include changes at the top at CytoAgents, Saniona and ProFound Therapeutics, plus Enveda Biosciences gets a new SVP from Novo Nordisk.
Scrip - December 26, 2025
How Novo Can Hold Sway Post Semaglutide LOE In India
Industry veterans put themselves in Novo’s shoes, suggesting pricing manoeuvres and tactical measures to blunt competition in India post semaglutide’s LOE in 2026. There’s also court action to watch.
Scrip - December 26, 2025

Executives On The Move: Replicate Bioscience Gets A New Chief Business Officer From Pfizer
Recent moves in the industry include changes at the top at CytoAgents, Saniona and ProFound Therapeutics, plus Enveda Biosciences gets a new SVP from Novo Nordisk.
Scrip - December 26, 2025
How Novo Can Hold Sway Post Semaglutide LOE In India
Industry veterans put themselves in Novo’s shoes, suggesting pricing manoeuvres and tactical measures to blunt competition in India post semaglutide’s LOE in 2026. There’s also court action to watch.
Scrip - December 26, 2025

Abbott Enters US PFA Market With Volt, Gets Clearance For Heart Delivery Device In Premature Babies
Abbott, which secured CE Mark approval earlier this year, is hopeful that Volt, which can integrate with a 3D mapping system, will bring an edge over competitors. It also won FDA approval and CE mark for a heart device for premature babies, the Piccolo Delivery System.
Medtech Insight - December 26, 2025
MiniMed Files for IPO, Bets On New Pumps And CGMs Amid Simplera Delays
MiniMed flagged launch-related challenges in its IPO filing, saying production of its Simplera CGM is scaling more slowly than expected due to underperformance in initial high-volume automated manufacturing.
Medtech Insight - December 26, 2025

Effective Engagement With The FDA During Recalls Starts With Effective Communication, Expert Says
During webinar hosted by Sedgwick, regulatory experts discussed how firms can optimize engagement with FDA, especially when it comes to communicating recalls and corrective actions.
HBW Insight - December 26, 2025

Alvotech Sees Out 2025 With Simponi Biosimilar Debut In Europe
Alvotech and marketing partner Advanz Pharma have claimed a first with the launch of their Gobivaz golimumab biosimilar rival to Simponi in Europe.
Generics Bulletin - December 22, 2025
BsUFA IV: Approval Criteria Shift May Mean US FDA User Fee Changes
A Teva official suggested the increasing reliance on analytical characterizations rather than clinical studies to show biosimilarity should warrant user fee structure changes.
Generics Bulletin - December 22, 2025
Biocon Strikes Aflibercept Deal And Launches Liraglutide In Europe
Biocon Biologics has announced a further settlement over Eylea (aflibercept) allowing launch of its Yesafili biosimilar in territories outside of the US and Canada early next year. Meanwhile, Biocon Limited has launched its liraglutide rival to Victoza and Saxenda in the Netherlands.
Generics Bulletin - December 22, 2025
Europe Leads Charge As Private Equity Roars Back Into Off-Patent Pharma
A pair of private equity mega-deals dominated the mergers and acquisitions landscape in 2025, but there was still a clear appetite for smaller, strategic takeovers and tuck-ins across the generics, biosimilars, and off-patent medicines field.
Generics Bulletin - December 22, 2025

Podcast: “We Are On The Cusp Of A Real Revolution”: OHC Rare Disease Center Boosts Innovation
Matthew Wood, director and chief scientific officer at Oxford-Harrington Rare Disease Center, discusses the state of rare disease R&D, the evolving landscape of genomics and genetic therapies, and the challenges around the biopharma industry’s narrow focus on only 5-10% of rare diseases.
In Vivo - December 22, 2025
Topadur Sees Future Expansion From Wound Healing Into Longevity
A new CEO, a passionate founder, early-stage R&D and hopes of an IPO – can Swiss biotech Topadur find success?
In Vivo - December 22, 2025
How MFN And IRP Convergence Are Rewriting Biotech’s Playbook
Biotech’s pricing playbook is being upended as US Most-Favored Nation rules collide with Europe’s evolving International Reference Pricing models. The result: launch strategies, deal structures and innovation pipelines are all under pressure.
In Vivo - December 22, 2025
Cell And Gene Therapy Leaders See Transformative Results Outweighing Industry Setbacks
Executives at the cell and gene therapy accelerator ElevateBio point to clinical impact, expanding toolbox and manufacturing improvements as reasons for optimism.
In Vivo - December 22, 2025