Latest Pharma Insights
After Digital Surgery Exit, Nehme Starts Regulatory Path For Morph’s Soft Robotics At Wellness
Jean Nehme, who sold Digital Surgery to Medtronic in 2020, has launched London start-up morph, building soft robotic cells — deformable materials that adapt in real time. His strategy: prove the platform in consumer wellness first, then build evidence for a regulated-device path.
HBW Insight - June 30, 2026
Jean Nehme, who sold Digital Surgery to Medtronic in 2020, has launched London start-up morph, building soft robotic cells — deformable materials that adapt in real time. His strategy: prove the platform in consumer wellness first, then build evidence for a regulated-device path.
HBW Insight - June 30, 2026
Testing Choices By Supplement Manufacturers Remain Common GMP Problems US FDA’s Finding
Small number among numerous requirements for manufacturing, packaging, holding and labeling set in 21 CFR Part 111are most common sources of problems FDA investigators continue to find since GMP rule effective for all manufacturers in 2010.
HBW Insight - June 30, 2026
Small number among numerous requirements for manufacturing, packaging, holding and labeling set in 21 CFR Part 111are most common sources of problems FDA investigators continue to find since GMP rule effective for all manufacturers in 2010.
HBW Insight - June 30, 2026
Amgen’s Dave Reese Passes The Baton To Jay Bradner In AI Marathon
Dave Reese previously handed over R&D leadership to serve as Amgen’s first chief technology officer and now that he’s retiring, Jay Bradner will oversee the company’s AI adoption.
Scrip - June 29, 2026
Dave Reese previously handed over R&D leadership to serve as Amgen’s first chief technology officer and now that he’s retiring, Jay Bradner will oversee the company’s AI adoption.
Scrip - June 29, 2026
Evommune Still Has Shot At Atopic Dermatitis With EVO756 After Urticaria Failure
The results of a Phase IIb trial in chronic spontaneous urticaria mean MRGPRX2 inhibition is unlikely to prove effective in that disease, but an analyst noted AD and migraine have biologically distinct mechanisms.
Scrip - June 29, 2026
The results of a Phase IIb trial in chronic spontaneous urticaria mean MRGPRX2 inhibition is unlikely to prove effective in that disease, but an analyst noted AD and migraine have biologically distinct mechanisms.
Scrip - June 29, 2026
Zymeworks Buys Theravance To Execute On New Business Strategy
The company will buy Theravance for $929m, gaining a revenue stream from a US profit-share with Viatris for the nebulized LAMA Yupelri for COPD.
Scrip - June 29, 2026
The company will buy Theravance for $929m, gaining a revenue stream from a US profit-share with Viatris for the nebulized LAMA Yupelri for COPD.
Scrip - June 29, 2026
AstraZeneca Details Bone Health Data For Strensiq Successor
The company believes that efzimfotase alfa, its new treatment for hypophosphatasia, could become a $5bn blockbuster.
Scrip - June 29, 2026
The company believes that efzimfotase alfa, its new treatment for hypophosphatasia, could become a $5bn blockbuster.
Scrip - June 29, 2026
Quotables: Pharma Leaders On The Month’s Hot Topics
The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.
Scrip - June 29, 2026
The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.
Scrip - June 29, 2026
Ipsen Buys Kartos And Its Phase III Navtemadlin, Undeterred By MDM2 Setbacks
Ipsen is betting up to $1.75bn on Kartos Therapeutics and its MDM2 inhibitor navtemadlin, a Phase III add-on therapy for myelofibrosis patients.
Scrip - June 29, 2026
Ipsen is betting up to $1.75bn on Kartos Therapeutics and its MDM2 inhibitor navtemadlin, a Phase III add-on therapy for myelofibrosis patients.
Scrip - June 29, 2026
Pipeline Watch: Japan Dominates Thirty-Four Approvals Plus Seven Phase III Readouts
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Scrip - June 29, 2026
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Scrip - June 29, 2026
Quick Listen: Scrip’s Five Must-Know Things
In this week's episode: China deal controls a hot BIO topic; pharma eyes $2 trillion in sales; Apogee helps AbbVie achieve vision; Sangamo files for bankruptcy; and a review of Weber’s time at Takeda.
Scrip - June 29, 2026
In this week's episode: China deal controls a hot BIO topic; pharma eyes $2 trillion in sales; Apogee helps AbbVie achieve vision; Sangamo files for bankruptcy; and a review of Weber’s time at Takeda.
Scrip - June 29, 2026
Latest FDA Device Classifications Include SNOO Sleeper, Radiology Software With PCCP
The FDA issued classification orders for 16 additional device types in the second half of June, continuing an ongoing surge.
Medtech Insight - June 29, 2026
The FDA issued classification orders for 16 additional device types in the second half of June, continuing an ongoing surge.
Medtech Insight - June 29, 2026
FDA Grants Aidoc Breakthrough Device Designation For First Read AI Chest X-Ray Reporting Tool
The US Food and Drug Administration has granted breakthrough device designation to First Read, which uses AI to generate written reports from chest X-rays. If approved by the FDA, it would be the first commercially available generative software featuring the function.
Medtech Insight - June 29, 2026
The US Food and Drug Administration has granted breakthrough device designation to First Read, which uses AI to generate written reports from chest X-rays. If approved by the FDA, it would be the first commercially available generative software featuring the function.
Medtech Insight - June 29, 2026
Execs On The Move: June 15–19, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - June 29, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - June 29, 2026
India Proposes Faster Medical Device Manufacturing License Timelines
India's health ministry has proposed cutting manufacturing license timelines for medical devices across risk classes, targeting greater regulatory efficiency — but industry body AiMeD has flagged a puzzling anomaly.
Medtech Insight - June 29, 2026
India's health ministry has proposed cutting manufacturing license timelines for medical devices across risk classes, targeting greater regulatory efficiency — but industry body AiMeD has flagged a puzzling anomaly.
Medtech Insight - June 29, 2026
Roche Bets Flexible Economics Can Loosen The Batching Trap That Defines NGS
Roche pitches AXELIOS 1's reusable-sensor economics as the cure for the NGS "batching penalty," backed by early collaborator data and a near-term NICU use case, as it starts on the path from research-use to clinical diagnostics.
Medtech Insight - June 29, 2026
Roche pitches AXELIOS 1's reusable-sensor economics as the cure for the NGS "batching penalty," backed by early collaborator data and a near-term NICU use case, as it starts on the path from research-use to clinical diagnostics.
Medtech Insight - June 29, 2026
Getting The EU MDR ‘Mostly Right’ Is A Juggling Act – The German Industry View
Germany’s BVMed industry association head of regulation Christina Ziegenberg laid out the possible route ahead for the EU co-legislators’ negotiations over amendments to the MDR and IVDR.
Medtech Insight - June 29, 2026
Germany’s BVMed industry association head of regulation Christina Ziegenberg laid out the possible route ahead for the EU co-legislators’ negotiations over amendments to the MDR and IVDR.
Medtech Insight - June 29, 2026
Roche Launches AXELIOS 1 Sequencer At $750,000, Targeting Illumina’s Market
Roche launches AXELIOS 1, a $750,000 sequencer offering $150 genomes and a sub-four-hour whole-genome turnaround under optimized conditions. With middle-ground read lengths and reusable sensor economics, will this broaden access or just add to an already crowded market.
Medtech Insight - June 29, 2026
Roche launches AXELIOS 1, a $750,000 sequencer offering $150 genomes and a sub-four-hour whole-genome turnaround under optimized conditions. With middle-ground read lengths and reusable sensor economics, will this broaden access or just add to an already crowded market.
Medtech Insight - June 29, 2026
After Digital Surgery Exit, Nehme Starts Regulatory Path For Morph’s Soft Robotics At Wellness
Jean Nehme, who sold Digital Surgery to Medtronic in 2020, has launched London start-up morph, building soft robotic cells — deformable materials that adapt in real time. His strategy: prove the platform in consumer wellness first, then build evidence for a regulated-device path.
HBW Insight - June 30, 2026
Jean Nehme, who sold Digital Surgery to Medtronic in 2020, has launched London start-up morph, building soft robotic cells — deformable materials that adapt in real time. His strategy: prove the platform in consumer wellness first, then build evidence for a regulated-device path.
HBW Insight - June 30, 2026
Testing Choices By Supplement Manufacturers Remain Common GMP Problems US FDA’s Finding
Small number among numerous requirements for manufacturing, packaging, holding and labeling set in 21 CFR Part 111are most common sources of problems FDA investigators continue to find since GMP rule effective for all manufacturers in 2010.
HBW Insight - June 30, 2026
Small number among numerous requirements for manufacturing, packaging, holding and labeling set in 21 CFR Part 111are most common sources of problems FDA investigators continue to find since GMP rule effective for all manufacturers in 2010.
HBW Insight - June 30, 2026
Sandoz Starts Generic Tirzepatide Race With FDA Filing Acceptance
Developed in-house by combining expertise in small molecules, devices, and biosimilars, Sandoz intends for its tirzepatide to be the first generic rival to Mounjaro/Zepbound autoinjectors.
Generics Bulletin - June 29, 2026
Developed in-house by combining expertise in small molecules, devices, and biosimilars, Sandoz intends for its tirzepatide to be the first generic rival to Mounjaro/Zepbound autoinjectors.
Generics Bulletin - June 29, 2026
Biocon Grows Malaysian Insulin Presence With A $54m Government Tender Deal
Three multi-year insulin product agreements with Biocon will push Malaysia’s ambition for healthcare self-reliance and domestic manufacturing security.
Generics Bulletin - June 29, 2026
Three multi-year insulin product agreements with Biocon will push Malaysia’s ambition for healthcare self-reliance and domestic manufacturing security.
Generics Bulletin - June 29, 2026
CHMP Nods Deepen Crowded Denosumab, Pegfilgrastim Biosimilar Fields
The EMA’s CHMP has backed Ascend’s self-titled denosumab and Qilu’s Nylaspeg, adding further competition to already crowded European denosumab and pegfilgrastim biosimilar markets.
Generics Bulletin - June 29, 2026
The EMA’s CHMP has backed Ascend’s self-titled denosumab and Qilu’s Nylaspeg, adding further competition to already crowded European denosumab and pegfilgrastim biosimilar markets.
Generics Bulletin - June 29, 2026
Norwich Ruling Strengthens Bausch’s Grip On Xifaxan
Norwich Pharmaceuticals has lost its administrative-law challenge to the FDA over its skinny-label generic of Bausch Health’s Xifaxan, with the D.C. Circuit affirming that the agency was right to withhold final approval until Salix’s hepatic-encephalopathy patents expire in 2029.
Generics Bulletin - June 29, 2026
Norwich Pharmaceuticals has lost its administrative-law challenge to the FDA over its skinny-label generic of Bausch Health’s Xifaxan, with the D.C. Circuit affirming that the agency was right to withhold final approval until Salix’s hepatic-encephalopathy patents expire in 2029.
Generics Bulletin - June 29, 2026
Top Medtechs’ Annual Average Growth Hits 8.5%
A handful of ranking changes among medtech’s topmost global tier in an industry showing healthy growth were reflected in In Vivo’s US dollar-rankings for calendar 2025.
In Vivo - June 29, 2026
A handful of ranking changes among medtech’s topmost global tier in an industry showing healthy growth were reflected in In Vivo’s US dollar-rankings for calendar 2025.
In Vivo - June 29, 2026
‘Stop Talking And Do’: The Team Player Taking A Proactive Oversight Approach At Link Biologics
Reuben Dawkins, CEO and co-founder of Link Biologics, knows the catalysts for innovation. The In Vivo Rising Leader discusses the gap between scientific discovery and commercialization, highlighting the potential of TSG-6, a naturally occurring protein just waiting to be commercialized.
In Vivo - June 29, 2026
Reuben Dawkins, CEO and co-founder of Link Biologics, knows the catalysts for innovation. The In Vivo Rising Leader discusses the gap between scientific discovery and commercialization, highlighting the potential of TSG-6, a naturally occurring protein just waiting to be commercialized.
In Vivo - June 29, 2026