Latest Pharma Insights
ViiV’s Cabenuva Takes The CROWN In Unsuppressed HIV Patients
The long-acting injectable was superior to daily oral therapy at viral suppression in treatment-experienced patients who had detectable virus when entering the study.
Scrip - October 6, 2026
The long-acting injectable was superior to daily oral therapy at viral suppression in treatment-experienced patients who had detectable virus when entering the study.
Scrip - October 6, 2026
ArriVent Stumbles With Phase III Miss For Rybrevant Competitor
ArriVent’s firmonertinib failed against chemo on PFS in NSCLC with exon 20 insertion mutations, but the firm also has the EGFR inhibitor in Phase III for the larger PACC mutation subpopulation.
Scrip - October 6, 2026
ArriVent’s firmonertinib failed against chemo on PFS in NSCLC with exon 20 insertion mutations, but the firm also has the EGFR inhibitor in Phase III for the larger PACC mutation subpopulation.
Scrip - October 6, 2026
Stryker CEO Kevin Lobo Plans To Hand Over Helm To Current COO Spencer Stiles
Kevin Lobo announced plans to step down as Stryker's CEO after 14 years in the role and 15 with the company, during which the company's annual sales tripled. Current COO Spencer Stiles will become CEO on Jan. 1, 2027.
Medtech Insight - October 6, 2026
Kevin Lobo announced plans to step down as Stryker's CEO after 14 years in the role and 15 with the company, during which the company's annual sales tripled. Current COO Spencer Stiles will become CEO on Jan. 1, 2027.
Medtech Insight - October 6, 2026
‘Worse Performance Than Previously Disclosed’ Prompts Class I Recall Of BD Alaris Infusion Pump Sets
The FDA has classified BD’s recall of certain Alaris Pump Infusion Sets as Class I after testing found the sets can perform worse than previously disclosed, potentially causing under- or over-infusion, delayed occlusion alarms, and inaccurate bolus doses.
Medtech Insight - October 6, 2026
The FDA has classified BD’s recall of certain Alaris Pump Infusion Sets as Class I after testing found the sets can perform worse than previously disclosed, potentially causing under- or over-infusion, delayed occlusion alarms, and inaccurate bolus doses.
Medtech Insight - October 6, 2026
Global Medtech Guidance Tracker: September 2026
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Medtech Insight - October 6, 2026
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Medtech Insight - October 6, 2026
BridgeBio’s Infigratinib Poised To Join Achondroplasia Market Early Next Year
The US FDA granted the FGFR3 inhibitor a priority review with an action date in February.
Scrip - October 6, 2026
The US FDA granted the FGFR3 inhibitor a priority review with an action date in February.
Scrip - October 6, 2026
FDA Approval Marks Manufacturing Success For Alvotech’s Humira Biosimilar
After a supplement to Alvotech's biologics license application for AVT02 (adalimumab-ryvk) was approved by the US FDA, the company prepares to widen manufacturing capabilities through a second production site located in Iceland's capital, Reykjavik.
Generics Bulletin - October 6, 2026
After a supplement to Alvotech's biologics license application for AVT02 (adalimumab-ryvk) was approved by the US FDA, the company prepares to widen manufacturing capabilities through a second production site located in Iceland's capital, Reykjavik.
Generics Bulletin - October 6, 2026
On-Pack Artwork And Brand Names Now Covered By EU Greenwashing Rules
New European Commission guidance warns that leaf and water-drop imagery on packs, and terms like "natural" or "eco" in brand names, can count as environmental claims under EU greenwashing rules that have applied since Sept. 27.
HBW Insight - October 6, 2026
New European Commission guidance warns that leaf and water-drop imagery on packs, and terms like "natural" or "eco" in brand names, can count as environmental claims under EU greenwashing rules that have applied since Sept. 27.
HBW Insight - October 6, 2026
How New Development Tools Are Reshaping CNS Drug Development
New approaches are changing how sponsors navigate complexity in CNS development
Scrip - October 6, 2026
New approaches are changing how sponsors navigate complexity in CNS development
Scrip - October 6, 2026
One Ambition, Four Distinct Markets: Nordics Reward Consumer Health Firms That Think Local
Consumer health sales are growing across the Nordics and access to non-prescription products is widening, but Conaxess Trade's Johan Lagerlöf says firms must tailor channel, regulatory and consumer strategies to each of the four markets to capture the opportunity.
HBW Insight - October 6, 2026
Consumer health sales are growing across the Nordics and access to non-prescription products is widening, but Conaxess Trade's Johan Lagerlöf says firms must tailor channel, regulatory and consumer strategies to each of the four markets to capture the opportunity.
HBW Insight - October 6, 2026
Off-Patent, On Record: Navigating The Financial Strategy Behind Litigation With Sandoz’s Julia Pike
Generics Bulletin’s senior reporter Urt? Fultinavi?i?t? is joined by Sandoz’s head of IP Julia Pike to analyze the European intellectual property system, how it compares to the US, and the financial decisions behind litigation for off-patent companies.
Generics Bulletin - October 6, 2026
Generics Bulletin’s senior reporter Urt? Fultinavi?i?t? is joined by Sandoz’s head of IP Julia Pike to analyze the European intellectual property system, how it compares to the US, and the financial decisions behind litigation for off-patent companies.
Generics Bulletin - October 6, 2026
RougeTx Launched With $58m To Target Vascular Diseases
The Netherlands-based biotech’s lead candidate aims to treat the rare blood vessel disorder hereditary hemorrhagic telangiectasia.
Scrip - October 6, 2026
The Netherlands-based biotech’s lead candidate aims to treat the rare blood vessel disorder hereditary hemorrhagic telangiectasia.
Scrip - October 6, 2026
ARPA-H Is Building Agentic AI For Heart Failure — And A Blueprint For Everyone Who Follows
ARPA-H has committed up to $62.7m to ready patient-facing agentic AI for FDA authorization in heart failure. Haider Warraich, who runs the program, says the goal is a regulatory template for others, with two teams building a separate layer to monitor the agents.
Medtech Insight - October 6, 2026
ARPA-H has committed up to $62.7m to ready patient-facing agentic AI for FDA authorization in heart failure. Haider Warraich, who runs the program, says the goal is a regulatory template for others, with two teams building a separate layer to monitor the agents.
Medtech Insight - October 6, 2026
GE HealthCare’s SOFIE Bet: Own The Supply Chain Before The PET Market Expands
GE HealthCare is paying $945m for SOFIE Biosciences to solve a physics problem: fluorine-18 PET tracers decay too fast to ship, so whoever owns the local cyclotrons and production sites controls access to the market.
Medtech Insight - October 6, 2026
GE HealthCare is paying $945m for SOFIE Biosciences to solve a physics problem: fluorine-18 PET tracers decay too fast to ship, so whoever owns the local cyclotrons and production sites controls access to the market.
Medtech Insight - October 6, 2026
UK Government Unconditionally Backs Ambitious MHRA AI Regulation Plans
MHRA will update its definition of “medical device” when it sets out implementation plans for a new AI regulatory framework in spring 2027.
Medtech Insight - October 6, 2026
MHRA will update its definition of “medical device” when it sets out implementation plans for a new AI regulatory framework in spring 2027.
Medtech Insight - October 6, 2026
Orion And Qilu Add To Pembrolizumab Line-Up In Europe
The latest deal for a Keytruda biosimilar has fallen into place, with Finland’s Orion Corporation reaching an agreement with China’s Qilu Pharma for the latter’s pembrolizumab candidate in Europe.
Generics Bulletin - October 6, 2026
The latest deal for a Keytruda biosimilar has fallen into place, with Finland’s Orion Corporation reaching an agreement with China’s Qilu Pharma for the latter’s pembrolizumab candidate in Europe.
Generics Bulletin - October 6, 2026
Strategic Intent: Using Agentic AI To Create ‘The Self-Driving Clinical Trial, Kind Of Like The Car’
In this Strategic Intent episode, In Vivo speaks with Ken Getz, executive director of the Tufts CSDD and research professor at the Tufts University School of Medicine, and Pamela Tanaerts, CMO and CSO at Medable, to discuss promising data from an AI Clinical Monitoring Agent.
In Vivo - October 6, 2026
In this Strategic Intent episode, In Vivo speaks with Ken Getz, executive director of the Tufts CSDD and research professor at the Tufts University School of Medicine, and Pamela Tanaerts, CMO and CSO at Medable, to discuss promising data from an AI Clinical Monitoring Agent.
In Vivo - October 6, 2026
Pipeline Watch: AbbVie and Mirum Score Back-to-Back FDA Wins With Juvmo and Atebrioz
Johnson & Johnson’s Tecvayli plus Darzalex Faspro improves overall survival in new analyses of the Phase III MajesTEC-3 in multiple myeloma, while Rafael Holdings’ Trappsol Cyclo missed its primary endpoint in a Phase III Niemann-Pick type C trial.
Scrip - October 6, 2026
Johnson & Johnson’s Tecvayli plus Darzalex Faspro improves overall survival in new analyses of the Phase III MajesTEC-3 in multiple myeloma, while Rafael Holdings’ Trappsol Cyclo missed its primary endpoint in a Phase III Niemann-Pick type C trial.
Scrip - October 6, 2026
Sanofi And Regeneron Show Alliances Are Never Finished, Only Renegotiated
Two decades, five approved drugs and four restructurings later, Sanofi and Regeneron are reopening the alliance that produced Dupixent.
In Vivo - October 6, 2026
Two decades, five approved drugs and four restructurings later, Sanofi and Regeneron are reopening the alliance that produced Dupixent.
In Vivo - October 6, 2026
The People Behind The Pipeline: How The Global Race For Talent Is Reshaping Pharma
The biopharma industry is accustomed to competing for capital, technology and promising assets. Increasingly, however, one of its most important constraints is human: securing the scientists, researchers and technical specialists capable of turning complex science into viable medicines.
In Vivo - October 6, 2026
The biopharma industry is accustomed to competing for capital, technology and promising assets. Increasingly, however, one of its most important constraints is human: securing the scientists, researchers and technical specialists capable of turning complex science into viable medicines.
In Vivo - October 6, 2026
US FDA Principal Deputy COO Melissa Shea Departs For NIH
Shea joined the agency in April 2025 and helped oversee the consolidation of HR, IT and other functions into the Office of Operations.
HBW Insight - October 6, 2026
Shea joined the agency in April 2025 and helped oversee the consolidation of HR, IT and other functions into the Office of Operations.
HBW Insight - October 6, 2026
AI Already Common Across US FDA, Consumer Health Industry With Plenty Still To Learn
FDA officials’ comments at recent CHPA conference describe a perception that much remains to be mastered about using AI even as it already is established a common tool across regulatory and business operations.
HBW Insight - October 6, 2026
FDA officials’ comments at recent CHPA conference describe a perception that much remains to be mastered about using AI even as it already is established a common tool across regulatory and business operations.
HBW Insight - October 6, 2026
ViiV’s Cabenuva Takes The CROWN In Unsuppressed HIV Patients
The long-acting injectable was superior to daily oral therapy at viral suppression in treatment-experienced patients who had detectable virus when entering the study.
Scrip - October 6, 2026
The long-acting injectable was superior to daily oral therapy at viral suppression in treatment-experienced patients who had detectable virus when entering the study.
Scrip - October 6, 2026
ArriVent Stumbles With Phase III Miss For Rybrevant Competitor
ArriVent’s firmonertinib failed against chemo on PFS in NSCLC with exon 20 insertion mutations, but the firm also has the EGFR inhibitor in Phase III for the larger PACC mutation subpopulation.
Scrip - October 6, 2026
ArriVent’s firmonertinib failed against chemo on PFS in NSCLC with exon 20 insertion mutations, but the firm also has the EGFR inhibitor in Phase III for the larger PACC mutation subpopulation.
Scrip - October 6, 2026
BridgeBio’s Infigratinib Poised To Join Achondroplasia Market Early Next Year
The US FDA granted the FGFR3 inhibitor a priority review with an action date in February.
Scrip - October 6, 2026
The US FDA granted the FGFR3 inhibitor a priority review with an action date in February.
Scrip - October 6, 2026
How New Development Tools Are Reshaping CNS Drug Development
New approaches are changing how sponsors navigate complexity in CNS development
Scrip - October 6, 2026
New approaches are changing how sponsors navigate complexity in CNS development
Scrip - October 6, 2026
RougeTx Launched With $58m To Target Vascular Diseases
The Netherlands-based biotech’s lead candidate aims to treat the rare blood vessel disorder hereditary hemorrhagic telangiectasia.
Scrip - October 6, 2026
The Netherlands-based biotech’s lead candidate aims to treat the rare blood vessel disorder hereditary hemorrhagic telangiectasia.
Scrip - October 6, 2026
Pipeline Watch: AbbVie and Mirum Score Back-to-Back FDA Wins With Juvmo and Atebrioz
Johnson & Johnson’s Tecvayli plus Darzalex Faspro improves overall survival in new analyses of the Phase III MajesTEC-3 in multiple myeloma, while Rafael Holdings’ Trappsol Cyclo missed its primary endpoint in a Phase III Niemann-Pick type C trial.
Scrip - October 6, 2026
Johnson & Johnson’s Tecvayli plus Darzalex Faspro improves overall survival in new analyses of the Phase III MajesTEC-3 in multiple myeloma, while Rafael Holdings’ Trappsol Cyclo missed its primary endpoint in a Phase III Niemann-Pick type C trial.
Scrip - October 6, 2026
Stryker CEO Kevin Lobo Plans To Hand Over Helm To Current COO Spencer Stiles
Kevin Lobo announced plans to step down as Stryker's CEO after 14 years in the role and 15 with the company, during which the company's annual sales tripled. Current COO Spencer Stiles will become CEO on Jan. 1, 2027.
Medtech Insight - October 6, 2026
Kevin Lobo announced plans to step down as Stryker's CEO after 14 years in the role and 15 with the company, during which the company's annual sales tripled. Current COO Spencer Stiles will become CEO on Jan. 1, 2027.
Medtech Insight - October 6, 2026
‘Worse Performance Than Previously Disclosed’ Prompts Class I Recall Of BD Alaris Infusion Pump Sets
The FDA has classified BD’s recall of certain Alaris Pump Infusion Sets as Class I after testing found the sets can perform worse than previously disclosed, potentially causing under- or over-infusion, delayed occlusion alarms, and inaccurate bolus doses.
Medtech Insight - October 6, 2026
The FDA has classified BD’s recall of certain Alaris Pump Infusion Sets as Class I after testing found the sets can perform worse than previously disclosed, potentially causing under- or over-infusion, delayed occlusion alarms, and inaccurate bolus doses.
Medtech Insight - October 6, 2026
Global Medtech Guidance Tracker: September 2026
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Medtech Insight - October 6, 2026
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Medtech Insight - October 6, 2026
ARPA-H Is Building Agentic AI For Heart Failure — And A Blueprint For Everyone Who Follows
ARPA-H has committed up to $62.7m to ready patient-facing agentic AI for FDA authorization in heart failure. Haider Warraich, who runs the program, says the goal is a regulatory template for others, with two teams building a separate layer to monitor the agents.
Medtech Insight - October 6, 2026
ARPA-H has committed up to $62.7m to ready patient-facing agentic AI for FDA authorization in heart failure. Haider Warraich, who runs the program, says the goal is a regulatory template for others, with two teams building a separate layer to monitor the agents.
Medtech Insight - October 6, 2026
GE HealthCare’s SOFIE Bet: Own The Supply Chain Before The PET Market Expands
GE HealthCare is paying $945m for SOFIE Biosciences to solve a physics problem: fluorine-18 PET tracers decay too fast to ship, so whoever owns the local cyclotrons and production sites controls access to the market.
Medtech Insight - October 6, 2026
GE HealthCare is paying $945m for SOFIE Biosciences to solve a physics problem: fluorine-18 PET tracers decay too fast to ship, so whoever owns the local cyclotrons and production sites controls access to the market.
Medtech Insight - October 6, 2026
UK Government Unconditionally Backs Ambitious MHRA AI Regulation Plans
MHRA will update its definition of “medical device” when it sets out implementation plans for a new AI regulatory framework in spring 2027.
Medtech Insight - October 6, 2026
MHRA will update its definition of “medical device” when it sets out implementation plans for a new AI regulatory framework in spring 2027.
Medtech Insight - October 6, 2026
On-Pack Artwork And Brand Names Now Covered By EU Greenwashing Rules
New European Commission guidance warns that leaf and water-drop imagery on packs, and terms like "natural" or "eco" in brand names, can count as environmental claims under EU greenwashing rules that have applied since Sept. 27.
HBW Insight - October 6, 2026
New European Commission guidance warns that leaf and water-drop imagery on packs, and terms like "natural" or "eco" in brand names, can count as environmental claims under EU greenwashing rules that have applied since Sept. 27.
HBW Insight - October 6, 2026
One Ambition, Four Distinct Markets: Nordics Reward Consumer Health Firms That Think Local
Consumer health sales are growing across the Nordics and access to non-prescription products is widening, but Conaxess Trade's Johan Lagerlöf says firms must tailor channel, regulatory and consumer strategies to each of the four markets to capture the opportunity.
HBW Insight - October 6, 2026
Consumer health sales are growing across the Nordics and access to non-prescription products is widening, but Conaxess Trade's Johan Lagerlöf says firms must tailor channel, regulatory and consumer strategies to each of the four markets to capture the opportunity.
HBW Insight - October 6, 2026
US FDA Principal Deputy COO Melissa Shea Departs For NIH
Shea joined the agency in April 2025 and helped oversee the consolidation of HR, IT and other functions into the Office of Operations.
HBW Insight - October 6, 2026
Shea joined the agency in April 2025 and helped oversee the consolidation of HR, IT and other functions into the Office of Operations.
HBW Insight - October 6, 2026
AI Already Common Across US FDA, Consumer Health Industry With Plenty Still To Learn
FDA officials’ comments at recent CHPA conference describe a perception that much remains to be mastered about using AI even as it already is established a common tool across regulatory and business operations.
HBW Insight - October 6, 2026
FDA officials’ comments at recent CHPA conference describe a perception that much remains to be mastered about using AI even as it already is established a common tool across regulatory and business operations.
HBW Insight - October 6, 2026
FDA Approval Marks Manufacturing Success For Alvotech’s Humira Biosimilar
After a supplement to Alvotech's biologics license application for AVT02 (adalimumab-ryvk) was approved by the US FDA, the company prepares to widen manufacturing capabilities through a second production site located in Iceland's capital, Reykjavik.
Generics Bulletin - October 6, 2026
After a supplement to Alvotech's biologics license application for AVT02 (adalimumab-ryvk) was approved by the US FDA, the company prepares to widen manufacturing capabilities through a second production site located in Iceland's capital, Reykjavik.
Generics Bulletin - October 6, 2026
Off-Patent, On Record: Navigating The Financial Strategy Behind Litigation With Sandoz’s Julia Pike
Generics Bulletin’s senior reporter Urt? Fultinavi?i?t? is joined by Sandoz’s head of IP Julia Pike to analyze the European intellectual property system, how it compares to the US, and the financial decisions behind litigation for off-patent companies.
Generics Bulletin - October 6, 2026
Generics Bulletin’s senior reporter Urt? Fultinavi?i?t? is joined by Sandoz’s head of IP Julia Pike to analyze the European intellectual property system, how it compares to the US, and the financial decisions behind litigation for off-patent companies.
Generics Bulletin - October 6, 2026
Orion And Qilu Add To Pembrolizumab Line-Up In Europe
The latest deal for a Keytruda biosimilar has fallen into place, with Finland’s Orion Corporation reaching an agreement with China’s Qilu Pharma for the latter’s pembrolizumab candidate in Europe.
Generics Bulletin - October 6, 2026
The latest deal for a Keytruda biosimilar has fallen into place, with Finland’s Orion Corporation reaching an agreement with China’s Qilu Pharma for the latter’s pembrolizumab candidate in Europe.
Generics Bulletin - October 6, 2026
Strategic Intent: Using Agentic AI To Create ‘The Self-Driving Clinical Trial, Kind Of Like The Car’
In this Strategic Intent episode, In Vivo speaks with Ken Getz, executive director of the Tufts CSDD and research professor at the Tufts University School of Medicine, and Pamela Tanaerts, CMO and CSO at Medable, to discuss promising data from an AI Clinical Monitoring Agent.
In Vivo - October 6, 2026
In this Strategic Intent episode, In Vivo speaks with Ken Getz, executive director of the Tufts CSDD and research professor at the Tufts University School of Medicine, and Pamela Tanaerts, CMO and CSO at Medable, to discuss promising data from an AI Clinical Monitoring Agent.
In Vivo - October 6, 2026
Sanofi And Regeneron Show Alliances Are Never Finished, Only Renegotiated
Two decades, five approved drugs and four restructurings later, Sanofi and Regeneron are reopening the alliance that produced Dupixent.
In Vivo - October 6, 2026
Two decades, five approved drugs and four restructurings later, Sanofi and Regeneron are reopening the alliance that produced Dupixent.
In Vivo - October 6, 2026
The People Behind The Pipeline: How The Global Race For Talent Is Reshaping Pharma
The biopharma industry is accustomed to competing for capital, technology and promising assets. Increasingly, however, one of its most important constraints is human: securing the scientists, researchers and technical specialists capable of turning complex science into viable medicines.
In Vivo - October 6, 2026
The biopharma industry is accustomed to competing for capital, technology and promising assets. Increasingly, however, one of its most important constraints is human: securing the scientists, researchers and technical specialists capable of turning complex science into viable medicines.
In Vivo - October 6, 2026