Latest Pharma Insights
Paradromics Joins Neurotech Race With FDA Nod To Test BCI For Restoring Speech
Paradromics won FDA clearance to test its Connexus BCI in two people with severe speech impairment. The 2026 trial will assess whether the device can decode speech in real time.
Medtech Insight - December 2, 2025
Paradromics won FDA clearance to test its Connexus BCI in two people with severe speech impairment. The 2026 trial will assess whether the device can decode speech in real time.
Medtech Insight - December 2, 2025
Jo Malone AI Scent Advisor Makes In-Store Consultation Experience Digital
Jo Malone London has launched an AI-powered Scent Advisor, built with Google’s Gemini and Vertex AI, to digitally recreate personalized in-store fragrance consultations, enhance online shopping confidence, and advance Estée Lauder’s broader strategy of AI-driven consumer personalization.
HBW Insight - December 2, 2025
Jo Malone London has launched an AI-powered Scent Advisor, built with Google’s Gemini and Vertex AI, to digitally recreate personalized in-store fragrance consultations, enhance online shopping confidence, and advance Estée Lauder’s broader strategy of AI-driven consumer personalization.
HBW Insight - December 2, 2025
Imvax Gets Positive Overall Survival Data From Phase IIb GBM Asset
The company plans to take IGV-001 to the FDA after the mid-stage trial showed a more than six-month improvement in overall survival compared with placebo.
Scrip - December 2, 2025
The company plans to take IGV-001 to the FDA after the mid-stage trial showed a more than six-month improvement in overall survival compared with placebo.
Scrip - December 2, 2025
Makary Continues To Seize On AI ‘To Modernize’ The FDA And Accelerate Advanced Treatments
With the roll out of agentic AI, the US FDA continues to expand AI capabilities across the agency. The latest AI deployment follows the agency’s May launch of Elsa, its generative AI tool, which marked ‘the dawn of the AI era’ at the FDA.
Medtech Insight - December 2, 2025
With the roll out of agentic AI, the US FDA continues to expand AI capabilities across the agency. The latest AI deployment follows the agency’s May launch of Elsa, its generative AI tool, which marked ‘the dawn of the AI era’ at the FDA.
Medtech Insight - December 2, 2025
ARPA-H Launches Mental Health Initiative Under New Director
US healthcare innovation agency ARPA-H has announced a $100m initiative focused on building up the evidence base for fast-acting mental health treatments such as neuromodulation and digital therapeutics. The project is the first major initiative to be led by new ARPA-H director Alicia Jackson.
Medtech Insight - December 2, 2025
US healthcare innovation agency ARPA-H has announced a $100m initiative focused on building up the evidence base for fast-acting mental health treatments such as neuromodulation and digital therapeutics. The project is the first major initiative to be led by new ARPA-H director Alicia Jackson.
Medtech Insight - December 2, 2025
Akeso’s Goals Beyond Ivonescimab: ‘We Can Hit Vertex And Regeneron-Level Innovation’
Akeso’s first-in-class PD-1/VEG-F bispecific ivonescimab is a landmark achievement for China’s biotech sector, but the firm is already expanding its ambitions in oncology and beyond, including a challenge to Roche in Alzheimer’s.
Scrip - December 2, 2025
Akeso’s first-in-class PD-1/VEG-F bispecific ivonescimab is a landmark achievement for China’s biotech sector, but the firm is already expanding its ambitions in oncology and beyond, including a challenge to Roche in Alzheimer’s.
Scrip - December 2, 2025
EU Deforestation Law: Parliament Votes For Delay For All Manufacturers Until End Of 2026
While no doubt welcome, yet another delay to the EU Deforestation Law and suggestion for another review next year could mean a “never-ending” regulatory exercise that creates uncertainty for manufacturers selling products containing or having been made using materials like palm oil, soya and wood.
HBW Insight - December 2, 2025
While no doubt welcome, yet another delay to the EU Deforestation Law and suggestion for another review next year could mean a “never-ending” regulatory exercise that creates uncertainty for manufacturers selling products containing or having been made using materials like palm oil, soya and wood.
HBW Insight - December 2, 2025
GDUFA IV: US FDA Wants to ‘Streamline’ Formal Meeting Structure
The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.
Generics Bulletin - December 2, 2025
The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.
Generics Bulletin - December 2, 2025
People On The Move: Appointments At ANEFP, Pharma Deutschland, Salus
A round up of the latest people moves in Europe: ANEFP names president; Pharma Deutschland makes board changes; Salus shakes up management.
HBW Insight - December 2, 2025
A round up of the latest people moves in Europe: ANEFP names president; Pharma Deutschland makes board changes; Salus shakes up management.
HBW Insight - December 2, 2025
More Launches Pile Pressure On European Denosumab Rivals
Hot on the heels of denosumab launches by four suppliers on the first day of December, more biosimilar challengers are piling into the European market with their own rivals to Prolia and Xgeva. And the space is only going to get more crowded as further versions launch.
Generics Bulletin - December 2, 2025
Hot on the heels of denosumab launches by four suppliers on the first day of December, more biosimilar challengers are piling into the European market with their own rivals to Prolia and Xgeva. And the space is only going to get more crowded as further versions launch.
Generics Bulletin - December 2, 2025
AstraZeneca Moves Ahead of Mineralys With Fast Baxdrostat Review
With the help of a purchased priority review voucher, the drug looks likely to become the first aldosterone synthase inhibitor to receive regulatory authorization, ahead of Mineralys' lorundrostat.
Scrip - December 2, 2025
With the help of a purchased priority review voucher, the drug looks likely to become the first aldosterone synthase inhibitor to receive regulatory authorization, ahead of Mineralys' lorundrostat.
Scrip - December 2, 2025
Belite Bio’s Tinlarebant? Shines In Phase III Stargardt Disease Trial
Promising Phase III results could help tinlarebant become the first approved treatment for the genetic eye disorder, with planned US FDA filing in 2026.
Scrip - December 2, 2025
Promising Phase III results could help tinlarebant become the first approved treatment for the genetic eye disorder, with planned US FDA filing in 2026.
Scrip - December 2, 2025
Celltrion’s Eydenzelt Becomes Third Aflibercept Biosimilar Approved In Canada
Korean firm’s Eydenzelt biosimilar win full label alignment with Eylea, including all approved ophthalmic indications.
Generics Bulletin - December 2, 2025
Korean firm’s Eydenzelt biosimilar win full label alignment with Eylea, including all approved ophthalmic indications.
Generics Bulletin - December 2, 2025
Can Biosimilars Take Root In Cell And Gene Therapy?
In an exclusive interview, Generics Bulletin spoke to a trio of experts who argue that biosimilar cell and gene therapies are technically within reach but demand unprecedented regulatory clarity, manufacturing evolution and economic alignment before they become reality.
Generics Bulletin - December 2, 2025
In an exclusive interview, Generics Bulletin spoke to a trio of experts who argue that biosimilar cell and gene therapies are technically within reach but demand unprecedented regulatory clarity, manufacturing evolution and economic alignment before they become reality.
Generics Bulletin - December 2, 2025
It Pays To Be Different: Philips’ Take On Purpose-Driven Imaging & Ultrasound
During his 40 years at Royal Philips, Bert van Meurs has seen the medical devices business grow in line with the evolving needs of healthcare providers with whom the company partners in customer and patient focused innovation.
In Vivo - December 2, 2025
During his 40 years at Royal Philips, Bert van Meurs has seen the medical devices business grow in line with the evolving needs of healthcare providers with whom the company partners in customer and patient focused innovation.
In Vivo - December 2, 2025
Compugen’s Former Head Reflects on Computational Discovery, Strategic Collaborations And AI
Anat Cohen-Dayag explains how Compugen transformed from computational service provider to clinical-stage biotech by integrating AI with biology and structuring strategic pharma collaborations.
In Vivo - December 2, 2025
Anat Cohen-Dayag explains how Compugen transformed from computational service provider to clinical-stage biotech by integrating AI with biology and structuring strategic pharma collaborations.
In Vivo - December 2, 2025
Parexel Exec On AI: RoI, US FDA’s ‘Open Table Discussions’
After AI’s magic wand status, it's now come to Google and Open AI CEOs talking of the likelihood of a bubble burst. In this interview, Parexel’s India head discusses how to view returns on such investments, the CRO’s own use cases and the US FDA’s keenness on transparency and open dialogue
Scrip - December 2, 2025
After AI’s magic wand status, it's now come to Google and Open AI CEOs talking of the likelihood of a bubble burst. In this interview, Parexel’s India head discusses how to view returns on such investments, the CRO’s own use cases and the US FDA’s keenness on transparency and open dialogue
Scrip - December 2, 2025
US OTC Switches: FDA Needs Comments To Guide Public Meeting, Congress Wants Progress Report
Agency intends to use information from comments to guide its planning for a public meeting during 2026, according to a Federal Register notice. A GAO report is due in a year to Congress profiling FDA’s progress on making more drugs available nonprescription through OTC switch applications.
HBW Insight - December 2, 2025
Agency intends to use information from comments to guide its planning for a public meeting during 2026, according to a Federal Register notice. A GAO report is due in a year to Congress profiling FDA’s progress on making more drugs available nonprescription through OTC switch applications.
HBW Insight - December 2, 2025
Wave Of Class Actions Targeting Influencer Marketing Signals Potential Trend – Attorney
Class action litigants are increasingly bringing forward lawsuits targeting influencer marketing practices, says a Morgan, Lewis & Bockius LLP attorney during the IBA Cosmetics Convergence Conference Nov. 13.
HBW Insight - December 2, 2025
Class action litigants are increasingly bringing forward lawsuits targeting influencer marketing practices, says a Morgan, Lewis & Bockius LLP attorney during the IBA Cosmetics Convergence Conference Nov. 13.
HBW Insight - December 2, 2025
Imvax Gets Positive Overall Survival Data From Phase IIb GBM Asset
The company plans to take IGV-001 to the FDA after the mid-stage trial showed a more than six-month improvement in overall survival compared with placebo.
Scrip - December 2, 2025
The company plans to take IGV-001 to the FDA after the mid-stage trial showed a more than six-month improvement in overall survival compared with placebo.
Scrip - December 2, 2025
Akeso’s Goals Beyond Ivonescimab: ‘We Can Hit Vertex And Regeneron-Level Innovation’
Akeso’s first-in-class PD-1/VEG-F bispecific ivonescimab is a landmark achievement for China’s biotech sector, but the firm is already expanding its ambitions in oncology and beyond, including a challenge to Roche in Alzheimer’s.
Scrip - December 2, 2025
Akeso’s first-in-class PD-1/VEG-F bispecific ivonescimab is a landmark achievement for China’s biotech sector, but the firm is already expanding its ambitions in oncology and beyond, including a challenge to Roche in Alzheimer’s.
Scrip - December 2, 2025
AstraZeneca Moves Ahead of Mineralys With Fast Baxdrostat Review
With the help of a purchased priority review voucher, the drug looks likely to become the first aldosterone synthase inhibitor to receive regulatory authorization, ahead of Mineralys' lorundrostat.
Scrip - December 2, 2025
With the help of a purchased priority review voucher, the drug looks likely to become the first aldosterone synthase inhibitor to receive regulatory authorization, ahead of Mineralys' lorundrostat.
Scrip - December 2, 2025
Belite Bio’s Tinlarebant? Shines In Phase III Stargardt Disease Trial
Promising Phase III results could help tinlarebant become the first approved treatment for the genetic eye disorder, with planned US FDA filing in 2026.
Scrip - December 2, 2025
Promising Phase III results could help tinlarebant become the first approved treatment for the genetic eye disorder, with planned US FDA filing in 2026.
Scrip - December 2, 2025
Parexel Exec On AI: RoI, US FDA’s ‘Open Table Discussions’
After AI’s magic wand status, it's now come to Google and Open AI CEOs talking of the likelihood of a bubble burst. In this interview, Parexel’s India head discusses how to view returns on such investments, the CRO’s own use cases and the US FDA’s keenness on transparency and open dialogue
Scrip - December 2, 2025
After AI’s magic wand status, it's now come to Google and Open AI CEOs talking of the likelihood of a bubble burst. In this interview, Parexel’s India head discusses how to view returns on such investments, the CRO’s own use cases and the US FDA’s keenness on transparency and open dialogue
Scrip - December 2, 2025
Paradromics Joins Neurotech Race With FDA Nod To Test BCI For Restoring Speech
Paradromics won FDA clearance to test its Connexus BCI in two people with severe speech impairment. The 2026 trial will assess whether the device can decode speech in real time.
Medtech Insight - December 2, 2025
Paradromics won FDA clearance to test its Connexus BCI in two people with severe speech impairment. The 2026 trial will assess whether the device can decode speech in real time.
Medtech Insight - December 2, 2025
Makary Continues To Seize On AI ‘To Modernize’ The FDA And Accelerate Advanced Treatments
With the roll out of agentic AI, the US FDA continues to expand AI capabilities across the agency. The latest AI deployment follows the agency’s May launch of Elsa, its generative AI tool, which marked ‘the dawn of the AI era’ at the FDA.
Medtech Insight - December 2, 2025
With the roll out of agentic AI, the US FDA continues to expand AI capabilities across the agency. The latest AI deployment follows the agency’s May launch of Elsa, its generative AI tool, which marked ‘the dawn of the AI era’ at the FDA.
Medtech Insight - December 2, 2025
ARPA-H Launches Mental Health Initiative Under New Director
US healthcare innovation agency ARPA-H has announced a $100m initiative focused on building up the evidence base for fast-acting mental health treatments such as neuromodulation and digital therapeutics. The project is the first major initiative to be led by new ARPA-H director Alicia Jackson.
Medtech Insight - December 2, 2025
US healthcare innovation agency ARPA-H has announced a $100m initiative focused on building up the evidence base for fast-acting mental health treatments such as neuromodulation and digital therapeutics. The project is the first major initiative to be led by new ARPA-H director Alicia Jackson.
Medtech Insight - December 2, 2025
Jo Malone AI Scent Advisor Makes In-Store Consultation Experience Digital
Jo Malone London has launched an AI-powered Scent Advisor, built with Google’s Gemini and Vertex AI, to digitally recreate personalized in-store fragrance consultations, enhance online shopping confidence, and advance Estée Lauder’s broader strategy of AI-driven consumer personalization.
HBW Insight - December 2, 2025
Jo Malone London has launched an AI-powered Scent Advisor, built with Google’s Gemini and Vertex AI, to digitally recreate personalized in-store fragrance consultations, enhance online shopping confidence, and advance Estée Lauder’s broader strategy of AI-driven consumer personalization.
HBW Insight - December 2, 2025
EU Deforestation Law: Parliament Votes For Delay For All Manufacturers Until End Of 2026
While no doubt welcome, yet another delay to the EU Deforestation Law and suggestion for another review next year could mean a “never-ending” regulatory exercise that creates uncertainty for manufacturers selling products containing or having been made using materials like palm oil, soya and wood.
HBW Insight - December 2, 2025
While no doubt welcome, yet another delay to the EU Deforestation Law and suggestion for another review next year could mean a “never-ending” regulatory exercise that creates uncertainty for manufacturers selling products containing or having been made using materials like palm oil, soya and wood.
HBW Insight - December 2, 2025
People On The Move: Appointments At ANEFP, Pharma Deutschland, Salus
A round up of the latest people moves in Europe: ANEFP names president; Pharma Deutschland makes board changes; Salus shakes up management.
HBW Insight - December 2, 2025
A round up of the latest people moves in Europe: ANEFP names president; Pharma Deutschland makes board changes; Salus shakes up management.
HBW Insight - December 2, 2025
US OTC Switches: FDA Needs Comments To Guide Public Meeting, Congress Wants Progress Report
Agency intends to use information from comments to guide its planning for a public meeting during 2026, according to a Federal Register notice. A GAO report is due in a year to Congress profiling FDA’s progress on making more drugs available nonprescription through OTC switch applications.
HBW Insight - December 2, 2025
Agency intends to use information from comments to guide its planning for a public meeting during 2026, according to a Federal Register notice. A GAO report is due in a year to Congress profiling FDA’s progress on making more drugs available nonprescription through OTC switch applications.
HBW Insight - December 2, 2025
Wave Of Class Actions Targeting Influencer Marketing Signals Potential Trend – Attorney
Class action litigants are increasingly bringing forward lawsuits targeting influencer marketing practices, says a Morgan, Lewis & Bockius LLP attorney during the IBA Cosmetics Convergence Conference Nov. 13.
HBW Insight - December 2, 2025
Class action litigants are increasingly bringing forward lawsuits targeting influencer marketing practices, says a Morgan, Lewis & Bockius LLP attorney during the IBA Cosmetics Convergence Conference Nov. 13.
HBW Insight - December 2, 2025
GDUFA IV: US FDA Wants to ‘Streamline’ Formal Meeting Structure
The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.
Generics Bulletin - December 2, 2025
The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.
Generics Bulletin - December 2, 2025
More Launches Pile Pressure On European Denosumab Rivals
Hot on the heels of denosumab launches by four suppliers on the first day of December, more biosimilar challengers are piling into the European market with their own rivals to Prolia and Xgeva. And the space is only going to get more crowded as further versions launch.
Generics Bulletin - December 2, 2025
Hot on the heels of denosumab launches by four suppliers on the first day of December, more biosimilar challengers are piling into the European market with their own rivals to Prolia and Xgeva. And the space is only going to get more crowded as further versions launch.
Generics Bulletin - December 2, 2025
Celltrion’s Eydenzelt Becomes Third Aflibercept Biosimilar Approved In Canada
Korean firm’s Eydenzelt biosimilar win full label alignment with Eylea, including all approved ophthalmic indications.
Generics Bulletin - December 2, 2025
Korean firm’s Eydenzelt biosimilar win full label alignment with Eylea, including all approved ophthalmic indications.
Generics Bulletin - December 2, 2025
Can Biosimilars Take Root In Cell And Gene Therapy?
In an exclusive interview, Generics Bulletin spoke to a trio of experts who argue that biosimilar cell and gene therapies are technically within reach but demand unprecedented regulatory clarity, manufacturing evolution and economic alignment before they become reality.
Generics Bulletin - December 2, 2025
In an exclusive interview, Generics Bulletin spoke to a trio of experts who argue that biosimilar cell and gene therapies are technically within reach but demand unprecedented regulatory clarity, manufacturing evolution and economic alignment before they become reality.
Generics Bulletin - December 2, 2025
It Pays To Be Different: Philips’ Take On Purpose-Driven Imaging & Ultrasound
During his 40 years at Royal Philips, Bert van Meurs has seen the medical devices business grow in line with the evolving needs of healthcare providers with whom the company partners in customer and patient focused innovation.
In Vivo - December 2, 2025
During his 40 years at Royal Philips, Bert van Meurs has seen the medical devices business grow in line with the evolving needs of healthcare providers with whom the company partners in customer and patient focused innovation.
In Vivo - December 2, 2025
Compugen’s Former Head Reflects on Computational Discovery, Strategic Collaborations And AI
Anat Cohen-Dayag explains how Compugen transformed from computational service provider to clinical-stage biotech by integrating AI with biology and structuring strategic pharma collaborations.
In Vivo - December 2, 2025
Anat Cohen-Dayag explains how Compugen transformed from computational service provider to clinical-stage biotech by integrating AI with biology and structuring strategic pharma collaborations.
In Vivo - December 2, 2025