Latest Pharma Insights
Certifications Over Speed: Tandem Health’s $100m Strategy To Win European AI
Tandem's $100m funding will be used to accelerate the adoption of AI across European healthcare, expanding from an AI medical assistant to an AI-native clinic operating system and doubling down across European markets.
Medtech Insight - September 14, 2026
Tandem's $100m funding will be used to accelerate the adoption of AI across European healthcare, expanding from an AI medical assistant to an AI-native clinic operating system and doubling down across European markets.
Medtech Insight - September 14, 2026
Ecommerce Sites Pushing Beauty Sellers To Find Nonexistent FDA Certificates; Regulatory Roundup
The US FDA pleads with online cosmetics sellers to cease requests for product registration certificates. Separately, IFRA has concluded the consultation on the 52nd amendment to its voluntary standards and Illinois institutes a ban on cosmetic ingredients.
HBW Insight - September 14, 2026
The US FDA pleads with online cosmetics sellers to cease requests for product registration certificates. Separately, IFRA has concluded the consultation on the 52nd amendment to its voluntary standards and Illinois institutes a ban on cosmetic ingredients.
HBW Insight - September 14, 2026
Sanofi Shifts Mature Brands To Cheplapharm, In Line With Big Pharma Trend
Sanofi will transition 20 mature medicines to German established products player Cheplapharm, including the off-patent blood thinner Lovenox (enoxaparin), in a strategic partnership.
Scrip - September 14, 2026
Sanofi will transition 20 mature medicines to German established products player Cheplapharm, including the off-patent blood thinner Lovenox (enoxaparin), in a strategic partnership.
Scrip - September 14, 2026
What’s Hot, Who’s Buying and Why Valuations Are Diverging In Consumer Health M&A
Senior advisors from Alantra, Bridgepoint, Capstone Partners, EY-Parthenon and OC&C share their view on the in-demand consumer health categories, the valuation drivers that matter most, and a buyer landscape shifting toward strategics. Part one of HBW's 'Inside Consumer Health M&A' series.
HBW Insight - September 14, 2026
Senior advisors from Alantra, Bridgepoint, Capstone Partners, EY-Parthenon and OC&C share their view on the in-demand consumer health categories, the valuation drivers that matter most, and a buyer landscape shifting toward strategics. Part one of HBW's 'Inside Consumer Health M&A' series.
HBW Insight - September 14, 2026
Novo Slims Down Name In Corporate Rebrand And Reset
After a troubled few years, the Denmark-headquartered firm is to shorten its name to simply 'Novo' and sharpen its corporate culture, though some investors believe major M&A would be the real answer to its problems.
Scrip - September 14, 2026
After a troubled few years, the Denmark-headquartered firm is to shorten its name to simply 'Novo' and sharpen its corporate culture, though some investors believe major M&A would be the real answer to its problems.
Scrip - September 14, 2026
No Surprise As SERENA-4 Serves Up A Miss For AstraZeneca’s Etcamah
Just days after securing FDA approval in a narrowly defined indication, the oral SERD failed to show significant improvement in progression-free survival in a Phase III first-line study.
Scrip - September 14, 2026
Just days after securing FDA approval in a narrowly defined indication, the oral SERD failed to show significant improvement in progression-free survival in a Phase III first-line study.
Scrip - September 14, 2026
Scrip Asks... What Does 2026 Hold For Biopharma? Part 2: Competitive Dynamics -A Landscape Reshaped
Key opinion leaders share their perspectives on the competitive dynamics reshaping the biopharma industry in 2026.
Scrip - September 14, 2026
Key opinion leaders share their perspectives on the competitive dynamics reshaping the biopharma industry in 2026.
Scrip - September 14, 2026
Pipeline Watch: One Approval And Three 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 - September 14, 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 - September 14, 2026
Advicenne Withdraws US 505(b)(2) Application For A Rare Kidney Disease Drug
Despite satisfying other regulators, Advicenne cited CMC-related requirements in its decision to withdraw its US application for Sibnayal (potassium citrate/potassium bicarbonate).
Generics Bulletin - September 14, 2026
Despite satisfying other regulators, Advicenne cited CMC-related requirements in its decision to withdraw its US application for Sibnayal (potassium citrate/potassium bicarbonate).
Generics Bulletin - September 14, 2026
EU Lawmakers Back Unlimited Biosimilar Stockpiling Under SPC Waiver
The EU’s JURI committee has backed removing the six-month stockpiling limit for biosimilars under the SPC waiver, a move welcomed by Medicines for Europe as a boost to EU manufacturing, competition and day-one market entry.
Generics Bulletin - September 14, 2026
The EU’s JURI committee has backed removing the six-month stockpiling limit for biosimilars under the SPC waiver, a move welcomed by Medicines for Europe as a boost to EU manufacturing, competition and day-one market entry.
Generics Bulletin - September 14, 2026
Amgen Leads The Pack With First Filing For US Opdivo Biosimilar
Amgen has revealed the first disclosed Opdivo (nivolumab) biosimilar filing with the US FDA, while also pointing to an imminent US submission for a Keytruda (pembrolizumab) rival by the end of the year, following positive trial readouts.
Generics Bulletin - September 14, 2026
Amgen has revealed the first disclosed Opdivo (nivolumab) biosimilar filing with the US FDA, while also pointing to an imminent US submission for a Keytruda (pembrolizumab) rival by the end of the year, following positive trial readouts.
Generics Bulletin - September 14, 2026
A Blood Test Rewrites The Economics Of Alzheimer’s Diagnosis
When a simple blood test can reduce reliance on complex, costly procedures and onward referral, specialist resources and expertise can be spent where they make the greatest difference.
In Vivo - September 14, 2026
When a simple blood test can reduce reliance on complex, costly procedures and onward referral, specialist resources and expertise can be spent where they make the greatest difference.
In Vivo - September 14, 2026
PharmaSynergyOTC: Rx-To-OTC Switch Should Be About Women’s Empowerment
Cemag Care's Clémence Desjardin told PharmaSynergyOTC delegates in Rome that switch is women's health's answer to decades of structural underinvestment, and set out the four dimensions behind the firm's 2025 reclassification of tranexamic acid in France.
HBW Insight - September 14, 2026
Cemag Care's Clémence Desjardin told PharmaSynergyOTC delegates in Rome that switch is women's health's answer to decades of structural underinvestment, and set out the four dimensions behind the firm's 2025 reclassification of tranexamic acid in France.
HBW Insight - September 14, 2026
WCLC 2026: GSK Sees The Start Of A Lung Cancer Franchise
For many years GSK insisted that it would only target specialist oncology indications but it is now looking to build a broad portfolio in lung cancer
Scrip - September 14, 2026
For many years GSK insisted that it would only target specialist oncology indications but it is now looking to build a broad portfolio in lung cancer
Scrip - September 14, 2026
WCLC 2026: Hansoh And GSK’s Ris-Rez Comes Out On Top In SCLC
Impressive Phase III results from China put the B7-H3–targeting ADC in the driving seat in second line small-cell lung cancer, with GSK aiming to replicate the survival improvement in a global study.
Scrip - September 14, 2026
Impressive Phase III results from China put the B7-H3–targeting ADC in the driving seat in second line small-cell lung cancer, with GSK aiming to replicate the survival improvement in a global study.
Scrip - September 14, 2026
Premium Pricing And Brand Loyalty Face AI Reckoning In Consumer Health
AI is making product ingredients and price differentials more transparent, threatening the premium pricing strategies and brand loyalty that underpin much of the consumer health industry, according to Jefferies analyst David Hayes.
HBW Insight - September 14, 2026
AI is making product ingredients and price differentials more transparent, threatening the premium pricing strategies and brand loyalty that underpin much of the consumer health industry, according to Jefferies analyst David Hayes.
HBW Insight - September 14, 2026
WCLC 2026: Phase III Overall Survival Win In SCLC For MediLink’s ADC
MediLink’s B7-H3-targeted antibody-drug conjugate tambotatug pelitecan achieves overall survival and progression-free survival benefits in Chinese patients with relapsed small cell lung cancer.
Scrip - September 14, 2026
MediLink’s B7-H3-targeted antibody-drug conjugate tambotatug pelitecan achieves overall survival and progression-free survival benefits in Chinese patients with relapsed small cell lung cancer.
Scrip - September 14, 2026
FDA Consumer Health Advisory: Industry Titan Leaves Lasting Legacy
What's happening, why it matters and what's next at FDA. This edition explores Peter Barton Hutt's legacy, an infant formula dispute and exceptions to the drug preclusion impediment to introducing new dietary ingredients.
HBW Insight - September 14, 2026
What's happening, why it matters and what's next at FDA. This edition explores Peter Barton Hutt's legacy, an infant formula dispute and exceptions to the drug preclusion impediment to introducing new dietary ingredients.
HBW Insight - September 14, 2026
Rakuten Fortifies Global Expertise With Ex-Takeda CEO Weber
Rakuten Medical expects experienced new board members will help it reach regulatory and commercial milestones in the US market.
Scrip - September 14, 2026
Rakuten Medical expects experienced new board members will help it reach regulatory and commercial milestones in the US market.
Scrip - September 14, 2026
Graveyard Drug Hunters: How Racura And Cereno Are Repurposing Drugs That Pharma Threw Away
A contrarian cohort of drug companies is betting that pharma's most undervalued assets are the ones it already threw away.
In Vivo - September 14, 2026
A contrarian cohort of drug companies is betting that pharma's most undervalued assets are the ones it already threw away.
In Vivo - September 14, 2026
Xlear Complaint Making Loper Bright Argument In Challenge To FTC Health Claim Policy Dismissed
With Xlear not contesting an active enforcement, “the case is not ripe for judicial review,” meaning the district “court lacks subject matter jurisdiction over the claims … and dismisses this action without prejudice,” Utah District Court ruling states.
HBW Insight - September 14, 2026
With Xlear not contesting an active enforcement, “the case is not ripe for judicial review,” meaning the district “court lacks subject matter jurisdiction over the claims … and dismisses this action without prejudice,” Utah District Court ruling states.
HBW Insight - September 14, 2026
Quick Listen: Scrip’s Five Must-Know Things
This week: what’s next in cardiovascular R&D following Phase III failures; gains for nine of world’s top 10 drugs in Q2; AstraZeneca’s COPD contender out-performs Dupixent in Phase III; Renexxion co-founder on naronapride in gastroparesis; and Chinese companies' global Phase III activity.
Scrip - September 14, 2026
This week: what’s next in cardiovascular R&D following Phase III failures; gains for nine of world’s top 10 drugs in Q2; AstraZeneca’s COPD contender out-performs Dupixent in Phase III; Renexxion co-founder on naronapride in gastroparesis; and Chinese companies' global Phase III activity.
Scrip - September 14, 2026
Sanofi Shifts Mature Brands To Cheplapharm, In Line With Big Pharma Trend
Sanofi will transition 20 mature medicines to German established products player Cheplapharm, including the off-patent blood thinner Lovenox (enoxaparin), in a strategic partnership.
Scrip - September 14, 2026
Sanofi will transition 20 mature medicines to German established products player Cheplapharm, including the off-patent blood thinner Lovenox (enoxaparin), in a strategic partnership.
Scrip - September 14, 2026
Novo Slims Down Name In Corporate Rebrand And Reset
After a troubled few years, the Denmark-headquartered firm is to shorten its name to simply 'Novo' and sharpen its corporate culture, though some investors believe major M&A would be the real answer to its problems.
Scrip - September 14, 2026
After a troubled few years, the Denmark-headquartered firm is to shorten its name to simply 'Novo' and sharpen its corporate culture, though some investors believe major M&A would be the real answer to its problems.
Scrip - September 14, 2026
No Surprise As SERENA-4 Serves Up A Miss For AstraZeneca’s Etcamah
Just days after securing FDA approval in a narrowly defined indication, the oral SERD failed to show significant improvement in progression-free survival in a Phase III first-line study.
Scrip - September 14, 2026
Just days after securing FDA approval in a narrowly defined indication, the oral SERD failed to show significant improvement in progression-free survival in a Phase III first-line study.
Scrip - September 14, 2026
Scrip Asks... What Does 2026 Hold For Biopharma? Part 2: Competitive Dynamics -A Landscape Reshaped
Key opinion leaders share their perspectives on the competitive dynamics reshaping the biopharma industry in 2026.
Scrip - September 14, 2026
Key opinion leaders share their perspectives on the competitive dynamics reshaping the biopharma industry in 2026.
Scrip - September 14, 2026
Pipeline Watch: One Approval And Three 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 - September 14, 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 - September 14, 2026
WCLC 2026: GSK Sees The Start Of A Lung Cancer Franchise
For many years GSK insisted that it would only target specialist oncology indications but it is now looking to build a broad portfolio in lung cancer
Scrip - September 14, 2026
For many years GSK insisted that it would only target specialist oncology indications but it is now looking to build a broad portfolio in lung cancer
Scrip - September 14, 2026
WCLC 2026: Hansoh And GSK’s Ris-Rez Comes Out On Top In SCLC
Impressive Phase III results from China put the B7-H3–targeting ADC in the driving seat in second line small-cell lung cancer, with GSK aiming to replicate the survival improvement in a global study.
Scrip - September 14, 2026
Impressive Phase III results from China put the B7-H3–targeting ADC in the driving seat in second line small-cell lung cancer, with GSK aiming to replicate the survival improvement in a global study.
Scrip - September 14, 2026
WCLC 2026: Phase III Overall Survival Win In SCLC For MediLink’s ADC
MediLink’s B7-H3-targeted antibody-drug conjugate tambotatug pelitecan achieves overall survival and progression-free survival benefits in Chinese patients with relapsed small cell lung cancer.
Scrip - September 14, 2026
MediLink’s B7-H3-targeted antibody-drug conjugate tambotatug pelitecan achieves overall survival and progression-free survival benefits in Chinese patients with relapsed small cell lung cancer.
Scrip - September 14, 2026
Rakuten Fortifies Global Expertise With Ex-Takeda CEO Weber
Rakuten Medical expects experienced new board members will help it reach regulatory and commercial milestones in the US market.
Scrip - September 14, 2026
Rakuten Medical expects experienced new board members will help it reach regulatory and commercial milestones in the US market.
Scrip - September 14, 2026
Quick Listen: Scrip’s Five Must-Know Things
This week: what’s next in cardiovascular R&D following Phase III failures; gains for nine of world’s top 10 drugs in Q2; AstraZeneca’s COPD contender out-performs Dupixent in Phase III; Renexxion co-founder on naronapride in gastroparesis; and Chinese companies' global Phase III activity.
Scrip - September 14, 2026
This week: what’s next in cardiovascular R&D following Phase III failures; gains for nine of world’s top 10 drugs in Q2; AstraZeneca’s COPD contender out-performs Dupixent in Phase III; Renexxion co-founder on naronapride in gastroparesis; and Chinese companies' global Phase III activity.
Scrip - September 14, 2026
Certifications Over Speed: Tandem Health’s $100m Strategy To Win European AI
Tandem's $100m funding will be used to accelerate the adoption of AI across European healthcare, expanding from an AI medical assistant to an AI-native clinic operating system and doubling down across European markets.
Medtech Insight - September 14, 2026
Tandem's $100m funding will be used to accelerate the adoption of AI across European healthcare, expanding from an AI medical assistant to an AI-native clinic operating system and doubling down across European markets.
Medtech Insight - September 14, 2026
Ecommerce Sites Pushing Beauty Sellers To Find Nonexistent FDA Certificates; Regulatory Roundup
The US FDA pleads with online cosmetics sellers to cease requests for product registration certificates. Separately, IFRA has concluded the consultation on the 52nd amendment to its voluntary standards and Illinois institutes a ban on cosmetic ingredients.
HBW Insight - September 14, 2026
The US FDA pleads with online cosmetics sellers to cease requests for product registration certificates. Separately, IFRA has concluded the consultation on the 52nd amendment to its voluntary standards and Illinois institutes a ban on cosmetic ingredients.
HBW Insight - September 14, 2026
What’s Hot, Who’s Buying and Why Valuations Are Diverging In Consumer Health M&A
Senior advisors from Alantra, Bridgepoint, Capstone Partners, EY-Parthenon and OC&C share their view on the in-demand consumer health categories, the valuation drivers that matter most, and a buyer landscape shifting toward strategics. Part one of HBW's 'Inside Consumer Health M&A' series.
HBW Insight - September 14, 2026
Senior advisors from Alantra, Bridgepoint, Capstone Partners, EY-Parthenon and OC&C share their view on the in-demand consumer health categories, the valuation drivers that matter most, and a buyer landscape shifting toward strategics. Part one of HBW's 'Inside Consumer Health M&A' series.
HBW Insight - September 14, 2026
PharmaSynergyOTC: Rx-To-OTC Switch Should Be About Women’s Empowerment
Cemag Care's Clémence Desjardin told PharmaSynergyOTC delegates in Rome that switch is women's health's answer to decades of structural underinvestment, and set out the four dimensions behind the firm's 2025 reclassification of tranexamic acid in France.
HBW Insight - September 14, 2026
Cemag Care's Clémence Desjardin told PharmaSynergyOTC delegates in Rome that switch is women's health's answer to decades of structural underinvestment, and set out the four dimensions behind the firm's 2025 reclassification of tranexamic acid in France.
HBW Insight - September 14, 2026
Premium Pricing And Brand Loyalty Face AI Reckoning In Consumer Health
AI is making product ingredients and price differentials more transparent, threatening the premium pricing strategies and brand loyalty that underpin much of the consumer health industry, according to Jefferies analyst David Hayes.
HBW Insight - September 14, 2026
AI is making product ingredients and price differentials more transparent, threatening the premium pricing strategies and brand loyalty that underpin much of the consumer health industry, according to Jefferies analyst David Hayes.
HBW Insight - September 14, 2026
FDA Consumer Health Advisory: Industry Titan Leaves Lasting Legacy
What's happening, why it matters and what's next at FDA. This edition explores Peter Barton Hutt's legacy, an infant formula dispute and exceptions to the drug preclusion impediment to introducing new dietary ingredients.
HBW Insight - September 14, 2026
What's happening, why it matters and what's next at FDA. This edition explores Peter Barton Hutt's legacy, an infant formula dispute and exceptions to the drug preclusion impediment to introducing new dietary ingredients.
HBW Insight - September 14, 2026
Xlear Complaint Making Loper Bright Argument In Challenge To FTC Health Claim Policy Dismissed
With Xlear not contesting an active enforcement, “the case is not ripe for judicial review,” meaning the district “court lacks subject matter jurisdiction over the claims … and dismisses this action without prejudice,” Utah District Court ruling states.
HBW Insight - September 14, 2026
With Xlear not contesting an active enforcement, “the case is not ripe for judicial review,” meaning the district “court lacks subject matter jurisdiction over the claims … and dismisses this action without prejudice,” Utah District Court ruling states.
HBW Insight - September 14, 2026
Advicenne Withdraws US 505(b)(2) Application For A Rare Kidney Disease Drug
Despite satisfying other regulators, Advicenne cited CMC-related requirements in its decision to withdraw its US application for Sibnayal (potassium citrate/potassium bicarbonate).
Generics Bulletin - September 14, 2026
Despite satisfying other regulators, Advicenne cited CMC-related requirements in its decision to withdraw its US application for Sibnayal (potassium citrate/potassium bicarbonate).
Generics Bulletin - September 14, 2026
EU Lawmakers Back Unlimited Biosimilar Stockpiling Under SPC Waiver
The EU’s JURI committee has backed removing the six-month stockpiling limit for biosimilars under the SPC waiver, a move welcomed by Medicines for Europe as a boost to EU manufacturing, competition and day-one market entry.
Generics Bulletin - September 14, 2026
The EU’s JURI committee has backed removing the six-month stockpiling limit for biosimilars under the SPC waiver, a move welcomed by Medicines for Europe as a boost to EU manufacturing, competition and day-one market entry.
Generics Bulletin - September 14, 2026
Amgen Leads The Pack With First Filing For US Opdivo Biosimilar
Amgen has revealed the first disclosed Opdivo (nivolumab) biosimilar filing with the US FDA, while also pointing to an imminent US submission for a Keytruda (pembrolizumab) rival by the end of the year, following positive trial readouts.
Generics Bulletin - September 14, 2026
Amgen has revealed the first disclosed Opdivo (nivolumab) biosimilar filing with the US FDA, while also pointing to an imminent US submission for a Keytruda (pembrolizumab) rival by the end of the year, following positive trial readouts.
Generics Bulletin - September 14, 2026
A Blood Test Rewrites The Economics Of Alzheimer’s Diagnosis
When a simple blood test can reduce reliance on complex, costly procedures and onward referral, specialist resources and expertise can be spent where they make the greatest difference.
In Vivo - September 14, 2026
When a simple blood test can reduce reliance on complex, costly procedures and onward referral, specialist resources and expertise can be spent where they make the greatest difference.
In Vivo - September 14, 2026
Graveyard Drug Hunters: How Racura And Cereno Are Repurposing Drugs That Pharma Threw Away
A contrarian cohort of drug companies is betting that pharma's most undervalued assets are the ones it already threw away.
In Vivo - September 14, 2026
A contrarian cohort of drug companies is betting that pharma's most undervalued assets are the ones it already threw away.
In Vivo - September 14, 2026