Latest Pharma Insights
Research Ethics Committees Debate Value of UK Trial Diversity Plans
A pilot shows the UK’s guidance on inclusion and diversity plans is steering study sponsors in the right direction, but further work is needed to determine how much information research ethics committees need to see and how it should be presented.
Medtech Insight - November 5, 2026
A pilot shows the UK’s guidance on inclusion and diversity plans is steering study sponsors in the right direction, but further work is needed to determine how much information research ethics committees need to see and how it should be presented.
Medtech Insight - November 5, 2026
China Partnering Pioneer Huyabio Ready To File Melanoma Therapy
Having built up its relationships with China’s drug developers over the last 20 years, Huyabio sees an opportunity for its lead candidate in improving metastatic melanoma treatment.
Scrip - November 5, 2026
Having built up its relationships with China’s drug developers over the last 20 years, Huyabio sees an opportunity for its lead candidate in improving metastatic melanoma treatment.
Scrip - November 5, 2026
Businesses Give Positive Feedback On UK Trial Diversity Plan Pilot
The UK’s pilot of voluntary clinical trial diversity plans will expand in early 2027, after commercial sponsors reported benefits, though non-commercial sponsors saw less value.
Medtech Insight - November 5, 2026
The UK’s pilot of voluntary clinical trial diversity plans will expand in early 2027, after commercial sponsors reported benefits, though non-commercial sponsors saw less value.
Medtech Insight - November 5, 2026
Revolution’s Rasonque Sets New Benchmark For Oncology Launch Sales, Scrip Analysis Shows
Rasonque’s $198m debut topped every oncology launch, beating the next best by more than $100m. Revolution Medicines said early sales reflect finite dynamics and are not necessarily indicative of the drug’s longer-term trajectory.
Scrip - November 5, 2026
Rasonque’s $198m debut topped every oncology launch, beating the next best by more than $100m. Revolution Medicines said early sales reflect finite dynamics and are not necessarily indicative of the drug’s longer-term trajectory.
Scrip - November 5, 2026
AASLD 2026: Gilead Eyes Wider Livdelzi Use As Phase III Data Bolster PBC Expansion Plans
Gilead is looking to take Livdelzi beyond its current reach in PBC, with new Phase III IDEAL data potentially paving the way for broader use.
Scrip - November 5, 2026
Gilead is looking to take Livdelzi beyond its current reach in PBC, with new Phase III IDEAL data potentially paving the way for broader use.
Scrip - November 5, 2026
Scrip’s Guide To November: Novel Anticancer Approvals Await
November will see a plethora of medical conferences, including the AHA and ACR, plus US FDA decisions on 12 novel drug applications, among other investor meetings.
Scrip - November 5, 2026
November will see a plethora of medical conferences, including the AHA and ACR, plus US FDA decisions on 12 novel drug applications, among other investor meetings.
Scrip - November 5, 2026
US Industry Urges Earlier FDA Calls On 180-Day Forfeiture
FDA’s practice of deciding forfeiture only when a later applicant seeks approval leaves first-filers guessing for years, industry reps say during an AAM conference session on potential GDUFA legislative policy riders.
Generics Bulletin - November 5, 2026
FDA’s practice of deciding forfeiture only when a later applicant seeks approval leaves first-filers guessing for years, industry reps say during an AAM conference session on potential GDUFA legislative policy riders.
Generics Bulletin - November 5, 2026
Alembic Eyes US Exclusivity For Venetoclax After FDA Approval
Alembic Pharmaceuticals is eyeing potential 180-day exclusivity in the $1.6bn US venetoclax market after receiving approval for its ANDA. However, a launch date remains unclear.
Generics Bulletin - November 5, 2026
Alembic Pharmaceuticals is eyeing potential 180-day exclusivity in the $1.6bn US venetoclax market after receiving approval for its ANDA. However, a launch date remains unclear.
Generics Bulletin - November 5, 2026
Amneal Dreams To Be The Second Xolair Rival In The US, Projecting Launch In Late 2027
Amneal raised its full-year guidance for a third time, as Xolair biosimilar commercialization planning is underway and the recent Kashiv acquisition is already delivering financial benefits.
Generics Bulletin - November 5, 2026
Amneal raised its full-year guidance for a third time, as Xolair biosimilar commercialization planning is underway and the recent Kashiv acquisition is already delivering financial benefits.
Generics Bulletin - November 5, 2026
Industry Push To Extend International Supplement Guidelines Beyond Vitamins And Minerals Turned Down
Codex’s nutrition committee declined to widen its international supplement guidelines beyond vitamins and minerals, agreeing only to update the 2005 text within its current scope, and to separately take stock of other substances, a sharp narrowing of industry's proposal.
HBW Insight - November 5, 2026
Codex’s nutrition committee declined to widen its international supplement guidelines beyond vitamins and minerals, agreeing only to update the 2005 text within its current scope, and to separately take stock of other substances, a sharp narrowing of industry's proposal.
HBW Insight - November 5, 2026
Zimmer Biomet Q3: Hips And Robotics Lift Guidance As Knees Lag; Monogram Launch Moves Up
Zimmer Biomet raised its 2026 outlook again as hips, robotics and S.E.T. offset a 2.6% knee decline. CEO Ivan Tornos blames knees mainly on commercial execution, not the market, a view Stryker’s slowdown warning contests, and says an autonomous Monogram robot could launch in H1 2027 if cleared.
Medtech Insight - November 5, 2026
Zimmer Biomet raised its 2026 outlook again as hips, robotics and S.E.T. offset a 2.6% knee decline. CEO Ivan Tornos blames knees mainly on commercial execution, not the market, a view Stryker’s slowdown warning contests, and says an autonomous Monogram robot could launch in H1 2027 if cleared.
Medtech Insight - November 5, 2026
UK’s Alethio Banks $90m In Bid To Transform ET Treatment
The spin-off from Oxford University has assembled a strong transatlantic syndicate to take its essential thrombocythemia candidate from patient studies into a registrational program.
Scrip - November 5, 2026
The spin-off from Oxford University has assembled a strong transatlantic syndicate to take its essential thrombocythemia candidate from patient studies into a registrational program.
Scrip - November 5, 2026
Dr Reddy’s Brazilian Semaglutide Nod Sets Up A Competitive Generic GLP-1 Market
After an earlier knockback, Dr Reddy’s has secured approval from Brazil’s Anvisa for its semaglutide generic. But with multiple other rivals approved in the market, competition is set to be fierce.
Generics Bulletin - November 5, 2026
After an earlier knockback, Dr Reddy’s has secured approval from Brazil’s Anvisa for its semaglutide generic. But with multiple other rivals approved in the market, competition is set to be fierce.
Generics Bulletin - November 5, 2026
Zydus Pulls Plug On Saroglitazar’s US MASH Plans, But Biomedtracker Sees 99% PBC Approval Odds
Zydus’ saroglitazar has a 99% likelihood of approval as a second-line treatment for primary biliary cholangitis in the US as per Biomedtracker, and is expected to be launched in March 2027, even though it will no longer be advanced as a MASH treatment in the US.
Scrip - November 5, 2026
Zydus’ saroglitazar has a 99% likelihood of approval as a second-line treatment for primary biliary cholangitis in the US as per Biomedtracker, and is expected to be launched in March 2027, even though it will no longer be advanced as a MASH treatment in the US.
Scrip - November 5, 2026
APSMI Summit: Health Literacy Needs Understandable Systems, Not ‘Heroic Consumers’
AI chatbots and online platforms have created a “crisis of judgment” for self-care consumers, a health literacy expert told the recent APSMI Summit, as Malaysia set out how 12,500 community volunteers are turning health information into safer self-care.
HBW Insight - November 5, 2026
AI chatbots and online platforms have created a “crisis of judgment” for self-care consumers, a health literacy expert told the recent APSMI Summit, as Malaysia set out how 12,500 community volunteers are turning health information into safer self-care.
HBW Insight - November 5, 2026
In 2027 International Regulatory Reliance Could Become The Rule, Not The Exception
Speakers at the Veeva MedTech Summit in Amsterdam agreed that greater international collaboration for medtech certification and post-market surveillance is needed. The next step is to decide how it will work.
Medtech Insight - November 5, 2026
Speakers at the Veeva MedTech Summit in Amsterdam agreed that greater international collaboration for medtech certification and post-market surveillance is needed. The next step is to decide how it will work.
Medtech Insight - November 5, 2026
Imviva Bets One Off-The-Shelf Platform Can Carry CAR-T From Leukemia To Autoimmune Disease
Imviva says its ANSWER platform fixes what undid first-generation allogeneic CAR-T, and is pursuing T-cell leukemia and autoimmune disease on the same technology.
In Vivo - November 5, 2026
Imviva says its ANSWER platform fixes what undid first-generation allogeneic CAR-T, and is pursuing T-cell leukemia and autoimmune disease on the same technology.
In Vivo - November 5, 2026
Education And Finding New ‘Champions’: How The US Midterms Will Reshape Off-Patent Lobbying Efforts
Speaking to Generics Bulletin after the US midterm elections, AAM chief executive John Murphy III says the new political landscape will require fresh education efforts and building “champions” to work with on affordability and access to medicines, as GDUFA and BsUFA reauthorizations loom.
Generics Bulletin - November 5, 2026
Speaking to Generics Bulletin after the US midterm elections, AAM chief executive John Murphy III says the new political landscape will require fresh education efforts and building “champions” to work with on affordability and access to medicines, as GDUFA and BsUFA reauthorizations loom.
Generics Bulletin - November 5, 2026
Astellas Optimistic On Padcev Growth But Braces For Xtandi IRA Impact
Along with forex tailwinds, positive growth for mainstay and other products leads Astellas to raise full-year sales forecast.
Scrip - November 5, 2026
Along with forex tailwinds, positive growth for mainstay and other products leads Astellas to raise full-year sales forecast.
Scrip - November 5, 2026
Lilly And J&J Back T-Therapeutics’ $133m Bet On TCR Bispecifics Beyond Cancer
T-Therapeutics' ability to validate its platform in humans will be the next test of its ambitions across oncology and autoimmune diseases.
Scrip - November 5, 2026
T-Therapeutics' ability to validate its platform in humans will be the next test of its ambitions across oncology and autoimmune diseases.
Scrip - November 5, 2026
Smith+Nephew Confirms J&J Talks Ended As US Knee And Hip Decline Continues
Smith+Nephew confirmed it approached J&J about a DePuy Synthes combination but those talks have ended. The company is now pursuing other options for orthopedics — while its US knee and hip business continues to decline and guidance has been cut again.
Medtech Insight - November 5, 2026
Smith+Nephew confirmed it approached J&J about a DePuy Synthes combination but those talks have ended. The company is now pursuing other options for orthopedics — while its US knee and hip business continues to decline and guidance has been cut again.
Medtech Insight - November 5, 2026
Times Up For Indian Toothpaste Manufacturer Using Color Additive Unallowed In US For 60 Years
Pritam International used color additive identified as “CI 14720,” also known as Ext. D&C Red No. 10, Acid Red No. 14, Food Red 3, Carmoisine or Azorubine and delisted since 1966, in Brush Buddies, evo and ARU children’s and other toothpastes available in US.
HBW Insight - November 5, 2026
Pritam International used color additive identified as “CI 14720,” also known as Ext. D&C Red No. 10, Acid Red No. 14, Food Red 3, Carmoisine or Azorubine and delisted since 1966, in Brush Buddies, evo and ARU children’s and other toothpastes available in US.
HBW Insight - November 5, 2026
Toothpaste, Hair Regrowth Recalls Hit US Market; EU Panel Sets Limits For Two Fragrance Ingredients
Recent beauty regulatory news includes US recalls of more than four million tubes of toothpaste and about 11,000 hair regrowth products, while an EU scientific committee found two fragrance ingredients safe at set limits.
HBW Insight - November 5, 2026
Recent beauty regulatory news includes US recalls of more than four million tubes of toothpaste and about 11,000 hair regrowth products, while an EU scientific committee found two fragrance ingredients safe at set limits.
HBW Insight - November 5, 2026
Forex Again Lifts Major Japanese Firms’ Results
Major Japanese firms report a generally positive quarter helped by forex effects, leading Takeda and Shionogi to revise upwards their guidance for the full fiscal year.
Scrip - November 5, 2026
Major Japanese firms report a generally positive quarter helped by forex effects, leading Takeda and Shionogi to revise upwards their guidance for the full fiscal year.
Scrip - November 5, 2026
China Partnering Pioneer Huyabio Ready To File Melanoma Therapy
Having built up its relationships with China’s drug developers over the last 20 years, Huyabio sees an opportunity for its lead candidate in improving metastatic melanoma treatment.
Scrip - November 5, 2026
Having built up its relationships with China’s drug developers over the last 20 years, Huyabio sees an opportunity for its lead candidate in improving metastatic melanoma treatment.
Scrip - November 5, 2026
Revolution’s Rasonque Sets New Benchmark For Oncology Launch Sales, Scrip Analysis Shows
Rasonque’s $198m debut topped every oncology launch, beating the next best by more than $100m. Revolution Medicines said early sales reflect finite dynamics and are not necessarily indicative of the drug’s longer-term trajectory.
Scrip - November 5, 2026
Rasonque’s $198m debut topped every oncology launch, beating the next best by more than $100m. Revolution Medicines said early sales reflect finite dynamics and are not necessarily indicative of the drug’s longer-term trajectory.
Scrip - November 5, 2026
AASLD 2026: Gilead Eyes Wider Livdelzi Use As Phase III Data Bolster PBC Expansion Plans
Gilead is looking to take Livdelzi beyond its current reach in PBC, with new Phase III IDEAL data potentially paving the way for broader use.
Scrip - November 5, 2026
Gilead is looking to take Livdelzi beyond its current reach in PBC, with new Phase III IDEAL data potentially paving the way for broader use.
Scrip - November 5, 2026
Scrip’s Guide To November: Novel Anticancer Approvals Await
November will see a plethora of medical conferences, including the AHA and ACR, plus US FDA decisions on 12 novel drug applications, among other investor meetings.
Scrip - November 5, 2026
November will see a plethora of medical conferences, including the AHA and ACR, plus US FDA decisions on 12 novel drug applications, among other investor meetings.
Scrip - November 5, 2026
UK’s Alethio Banks $90m In Bid To Transform ET Treatment
The spin-off from Oxford University has assembled a strong transatlantic syndicate to take its essential thrombocythemia candidate from patient studies into a registrational program.
Scrip - November 5, 2026
The spin-off from Oxford University has assembled a strong transatlantic syndicate to take its essential thrombocythemia candidate from patient studies into a registrational program.
Scrip - November 5, 2026
Zydus Pulls Plug On Saroglitazar’s US MASH Plans, But Biomedtracker Sees 99% PBC Approval Odds
Zydus’ saroglitazar has a 99% likelihood of approval as a second-line treatment for primary biliary cholangitis in the US as per Biomedtracker, and is expected to be launched in March 2027, even though it will no longer be advanced as a MASH treatment in the US.
Scrip - November 5, 2026
Zydus’ saroglitazar has a 99% likelihood of approval as a second-line treatment for primary biliary cholangitis in the US as per Biomedtracker, and is expected to be launched in March 2027, even though it will no longer be advanced as a MASH treatment in the US.
Scrip - November 5, 2026
Astellas Optimistic On Padcev Growth But Braces For Xtandi IRA Impact
Along with forex tailwinds, positive growth for mainstay and other products leads Astellas to raise full-year sales forecast.
Scrip - November 5, 2026
Along with forex tailwinds, positive growth for mainstay and other products leads Astellas to raise full-year sales forecast.
Scrip - November 5, 2026
Lilly And J&J Back T-Therapeutics’ $133m Bet On TCR Bispecifics Beyond Cancer
T-Therapeutics' ability to validate its platform in humans will be the next test of its ambitions across oncology and autoimmune diseases.
Scrip - November 5, 2026
T-Therapeutics' ability to validate its platform in humans will be the next test of its ambitions across oncology and autoimmune diseases.
Scrip - November 5, 2026
Forex Again Lifts Major Japanese Firms’ Results
Major Japanese firms report a generally positive quarter helped by forex effects, leading Takeda and Shionogi to revise upwards their guidance for the full fiscal year.
Scrip - November 5, 2026
Major Japanese firms report a generally positive quarter helped by forex effects, leading Takeda and Shionogi to revise upwards their guidance for the full fiscal year.
Scrip - November 5, 2026
Research Ethics Committees Debate Value of UK Trial Diversity Plans
A pilot shows the UK’s guidance on inclusion and diversity plans is steering study sponsors in the right direction, but further work is needed to determine how much information research ethics committees need to see and how it should be presented.
Medtech Insight - November 5, 2026
A pilot shows the UK’s guidance on inclusion and diversity plans is steering study sponsors in the right direction, but further work is needed to determine how much information research ethics committees need to see and how it should be presented.
Medtech Insight - November 5, 2026
Businesses Give Positive Feedback On UK Trial Diversity Plan Pilot
The UK’s pilot of voluntary clinical trial diversity plans will expand in early 2027, after commercial sponsors reported benefits, though non-commercial sponsors saw less value.
Medtech Insight - November 5, 2026
The UK’s pilot of voluntary clinical trial diversity plans will expand in early 2027, after commercial sponsors reported benefits, though non-commercial sponsors saw less value.
Medtech Insight - November 5, 2026
Zimmer Biomet Q3: Hips And Robotics Lift Guidance As Knees Lag; Monogram Launch Moves Up
Zimmer Biomet raised its 2026 outlook again as hips, robotics and S.E.T. offset a 2.6% knee decline. CEO Ivan Tornos blames knees mainly on commercial execution, not the market, a view Stryker’s slowdown warning contests, and says an autonomous Monogram robot could launch in H1 2027 if cleared.
Medtech Insight - November 5, 2026
Zimmer Biomet raised its 2026 outlook again as hips, robotics and S.E.T. offset a 2.6% knee decline. CEO Ivan Tornos blames knees mainly on commercial execution, not the market, a view Stryker’s slowdown warning contests, and says an autonomous Monogram robot could launch in H1 2027 if cleared.
Medtech Insight - November 5, 2026
In 2027 International Regulatory Reliance Could Become The Rule, Not The Exception
Speakers at the Veeva MedTech Summit in Amsterdam agreed that greater international collaboration for medtech certification and post-market surveillance is needed. The next step is to decide how it will work.
Medtech Insight - November 5, 2026
Speakers at the Veeva MedTech Summit in Amsterdam agreed that greater international collaboration for medtech certification and post-market surveillance is needed. The next step is to decide how it will work.
Medtech Insight - November 5, 2026
Smith+Nephew Confirms J&J Talks Ended As US Knee And Hip Decline Continues
Smith+Nephew confirmed it approached J&J about a DePuy Synthes combination but those talks have ended. The company is now pursuing other options for orthopedics — while its US knee and hip business continues to decline and guidance has been cut again.
Medtech Insight - November 5, 2026
Smith+Nephew confirmed it approached J&J about a DePuy Synthes combination but those talks have ended. The company is now pursuing other options for orthopedics — while its US knee and hip business continues to decline and guidance has been cut again.
Medtech Insight - November 5, 2026
Industry Push To Extend International Supplement Guidelines Beyond Vitamins And Minerals Turned Down
Codex’s nutrition committee declined to widen its international supplement guidelines beyond vitamins and minerals, agreeing only to update the 2005 text within its current scope, and to separately take stock of other substances, a sharp narrowing of industry's proposal.
HBW Insight - November 5, 2026
Codex’s nutrition committee declined to widen its international supplement guidelines beyond vitamins and minerals, agreeing only to update the 2005 text within its current scope, and to separately take stock of other substances, a sharp narrowing of industry's proposal.
HBW Insight - November 5, 2026
APSMI Summit: Health Literacy Needs Understandable Systems, Not ‘Heroic Consumers’
AI chatbots and online platforms have created a “crisis of judgment” for self-care consumers, a health literacy expert told the recent APSMI Summit, as Malaysia set out how 12,500 community volunteers are turning health information into safer self-care.
HBW Insight - November 5, 2026
AI chatbots and online platforms have created a “crisis of judgment” for self-care consumers, a health literacy expert told the recent APSMI Summit, as Malaysia set out how 12,500 community volunteers are turning health information into safer self-care.
HBW Insight - November 5, 2026
Times Up For Indian Toothpaste Manufacturer Using Color Additive Unallowed In US For 60 Years
Pritam International used color additive identified as “CI 14720,” also known as Ext. D&C Red No. 10, Acid Red No. 14, Food Red 3, Carmoisine or Azorubine and delisted since 1966, in Brush Buddies, evo and ARU children’s and other toothpastes available in US.
HBW Insight - November 5, 2026
Pritam International used color additive identified as “CI 14720,” also known as Ext. D&C Red No. 10, Acid Red No. 14, Food Red 3, Carmoisine or Azorubine and delisted since 1966, in Brush Buddies, evo and ARU children’s and other toothpastes available in US.
HBW Insight - November 5, 2026
Toothpaste, Hair Regrowth Recalls Hit US Market; EU Panel Sets Limits For Two Fragrance Ingredients
Recent beauty regulatory news includes US recalls of more than four million tubes of toothpaste and about 11,000 hair regrowth products, while an EU scientific committee found two fragrance ingredients safe at set limits.
HBW Insight - November 5, 2026
Recent beauty regulatory news includes US recalls of more than four million tubes of toothpaste and about 11,000 hair regrowth products, while an EU scientific committee found two fragrance ingredients safe at set limits.
HBW Insight - November 5, 2026
US Industry Urges Earlier FDA Calls On 180-Day Forfeiture
FDA’s practice of deciding forfeiture only when a later applicant seeks approval leaves first-filers guessing for years, industry reps say during an AAM conference session on potential GDUFA legislative policy riders.
Generics Bulletin - November 5, 2026
FDA’s practice of deciding forfeiture only when a later applicant seeks approval leaves first-filers guessing for years, industry reps say during an AAM conference session on potential GDUFA legislative policy riders.
Generics Bulletin - November 5, 2026
Alembic Eyes US Exclusivity For Venetoclax After FDA Approval
Alembic Pharmaceuticals is eyeing potential 180-day exclusivity in the $1.6bn US venetoclax market after receiving approval for its ANDA. However, a launch date remains unclear.
Generics Bulletin - November 5, 2026
Alembic Pharmaceuticals is eyeing potential 180-day exclusivity in the $1.6bn US venetoclax market after receiving approval for its ANDA. However, a launch date remains unclear.
Generics Bulletin - November 5, 2026
Amneal Dreams To Be The Second Xolair Rival In The US, Projecting Launch In Late 2027
Amneal raised its full-year guidance for a third time, as Xolair biosimilar commercialization planning is underway and the recent Kashiv acquisition is already delivering financial benefits.
Generics Bulletin - November 5, 2026
Amneal raised its full-year guidance for a third time, as Xolair biosimilar commercialization planning is underway and the recent Kashiv acquisition is already delivering financial benefits.
Generics Bulletin - November 5, 2026
Dr Reddy’s Brazilian Semaglutide Nod Sets Up A Competitive Generic GLP-1 Market
After an earlier knockback, Dr Reddy’s has secured approval from Brazil’s Anvisa for its semaglutide generic. But with multiple other rivals approved in the market, competition is set to be fierce.
Generics Bulletin - November 5, 2026
After an earlier knockback, Dr Reddy’s has secured approval from Brazil’s Anvisa for its semaglutide generic. But with multiple other rivals approved in the market, competition is set to be fierce.
Generics Bulletin - November 5, 2026
Education And Finding New ‘Champions’: How The US Midterms Will Reshape Off-Patent Lobbying Efforts
Speaking to Generics Bulletin after the US midterm elections, AAM chief executive John Murphy III says the new political landscape will require fresh education efforts and building “champions” to work with on affordability and access to medicines, as GDUFA and BsUFA reauthorizations loom.
Generics Bulletin - November 5, 2026
Speaking to Generics Bulletin after the US midterm elections, AAM chief executive John Murphy III says the new political landscape will require fresh education efforts and building “champions” to work with on affordability and access to medicines, as GDUFA and BsUFA reauthorizations loom.
Generics Bulletin - November 5, 2026
Imviva Bets One Off-The-Shelf Platform Can Carry CAR-T From Leukemia To Autoimmune Disease
Imviva says its ANSWER platform fixes what undid first-generation allogeneic CAR-T, and is pursuing T-cell leukemia and autoimmune disease on the same technology.
In Vivo - November 5, 2026
Imviva says its ANSWER platform fixes what undid first-generation allogeneic CAR-T, and is pursuing T-cell leukemia and autoimmune disease on the same technology.
In Vivo - November 5, 2026