Latest Pharma Insights
Amgen’s Uplizna Approved For Its Largest And Most Competitive Indication Yet
The US FDA approved Uplizna (inebilizumab) for generalized myasthenia gravis, an increasingly crowded market. Amgen believes it can compete due to the CD19-targeting antibody’s durable efficacy with twice-yearly dosing.
Scrip - December 12, 2025
The US FDA approved Uplizna (inebilizumab) for generalized myasthenia gravis, an increasingly crowded market. Amgen believes it can compete due to the CD19-targeting antibody’s durable efficacy with twice-yearly dosing.
Scrip - December 12, 2025
GSK Sees Community Niche For Blenrep, But Bispecifics Are Making Inroads
The drugmaker presented multiple posters of data for the recently reapproved BCMA-targeting antibody-drug conjugate at the just concluded ASH meeting.
Scrip - December 12, 2025
The drugmaker presented multiple posters of data for the recently reapproved BCMA-targeting antibody-drug conjugate at the just concluded ASH meeting.
Scrip - December 12, 2025
Arcus Calls Quits On Anti-TIGIT Candidate After Phase III Termination
Arcus is ending development of its TIGIT-targeted antibody domvanalimab after it was determined a Phase III study would not show a survival benefit in gastrointestinal cancers.
Scrip - December 12, 2025
Arcus is ending development of its TIGIT-targeted antibody domvanalimab after it was determined a Phase III study would not show a survival benefit in gastrointestinal cancers.
Scrip - December 12, 2025
Effective Engagement With The FDA During Recalls Starts With Effective Communication, Expert Says
During a webinar hosted by Sedgwick, a pair of regulatory experts discussed how medtech firms can optimize their engagement with the FDA, especially when it comes to communicating recalls and corrective actions.
Medtech Insight - December 12, 2025
During a webinar hosted by Sedgwick, a pair of regulatory experts discussed how medtech firms can optimize their engagement with the FDA, especially when it comes to communicating recalls and corrective actions.
Medtech Insight - December 12, 2025
Top 100 Ranking: Chinese Medtechs Make Their Presence Felt In Latest Top 100 By Revenues
With the last of the Top 100 medtech companies filing 2024-25 revenues in November, Medtech Insight now presents its latest ranking of cardiology, orthopedic, diagnostic imaging and in vitro diagnostics companies.
Medtech Insight - December 12, 2025
With the last of the Top 100 medtech companies filing 2024-25 revenues in November, Medtech Insight now presents its latest ranking of cardiology, orthopedic, diagnostic imaging and in vitro diagnostics companies.
Medtech Insight - December 12, 2025
Industry Blasts Commission’s Urban Wastewater Directive Cost Review
Only taking inflation into account, the European Commission’s new cost estimate of between €1.48bn to €1.8bn per year, when adjusted for inflation, results in a total very similar to the original €1.2bn estimate.
HBW Insight - December 12, 2025
Only taking inflation into account, the European Commission’s new cost estimate of between €1.48bn to €1.8bn per year, when adjusted for inflation, results in a total very similar to the original €1.2bn estimate.
HBW Insight - December 12, 2025
MTI 100: Separations, Value Creation And Innovation Top The Agenda For Healthtechs
Six companies exceeded $20bn in the latest Top 100 ranking of global medtechs by revenues, but with a slew of structural changes ahead, the leader board could change in 2026.
Medtech Insight - December 12, 2025
Six companies exceeded $20bn in the latest Top 100 ranking of global medtechs by revenues, but with a slew of structural changes ahead, the leader board could change in 2026.
Medtech Insight - December 12, 2025
AC Immune Perks Up On Positive Parkinson’s Data
The Switzerland-based group’s alpha-synuclein-targeted immunotherapy shows promise in slowing progression of the degenerative brain condition.
Scrip - December 12, 2025
The Switzerland-based group’s alpha-synuclein-targeted immunotherapy shows promise in slowing progression of the degenerative brain condition.
Scrip - December 12, 2025
Top 10 Drugs Q3 2025: Obesity Gold Rush Helps Add $10bn To Revenues
Merck & Co.’s checkpoint inhibitor Keytruda remains the best-selling drug worldwide. The top 10 products generated nearly $47bn in third-quarter revenues for big pharma, boosted by swelling sales of obesity drugs.
Scrip - December 12, 2025
Merck & Co.’s checkpoint inhibitor Keytruda remains the best-selling drug worldwide. The top 10 products generated nearly $47bn in third-quarter revenues for big pharma, boosted by swelling sales of obesity drugs.
Scrip - December 12, 2025
Biologics-In-A-Pill Firm PsiThera Launched With Series A $47.5m
Having worked in stealth on its predictive computational R&D models, PsiThera has emerged to develop oral versions of blockbuster drug targets in inflammation and immunology.
Scrip - December 12, 2025
Having worked in stealth on its predictive computational R&D models, PsiThera has emerged to develop oral versions of blockbuster drug targets in inflammation and immunology.
Scrip - December 12, 2025
Teva’s Estradiol Approved As The First Generic To Imvexxy By The FDA
The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.
Generics Bulletin - December 12, 2025
The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.
Generics Bulletin - December 12, 2025
Executives On The Move: Kriya Therapeutics Gets A New CMO From Pfizer
Recent moves in the industry include C-suite changes at Tyra Biosciences and HLB, plus seven companies get new CMOs and nine companies get new CFOs.
Scrip - December 12, 2025
Recent moves in the industry include C-suite changes at Tyra Biosciences and HLB, plus seven companies get new CMOs and nine companies get new CFOs.
Scrip - December 12, 2025
US FDA Brings Rx Generics Marketers Up To Date On OTC Switch Regulatory Landscape
CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.
Generics Bulletin - December 12, 2025
CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.
Generics Bulletin - December 12, 2025
Tyzavan Launch Marks Next Step In Hikma’s Global Injectables Growth Strategy
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.
Generics Bulletin - December 12, 2025
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.
Generics Bulletin - December 12, 2025
ASH: Early Results Ready Lupeng’s Rocbrutinib For Potential Head-To-Head With Jaypirca
Lupeng's BTK inhibitor rocbrutinib has shown an 80.0% ORR in a Phase I trial in patients who had received a covalent or non-covalent BTK inhibitor plus BCL-2 inhibitor, setting the stage for a comparative trial, possibly with Jaypirca.
Scrip - December 12, 2025
Lupeng's BTK inhibitor rocbrutinib has shown an 80.0% ORR in a Phase I trial in patients who had received a covalent or non-covalent BTK inhibitor plus BCL-2 inhibitor, setting the stage for a comparative trial, possibly with Jaypirca.
Scrip - December 12, 2025
Quotable: Words Of Wisdom From Our Recent APAC Coverage
Scrip's APAC team selects notable quotes from recent interviews, conferences and other coverage to highlight the views of senior executives and officials on major topics facing the biopharma sector in the region and more widely.
Scrip - December 12, 2025
Scrip's APAC team selects notable quotes from recent interviews, conferences and other coverage to highlight the views of senior executives and officials on major topics facing the biopharma sector in the region and more widely.
Scrip - December 12, 2025
Slow Burn For US Sunscreen Innovation While FDA Lights Lamp For Monograph Overhaul Deadlines
Sunscreen products industry and public health advocacy groups have been critical that FDA has not approved a new filter since 1999 even as countries in Europe and other regions allow using numerous additional ingredients in sunscreens.
HBW Insight - December 12, 2025
Sunscreen products industry and public health advocacy groups have been critical that FDA has not approved a new filter since 1999 even as countries in Europe and other regions allow using numerous additional ingredients in sunscreens.
HBW Insight - December 12, 2025
US Sunscreen And OTC Monograph Milestones Marked By DSM-Firmenich’s Bemotrizinol Proposal
FDA’s proposed order follows its review of OMOR DSM-Firmenich submitted showing bemotrizinol, at concentrations up to 6%, is generally recognized as safe and effective and can be added as an active ingredient to sunscreen monograph.
HBW Insight - December 12, 2025
FDA’s proposed order follows its review of OMOR DSM-Firmenich submitted showing bemotrizinol, at concentrations up to 6%, is generally recognized as safe and effective and can be added as an active ingredient to sunscreen monograph.
HBW Insight - December 12, 2025
Amgen’s Uplizna Approved For Its Largest And Most Competitive Indication Yet
The US FDA approved Uplizna (inebilizumab) for generalized myasthenia gravis, an increasingly crowded market. Amgen believes it can compete due to the CD19-targeting antibody’s durable efficacy with twice-yearly dosing.
Scrip - December 12, 2025
The US FDA approved Uplizna (inebilizumab) for generalized myasthenia gravis, an increasingly crowded market. Amgen believes it can compete due to the CD19-targeting antibody’s durable efficacy with twice-yearly dosing.
Scrip - December 12, 2025
GSK Sees Community Niche For Blenrep, But Bispecifics Are Making Inroads
The drugmaker presented multiple posters of data for the recently reapproved BCMA-targeting antibody-drug conjugate at the just concluded ASH meeting.
Scrip - December 12, 2025
The drugmaker presented multiple posters of data for the recently reapproved BCMA-targeting antibody-drug conjugate at the just concluded ASH meeting.
Scrip - December 12, 2025
Arcus Calls Quits On Anti-TIGIT Candidate After Phase III Termination
Arcus is ending development of its TIGIT-targeted antibody domvanalimab after it was determined a Phase III study would not show a survival benefit in gastrointestinal cancers.
Scrip - December 12, 2025
Arcus is ending development of its TIGIT-targeted antibody domvanalimab after it was determined a Phase III study would not show a survival benefit in gastrointestinal cancers.
Scrip - December 12, 2025
AC Immune Perks Up On Positive Parkinson’s Data
The Switzerland-based group’s alpha-synuclein-targeted immunotherapy shows promise in slowing progression of the degenerative brain condition.
Scrip - December 12, 2025
The Switzerland-based group’s alpha-synuclein-targeted immunotherapy shows promise in slowing progression of the degenerative brain condition.
Scrip - December 12, 2025
Top 10 Drugs Q3 2025: Obesity Gold Rush Helps Add $10bn To Revenues
Merck & Co.’s checkpoint inhibitor Keytruda remains the best-selling drug worldwide. The top 10 products generated nearly $47bn in third-quarter revenues for big pharma, boosted by swelling sales of obesity drugs.
Scrip - December 12, 2025
Merck & Co.’s checkpoint inhibitor Keytruda remains the best-selling drug worldwide. The top 10 products generated nearly $47bn in third-quarter revenues for big pharma, boosted by swelling sales of obesity drugs.
Scrip - December 12, 2025
Biologics-In-A-Pill Firm PsiThera Launched With Series A $47.5m
Having worked in stealth on its predictive computational R&D models, PsiThera has emerged to develop oral versions of blockbuster drug targets in inflammation and immunology.
Scrip - December 12, 2025
Having worked in stealth on its predictive computational R&D models, PsiThera has emerged to develop oral versions of blockbuster drug targets in inflammation and immunology.
Scrip - December 12, 2025
Executives On The Move: Kriya Therapeutics Gets A New CMO From Pfizer
Recent moves in the industry include C-suite changes at Tyra Biosciences and HLB, plus seven companies get new CMOs and nine companies get new CFOs.
Scrip - December 12, 2025
Recent moves in the industry include C-suite changes at Tyra Biosciences and HLB, plus seven companies get new CMOs and nine companies get new CFOs.
Scrip - December 12, 2025
ASH: Early Results Ready Lupeng’s Rocbrutinib For Potential Head-To-Head With Jaypirca
Lupeng's BTK inhibitor rocbrutinib has shown an 80.0% ORR in a Phase I trial in patients who had received a covalent or non-covalent BTK inhibitor plus BCL-2 inhibitor, setting the stage for a comparative trial, possibly with Jaypirca.
Scrip - December 12, 2025
Lupeng's BTK inhibitor rocbrutinib has shown an 80.0% ORR in a Phase I trial in patients who had received a covalent or non-covalent BTK inhibitor plus BCL-2 inhibitor, setting the stage for a comparative trial, possibly with Jaypirca.
Scrip - December 12, 2025
Quotable: Words Of Wisdom From Our Recent APAC Coverage
Scrip's APAC team selects notable quotes from recent interviews, conferences and other coverage to highlight the views of senior executives and officials on major topics facing the biopharma sector in the region and more widely.
Scrip - December 12, 2025
Scrip's APAC team selects notable quotes from recent interviews, conferences and other coverage to highlight the views of senior executives and officials on major topics facing the biopharma sector in the region and more widely.
Scrip - December 12, 2025
Effective Engagement With The FDA During Recalls Starts With Effective Communication, Expert Says
During a webinar hosted by Sedgwick, a pair of regulatory experts discussed how medtech firms can optimize their engagement with the FDA, especially when it comes to communicating recalls and corrective actions.
Medtech Insight - December 12, 2025
During a webinar hosted by Sedgwick, a pair of regulatory experts discussed how medtech firms can optimize their engagement with the FDA, especially when it comes to communicating recalls and corrective actions.
Medtech Insight - December 12, 2025
Top 100 Ranking: Chinese Medtechs Make Their Presence Felt In Latest Top 100 By Revenues
With the last of the Top 100 medtech companies filing 2024-25 revenues in November, Medtech Insight now presents its latest ranking of cardiology, orthopedic, diagnostic imaging and in vitro diagnostics companies.
Medtech Insight - December 12, 2025
With the last of the Top 100 medtech companies filing 2024-25 revenues in November, Medtech Insight now presents its latest ranking of cardiology, orthopedic, diagnostic imaging and in vitro diagnostics companies.
Medtech Insight - December 12, 2025
MTI 100: Separations, Value Creation And Innovation Top The Agenda For Healthtechs
Six companies exceeded $20bn in the latest Top 100 ranking of global medtechs by revenues, but with a slew of structural changes ahead, the leader board could change in 2026.
Medtech Insight - December 12, 2025
Six companies exceeded $20bn in the latest Top 100 ranking of global medtechs by revenues, but with a slew of structural changes ahead, the leader board could change in 2026.
Medtech Insight - December 12, 2025
Industry Blasts Commission’s Urban Wastewater Directive Cost Review
Only taking inflation into account, the European Commission’s new cost estimate of between €1.48bn to €1.8bn per year, when adjusted for inflation, results in a total very similar to the original €1.2bn estimate.
HBW Insight - December 12, 2025
Only taking inflation into account, the European Commission’s new cost estimate of between €1.48bn to €1.8bn per year, when adjusted for inflation, results in a total very similar to the original €1.2bn estimate.
HBW Insight - December 12, 2025
Slow Burn For US Sunscreen Innovation While FDA Lights Lamp For Monograph Overhaul Deadlines
Sunscreen products industry and public health advocacy groups have been critical that FDA has not approved a new filter since 1999 even as countries in Europe and other regions allow using numerous additional ingredients in sunscreens.
HBW Insight - December 12, 2025
Sunscreen products industry and public health advocacy groups have been critical that FDA has not approved a new filter since 1999 even as countries in Europe and other regions allow using numerous additional ingredients in sunscreens.
HBW Insight - December 12, 2025
US Sunscreen And OTC Monograph Milestones Marked By DSM-Firmenich’s Bemotrizinol Proposal
FDA’s proposed order follows its review of OMOR DSM-Firmenich submitted showing bemotrizinol, at concentrations up to 6%, is generally recognized as safe and effective and can be added as an active ingredient to sunscreen monograph.
HBW Insight - December 12, 2025
FDA’s proposed order follows its review of OMOR DSM-Firmenich submitted showing bemotrizinol, at concentrations up to 6%, is generally recognized as safe and effective and can be added as an active ingredient to sunscreen monograph.
HBW Insight - December 12, 2025
Teva’s Estradiol Approved As The First Generic To Imvexxy By The FDA
The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.
Generics Bulletin - December 12, 2025
The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.
Generics Bulletin - December 12, 2025
US FDA Brings Rx Generics Marketers Up To Date On OTC Switch Regulatory Landscape
CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.
Generics Bulletin - December 12, 2025
CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.
Generics Bulletin - December 12, 2025
Tyzavan Launch Marks Next Step In Hikma’s Global Injectables Growth Strategy
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.
Generics Bulletin - December 12, 2025
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.
Generics Bulletin - December 12, 2025
German Giants Rise Up The Ranks In Generics Bulletin’s Top 50
Two leading German generics and biosimilars giants are the big movers at the top of our annual ranking of off-patent industry leaders. We reveal the latest developments in this year’s Generics Bulletin Top 50.
In Vivo - December 10, 2025
Two leading German generics and biosimilars giants are the big movers at the top of our annual ranking of off-patent industry leaders. We reveal the latest developments in this year’s Generics Bulletin Top 50.
In Vivo - December 10, 2025
Europe Leads Charge As Private Equity Roars Back Into Off-Patent Pharma
A pair of private equity mega-deals dominated the mergers and acquisitions landscape in 2025, but there was still a clear appetite for smaller, strategic takeovers and tuck-ins across the generics, biosimilars, and off-patent medicines field.
In Vivo - December 10, 2025
A pair of private equity mega-deals dominated the mergers and acquisitions landscape in 2025, but there was still a clear appetite for smaller, strategic takeovers and tuck-ins across the generics, biosimilars, and off-patent medicines field.
In Vivo - December 10, 2025
Execs On The Move: November 2025
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
In Vivo - December 10, 2025
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
In Vivo - December 10, 2025
Indegene Exec On R&D Operations In The Age Of GenAI, One Click Submissions
Senior Indegene executive discusses why pharma R&D organizations of the future will need to be agile, modular and AI-native by design. Industry pilots are pointing the way to potential one click regulatory submissions.
In Vivo - December 10, 2025
Senior Indegene executive discusses why pharma R&D organizations of the future will need to be agile, modular and AI-native by design. Industry pilots are pointing the way to potential one click regulatory submissions.
In Vivo - December 10, 2025
Podcast: Kairos Pharma’s Approach To Resensitizing Tumors
In this episode of the In Vivo podcast, Kairos Pharma's chief scientific officer discusses developing therapies to reverse drug resistance in oncology, with ENV-105 showing promising Phase II results in resensitizing hormone-resistant prostate cancer.
In Vivo - December 10, 2025
In this episode of the In Vivo podcast, Kairos Pharma's chief scientific officer discusses developing therapies to reverse drug resistance in oncology, with ENV-105 showing promising Phase II results in resensitizing hormone-resistant prostate cancer.
In Vivo - December 10, 2025