Latest Pharma Insights
AstraZeneca Scores FDA Win For Imfinzi In Perioperative Stomach Cancer
The agency’s approval of Imfinzi combined with chemotherapy makes it the only immunotherapy for perioperative gastric and gastroesophageal cancers.
Scrip - November 26, 2025
The agency’s approval of Imfinzi combined with chemotherapy makes it the only immunotherapy for perioperative gastric and gastroesophageal cancers.
Scrip - November 26, 2025
FDA Withdraws Proposed Rule On Talc, Citing MAHA Priorities, ‘Complexity’ Of Asbestos Testing
The US FDA announces in a Nov. 28 Federal Register notice that it will withdraw its proposed rule under MoCRA for testing asbestos in talc-containing products, but remains committed to meeting its statutory requirements under the law.
HBW Insight - November 26, 2025
The US FDA announces in a Nov. 28 Federal Register notice that it will withdraw its proposed rule under MoCRA for testing asbestos in talc-containing products, but remains committed to meeting its statutory requirements under the law.
HBW Insight - November 26, 2025
Satellos Tackles Duchenne ‘As Stem Cell People Solving a Stem Cell Problem’
Satellos is moving to start a double-blinded Phase II trial of its experimental Duchenne muscular dystrophy candidate that looks to mimic the effects of dystrophin on muscle stem cells.
Scrip - November 26, 2025
Satellos is moving to start a double-blinded Phase II trial of its experimental Duchenne muscular dystrophy candidate that looks to mimic the effects of dystrophin on muscle stem cells.
Scrip - November 26, 2025
Gilead Teams Up With Sweden’s Sprint For Latest Oncology Pact
Deal Snapshot: The US company has entered into another cancer drug transaction and bought Sprint's preclinical TREX1 program in a deal that could be worth around $400m.
Scrip - November 26, 2025
Deal Snapshot: The US company has entered into another cancer drug transaction and bought Sprint's preclinical TREX1 program in a deal that could be worth around $400m.
Scrip - November 26, 2025
Onshoring Incentives Among US FDA’s GDUFA IV Proposals
During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.
Generics Bulletin - November 26, 2025
During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.
Generics Bulletin - November 26, 2025
Regulatory Recap: FDA’s Competitive Generic Therapy Exclusivity Leads To Faster Market Launch
Generics Bulletin reviews global regulatory developments across the world.
Generics Bulletin - November 26, 2025
Generics Bulletin reviews global regulatory developments across the world.
Generics Bulletin - November 26, 2025
Manufacturing Hurdles Push Xbrane’s Ranibizumab Timeline To Late 2026
Xbrane now expects to refile its Lucamzi biosimilar application in March 2026 after FDA manufacturing observations triggered a delay, pushing the potential approval date to September.
Generics Bulletin - November 26, 2025
Xbrane now expects to refile its Lucamzi biosimilar application in March 2026 after FDA manufacturing observations triggered a delay, pushing the potential approval date to September.
Generics Bulletin - November 26, 2025
Celltrion’s EU-Approved Liquid Infliximab Promises Faster Prep, Lower Costs
European Commission approval positions Celltrion to streamline hospital workflows, with modelling suggesting millions in potential annual savings for healthcare systems.
Generics Bulletin - November 26, 2025
European Commission approval positions Celltrion to streamline hospital workflows, with modelling suggesting millions in potential annual savings for healthcare systems.
Generics Bulletin - November 26, 2025
Medicare Negotiations 2.0 Slash Prices Up To 85%, But Mean Cuts Barely Budge
The second cycle of IRA price negotiations could result in price cuts as high as 85% to the 2024 list prices, but the mean discount across the 15 negotiated drugs appears similar to the previous round.
Scrip - November 26, 2025
The second cycle of IRA price negotiations could result in price cuts as high as 85% to the 2024 list prices, but the mean discount across the 15 negotiated drugs appears similar to the previous round.
Scrip - November 26, 2025
Proposed Revision Of Digital Rules – EU’s Good Start But Medtech Advises Caution
The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?
Medtech Insight - November 26, 2025
The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?
Medtech Insight - November 26, 2025
US FDA Reviewing Data To Determine Need For Biosimilar Suffixes
After 10 years of adding suffixes to all new biologic and biosimilar nonproprietary names, FDA officials are considering whether it is still necessary for pharmacovigilance purposes.
Generics Bulletin - November 26, 2025
After 10 years of adding suffixes to all new biologic and biosimilar nonproprietary names, FDA officials are considering whether it is still necessary for pharmacovigilance purposes.
Generics Bulletin - November 26, 2025
Zimmer Biomet Readies Iodine-Coated Hip For 2025 Japan Launch, Plans To Expand Platform To New Joint
Zimmer Biomet is preparing to introduce iodine-coated hip implants to international markets, offering joint replacement patients a new alternative intended to ward off infection. The company intends to broaden the platform’s reach into “knees, shoulders and other categories in due time.”
Medtech Insight - November 26, 2025
Zimmer Biomet is preparing to introduce iodine-coated hip implants to international markets, offering joint replacement patients a new alternative intended to ward off infection. The company intends to broaden the platform’s reach into “knees, shoulders and other categories in due time.”
Medtech Insight - November 26, 2025
From Risk Aversion to Real-World Impact: How Medtech Firms Can Harness AI
Medical device companies are increasingly using AI to improve regulatory affairs strategies but face barriers such as risk aversion, regulatory clarity and data governance issues. Experts suggest a design control approach and human oversight to ensure successful AI integration.
Medtech Insight - November 26, 2025
Medical device companies are increasingly using AI to improve regulatory affairs strategies but face barriers such as risk aversion, regulatory clarity and data governance issues. Experts suggest a design control approach and human oversight to ensure successful AI integration.
Medtech Insight - November 26, 2025
US Makes First Reformulated Ranitidine Approval Since Withdrawal, Starting With Rx Tablets
In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.
HBW Insight - November 26, 2025
In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.
HBW Insight - November 26, 2025
California Targets Hair Relaxers, Musk Substances As Vermont Passes First-Of-Its Kind EPR Law – IBA
State laws targeting the cosmetic and personal care industries have a sense of urgency, given the vacuum of action on the federal level, says the Independent Beauty Association during its Cosmetics Convergence Conference, which highlighted the new crop of laws, including a handful from California.
HBW Insight - November 26, 2025
State laws targeting the cosmetic and personal care industries have a sense of urgency, given the vacuum of action on the federal level, says the Independent Beauty Association during its Cosmetics Convergence Conference, which highlighted the new crop of laws, including a handful from California.
HBW Insight - November 26, 2025
AstraZeneca Scores FDA Win For Imfinzi In Perioperative Stomach Cancer
The agency’s approval of Imfinzi combined with chemotherapy makes it the only immunotherapy for perioperative gastric and gastroesophageal cancers.
Scrip - November 26, 2025
The agency’s approval of Imfinzi combined with chemotherapy makes it the only immunotherapy for perioperative gastric and gastroesophageal cancers.
Scrip - November 26, 2025
Satellos Tackles Duchenne ‘As Stem Cell People Solving a Stem Cell Problem’
Satellos is moving to start a double-blinded Phase II trial of its experimental Duchenne muscular dystrophy candidate that looks to mimic the effects of dystrophin on muscle stem cells.
Scrip - November 26, 2025
Satellos is moving to start a double-blinded Phase II trial of its experimental Duchenne muscular dystrophy candidate that looks to mimic the effects of dystrophin on muscle stem cells.
Scrip - November 26, 2025
Gilead Teams Up With Sweden’s Sprint For Latest Oncology Pact
Deal Snapshot: The US company has entered into another cancer drug transaction and bought Sprint's preclinical TREX1 program in a deal that could be worth around $400m.
Scrip - November 26, 2025
Deal Snapshot: The US company has entered into another cancer drug transaction and bought Sprint's preclinical TREX1 program in a deal that could be worth around $400m.
Scrip - November 26, 2025
Medicare Negotiations 2.0 Slash Prices Up To 85%, But Mean Cuts Barely Budge
The second cycle of IRA price negotiations could result in price cuts as high as 85% to the 2024 list prices, but the mean discount across the 15 negotiated drugs appears similar to the previous round.
Scrip - November 26, 2025
The second cycle of IRA price negotiations could result in price cuts as high as 85% to the 2024 list prices, but the mean discount across the 15 negotiated drugs appears similar to the previous round.
Scrip - November 26, 2025
Proposed Revision Of Digital Rules – EU’s Good Start But Medtech Advises Caution
The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?
Medtech Insight - November 26, 2025
The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?
Medtech Insight - November 26, 2025
Zimmer Biomet Readies Iodine-Coated Hip For 2025 Japan Launch, Plans To Expand Platform To New Joint
Zimmer Biomet is preparing to introduce iodine-coated hip implants to international markets, offering joint replacement patients a new alternative intended to ward off infection. The company intends to broaden the platform’s reach into “knees, shoulders and other categories in due time.”
Medtech Insight - November 26, 2025
Zimmer Biomet is preparing to introduce iodine-coated hip implants to international markets, offering joint replacement patients a new alternative intended to ward off infection. The company intends to broaden the platform’s reach into “knees, shoulders and other categories in due time.”
Medtech Insight - November 26, 2025
From Risk Aversion to Real-World Impact: How Medtech Firms Can Harness AI
Medical device companies are increasingly using AI to improve regulatory affairs strategies but face barriers such as risk aversion, regulatory clarity and data governance issues. Experts suggest a design control approach and human oversight to ensure successful AI integration.
Medtech Insight - November 26, 2025
Medical device companies are increasingly using AI to improve regulatory affairs strategies but face barriers such as risk aversion, regulatory clarity and data governance issues. Experts suggest a design control approach and human oversight to ensure successful AI integration.
Medtech Insight - November 26, 2025
FDA Withdraws Proposed Rule On Talc, Citing MAHA Priorities, ‘Complexity’ Of Asbestos Testing
The US FDA announces in a Nov. 28 Federal Register notice that it will withdraw its proposed rule under MoCRA for testing asbestos in talc-containing products, but remains committed to meeting its statutory requirements under the law.
HBW Insight - November 26, 2025
The US FDA announces in a Nov. 28 Federal Register notice that it will withdraw its proposed rule under MoCRA for testing asbestos in talc-containing products, but remains committed to meeting its statutory requirements under the law.
HBW Insight - November 26, 2025
US Makes First Reformulated Ranitidine Approval Since Withdrawal, Starting With Rx Tablets
In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.
HBW Insight - November 26, 2025
In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.
HBW Insight - November 26, 2025
California Targets Hair Relaxers, Musk Substances As Vermont Passes First-Of-Its Kind EPR Law – IBA
State laws targeting the cosmetic and personal care industries have a sense of urgency, given the vacuum of action on the federal level, says the Independent Beauty Association during its Cosmetics Convergence Conference, which highlighted the new crop of laws, including a handful from California.
HBW Insight - November 26, 2025
State laws targeting the cosmetic and personal care industries have a sense of urgency, given the vacuum of action on the federal level, says the Independent Beauty Association during its Cosmetics Convergence Conference, which highlighted the new crop of laws, including a handful from California.
HBW Insight - November 26, 2025
Onshoring Incentives Among US FDA’s GDUFA IV Proposals
During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.
Generics Bulletin - November 26, 2025
During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.
Generics Bulletin - November 26, 2025
Regulatory Recap: FDA’s Competitive Generic Therapy Exclusivity Leads To Faster Market Launch
Generics Bulletin reviews global regulatory developments across the world.
Generics Bulletin - November 26, 2025
Generics Bulletin reviews global regulatory developments across the world.
Generics Bulletin - November 26, 2025
Manufacturing Hurdles Push Xbrane’s Ranibizumab Timeline To Late 2026
Xbrane now expects to refile its Lucamzi biosimilar application in March 2026 after FDA manufacturing observations triggered a delay, pushing the potential approval date to September.
Generics Bulletin - November 26, 2025
Xbrane now expects to refile its Lucamzi biosimilar application in March 2026 after FDA manufacturing observations triggered a delay, pushing the potential approval date to September.
Generics Bulletin - November 26, 2025
Celltrion’s EU-Approved Liquid Infliximab Promises Faster Prep, Lower Costs
European Commission approval positions Celltrion to streamline hospital workflows, with modelling suggesting millions in potential annual savings for healthcare systems.
Generics Bulletin - November 26, 2025
European Commission approval positions Celltrion to streamline hospital workflows, with modelling suggesting millions in potential annual savings for healthcare systems.
Generics Bulletin - November 26, 2025
US FDA Reviewing Data To Determine Need For Biosimilar Suffixes
After 10 years of adding suffixes to all new biologic and biosimilar nonproprietary names, FDA officials are considering whether it is still necessary for pharmacovigilance purposes.
Generics Bulletin - November 26, 2025
After 10 years of adding suffixes to all new biologic and biosimilar nonproprietary names, FDA officials are considering whether it is still necessary for pharmacovigilance purposes.
Generics Bulletin - November 26, 2025
Inside Regeneron’s 3-Million-Sample Bet On Collaborative Genomics
By offering free sequencing and embracing radical openness with global partners, Regeneron Genetics Center has gathered over 3 million samples, leading to the identification of over 30 drug targets now in Regeneron’s pipeline.
In Vivo - November 25, 2025
By offering free sequencing and embracing radical openness with global partners, Regeneron Genetics Center has gathered over 3 million samples, leading to the identification of over 30 drug targets now in Regeneron’s pipeline.
In Vivo - November 25, 2025