Latest Pharma Insights
FDA Backs PFAS In Medical Devices As Europe Moves To Ban Them And Suppliers Offer Alternatives
FDA reaffirms fluoropolymers such as PTFE are safe and irreplaceable in devices, but the reprieve is US-only: an EU REACH restriction, tighter EPA reporting and supplier exits are already pushing device makers toward PFAS-free alternatives.
Medtech Insight - September 7, 2026
FDA reaffirms fluoropolymers such as PTFE are safe and irreplaceable in devices, but the reprieve is US-only: an EU REACH restriction, tighter EPA reporting and supplier exits are already pushing device makers toward PFAS-free alternatives.
Medtech Insight - September 7, 2026
Claret Capital Fund IV: €575m European Growth Lending Closes With Life Sciences Focus
Growth-stage and start-up companies in medical devices and life sciences are looking at debt growth capital with new eyes. A just-closed €575m European growth lending fund from Claret Capital Partners will meet some of the rising demand, says Joey Mason, life sciences venture partner at the firm.
In Vivo - September 7, 2026
Growth-stage and start-up companies in medical devices and life sciences are looking at debt growth capital with new eyes. A just-closed €575m European growth lending fund from Claret Capital Partners will meet some of the rising demand, says Joey Mason, life sciences venture partner at the firm.
In Vivo - September 7, 2026
Novartis’s Lp(a) Inhibitor Pelacarsen Fails Phase III Cardiovascular Outcomes Trial
The closely watched class of lipoprotein (a) inhibitors has the potential to be the next blockbuster class of cardiovascular disease drugs, but Novartis’s Ionis-partnered pelacarsen failed in Phase III.
Scrip - September 4, 2026
The closely watched class of lipoprotein (a) inhibitors has the potential to be the next blockbuster class of cardiovascular disease drugs, but Novartis’s Ionis-partnered pelacarsen failed in Phase III.
Scrip - September 4, 2026
AstraZeneca’s Etcamah Gets Long-Awaited FDA Breast Cancer Approval
The US FDA gave accelerated approval to the oral SERD for use in combination with CDK4/6 inhibitors among patients with ESR1-mutated breast cancer.
Scrip - September 4, 2026
The US FDA gave accelerated approval to the oral SERD for use in combination with CDK4/6 inhibitors among patients with ESR1-mutated breast cancer.
Scrip - September 4, 2026
Deal Watch: RedHill Switches Tracks With Ferring In-License, Apotex Out-Licensing Deals
Plus deals involving Novartis/Alteogen, Evotec/Plectonic, Leios/CMS, Heidelberg/Huadong, Lupin/Visus and more.
Scrip - September 4, 2026
Plus deals involving Novartis/Alteogen, Evotec/Plectonic, Leios/CMS, Heidelberg/Huadong, Lupin/Visus and more.
Scrip - September 4, 2026
Revolution’s Rasonque Shows Promise In Lung Cancer
Now approved in pancreatic cancer, Revolution is hoping to extend the use of Rasonque into non-small cell lung cancer, alongside developing its other more mutation-specific RAS inhibitors in the pipeline.
Scrip - September 4, 2026
Now approved in pancreatic cancer, Revolution is hoping to extend the use of Rasonque into non-small cell lung cancer, alongside developing its other more mutation-specific RAS inhibitors in the pipeline.
Scrip - September 4, 2026
Menarini Moves into Obesity Market With Gan & Lee Pact
Deal Snapshot: The Italy-headquartered firm is linking up with the Chinese metabolic disease specialist and has bagged the rights in Europe to bofanglutide, a fortnightly injection for weight management.
Scrip - September 4, 2026
Deal Snapshot: The Italy-headquartered firm is linking up with the Chinese metabolic disease specialist and has bagged the rights in Europe to bofanglutide, a fortnightly injection for weight management.
Scrip - September 4, 2026
Executives On The Move: A New CCO At Oruka As It Looks To Advance Its Novel Skin Therapies
Other executive moves this week include Vivace and Ambros making senior executive changes ahead of Phase III milestones.
Scrip - September 4, 2026
Other executive moves this week include Vivace and Ambros making senior executive changes ahead of Phase III milestones.
Scrip - September 4, 2026
Mineralys CEO Makes The Case For Lorundrostat Ahead Of FDA Verdict
AstraZeneca's Baxfendy approval has opened the door for aldosterone synthase inhibitors in hypertension, and Mineralys's lorundrostat could be the next one through.
Scrip - September 4, 2026
AstraZeneca's Baxfendy approval has opened the door for aldosterone synthase inhibitors in hypertension, and Mineralys's lorundrostat could be the next one through.
Scrip - September 4, 2026
Positive MASH Data Keep Zydus’s Saroglitazar In The Race Against GLP-1s, Others
Zydus’s novel drug saroglitazar hit the primary endpoint in a Phase IIb trial for MASH but other key data are held back for a reveal at forthcoming liver Congresses. The investigative drug faces hotter competition and a broader MASH pipeline in the US post approval of Novo’s semaglutide.
Scrip - September 4, 2026
Zydus’s novel drug saroglitazar hit the primary endpoint in a Phase IIb trial for MASH but other key data are held back for a reveal at forthcoming liver Congresses. The investigative drug faces hotter competition and a broader MASH pipeline in the US post approval of Novo’s semaglutide.
Scrip - September 4, 2026
China Approves Global-First Nine-Month Prophylactic Antibody For Infant RSV
Trinomab’s global-first long-acting prophylactic antibody provides nine months of protection for newborns and infants entering their first respiratory syncytial virus season. Greater efficacy was seen in those at high risk of infection.
Scrip - September 4, 2026
Trinomab’s global-first long-acting prophylactic antibody provides nine months of protection for newborns and infants entering their first respiratory syncytial virus season. Greater efficacy was seen in those at high risk of infection.
Scrip - September 4, 2026
Chinese Firms Start Six Global Phase III Trials With US Sites So Far In 2026
Over the past eight months, multiple Chinese firms including Ascletis, Biokin/SystImmune, Akeso, Lupeng/Newave and Hengrui have progressed late-stage multiregional clinical trial programs that include US sites.
Scrip - September 4, 2026
Over the past eight months, multiple Chinese firms including Ascletis, Biokin/SystImmune, Akeso, Lupeng/Newave and Hengrui have progressed late-stage multiregional clinical trial programs that include US sites.
Scrip - September 4, 2026
FDA Backs PFAS In Medical Devices As Europe Moves To Ban Them And Suppliers Offer Alternatives
FDA reaffirms fluoropolymers such as PTFE are safe and irreplaceable in devices, but the reprieve is US-only: an EU REACH restriction, tighter EPA reporting and supplier exits are already pushing device makers toward PFAS-free alternatives.
Medtech Insight - September 7, 2026
FDA reaffirms fluoropolymers such as PTFE are safe and irreplaceable in devices, but the reprieve is US-only: an EU REACH restriction, tighter EPA reporting and supplier exits are already pushing device makers toward PFAS-free alternatives.
Medtech Insight - September 7, 2026
EU Advocate General Says Scrap 80% Cosmetics And Pharma Wastewater Cost Share
An Advocate General has recommended that the European Court of Justice annul the provision requiring medicines and cosmetics producers to fund at least 80% of quaternary wastewater treatment costs, finding that the EU institutions cannot show how they calculated the sector split.
HBW Insight - September 4, 2026
An Advocate General has recommended that the European Court of Justice annul the provision requiring medicines and cosmetics producers to fund at least 80% of quaternary wastewater treatment costs, finding that the EU institutions cannot show how they calculated the sector split.
HBW Insight - September 4, 2026
Cyclical Or Structural? Investors Watching As ‘Critical’ Cough & Cold Season Approaches
After two soft seasons, analysts and investors are watching the approaching cough and cold cycle closely. Jefferies' David Hayes told a recent HBW Insight webinar that the coming winter will test whether the slowdown is cyclical, or more of a structural issue.
HBW Insight - September 4, 2026
After two soft seasons, analysts and investors are watching the approaching cough and cold cycle closely. Jefferies' David Hayes told a recent HBW Insight webinar that the coming winter will test whether the slowdown is cyclical, or more of a structural issue.
HBW Insight - September 4, 2026
US FDA, SEC Will Share Information, Not Trade Secrets
Memorandum of understanding allows two agencies to share non-public information in order to improve enforcement and compliance, but agreement maintains FDA’s prohibition on sharing trade secrets.
HBW Insight - September 4, 2026
Memorandum of understanding allows two agencies to share non-public information in order to improve enforcement and compliance, but agreement maintains FDA’s prohibition on sharing trade secrets.
HBW Insight - September 4, 2026
Aspen Targets Broader GLP-1 Growth As Semaglutide Supply Clarity Nears
Aspen expects clarity within weeks on the API issue delaying its Canadian semaglutide, while backing a broader GLP-1 growth opportunity driven by lower prices, higher volumes and emerging-market expansion.
Generics Bulletin - September 4, 2026
Aspen expects clarity within weeks on the API issue delaying its Canadian semaglutide, while backing a broader GLP-1 growth opportunity driven by lower prices, higher volumes and emerging-market expansion.
Generics Bulletin - September 4, 2026
EU Legal Opinion Offers Industry Reprieve On UWWTD
A key tenet of the controversial extended producer responsibility scheme that forms part of the EU’s Urban Waste Water Treatment Directive should be annulled, according to an opinion from CJEU advocate general Juliane Kokott that has been celebrated by the pharmaceutical industry.
Generics Bulletin - September 4, 2026
A key tenet of the controversial extended producer responsibility scheme that forms part of the EU’s Urban Waste Water Treatment Directive should be annulled, according to an opinion from CJEU advocate general Juliane Kokott that has been celebrated by the pharmaceutical industry.
Generics Bulletin - September 4, 2026
FTC Backing Could Open New Antitrust Route For Biosimilars
The FTC has urged the Fourth Circuit to keep acquisitions of pending patent applications within reach of antitrust law in a dispute over Amgen’s Enbrel (etanercept).
Generics Bulletin - September 4, 2026
The FTC has urged the Fourth Circuit to keep acquisitions of pending patent applications within reach of antitrust law in a dispute over Amgen’s Enbrel (etanercept).
Generics Bulletin - September 4, 2026
Claret Capital Fund IV: €575m European Growth Lending Closes With Life Sciences Focus
Growth-stage and start-up companies in medical devices and life sciences are looking at debt growth capital with new eyes. A just-closed €575m European growth lending fund from Claret Capital Partners will meet some of the rising demand, says Joey Mason, life sciences venture partner at the firm.
In Vivo - September 7, 2026
Growth-stage and start-up companies in medical devices and life sciences are looking at debt growth capital with new eyes. A just-closed €575m European growth lending fund from Claret Capital Partners will meet some of the rising demand, says Joey Mason, life sciences venture partner at the firm.
In Vivo - September 7, 2026