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Latest Pharma Insights



Don’t Sleep On It: Melatonin Ban In Hungary Is Wake Up Call For Supplements Industry
Hungary's ban on melatonin in supplements has put the ingredient's EU regulatory status back under the microscope. Experts warn the decision could encourage other member states to review their own positions and may reactivate an on-hold EU-wide Article 8 safety review.
HBW Insight - August 26, 2026
Spyre Misses In RA But Autoimmune Combos Could Pay Off
The rheumatoid arthritis failure for its TL1A antibody was not unexpected and analysts see the US biotech’s attempt to develop two-drug combinations in ulcerative colitis as its best chance in a crowded field.
Scrip - August 26, 2026
Immatics Tops Up Coffers As Cancer Drugs Advance
The Germany-based biotech has decided to bolster the balance sheet as it prepares for key readouts on its cell therapy and bispecific candidates.
Scrip - August 26, 2026
India’s Device Rule Changes Draw Fire From Domestic Makers Over EU Waiver And Sterilizer Labeling
Two amendments to India's Medical Devices Rules, 2017, were positioned as pro-business. The reaction from industry suggests they landed differently depending on which side of the import ledger a manufacturer sits on.
Medtech Insight - August 26, 2026
Zydus Gets CGT Exclusivity On Scurvy Treatment
Zydus Lifesciences has announced US Food and Drug Administration approval for its generic ascorbic acid for injection, accompanied by 180 days of CGT exclusivity.
Generics Bulletin - August 26, 2026
Biocon And Sandoz Broaden Japanese Biosimilars Alliance With Pegfilgrastim Nod
Biocon has received a Japanese approval for its pegfilgrastim biosimilar rival to Amgen’s Neulasta, which will be marketed through an alliance with Sandoz.
Generics Bulletin - August 26, 2026
Surgical Science Launches Novel Simulator for Point-of-Care Ultrasound Training
Surgical Science has launched Aeris, a portable ultrasound simulator designed to make POCUS training more accessible without specialized rooms, equipment or anatomical models. The company plans to expand the pathology-focused platform into other fields with US orders expected to open in Q4 2026.
Medtech Insight - August 26, 2026
Jazz Forecasts Up To $5bn In Ziihera Peak Sales After Gastroesophageal Cancer Approval
The focus will now shift to launch uptake, competitive displacement and whether the drug can establish itself across a broader HER2 franchise.
Scrip - August 26, 2026
FDA’s 510(k) Route Is Clearing Thousands Of AI Devices With No Proven Patient Benefit
Only three AI medical devices approved by the US regulator have been tested on whether they improve patient outcomes, new research finds.
Medtech Insight - August 26, 2026
Alvotech’s Reykjavik Recovery Sets Stage For Pivotal Quarter
Alvotech is looking to a pivotal fourth quarter of FDA decisions, potential legal developments and stronger supply as it works to support 2026 guidance and prepare multiple US biosimilar launches.
Generics Bulletin - August 26, 2026
US Alzheimer’s Blood Test Battle Begins With Roche, C2N FDA Clearence
Roche and Lilly’s p-tau217 test targets primary care, while C2N gets indication for younger patients.
Medtech Insight - August 26, 2026
New Standard Of Care As Ivonescimab Bests Imfinzi In 1L Biliary Tract Cancer?
Akeso’s ivonescimab plus chemo beats Imfinzi plus chemo in overall survival terms in head-to-head Phase III trial in untreated biliary tract cancer.
Scrip - August 26, 2026
Big Pharma’s Revenue Mix Is Shifting Back Toward Homegrown Drugs
Big pharma's revenue mix is tilting back to homegrown drugs — organic assets hit 53% of top-15 sales by 2025. However, some firms are increasingly reliant on partnered or acquired products, while others face looming patent cliffs.
In Vivo - August 26, 2026
Paradromics Gets FDA Approval To Embed BCI Software In Personal Devices
Paradromics gained FDA approval to expand its BCI access from research laptops to personal devices during clinical trials. Medtech Insight spoke with CCO William Marks about the implications of the new approval and progress of the first patient in the feasibility study to closed-loop stage.
Medtech Insight - August 26, 2026

Spyre Misses In RA But Autoimmune Combos Could Pay Off
The rheumatoid arthritis failure for its TL1A antibody was not unexpected and analysts see the US biotech’s attempt to develop two-drug combinations in ulcerative colitis as its best chance in a crowded field.
Scrip - August 26, 2026
Immatics Tops Up Coffers As Cancer Drugs Advance
The Germany-based biotech has decided to bolster the balance sheet as it prepares for key readouts on its cell therapy and bispecific candidates.
Scrip - August 26, 2026
Jazz Forecasts Up To $5bn In Ziihera Peak Sales After Gastroesophageal Cancer Approval
The focus will now shift to launch uptake, competitive displacement and whether the drug can establish itself across a broader HER2 franchise.
Scrip - August 26, 2026
New Standard Of Care As Ivonescimab Bests Imfinzi In 1L Biliary Tract Cancer?
Akeso’s ivonescimab plus chemo beats Imfinzi plus chemo in overall survival terms in head-to-head Phase III trial in untreated biliary tract cancer.
Scrip - August 26, 2026

India’s Device Rule Changes Draw Fire From Domestic Makers Over EU Waiver And Sterilizer Labeling
Two amendments to India's Medical Devices Rules, 2017, were positioned as pro-business. The reaction from industry suggests they landed differently depending on which side of the import ledger a manufacturer sits on.
Medtech Insight - August 26, 2026
Surgical Science Launches Novel Simulator for Point-of-Care Ultrasound Training
Surgical Science has launched Aeris, a portable ultrasound simulator designed to make POCUS training more accessible without specialized rooms, equipment or anatomical models. The company plans to expand the pathology-focused platform into other fields with US orders expected to open in Q4 2026.
Medtech Insight - August 26, 2026
FDA’s 510(k) Route Is Clearing Thousands Of AI Devices With No Proven Patient Benefit
Only three AI medical devices approved by the US regulator have been tested on whether they improve patient outcomes, new research finds.
Medtech Insight - August 26, 2026
US Alzheimer’s Blood Test Battle Begins With Roche, C2N FDA Clearence
Roche and Lilly’s p-tau217 test targets primary care, while C2N gets indication for younger patients.
Medtech Insight - August 26, 2026
Paradromics Gets FDA Approval To Embed BCI Software In Personal Devices
Paradromics gained FDA approval to expand its BCI access from research laptops to personal devices during clinical trials. Medtech Insight spoke with CCO William Marks about the implications of the new approval and progress of the first patient in the feasibility study to closed-loop stage.
Medtech Insight - August 26, 2026

Don’t Sleep On It: Melatonin Ban In Hungary Is Wake Up Call For Supplements Industry
Hungary's ban on melatonin in supplements has put the ingredient's EU regulatory status back under the microscope. Experts warn the decision could encourage other member states to review their own positions and may reactivate an on-hold EU-wide Article 8 safety review.
HBW Insight - August 26, 2026

Zydus Gets CGT Exclusivity On Scurvy Treatment
Zydus Lifesciences has announced US Food and Drug Administration approval for its generic ascorbic acid for injection, accompanied by 180 days of CGT exclusivity.
Generics Bulletin - August 26, 2026
Biocon And Sandoz Broaden Japanese Biosimilars Alliance With Pegfilgrastim Nod
Biocon has received a Japanese approval for its pegfilgrastim biosimilar rival to Amgen’s Neulasta, which will be marketed through an alliance with Sandoz.
Generics Bulletin - August 26, 2026
Alvotech’s Reykjavik Recovery Sets Stage For Pivotal Quarter
Alvotech is looking to a pivotal fourth quarter of FDA decisions, potential legal developments and stronger supply as it works to support 2026 guidance and prepare multiple US biosimilar launches.
Generics Bulletin - August 26, 2026

Big Pharma’s Revenue Mix Is Shifting Back Toward Homegrown Drugs
Big pharma's revenue mix is tilting back to homegrown drugs — organic assets hit 53% of top-15 sales by 2025. However, some firms are increasingly reliant on partnered or acquired products, while others face looming patent cliffs.
In Vivo - August 26, 2026