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Biocon Opens Up China, Brazil And Seven More Markets For Stelara Biosimilar
Nine additional markets, including Brazil and China, have opened for Biocon and its Yesintek (ustekinumab-kfce) biosimilar, as J&J's Q3 2026 earnings show Stelara global revenues fell 54% under biosimilar competitive pressure.
Generics Bulletin - October 26, 2026
ESMO 2026: Akeso’s Ivonescimab Looks To Unseat Imfinzi In BTC
The full dataset from HARMONi-GI1 will provide the basis for a China filing in biliary tract cancer of the anti-PD-1 x VEGF bispecific antibody, which is already approved in the country for lung cancer.
Scrip - October 26, 2026
Consumer Health Advisory: NAD Finds ‘Fatal Flaws’ In Lumineux Studies
What’s happening, why it matters and what’s next in US consumer health. This edition explores NAD rejecting Lumineux’s 30-minute whitening claim over flawed studies, NIH’s call to prioritize GLP-1 user nutrition products, and how AI chatbots create regulatory risk for brands.
HBW Insight - October 26, 2026
Adalvo And Olpha Partnership Ready To Bring Semaglutide To The Baltic Region
Adalvo has signed a semaglutide partnership agreement with Olpha for the Baltic region to reinforce its expanding presence in the rapidly growing GLP-1 receptor agonist market.
Generics Bulletin - October 26, 2026
FDA Scolds Baxter Over Repeated ‘Significant Violations’ In Manufacturing Facilities
The FDA has issued a warning letter to Baxter International over cGMP violations at its sterile injectables facility, noting similar violations at other Baxter sites and calling management oversight "inadequate."
Generics Bulletin - October 26, 2026
Do We Know Enough to Build Longevity Medicine? Church Says Yes, And The Field Is About to Find Out
The Harvard geneticist says we already know enough biology to start building longevity medicine. The first human data, a newly interested FDA, and his own company’s balance sheet are about to test him.
In Vivo - October 26, 2026
ESMO 2026: Pfizer Oncology Chief On The ADC SV After Failing Phase III
Pfizer chief oncology officer Jeff Legos talked to Scrip about the Phase III failure of sigvotatug vedotin in previously treated NSCLC and why Pfizer still has hopes for the ADC.
Scrip - October 26, 2026
Real-World Evidence For Medical Devices: CDRH Advice On Q-Submissions, Data And Bias
CDRH officials said real-world evidence has supported more than 160 premarket authorizations and advised developers to plan data systems early, confirm data sources through Q-Submissions and address bias up front.
Medtech Insight - October 26, 2026
US FDA Drops CIO, But Keeps Sanjay Sahoo As Acting Head Of New Mission IT Office
FDA retired Chief Information Officer title, but Sanjay Sahoo moved to temporarily lead new Office of Mission Information Technology Services as agency’s technology push shifts to Jared Seehafer, deputy commissioner for technology and artificial intelligence.
HBW Insight - October 26, 2026
ESMO 2026: Sac-TMT Blazes Trail For Chemo-Free ADC/IO Regimen In 1L NSCLC
In a global-first for antibody-drug conjugates, Kelun-Biotech/Merck’s sacituzumab tirumotecan is set to supersede chemotherapy in combination with Keytruda in first-line, PD-L1-negative non-squamous non-small cell lung cancer, based on strong progression-free survival outcomes.
Scrip - October 26, 2026
Scrip’s Five Must-Know Things: Key ESMO Readouts, Next-Gen ADCs And Mid-Cap Winners
In this week's episode: key expectations from ESMO meeting; next-generation antibody-drug conjugates; rising mid-cap stars; GSK's novel hepatitis B launch; and significant private company financings.
Scrip - October 26, 2026

ESMO 2026: Akeso’s Ivonescimab Looks To Unseat Imfinzi In BTC
The full dataset from HARMONi-GI1 will provide the basis for a China filing in biliary tract cancer of the anti-PD-1 x VEGF bispecific antibody, which is already approved in the country for lung cancer.
Scrip - October 26, 2026
ESMO 2026: Pfizer Oncology Chief On The ADC SV After Failing Phase III
Pfizer chief oncology officer Jeff Legos talked to Scrip about the Phase III failure of sigvotatug vedotin in previously treated NSCLC and why Pfizer still has hopes for the ADC.
Scrip - October 26, 2026
ESMO 2026: Sac-TMT Blazes Trail For Chemo-Free ADC/IO Regimen In 1L NSCLC
In a global-first for antibody-drug conjugates, Kelun-Biotech/Merck’s sacituzumab tirumotecan is set to supersede chemotherapy in combination with Keytruda in first-line, PD-L1-negative non-squamous non-small cell lung cancer, based on strong progression-free survival outcomes.
Scrip - October 26, 2026
Scrip’s Five Must-Know Things: Key ESMO Readouts, Next-Gen ADCs And Mid-Cap Winners
In this week's episode: key expectations from ESMO meeting; next-generation antibody-drug conjugates; rising mid-cap stars; GSK's novel hepatitis B launch; and significant private company financings.
Scrip - October 26, 2026

Real-World Evidence For Medical Devices: CDRH Advice On Q-Submissions, Data And Bias
CDRH officials said real-world evidence has supported more than 160 premarket authorizations and advised developers to plan data systems early, confirm data sources through Q-Submissions and address bias up front.
Medtech Insight - October 26, 2026

Consumer Health Advisory: NAD Finds ‘Fatal Flaws’ In Lumineux Studies
What’s happening, why it matters and what’s next in US consumer health. This edition explores NAD rejecting Lumineux’s 30-minute whitening claim over flawed studies, NIH’s call to prioritize GLP-1 user nutrition products, and how AI chatbots create regulatory risk for brands.
HBW Insight - October 26, 2026
US FDA Drops CIO, But Keeps Sanjay Sahoo As Acting Head Of New Mission IT Office
FDA retired Chief Information Officer title, but Sanjay Sahoo moved to temporarily lead new Office of Mission Information Technology Services as agency’s technology push shifts to Jared Seehafer, deputy commissioner for technology and artificial intelligence.
HBW Insight - October 26, 2026

Biocon Opens Up China, Brazil And Seven More Markets For Stelara Biosimilar
Nine additional markets, including Brazil and China, have opened for Biocon and its Yesintek (ustekinumab-kfce) biosimilar, as J&J's Q3 2026 earnings show Stelara global revenues fell 54% under biosimilar competitive pressure.
Generics Bulletin - October 26, 2026
Adalvo And Olpha Partnership Ready To Bring Semaglutide To The Baltic Region
Adalvo has signed a semaglutide partnership agreement with Olpha for the Baltic region to reinforce its expanding presence in the rapidly growing GLP-1 receptor agonist market.
Generics Bulletin - October 26, 2026
FDA Scolds Baxter Over Repeated ‘Significant Violations’ In Manufacturing Facilities
The FDA has issued a warning letter to Baxter International over cGMP violations at its sterile injectables facility, noting similar violations at other Baxter sites and calling management oversight "inadequate."
Generics Bulletin - October 26, 2026

Do We Know Enough to Build Longevity Medicine? Church Says Yes, And The Field Is About to Find Out
The Harvard geneticist says we already know enough biology to start building longevity medicine. The first human data, a newly interested FDA, and his own company’s balance sheet are about to test him.
In Vivo - October 26, 2026