Xencor Sees Accelerated Approval Potential For Bispecific TCE In Renal Cancer
The biotech will ask the US FDA about considering accelerated approval based on Phase I data in clear cell renal cell carcinoma patients who have exhausted standard-of-care options.
Scrip - October 26, 2026

Finance Watch: IPO Count Rises Again As Do Alternate Routes To Public Markets
Public Company Edition: Lycia raised $317.5m in its initial public offering, bringing the biopharma IPO count to 27 in the US. Also, Prana will gain a public listing through its reverse merger with Bolt, while Corxel and TriGemX will go public in SPAC mergers.
Scrip - October 26, 2026

ESMO 2026: BMS/SystImmune’s Iza-Bren Shows Benefit In NSCLC
The bispecific antibody-drug conjugate showed a significant benefit in PFS in previously treated NSCLC, days after showing an efficacy benefit in previously treated breast cancer.
Scrip - October 26, 2026

When AI Becomes a Medical Device: FDA Boundaries for Patient-Facing Health Tools
The FDA evaluates AI health software based on its intended use and functionality. Attorneys explain how to design AI features that preserve clinicians’ independent judgment and support exclusion from device regulation, and when patient-facing tools may trigger FDA oversight.
Medtech Insight - October 26, 2026

ESMO 2026: Merck & Co Close To Sealing Its First Approval For Sac-TMT
The TROP2-directed antibody-drug conjugate cut risk of death by 32% in advanced endometrial cancer in the TroFuse-005 trial.
Scrip - October 26, 2026

Skeptics Proven Wrong, Iovance Targets Lung Cancer Next With TIL Therapy
The best performing mid-cap biotech stock this year thanks to Amtagvi, Iovance will shortly present lung cancer data that, if successful, could transform its outlook. Brian Gastman, head of translational medicine and research, spoke to Scrip.
Scrip - October 26, 2026

Two Crucial Months For Dr. Reddy’s As It Awaits Abatacept Decision, Semaglutide Relaunch
Dr. Reddy’s is banking on a Dec. 22 US FDA decision on its abatacept biosimilar, along with a semaglutide launch in Brazil by March 2027 and relaunch in Canada in November 2026, to buoy performance after lenalidomide sales continued to slide in the second quarter.
Generics Bulletin - October 26, 2026

ESMO 2026: AstraZeneca Raises The Claudin18.2 ADC Stakes In Gastric Cancer
The company’s sone-ve has shown a survival benefit in patients with low Claudin18.2 expression in the global CLARITY-Gastric01 study, cementing an edge over class rivals.
Scrip - October 26, 2026

Opella Eyes Daily Content Publishing As Microsoft AI Partnership Aims To Cut Approval Time
Opella tells HBW Insight it hopes to move from weekly to daily publishing of digital content in some markets thanks to the introduction of its Lumen AI platform, which the company has developed in partnership with Microsoft.
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

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