PhRMA sued CMS in the US District Court for the District of Columbia on October 7, seeking to vacate the finalized GLOBE model, arguing the agency acted beyond its legal authority. GLOBE, finalized September 30, is the mandatory enforcement tool under the Trump administration's Most Favored Nation pricing framework for the Medicare Part B channel, covering drugs administered in physician offices and hospitals. The court has yet to rule.
The FDA has compiled the status of postmarketing confirmatory trials for cancer drugs granted accelerated approval, including sevabertinib for HER2-mutated NSCLC (trial SOHO-02) and camizestrant for HR+/HER2- ESR1-mutated breast cancer.
AstraZeneca has placed a $2 billion bet on ivonescimab, aiming to find a next-generation partner for its ADCs. The deal centers on ivonescimab and is intended to strengthen its pipeline positioning in ADC combination therapy.
Franck Le Deu of KerZheng Ventures argues that Chinese biopharma companies are unlikely to become conventional global competitors by 2030, despite strong science, because the U.S. dominates the profit pool, taking about 53% of world prescription-medicine sales in 2025 and 74% of sales of medicines launched in 2020-24. He weighs Pfizer's Innovent Biologics collaboration worth up to $10.5 billion and China's Five-Year Plan targets, including first-in-class drugs reaching a quarter of the global total and five products exceeding $1 billion in sales by 2030, against barriers like CFIUS and geopolitics. He suggests few will succeed in the Western model, and alternative paths such as affordable innovation outside the U.S. market may define globalization instead.
The FDA on August 25, 2026 approved Ziihera (zanidatamab-hrii) for first-line unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma: IHC 3+ and IHC 2+/ISH+ patients can receive it with tislelizumab plus chemotherapy, and IHC 3+ patients with chemotherapy alone. Under the BeOne Medicines collaboration, Zymeworks has received $81 million, with up to $144 million in further milestones and tiered royalties of up to 19.5%. The approval triggers the structure set up on March 2, 2026, when Zymeworks BC moved 30% of future Ziihera royalties into Zymeworks Royalty Limited Partnership, which borrowed $250 million in non-recourse notes from Royalty Pharma secured solely on those royalties.
Why it matters: FDA approval of a bispecific antibody in first-line gastric cancer activates milestone payments and a $250 million royalty-backed financing.
The White House said on August 31 that President Trump signed new most-favored-nation drug pricing agreements with nine manufacturers: Alcon, Astellas Pharma, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals and UCB. The deals push US prescription drug prices down to the lowest level among other developed countries. With this round, 26 companies have signed MFN agreements, covering 89% of the US brand-drug market.
Why it matters: MFN pricing agreements now cover 89% of the US brand-drug market, directly affecting drugmakers including BeOne Medicines.
The White House announced on August 31 most-favored-nation drug pricing agreements with nine pharmaceutical companies: Alcon, Astellas, BeiGene, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva and UCB. The move extends the negotiation effort beyond large multinationals to mid-sized drugmakers. Companies with MFN arrangements now total 26, covering about 89% of the US branded drug market.
Why it matters: The MFN pricing push now covers most of the US branded drug market and has reached mid-sized manufacturers.
The Trump administration has reached price-reduction agreements with nine more pharmaceutical companies: Alcon, Astellas, BeOne, BridgeBio, CSL, Sun Pharma, Kyowa Kirin, Teva and UCB. The new deals bring the total number of signatory companies to 26.
The US FDA approved a new indication for tislelizumab on August 26, 2026, combining it with zanidatamab plus chemotherapy as first-line treatment for HER2-positive gastroesophageal adenocarcinoma (GEA). The approval covers patients regardless of PD-L1 expression and is the first approved regimen pairing a HER2 bispecific antibody with a PD-1 inhibitor. It rests on the HERIZON-GEA-01 trial, published in the New England Journal of Medicine and presented orally at the 2026 ASCO annual meeting.
Why it matters: First approved HER2 bispecific plus PD-1 combination for first-line HER2-positive gastroesophageal adenocarcinoma.
On August 25, the FDA approved zanidatamab (Ziihera) combined with tislelizumab (Tevimbra) and chemotherapy for first-line treatment of HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma. The FDA also approved zanidatamab plus chemotherapy without a PD-1 inhibitor for the same indication in HER2 IHC 3+ patients. This is the first approved HER2 bispecific plus PD-1 antibody combination worldwide, developed by BeiGene.
Why it matters: First global approval of a HER2 bispecific plus PD-1 antibody combination for first-line gastroesophageal cancer.
The FDA has approved BeiGene's supplemental application for Tevimbra (tislelizumab) in combination with zanidatamab and chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma (GEA). About 20% of GEA patients are HER2-positive, a subtype that has long been difficult to treat.
Why it matters: Adds a first-line FDA-approved regimen for a hard-to-treat HER2-positive gastroesophageal adenocarcinoma population.
BeiGene said the FDA has approved a supplemental application for its PD-1 antibody tislelizumab (BaiZeAn) in combination with zanidatamab and chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma. Results were published earlier this year in the New England Journal of Medicine. The material cites five-year survival below 30 percent for gastric cancer and about 19 percent for esophageal adenocarcinoma.
Why it matters: First-line FDA approval expands tislelizumab's use in HER2-positive gastroesophageal adenocarcinoma.
The US FDA approved two first-line treatment regimens combining Jazz Pharmaceuticals' HER2 bispecific antibody Ziihera (zanidatamab-hrii) with tislelizumab, a PD-1 antibody originally developed by BeiGene, on August 25. The approval adds tislelizumab to first-line combination treatment for HER2-positive gastroesophageal adenocarcinoma in the United States. The approval covers two distinct Ziihera-based regimens.
Why it matters: FDA approval extends BeiGene's PD-1 antibody tislelizumab into a US first-line indication.
China has approved BeiGene's regimen combining a HER2 bispecific antibody with a PD-1 inhibitor for first-line treatment of HER2-positive gastroesophageal adenocarcinoma, regardless of patients' PD-L1 expression status. The article calls it the first and only immuno-oncology combination in that first-line setting to achieve a median overall survival of more than two years. A marketing application for the indication had already been filed in China.
Why it matters: First-line approval in HER2-positive gastroesophageal adenocarcinoma adds an option where about 20% of patients need better treatment.
Adding perioperative tislelizumab to chemotherapy raised the major pathological response rate in tsMHC-II-positive operable locally advanced gastric or gastroesophageal junction cancer (61.8% vs. 26.5%, p = 0.003), meeting the primary endpoint of the phase 2 Mountain-02 trial in 136 patients. No significant benefit appeared in tsMHC-II-negative patients, and tsMHC-II positivity also tracked with higher pCR (32.4% vs. 5.9%). The results position tumor-specific MHC class II expression as a candidate biomarker for selecting patients for perioperative immunotherapy.
Why it matters: Identifies a predictive biomarker that separates responders from non-responders to perioperative immunotherapy in gastric cancer.
Long-term follow-up results from the SEQUOIA trial have been published in the Journal of Clinical Oncology. First author Professor Mazyar Shadman of Fred Hutchinson Cancer Center led the analysis, which focuses on the long-term performance of zanubrutinib as first-line treatment of previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
Why it matters: Long-term SEQUOIA follow-up data published in JCO provide extended-follow-up reference for zanubrutinib versus chemoimmunotherapy in untreated CLL/SLL.
This review outlines treatment strategies for relapsed/refractory CLL/SLL: second-generation cBTK inhibitors (acalabrutinib, zanubrutinib), fixed-duration venetoclax, the ncBTK inhibitor pirtobrutinib, and lisocabtagene maraleucel cell therapy each have distinct roles across multiple lines of therapy.