Lubiprostone

Takeda said Friday that it will record a legal provision of JPY 402.5 billion ($2.5 billion) in the financial year ended March 31 to cover damages recently awarded by a US jury in a case related to generic versions of the constipation treatment Amitiza (lubiprostone).The company warned last month that such a charge was likely after a jury awarded plaintiffs just shy of $885 million in damages — a figure that will be automatically tripled once the court enters the judgment. The lawsuit, brought by pharmacies, insurers, health funds and retailers, including CVS and Walgreens, alleged that Takeda entered an agreement with Par Pharmaceuticals to delay the launch of Amitiza generics, breaching antitrust laws. Takeda reiterated on Friday that it will "vigorously pursue post-trial motions and an appeal," including a stay of execution of the judgment while these are ongoing. The total liability from the Amitiza antitrust litigation has not yet been finalised, the company added, noting that it also expects a district court judgment in the second half of 2026.In the meantime, Takeda said the legal provision means that it swung to a loss in fiscal year 2025 of around JPY 152 billion ($951 million), having previously recorded a profit of about JPY 192 billion ($1.2 billion).However, the company, which is in the midst of a transformation programme set to hit around 4500 jobs, said the revision does not affect its outlook for fiscal 2026.

Sac-TMT's three positive phase 3 trials, strategies in striking China biotech deals, and Takeda's first-of-its-kind pay-for-delay verdict made our news this week. Merck & Co. and Kelun-Biotech's sac-TMT is on fire this week with details or first reports of three positive phase 3 trials. Local know-how, proper due diligence and AI are helpful in striking licensing deals in China, experts say. For the first time, a federal jury has found a drugmaker liable in a pay-for-delay case. And more.1. ASCO: Merck, Kelun's sac-TMT ADC combo beats Keytruda by 65% on progression in first-line lung cancerMerck, Kelun score with sac-TMT in endometrial cancer trialCombining Merck & Co. and Kelun-Biotech’s TROP2 antibody-drug conjugate sac-TMT with Keytruda cut the risk of progression or death by 65% versus Keytruda alone in first-line, PD-L1-positive non-small cell lung cancer, according to an ASCO 2026 abstract detailing results from the OptiTROP-Lung05 study in China. The data look competitive compared with Akeso and Summit Therapeutics’ PD-1xVEGF bispecific ivonescimab as a monotherapy.Meanwhile, sac-TMT just had its first global phase 3 win, as Merck’s TroFuse-005 trial met both its progression-free survival and overall survival endpoints at an interim analysis. The study pitted sac-TMT against chemo in previously treated endometrial cancer. Then, Kelun announced that its OptiTROP-Breast03 trial in China also showed a “statistically significant and clinically meaningful improvement” in PFS and a “positive trend” regarding OS for sac-TMT versus chemotherapy at an interim analysis. The first-line triple-negative breast cancer study enrolled patients with PD-L1-negative tumors, as well as those with PD-L1-positive expression who had received prior anti-PD-(L)1 inhibitor therapy in early-stage disease.2. Facing mounting China licensing costs, biopharma buyers turn to AI and local know-how to keep upWhen doing biotech deals in China, Geoff Meyerson, founder and CEO of Locust Walk, stressed the importance of having people on the ground. Sidley Austin lawyer Adam Welland highlighted the importance of due diligence, including around development strategies. And Mwyngil Therapeutics CEO Luba Greenwood said the explosion of data and candidates in China makes AI a powerful sourcing tool.3. Takeda slapped with $885M verdict in pay-for-delay antitrust caseA federal jury in Boston has found that Takeda conspired with a competitor to delay the entry of a generic version of its constipation drug Amitiza as part of a class-action lawsuit filed by purchasers of the drug. The jury ordered the company to pay $885 million in damages, which will be tripled upon final decision under antitrust law.  4. Daiichi, AstraZeneca’s Enhertu breaks into early breast cancer with dual FDA approvalsDaiichi Sankyo and AstraZeneca’s Enhertu got two simultaneous FDA go-aheads in early breast cancer, making the HER2 ADC both a neoadjuvant and an adjuvant treatment. However, the adjuvant label excludes the possibility of continued use of Enhertu in patients who already received it in the neoadjuvant setting.5. Eisai's slow push toward blockbuster Leqembi sales gains steam with $900M forecastBiogen-shared Alzheimer’s disease drug Lemqebi generated 88 billion ($555 million) Japanese yen of sales in Eisai’s 2025 fiscal year. As the use of blood-based tests increases and more convenient formulations attract new patients, Eisai hopes the anti-amyloid antibody will reach 143.5 billion yen ($905 million) in fiscal 2026 sales. 6. Amgen's Tavneos, facing liver injury scrutiny, gets label update in Japan as patient starts resumeAfter Kissei Pharmaceutical paused new patient starts of Amgen-partnered rare disease med Tavneos in Japan, the company has worked with the local authority to revise the drug’s label, and doctors can now resume prescriptions. The move followed reports of 20 fatal cases of serious liver injury among Tavneos takers in the country, and it came as the same problem has drawn regulatory concerns in both EU and the U.S.Other News of Note:7. Novartis terminates plant contract with Chinese CDMO Porton, threatens $64M in legal claims8. Gilead inks another deal with Korean API manufacturer Yuhan, this time worth $140M9. Vincentage sees 12.4% weight loss for oral GLP-1, will chase Lilly to Chinese regulators10. GHO Capital, CBC Group plan to merge, forming $21B healthcare investment firm11. Roche signs generic Xofluza licensing deal with Medicines Patent Pool for 129 countries12. Otsuka can’t reverse generic’s win over kidney drug patents (Bloomberg Law)13. Singapore court keeps injunction against KBP as Novo fraud case plays out in arbitration (release)