Teclistamab

Generic drugmakers will face import tariffs in the U.S., President Donald Trump announced this week. Samsung Biologics is pursuing the biggest M&A deal ever for a Korean biopharma company. In an unconventional move, a U.S. biotech is gunning for an IPO in Hong Kong first. And more. 1. Trump floats countdown to 200% tariffs on generic drugs imported to US The U.S. will implement a 100% tariff on generic drug imports beginning in August of 2028, after which it will be raised to 200% the following year, President Donald Trump declared on social media. According to a person familiar with the matter, the policy will apply to both finished drugs and API. While generic makers don’t have to sign formal deals with the White House, they have a two-year window to reshore production before tariffs kick in, the person said. 2. Samsung Biologics spreads wings with proposed $1.8B acquisition of Swiss CDMO PolyPeptide In the biggest acquisition on record by a Korean biopharma company, Samsung Biologics will buy Swiss CDMO PolyPepide for 1.46 Swiss francs ($1.8 billion). The deal “reinforces our long-term growth strategy by not only broadening our service portfolio with modality expansion into peptides including GLP-1, but by also boosting our geographic reach,” Samsung Biologics CEO John Rim said. 3. ‘There is always a first’: Why US biotech Axiom will begin its IPO journey in Hong Kong In a first for a U.S. biotech, Axiom Biosciences plans to go public on the Hong Kong Stock Exchange first, followed by a double listing on the Nasdaq. The company’s international investor pool, coupled with a partnership with Korea’s Medinno on its lead cell therapy for two fatal newborn neurological diseases, made the Hong Kong listing an easy choice, CEO Remo Moomiaie-Qajar, M.D., said. 4. ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins India has seen some “green shoots” of biotech innovation, with more than 10 novel assets by local drugmakers over the past decade, according to a new report from HealthKois and Boston Consulting Group. India’s annual pharma R&D spend, at around $2 billion to $3 billion, continues to lag that of other countries, but the Indian government is funding emerging technologies. 5. Why Legend Biotech stock fell 10% despite record Carvykti sales J&J’s bispecific combo slashes myeloma progression risk by 89% in phase 3 trial After Johnson & Johnson reported record Carvykti sales and strong growth, its partner Legend Biotech’s shares tanked 10% on July 15. Investors were likely rattled by comments that J&J’s innovative medicine chief, Jennifer Taubert, made during the earnings call, where she described the company’s alternative bispecific Tecvayli as holding “the potential for cure.” Then this week, J&J reported the doublet of Tecvayli and Talvey improved progression-free survival by 89% and overall survival by 62% compared with standard of care in previously treated multiple myeloma. However, the company indicated that this combo won’t be a major threat to Carvykti. 6. Summit Therapeutics updates ivonescimab survival data ahead of FDA decision date Summit Therapeutics offered another look at the overall survival data in the Western population of the phase 3 HARMONi trial for Akeso-partnered ivonescimab. At a data cut-off in June 2026, the OS hazard ratio in that subgroup improved to 0.76, matching the overall trial population. While the data do not bear statistical significance, Summit has shared them with the FDA amid an ongoing review in previously treated EGFR-mutated non-small cell lung cancer. 7. Takeda’s zasocitinib proves ‘top-notch’ for difficult-to-treat psoriasis in phase 3 update 8. Roche Diagnostics growth remains muted amid China headwinds 9. Huahai poaches quality chief from Hengrui amid FDA manufacturing citations 10. China 1st to endorse Takeda's narcolepsy drug (Regulatory tracker) 11. A Fatal Reaction—A cutting-edge gene-editing trial in China went disastrously wrong (Science) 12. Indian generics maker Lupin seeds US spinout Kaveri with cash, clinical-phase cancer assets 13. Alembic site slapped with FDA warning letter over patient consent concerns 14. FDA rebukes 2 Indian API plants over data controls, sanitation issues 15. Jasper finds new purpose in merger with Kira, while offloading Tavneos rival to Mirador

Johnson & Johnson reported another positive Phase III study in relapsed or refractory multiple myeloma, saying its dual bispecific combination comprising Tecvayli (teclistamab) and Talvey (talquetamab) significantly extended both progression-free survival (PFS) and overall survival (OS) in patients who had received one to four prior lines of therapy."These findings further reinforce immunotherapy as a cornerstone of multiple myeloma care," said Yusri Elsayed, global therapeutic area head for oncology, in a company release Thursday.Tecvayli, a bispecific that targets BCMA, is currently indicated for multiple myeloma in the fifth-line setting; earlier this year it also obtained an approval for use together with J&J's Darzelex Faspro (daratumumab/hyaluronidase) in patients who have received at least one prior line of therapy.Talvey, which zeroes in on GPRC5D, is also currently approved for fifth-line multiple myeloma. J&J has been looking to move the therapy earlier in the course of treatment and recently posted Phase III results from the MonumenTAL-3 study, where Talvey plus Darzalex Faspro lowered the risk of disease progression or death by up to 72% at a median follow-up of two years.PFS rate of 89%Thursday's topline readout centred on MonumenTAL-6, a three-arm trial evaluating Talvey plus Tecvayli, Talevy plus pomalidomide, or investigator's choice standard care in an estimated 795 patients who received one to four prior lines of therapy, including an anti-CD38 antibody and lenalidomide.On the primary endpoint, J&J's BCMA- and GPRC5D-targeting combo reduced the risk of disease progression or death by 89% versus investigator's choice. It also lowered the risk of death, a secondary goal of the study, by 62%. Both outcomes were statistically significant."This represents the lowest hazard ratio seen across any Phase III study evaluating bispecific therapies in relapsed/refractory multiple myeloma," the company said.The other experimental arm of the study, Talevy and pomalidomide, also succeeded on both those measures; J&J said this arm achieved a PFS rate of 73%. Full results will be presented at a future major medical meeting and shared with global health authorities.The overall safety profiles for the two treatment arms were also consistent with the known safety profiles of each monotherapy, the company said. An independent data monitoring committee has now recommended unblinding the study at the first interim analysis.Key opinion leaders told FirstWord in a recent report that they expected MonumenTAL-3 and MonumenTAL-6 to succeed. However, one expert suggested that Talvey's "side-effect profile is a sufficient deterrent to numb the enthusiasm for the drug," while another said combination regimens may allow lower Talvey dosing that could improve tolerability (see – KOL Insight - Multiple Myeloma).