https://www.bioworld.com/rss en-us Signs of recovery are emerging in the biotechnology investment sector, although investors across Asia say that capital is flowing selectively to companies that can demonstrate clinical differentiation, strong management teams and a clear path to commercialization. http://www.bioworld.com/articles/732842 Tue, 21 Jul 2026 11:00:00 -0400 https://www.bioworld.com/articles/732842-capital-remains-selective-in-barbell-biotech-market International currency symbols Signs of recovery are emerging in the biotechnology investment sector, although investors across Asia say that capital is flowing selectively to companies that can demonstrate clinical differentiation, strong management teams and a clear path to commercialization. http://www.bioworld.com/articles/732692 Thu, 16 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732692-capital-remains-selective-in-barbell-biotech-market International currency symbols Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody mezagitamab (TAK-079) is showing benefits beyond platelet restoration, with new data suggesting the candidate may improve quality of life for patients with chronic immune thrombocytopenia (ITP) and sustain those gains after treatment ends. http://www.bioworld.com/articles/732669 Tue, 14 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732669-takedas-mezagitamab-adds-quality-of-life-gains-to-itp-responses Antibodies and red blood cells Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody mezagitamab (TAK-079) is showing benefits beyond platelet restoration, with new data suggesting the candidate may improve quality of life for patients with chronic immune thrombocytopenia (ITP) and sustain those gains after treatment ends. http://www.bioworld.com/articles/732586 Mon, 13 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732586-takedas-mezagitamab-adds-quality-of-life-gains-to-itp-responses Antibodies and red blood cells Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8. http://www.bioworld.com/articles/732352 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732352-otsukas-centanafadine-scores-in-adhd-comorbid-anxiety-trial Illustration of woman with anxiety, ADHD The academic authors of the paper describing the pivotal trial of Amgen Inc.’s Tavneos (avacopan) have retracted it from The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded. The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded.]]> http://www.bioworld.com/articles/732242 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732242-nejm-paper-on-tavneos-pivotal-trial-retracted-by-academic-authors Photo of pen and marker on science journal article Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8. http://www.bioworld.com/articles/732174 Fri, 26 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732174-otsukas-centanafadine-scores-in-adhd-comorbid-anxiety-trial Illustration of woman with anxiety, ADHD Nippon Shinyaku Co. Ltd.’s NS-035 has been awarded Japanese orphan drug designation for the treatment of Fukuyama congenital muscular dystrophy. http://www.bioworld.com/articles/732135 Thu, 25 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732135-nippon-shinyakus-ns-035-designated-orphan-drug-in-japan 3d illustration of human body muscle tissue anatomy J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment. http://www.bioworld.com/articles/732153 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732153-j-pharma-drives-first-cancer-lat1-to-phase-iii-study-with-fda-nod Illustration of cancer in the bile ducts J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment. http://www.bioworld.com/articles/731921 Thu, 18 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731921-j-pharma-drives-first-cancer-lat1-to-phase-iii-study-with-fda-nod Illustration of cancer in the bile ducts Takeda Pharmaceutical Co. Ltd.’s oral TYK2 inhibitor zasocitinib (TAK-279) demonstrated statistical superiority over Bristol Myers Squibb Co.’s first-in-class Sotyktu (deucravacitinib) in a top-line phase III Latitude Atlas readout of moderate to severe plaque psoriasis. http://www.bioworld.com/articles/731981 Tue, 16 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731981-takedas-zasocitinib-bests-sotyktu-in-phase-iii-psoriasis-trial Dermatology exam Immunomic Therapeutics Inc. has obtained clinical trial notification (CTN) clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for ITI-9001, an investigational immunotherapy for Japanese red cedar allergy. The first-in-human phase I trial will begin in Japan in the second quarter. http://www.bioworld.com/articles/731962 Tue, 16 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731962-immunomics-iti-9001-to-enter-clinic-for-japanese-red-cedar-allergy Photo of pollen cloud from cedar tree Takeda Pharmaceutical Co. Ltd.’s oral TYK2 inhibitor zasocitinib (TAK-279) demonstrated statistical superiority over Bristol Myers Squibb Co.’s first-in-class Sotyktu (deucravacitinib) in a top-line phase III Latitude Atlas readout of moderate to severe plaque psoriasis. http://www.bioworld.com/articles/731816 Fri, 12 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731816-takedas-zasocitinib-bests-sotyktu-in-phase-iii-psoriasis-trial Dermatology exam Japan has granted marketing approval to Oncolys Biopharma Inc.’s oncolytic adenovirus product, Telomelysin (suratadenoturev, OBP-301), for treating esophageal cancer in patients who are not eligible for curative resection or chemoradiotherapy. The approval marks the first oncolytic adenovirus product approved for esophageal cancer. http://www.bioworld.com/articles/731711 Tue, 09 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731711-japan-backs-oncolys-virus-therapy-for-esophageal-cancer Illustration of cancer on the esophagus The U.S. FDA approved Shionogi & Co. Ltd.’s Xocova (ensitrelvir) as the first oral post-exposure prophylactic option in the U.S. to prevent COVID-19, with the decision coming ahead of a PDUFA target date of June 16. http://www.bioworld.com/articles/731531 Tue, 02 Jun 2026 08:00:00 -0400 https://www.bioworld.com/articles/731531-fda-clears-shionogis-xocova-as-first-covid-19-prevention-pill Xocova blister pack Credit: Shionogi & Co. Ltd. Acknowledging that the spread of the Andes virus and the resulting disease, hantavirus pulmonary syndrome, “constitutes a credible risk of a future public health emergency,” U.S. Health and Human Services Secretary Robert Kennedy is issuing a declaration to provide liability protection for manufacturers, distributors and providers using favipiravir as a medical countermeasure (MCM) against the virus. http://www.bioworld.com/articles/731406 Tue, 26 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731406-kennedy-offers-emergency-immunity-for-use-of-mcm-in-hantavirus Singapore’s Communicable Diseases Agency on May 7 said that it isolated two residents for hantavirus testing after the individuals disembarked from an Atlantic cruise ship on May 2 and May 6, respectively. The measure comes in response to the cluster of cases from the cruise ship, MV Hondius, that has resulted in three deaths so far. MV Hondius, that has resulted in three deaths so far.]]> http://www.bioworld.com/articles/731223 Tue, 12 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731223-apac-monitors-hantavirus-as-singapore-isolates-2-from-cruise-ship Hantavirus cells Singapore’s Communicable Diseases Agency on May 7 said that it isolated two residents for hantavirus testing after the individuals disembarked from an Atlantic cruise ship on May 2 and May 6, respectively. The measure comes in response to the cluster of cases from the cruise ship, MV Hondius, that has resulted in three deaths so far. MV Hondius, that has resulted in three deaths so far.]]> http://www.bioworld.com/articles/730984 Fri, 08 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/730984-apac-monitors-hantavirus-as-singapore-isolates-2-from-cruise-ship Hantavirus cells Sonire Therapeutics Inc. initiated a U.S.-based Sunrise II study of Suizenji, its novel ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors, after closing an $18 million series A financing round April 15. http://www.bioworld.com/articles/730922 Tue, 05 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/730922-sonire-starts-us-study-of-cancer-hifu-after-18m-series-a Pancreas For the first time in 13 years, the U.S. Trade Representative (USTR) singled out one of the U.S. trading partners as the worst of the worst when it named Vietnam as a Priority Foreign Country (PFC) in its newly released Special 301 Report. http://www.bioworld.com/articles/730920 Tue, 05 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/730920-ustr-calls-out-trade-partners-for-rx-med-tech-pricing-policies Map of Vietnam For the first time in 13 years, the U.S. Trade Representative (USTR) singled out one of the U.S. trading partners as the worst of the worst when it named Vietnam as a Priority Foreign Country (PFC) in its newly released Special 301 Report. http://www.bioworld.com/articles/730832 Mon, 04 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/730832-ustr-calls-out-trade-partners-for-rx-med-tech-pricing-policies Map of Vietnam Sonire Therapeutics Inc. initiated a U.S.-based Sunrise II study of Suizenji, its novel ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors, after closing an $18 million series A financing round April 15. http://www.bioworld.com/articles/730769 Fri, 01 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/730769-sonire-starts-us-study-of-cancer-hifu-after-18m-series-a Pancreas Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval. http://www.bioworld.com/articles/730581 Tue, 21 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730581-delta-fly-eyes-nda-path-despite-aml-phase-iii-miss Acute myeloid leukemia illustration The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer. http://www.bioworld.com/articles/730580 Tue, 21 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730580-fda-grants-priority-review-to-merck-daiichis-b7-h3-cancer-adc Lung cancer illustration Daiichi Sankyo. Co. Ltd. will begin a phased sale of its consumer health subsidiary, Daiichi Sankyo Healthcare Co. Ltd., to Suntory Holdings Ltd., as the Tokyo-based drugmaker sharpens its focus on oncology. http://www.bioworld.com/articles/730574 Tue, 21 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730574-daiichi-to-divest-consumer-health-unit-to-suntory-for-15b Two arrows in opposite directions Daiichi Sankyo. Co. Ltd. will begin a phased sale of its consumer health subsidiary, Daiichi Sankyo Healthcare Co. Ltd., to Suntory Holdings Ltd., as the Tokyo-based drugmaker sharpens its focus on oncology. http://www.bioworld.com/articles/730407 Fri, 17 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730407-daiichi-to-divest-consumer-health-unit-to-suntory-for-15b Two arrows in opposite directions Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval. http://www.bioworld.com/articles/730406 Fri, 17 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730406-delta-fly-eyes-nda-path-despite-aml-phase-iii-miss Acute myeloid leukemia illustration Roche Holding AG is making good on its promise to try and convince the EMA of the benefits of Elevidys (delandistrogene moxeparvovec), announcing a further global phase III trial of the Duchenne muscular dystrophy gene therapy. http://www.bioworld.com/articles/730404 Fri, 17 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730404-roche-plots-route-to-ema-approval-for-dmd-gene-therapy Green strand of DNA The U.S. FDA has accepted and granted priority review to Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer. http://www.bioworld.com/articles/730392 Thu, 16 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730392-fda-grants-priority-review-to-merck-daiichis-b7-h3-cancer-adc Lung cancer illustration Glyconex Inc. has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the initiation of a first-in-human phase I trial of GNX-1021, the company’s lead antibody-drug conjugate (ADC) candidate, in patients with advanced gastrointestinal (GI) cancers. http://www.bioworld.com/articles/730373 Wed, 15 Apr 2026 09:00:00 -0400 https://www.bioworld.com/articles/730373-glyconexs-gnx-1021-cleared-for-clinic-in-japan-for-gi-cancers Floating antibody drug conjugates