CHINA NMPA ACCEPTS NEW DRUG APPLICATION FOR HS-10365 CAPSULES FOR THE TREATMENT OF RET FUSION-POSITIVE NSCLC Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) today announces that the New Drug Application(NDA) of the Group’s innovative drug “HS-10365 capsules”, a potent…
Arcturus Plunges on ‘Mixed’ Cystic Fibrosis Data for Inhaled mRNA Drug Arcturus Therapeutics’ inhaled mRNA therapy ARCT-032 failed to show meaningful improvements in lung function in a Phase II trial for cystic fibrosis, sending the company’s shares tumbling by nearly…
MERS-CoV virus isolate added to the WHO BioHub System, enabling further research and pandemic preparedness Through the BioHub, countries can voluntarily share and request biological materials with epidemic or pandemic potential. This initiative, set up by the Director-General of WHO…
Biotech Markets Turn Positive but Experts Say Don’t Call It a Comeback—Yet M&A is back, the S&P XBI is rising again, a biotech pulled off an IPO and positive data is pulling in investors again. This may just be the…
Leadership Lab: How To Spot When Employees Are About To Walk Away Employees rarely leave companies for one reason alone. In this column, Kaye/Bassman’s Michael Pietrack shares a framework that helps leaders identify when their team members are thinking about…
Recognition highlights WuXi Biologics’ commitment to delivering exceptional value and innovative solutions to its global clients. WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has been honored with the Frost &…
New findings underscore Cefiderocol’s efficacy and reliability in managing complex, multidrug-resistant bacterial infections. Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) presents new data at IDWeek 2025, demonstrating broad activity of Fetroja®/Fetcroja®…
Replimune Soars Upon FDA Resubmission for Advanced Melanoma Drug Last month, investors’ hopes were dashed as Replimune suggested alignment had not yet been reached with the FDA on RP1’s future. Now, the regulator has accepted a refiled application after all.…
The FDA approval marks Gazyva’s first non-oncology indication, expanding Roche’s presence into autoimmune disease treatment. The anti-CD20 antibody, developed by Roche’s Genentech along with Biogen and already approved for multiple oncology indications, is branching into autoimmune disease. Its B cell–targeting…
Despite major therapeutic advances, patients with multiple myeloma continue to face relapse and resistance—demanding renewed focus and innovation. Recent headlines proclaim a ‘potential’ or ‘functional’ cure for multiple myeloma, but the fight against the disease must continue. Nothing is more…
The investigational B7-H4–targeted antibody–drug conjugate HS-20089 demonstrates encouraging efficacy and manageable safety in patients with platinum-resistant ovarian cancer. Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) today announced positive phase 2 study findings of HS-20089, a B7-H4-targeted Antibody-drug Conjugate, in patients…
The World Health Organization confirms Fiji has eliminated trachoma as a public health problem, marking a major step toward global eye health goals. In a landmark public health achievement, Fiji has been validated by the World Health Organization (WHO) for…