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US FDA Approves Pfizer's HYMPAVZI for Treatment of Additional Hemophilia A and B Patients
Pfizer’s HYMPAVZI has received expanded US FDA approval for hemophilia A and B patients aged 12 years and older with inhibitors, as well as children aged 6-11 years with or without inhibitors. The approval makes HYMPAVZI the first subcutaneous non-factor therapy available for pediatric hemophilia B patients ages 6 to 11 years old.
Gilead and Merck Report Positive Phase 3 Results for Weekly HIV Pill
Gilead and Merck reported positive phase 3 results for the investigational once-weekly oral HIV therapy islatravir/lenacapavir, which has the potential to become the first approved long-acting weekly oral treatment for people living with HIV.
Zai Lab Secures China Approval for TIVDAK
Zai Lab has received China NMPA approval for TIVDAK (tisotumab vedotin), the first Antibody-Drug Conjugate (ADC) approved for previously treated recurrent or metastatic cervical cancer in China. The approval is supported by phase 3 innovaTV 301 trial data demonstrating a statistically significant overall survival benefit.
Coya Therapeutics Advances ALSTARS Trial into Active-Treatment Extension Phase
Coya Therapeutics announced that the first cohort of ALS patients in the ALSTARS trial has entered the 24-week blinded active-treatment extension phase, where all participants will receive COYA 302.
Incyte to Acquire Vega Therapeutics, Expanding Hematology Portfolio
Incyte has agreed to acquire Vega Therapeutics, expanding its hematology portfolio into bleeding disorders with the addition of VGA039, a phase 3 investigational monoclonal antibody for von Willebrand disease. The deal includes USD 1.25 billion upfront and up to USD 750 million in additional payments upon achievement of sales milestones.
Made Scientific and Pluristyx Partner to Advance iPSC Cell Therapies
Made Scientific and Pluristyx have launched a strategic partnership to streamline iPSC-derived cell therapy development and manufacturing. By integrating Pluristyx’s clinical-grade iPSC platform with Made Scientific’s CDMO services, the collaboration provides developers with a single-source pathway from cell line development to commercial supply.
Mabwell's 9MW5211 Gains NMPA IND Clearance for Inflammatory Bowel Disease
Mabwell’s 9MW5211 has received IND clearance from China’s NMPA for the treatment of Inflammatory Bowel Disease (IBD). As the first drug candidate globally targeting this novel mechanism to enter clinical development, 9MW5211 represents a significant advancement in the search for innovative therapies for IBD patients.
Lupin Partners with ERN to Launch Luforbec in Spain
Lupin has partnered with ERN to launch Luforbec (beclometasone/formoterol) pMDI in Spain, combining Lupin’s respiratory expertise and advanced inhaler manufacturing capabilities with ERN’s strong market presence to expand access to high-quality respiratory care for patients across the country.
Chiesi Global Rare Diseases Announces EC Approval of Lojuxta Capsules
Chiesi Global Rare Diseases has secured European Commission approval for Lojuxta (lomitapide) in children aged 5 years and older with Homozygous Familial Hypercholesterolaemia (HoFH), expanding treatment options for this ultra-rare genetic cholesterol disorder across the EU.
Sophia Genetics Signs MoU with Memorial Sloan Kettering Cancer Center
Sophia Genetics has signed a strategic collaboration Memorandum of Understanding (MoU) with Memorial Sloan Kettering Cancer Center to establish a next-generation precision medicine hub.
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