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News
Sanofi abandons eczema drug approval efforts in another blow to OX40 class
1+ day, 19+ hour ago (339+ words) While amlitelimab elicited durable responses in AD, Sanofi does not believe the drug is meaningfully differentiated from current eczema treatment offerings. Sanofi has chosen not to file for approval or continue the development of its immunology therapy, amlitelimab, in atopic…...
Grifols Plasma Fractionation Plant, Barcelona, Spain
2+ day, 22+ hour ago (579+ words) Grifols’ new plant in Llica de Vall will increase the company’s plasma fractionation capacity by three million litres annually. Initial Phase: €160m ($186.3m) Grifols is developing a new plasma fractionation plant in Llica de Vall, Barcelona, Spain, to address rising demand for…...
GSK secures first lung cancer approval, validating $10.6bn Nuvalent bet
2+ day, 17+ hour ago (369+ words) Jideytro will now enter a lung cancer niche dominated by Pfizer’s Lorbrena. Just days after completing a $10.6bn takeover of lung cancer biotech Nuvalent, GSK is already reaping the rewards with Jideytro (zidesamtinib) having gained US approval in ROS1-positive non-small cell…...
Affinia Therapeutics receives FDA orphan drug designation for AFTX-201
2+ day, 23+ hour ago (330+ words) Affinia Therapeutics has received the US Food and Drug Administration (FDA) orphan drug designation for AFTX-201, a treatment in development for BAG3-associated dilated cardiomyopathy (DCM). The gene therapy is under investigation in adults living with BAG3 DCM, a genetic condition that leads…...
Evogene and ELEO to develop new oral PCSK9 inhibitors
2+ day, 23+ hour ago (247+ words) ELEO will provide experimental resources and screening platforms to test and refine molecules produced via computational methods. As part of the collaboration, Evogene will use its ChemPass AI platform, a computational chemistry system aimed at generative molecular design, to create,…...
Speciality versus diversity: the four-way CDMO race in outsourced HPAPI manufacturing
3+ day, 18+ hour ago (543+ words) Pharmaceutical Technology Known for their low-dose therapeutic efficacy and high target affinity, HPAPIs are in high demand by biopharma companies, which often outsource their production. Approximately 41% of innovator and biosimilar high-potency active pharmaceutical ingredients (HPAPIs) come from contract development and…...
Samsung Biologics: geographic diversification is a sound business decision
3+ day, 18+ hour ago (538+ words) Executive vice-president James Choi discusses the CDMO’s growth strategy and acquiring its first US manufacturing site from GSK. South Korean contract development and manufacturing organisation (CDMO) Samsung Biologics has been on a steep upward growth trajectory since receiving its first…...
US generic tariff reprieve on the rocks as Trump proposes 100% rate in 2028
3+ day, 22+ hour ago (281+ words) If introduced, the 100% tariffs would apply to all generics imported to the US, which make up 90% of the nation’s prescriptions. Following a period of immunity from US import tariffs, the global generics sector may now have to contend with similar…...
Cellares, Papillon team up for PPL-001 manufacturing automation
4+ day, 7+ min ago (259+ words) Cellares and Papillon Therapeutics have entered a partnership to automate the manufacturing of PPL-001, an investigational therapy developed by the latter for Friedreich’s ataxia (FA), a rare inherited neurodegenerative disorder. PPL-001 is a gene-corrected haematopoietic stem and progenitor cell (HSPC)…...
CHMP grants PRIME status to AbelZeta’s C-CAR168
4+ day, 23+ hour ago (265+ words) C-CAR168 is aimed at depleting both autoreactive B cells and antibody-producing plasma cells. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted priority medicines (PRIME) designation to AbelZeta Pharma’s C-CAR168. SLE is a chronic autoimmune…...