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The approval is based on the Phase I/II GO29781 clinical study, with full approval contingent upon further confirmatory trials. Lunsumio VELO's SC injection requires around one minute, compared The post Genentech secures FDA approval for Lunsumio VELO SC for follicular lymphoma appeared first on Pharmaceutical Business review....

The move will give Samsung Biologics its first manufacturing site in the country as part of its long-term commitment to the market. The Rockville, Maryland facility is located The post Samsung Biologics to acquire Human Genome Sciences appeared first on Pharmaceutical Business review....

In patients suffering with oHCM, myosin inhibition with MYQORZO, which is an allosteric and reversible inhibitor of cardiac myosin motor activity, lowers left ventricular outflow tract (LVOT) obstruction The post Cytokinetics receives FDA approval for MYQORZO tablets for oHCM appeared first on Pharmaceutical Business review....

The agreement covers the promotion license, sales, and distribution of CARTISTEM. MEDIPOST will supply the drug substance and retain manufacturing rights, while the exclusive rights for the Japanese The post MEDIPOST, Teikoku Seiyaku partner for CARTISTEM commercialisation in Japan appeared first on Pharmaceutical Business review....

Under the agreement, Novartis has voluntarily committed to several actions. These include launching future medicines with prices comparable to those in other high-income countries; establishing direct-to-patient platforms for The post Novartis, US government reach agreement to lower drug prices appeared first on Pharmaceutical Business review....

The initiative aims to shape future standards and safeguards for the way AI is used in healthcare settings. This call for evidence will inform the work of the The post MHRA launches call for evidence on AI regulation in UK healthcare sector appeared first on Pharmaceutical Business review....

The approval covers all existing indications for Rybrevant. The SC formulation reduces administration time from several hours to five minutes, compared to intravenous (IV) delivery, offering increased patient The post J&J receives FDA approval for lung cancer therapy appeared first on Pharmaceutical Business review....

FL is the most common slow-growing B-cell non-Hodgkin lymphoma form. Minjuvi is a humanised, fragment crystallisable-modified cytolytic monoclonal antibody targeting cluster of differentiation 19. The EC approval follows The post EC approves Incyte's Minjuvi combo for follicular lymphoma appeared first on Pharmaceutical Business review....

This is claimed to become the first fully dedicated small-interfering RNA (siRNA) enzymatic-ligation manufacturing facility. The facility expansion is intended to increase capacity, lower production expenses, and enable The post Alnylam plans $250m investment in Norton manufacturing facility, US appeared first on Pharmaceutical Business review....

Harbour BioMed will work alongside BMS to progress and expedite the programmes aimed at the discovery of the antibodies. Harbour BioMed, in exchange, is eligible to obtain payments The post Harbour BioMed and BMS sign multi-specific antibody collab appeared first on Pharmaceutical Business review....

The company's plans are expected to increase the capacity for injectable drug products. The expansion, scheduled to commence in early 2026, will add around 300,000ft² of purpose-built space The post INCOG reveals $200m injectable drug expansion in Indiana appeared first on Pharmaceutical Business review....

The expansion is targeted at individuals for whom topical corticosteroids are not sufficient or appropriate. The European regulator has accepted the application for review. The submission is based The post LEO Pharma applies to EMA to expand Anzupgo use to adolescents appeared first on Pharmaceutical Business review....

The investment values Swixx at more than €1.5bn ($1.76bn). Swixx operates as a commercialisation platform for pharma companies, focusing on markets where those companies have chosen not to The post SK Capital Partners supports Swixx BioPharma's global expansion appeared first on Pharmaceutical Business review....

Rett syndrome is a rare neurodevelopmental disorder that progresses through four stages. The formulation is intended to treat the condition in adult and paediatric patients aged two years The post FDA approves Acadia's Daybue Stix for Rett syndrome appeared first on Pharmaceutical Business review....

Sobi will purchase for Arthrosi Skr9.1bn ($950m) in cash. Additional payments of up to Skr5.3bn ($550m) may be made based on clinical, regulatory and sales milestones. The acquisition The post Sobi buys Arthrosi to expand gout treatment pipeline appeared first on Pharmaceutical Business review....

The approval marks the first new treatment for the adult population with PPF in more than five years, offering a new alternative for those with this life-threatening lung The post Boehringer's Jascayd gains China's NMPA approval for PPF appeared first on Pharmaceutical Business review....

This next-generation central nervous system (CNS)-penetrant will be developed by Bleecker Bio, a newly established subsidiary of Formation. Lynk Pharmaceuticals will obtain a minority equity stake in Bleecker, The post Formation Bio gains global rights to Lynk Pharma's TYK2 inhibitor appeared first on Pharmaceutical Business review....

The approvals mark the fourth and fifth clearances for the company in the country in 2025. Qfitlia is the antithrombin-lowering therapy indicated for routine prophylaxis in individuals with The post China's NMPA approves Sanofi's rare haematologic disease treatments appeared first on Pharmaceutical Business review....

The multi-programme partnership leverages Zealand Pharma's experience in obesity and metabolic health alongside OTR Therapeutics' research and development (R&D) platform to address the needs of people with metabolic The post Zealand Pharma and OTR to develop metabolic disease therapeutics appeared first on Pharmaceutical Business review....

Formycon will complete the development of FYB206, prepare and file the regulatory dossier, and supply the biosimilar product. Zydus will manage its commercialisation. FYB206 is nearing the end The post Formycon and Zydus sign exclusive agreement for FYB206 supply appeared first on Pharmaceutical Business review....