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The approval offers healthcare providers with an additional option alongside the existing 1g version. The new kit contains 100ml Water for Infusion (WFI) and includes the nextaro reconstitution The post Octapharma receives FDA approval for new Fibryga formulation in AFD appeared first on Pharmaceutical Business review....

The tender offer expired on 5 January 2026. The transaction involved purchasing all outstanding shares of Mersana at $25 per share in cash, along with one non-tradable contingent The post Day One concludes Mersana Therapeutics acquisition appeared first on Pharmaceutical Business review....

The approval applies to patients whose disease is metastatic or locally advanced, or where surgery may cause morbidity, and who have progressed on prior therapies or lack satisfactory The post Zai Lab's Augtyro receives NMPA approval for solid tumours in China appeared first on Pharmaceutical Business review....

The condition has an estimated prevalence of 25,000 patients in the US and an annual incidence of one to three new cases per 100,000 people. CK0804 is an The post Cellenkos gains FDA orphan drug status for CK0804 to treat myelofibrosis appeared first on Pharmaceutical Business review....

The first-in-class, subcutaneously administered hepcidin mimetic peptide, rusfertide is intended to regulate iron homeostasis and red blood cell production to help manage haematocrit levels in PV patients. The The post Takeda and Protagonist seek FDA approval for rusfertide to treat PV appeared first on Pharmaceutical Business review....

The approval provides a new treatment option for this rare condition, which is linked to extremely elevated triglyceride levels and an increased risk of acute, recurrent pancreatitis. Redemplo The post Arrowhead receives Health Canada authorisation for Redemplo to treat FCS appeared first on Pharmaceutical Business review....

The partnership combines Insilico's AI drug discovery platforms with Servier's expertise in cancer drug development, aiming to address challenging targets in the oncology field. Under the agreement, Insilico The post Insilico and Servier announce $888m oncology research agreement appeared first on Pharmaceutical Business review....

The company has assumed commercial rights for Byooviz from Biogen, and the product will now be available as a Samsung Bioepis brand across several European countries as part The post Samsung Bioepis initiates Byooviz commercialisation in Europe appeared first on Pharmaceutical Business review....

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....