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Otsuka's NDA covers the use of centanafadine as a treatment for ADHD in adolescents, adults, and children. Centanafadine is a norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). The The post FDA accepts Otsuka's centanafadine application for ADHD treatment appeared first on Pharmaceutical Business review....

The partnership will leverage Insilico's Pharma.AI platform for the development of small molecule inhibitors, with the agreement valued at nearly $120m. This agreement includes development and commercial milestone The post Insilico and Qilu Pharmaceutical sign deal for cardiometabolic therapies appeared first on Pharmaceutical Business review....

Agreed in December 2025, the transaction is valued at up to $820m and brings the late-stage monoclonal antibody brelovitug, a candidate for chronic hepatitis delta virus (HDV), into The post Mirum acquires Bluejay Therapeutics to expand rare liver disease pipeline appeared first on Pharmaceutical Business review....

The submission relates to patients with mild cognitive impairment or mild dementia due to Alzheimer's. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date The post FDA to review Eisai's Leqembi Iqlik sBLA for Alzheimer's appeared first on Pharmaceutical Business review....

For the entire year, sales grew by 6% to $94.2bn, and full-year earnings per share (EPS) registered at $11.03. The diluted earnings per share (EPS) for Q4 2025 The post Johnson & Johnson reports 9.1% increase in sales for Q4 2025 appeared first on Pharmaceutical Business review....

The International Nonproprietary Names (INN) approved the generic name zavabresib for OPN-2853. Myelofibrosis is a rare blood cancer involving bone marrow scarring, resulting in anaemia, severe fatigue, ineffective The post Opna Bio's OPN-2853 secures FDA's orphan drug status for myelofibrosis appeared first on Pharmaceutical Business review....

The collaboration, which began in 2023, aims to create therapies that can replace, repair, or supplement biological functions in patients, advancing the development of disease-modifying treatments. Under the The post Novo Nordisk and Aspect Biosystems advance partnership for diabetes therapies appeared first on Pharmaceutical Business review....

The collaboration will deploy radiology AI algorithms cleared by the US Food and Drug Administration (FDA) through Microsoft's Precision Imaging Network, a component of its healthcare radiology solutions. The post BMS and Microsoft partner for AI-based lung cancer detection appeared first on Pharmaceutical Business review....

The new solution is intended for pharmaceutical and medical device manufacturers, enabling them to train operators, guide execution, and verify critical tasks using advanced AI-technologies. Pharmaceutical manufacturers frequently The post DeepHow introduces PharmaCloud for pharmaceutical manufacturers appeared first on Pharmaceutical Business review....

This marks the first instance of an allogeneic induced pluripotent stem cell (iPSC)-derived cell therapy receiving both fast track and RMAT designations from the FDA, with the former The post iRegene receives FDA RMAT designation for NouvNeu001 to treat Parkinson's appeared first on Pharmaceutical Business review....

The acquisition gives AstraZeneca full global control over the development, manufacturing, and commercialisation of the therapy. AbelZeta will receive up to $630m from AstraZeneca, including upfront payments and The post AstraZeneca to acquire China rights for AbelZeta's CAR-T therapy appeared first on Pharmaceutical Business review....

Ianalumab is a fully human monoclonal antibody that targets B-cells and inhibits their activation and survival by blocking B-cell activating factor receptor (BAFF-R). Novartis intends to submit ianalumab The post FDA grants Novartis' ianalumab breakthrough therapy status for Sjögren's disease appeared first on Pharmaceutical Business review....

Financial details of the transaction have not been disclosed. The partnership aims to deliver durable weight loss with improved tolerability, focusing on a target and modality of established The post InterAx and Alveus collaborate on small-molecule metabolic treatment appeared first on Pharmaceutical Business review....

The collaboration secures funding and sustained biologics manufacturing capacity in the US for Agenus, supporting clinical development, early access initiatives, and future commercial production. Under the agreement, Agenus The post Agenus and Zydus complete $141m BOT+BAL immunotherapy collaboration deal appeared first on Pharmaceutical Business review....

Menkes disease is a rare X-linked recessive disorder caused by mutations in the ATP7A gene, resulting in impaired copper absorption and transport. Zycubo is administered subcutaneously to restore The post Fortress Biotech receives FDA approval for Zycubo to treat Menkes disease appeared first on Pharmaceutical Business review....

The company aims to strengthen the pharmaceutical supply chain and accelerate the delivery of biologic and glucagon-like peptide-1 (GLP-1) drugs. BD will introduce Neopak Glass Prefillable Syringe manufacturing The post BD invests $110m to expand US prefillable syringe production appeared first on Pharmaceutical Business review....

The agreement will leverage SciNeuro's proprietary blood-brain barrier shuttle technology, aiming to deliver potential differentiation from current amyloid beta agents in development or on the market. Both companies The post SciNeuro and Novartis sign global licensing deal for Alzheimer's antibody appeared first on Pharmaceutical Business review....

The application sought approval for Ebvallo as monotherapy in adult and paediatric patients aged two years and above with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD), who have The post Atara receives FDA complete response letter for Ebvallo BLA application appeared first on Pharmaceutical Business review....

The facility forms a key component of the company's $23bn US investment programme, first outlined in April 2025, and aims to enhance the supply of RLT cancer treatments The post Novartis to build fourth US radioligand therapy facility in Florida appeared first on Pharmaceutical Business review....

Under the agreement, MediLink will receive upfront and near-term milestone payments totalling $570m. Additional development, regulatory, and commercial milestone payments are included in the deal, along with tiered The post MediLink and Roche announce exclusive licensing agreement for YL201c appeared first on Pharmaceutical Business review....