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The designation covers CMT as a whole and is not restricted to specific subtypes. The RPDD programme seeks to promote the development of therapies for rare, serious or The post FDA grants RPDD to ReviR's RTX-117 for CMT appeared first on Pharmaceutical Business review....

The therapy is indicated for children who are either new to treatment or have prior experience with antiretroviral therapies but have not been treated with integrase strand transfer The post ViiV Healthcare's Tivicay PD gains FDA approval for paediatric HIV therapy appeared first on Pharmaceutical Business review....

The regimens include Ziihera combined with Tevimbra (tislelizumab-jsgr) and fluoropyrimidine- and platinum-containing chemotherapy for patients with HER2+ immunohistochemistry (IHC) 3+ or IHC 2+/in situ hybridisation (ISH)+. The other The post Jazz secures FDA approval for Ziihera in advanced HER2+ GEA appeared first on Pharmaceutical Business review....

McKesson believes that the deal will support its clinical research and biopharmaceutical commercialisation services. Upon completion of the transaction, Precision Medicine Group will operate under McKesson's oncology and The post McKesson to acquire Precision Medicine Group for $2.25bn appeared first on Pharmaceutical Business review....

This regulatory status is designed for therapies targeting rare, life-threatening, or chronically debilitating diseases. Cushing's syndrome of endogenous origin is a rare endocrine disease caused in most instances The post Lundbeck's asedebart receives EC orphan designation in Cushing's syndrome appeared first on Pharmaceutical Business review....

This decision makes Orzeyful the only treatment in Japan currently indicated to address the underlying cause of narcolepsy type 1, also known as narcolepsy with cataplexy, rather than The post Takeda's Orzeyful secured Japan MHLW approval for narcolepsy type 1 appeared first on Pharmaceutical Business review....

Seralutinib is intended for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The private investment comprises an initial closing, a The post Gossamer Bio announces $250m in funding to advance seralutinib appeared first on Pharmaceutical Business review....

This decision provides a new therapeutic option for patients who have received at least one previous treatment. Teclistamab is a bispecific antibody administered via subcutaneous injection. It targets The post Johnson & Johnson's multiple myeloma treatment secures EC approval appeared first on Pharmaceutical Business review....

The development marks the next stage of a partnership that began in 2017 and saw further expansion in 2021. Over the last five years, more than 1,300 WellSpan The post WellSpan and Johns Hopkins renew partnership for advanced cancer care access appeared first on Pharmaceutical Business review....

Utilising its analytical platforms such as next-generation sequencing (NGS), Charles River will assist with chemistry, manufacturing, and controls (CMC) activities related to the vaccine's development. The agreement aims The post Charles River and MVC to develop enterovirus vaccine appeared first on Pharmaceutical Business review....

The approval covers both adult and paediatric patients aged eight years and above. GSDIa is a rare genetic metabolic disorder caused by a deficiency in the enzyme required The post FDA grants accelerated approval to Ultragenyx's Genglycos gene therapy appeared first on Pharmaceutical Business review....

AQPotency is accessible through Claude via the Model Context Protocol (MCP), as well as through the SandboxAQ website, with plans for listing on Google Cloud's Marketplace. It enables The post SandboxAQ introduces AQPotency for virtual drug screening appeared first on Pharmaceutical Business review....

The partnership aims to progress this gene therapy using Andelyn's AAV Curator Platform. GM2 gangliosidosis is a rare genetic disorder that leads to the progressive loss of nerve The post Andelyn Biosciences to develop GM2 gangliosidosis therapy appeared first on Pharmaceutical Business review....

The renewed agreement is expected to reach approximately 1,000 patients cumulatively by its conclusion. This partnership, which began in 2023, has so far provided Brukinsa to more than The post BeOne Medicines and partners renew Brukinsa access programme for CLL appeared first on Pharmaceutical Business review....

The designation applies specifically to patients whose tumours contain a phosphatidylinositol 3-kinase / protein kinase B / mechanistic target of rapamycin (PI3K/AKT/mTOR) pathway alteration. It also applies to The post Faeth's PIKTOR plus paclitaxel combo gains FDA fast track status appeared first on Pharmaceutical Business review....

The combined organisation, which will operate as Slate Medicines, is expected to be listed on Nasdaq under the “SLTE” ticker symbol. Following completion of the merger, the new The post Fulcrum and Slate Medicines sign merger agreement appeared first on Pharmaceutical Business review....

With this validation, the agency will begin its formal assessment of the application. The submission is supported by efficacy and safety data from the Phase III VALOR clinical The post EMA validates Pfizer and Valneva's Lyme disease vaccine appeared first on Pharmaceutical Business review....

The company is evaluating spevatamig in Phase II clinical studies for various gastrointestinal cancers. Spevatamig is a bispecific antibody targeting claudin 18.2 and cluster of differentiation 47 (CD47), The post FDA grants fast track status to Phanes' spevatamig for advanced BTC appeared first on Pharmaceutical Business review....

The collaboration aims to develop new quantum algorithms that could accelerate the design of next-generation photosensitisers for photodynamic therapy, a non-invasive treatment approach targeting tumour cells. The project The post Xanadu and University of Alberta to develop quantum algorithms for cancer appeared first on Pharmaceutical Business review....

The combination is intended for patients who have previously received at least one line of therapy that included both a proteasome inhibitor and an immunomodulatory agent. Zenbexus is The post BMS secures FDA accelerated approval for Zenbexus in multiple myeloma appeared first on Pharmaceutical Business review....