GSK enters agreement to acquire CMG1A46 from Chimagen Biosciences to expand immunology pipeline
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- Category: GlaxoSmithKline
GSK plc (LSE/NYSE: GSK) and Chimagen Biosciences (Chimagen), a privately held biotechnology company, announced an agreement for GSK to acquire CMG1A46, a clinical-stage dual CD19 and CD20-targeted T cell-engager (TCE), from Chimagen for $300 million upfront. GSK plans to develop and commercialise CMG1A46 with a focus on B cell-driven autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis (LN), with potential to expand into related autoimmune diseases.
Bayer and Dewpoint Therapeutics sign licensing agreement for heart disease program
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- Category: Bayer
Bayer has entered into an exclusive licensing agreement with Dewpoint Therapeutics, Inc. for a heart disease program to treat dilated cardiomyopathy (DCM) patients, who are characterized through carrying specific mutations. This is the first option exercise under the research collaboration between Bayer and Dewpoint Therapeutics, Inc., which began in November 2019. It leverages Dewpoint's proprietary platform for biomolecular condensates and Bayer's small molecule R&D capabilities to develop new treatments for cardiovascular and renal diseases.
U.S. FDA approves Pfizer's RSV vaccine ABRYSVO® for adults aged 18 to 59 at increased risk for disease
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO ® (Respiratory Syncytial Virus Vaccine), the company's bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. ABRYSVO now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older.
Roche's Vabysmo improved vision in underrepresented populations with diabetic macular edema (DME) in a first-of-its-kind study
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline one-year results from the open-label, single-arm phase IV ELEVATUM study evaluating Vabysmo® (faricimab) for the treatment of diabetic macular edema (DME) in people from racial and ethnic groups that are often underrepresented in clinical trials.(4)
The ELEVATUM study showed clinically meaningful improvement in vision and reduction in retinal fluid in people with diabetic macular edema (DME) treated with Vabysmo who identify as African American, Black, Hispanic and Latino.
Bayer submits EU marketing authorization application for elinzanetant to treat moderate to severe vasomotor symptoms
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- Category: Bayer
Bayer has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy.
Recent survey showed that 67% of European women reported vasomotor symptoms during menopause transition.
Novo Nordisk launches new initiative to prevent childhood obesity in disadvantaged urban communities
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- Category: Novo Nordisk
Novo Nordisk today announced a new global initiative to prevent obesity in children. The Childhood Obesity Prevention Initiative aims to accelerate the prevention of childhood obesity in disadvantaged urban communities globally. Together with a coalition of partners such as city governments, academic institutions and non-profit organisations, the initiative will support six cities in designing, implementing and evaluating tailored solutions focused on physical activity and healthy eating.
Calquence granted Priority Review in the US for patients with untreated mantle cell lymphoma
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- Category: AstraZeneca
AstraZeneca's supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).
The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.
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