Bayer Consumer Health leaders propose new principles for science-led self-care
Empowering consumers to take more control over their own health means ensuring they have the knowledge and trust that products are safe and will work…
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Roche’s subcutaneous formulation of Tecentriq demonstrates positive Phase III results
IMscin001 study showed non-inferior levels of cancer immunotherapy Tecentriq in the blood, when injected subcutaneously, compared to intravenous infusion, in people with advanced non-small cell lung cancer…
GSK signs agreement to support pandemic preparedness in Europe
GSK plc (LSE/NYSE: GSK) announced it had signed a framework contract with the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA) for the…
Bayer expands existing investment to acquire majority share in sustainable lower carbon oilseed producer CoverCress Inc.
Investment delivers on Bayer’s commitments to sustainability and may help decarbonize agriculture and reduce reliance on nitrogen fertilizer with combined expertise of existing investors, Bunge…
Pfizer and BioNTech advance COVID-19 vaccine strategy with study start of next-generation vaccine candidate based on enhanced spike protein design
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate…
Enhertu granted Priority Review in the US for patients with HER2-low metastatic breast cancer
Based on DESTINY-Breast04 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu is the first HER2-directed therapy to demonstrate a survival benefit in this population Application…
Applications for proposed first-of-a-kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA
Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple sclerosis in US and EU Multiple sclerosis (MS)…
Tezspire recommended for approval in the EU by CHMP for the treatment of severe asthma
First and only biologic recommended for EU approval in patients with severe asthmawith no phenotype or biomarker limitations AstraZeneca’s Tezspire (tezepelumab) has been recommended for marketing authorisation…
CHMP recommends EU approval of Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
Vabysmo (faricimab) simultaneously targets and inhibits two disease pathways that drive neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME) The CHMP recommendation is based…
Kite’s CAR T-cell Therapy Tecartus® Receives Positive CHMP Opinion in Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL)
– Tecartus ® (Brexucabtagene Autoleucel) First and Only CAR T in Europe to Receive Positive CHMP Opinion to Treat Adults 26+ with r/r ALL – – If Approved, it will Address…
Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for LAG-3-Blocking Antibody Combination Opdualag (nivolumab and relatlimab) for Treatment of Patients with Unresectable or Metastatic Melanoma
Approval recommended for first-line treatment of advanced melanoma patients with tumor cell PD-L1 expression < 1% Recommendation based on results from the Phase 2/3 RELATIVITY-047…
AstraZeneca to acquire TeneoTwo and its clinical-stage T-cell engager
AstraZeneca announced an agreement to acquire TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory…