pharma news
Jun 25, 2024
Alnylam’s HELIOS-B Phase III Study of Vutrisiran; Bristol Myers Squibb Secures FDA Nod for KRAZATI and Cetuximab; Daichii Sankyo’s EZHARMIA® Receives Japan Approval; Vertex’s Phase I/II VX-880 Trial; argenx’s VYVGART Hytrulo FDA Approval
Alnylam's HELIOS-B Phase III Study of Vutrisiran Shows Positive Results, Meeting All Primary and Secondary Endpoints Alnylam Pharmaceuticals, Inc. reported encouraging topline outcomes from its HELIOS-B Phase III study of vutrisiran, an experimental RNAi therapy being developed to treat ATTR amyloidosis with car...
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Jun 18, 2024
Takeda Showcase Phase III Results for Soticlestat; Imfinzi and Chemotherapy Combination Gains US Approval; Nipocalimab Shows Notable Efficacy in Phase II Study; Bristol Myers Squibb’s Augtyro FDA Approval; AstraZeneca’s Farxiga FDA Approval
Takeda Reveals Phase III Results for Soticlestat (TAK-935) in Dravet and Lennox-Gastaut Syndromes Takeda revealed topline results from its SKYLINE and SKYWAY studies. SKYLINE (TAK-935-3001) was a multicenter, randomized, double-blind Phase III trial assessing soticlestat (TAK-935) plus standard care against plac...
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Jun 11, 2024
Moderna’s Phase III Trials for Dual Influenza and COVID-19 Vaccine; Almirall’s Klisyri FDA Approval; Lilly’s Tirzepatide MASH Trial; Cycle Pharmaceuticals Acquisition of Vanda Pharmaceuticals; Ipsen’s Iqirvo FDA Approval
Moderna Reports Successful Phase III Trials for Dual Influenza and COVID-19 Vaccine Moderna, Inc. has reported that its Phase III trial for mRNA-1083, an experimental combination vaccine targeting both influenza and COVID-19, achieved its main objectives by generating a stronger immune response than the approved...
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Jun 04, 2024
Moderna’s mRESVIA(R) FDA Approval; Novartis Scemblix® Phase III Data; Kite’s Tecartus for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia; Astellas’ Zolbetuximab Biologics License Application; CHMP Recommends AstraZeneca’s Tagrisso
FDA Greenlights Moderna's RSV Vaccine mRESVIA(R) Moderna, Inc. has announced that the FDA has approved mRESVIA (mRNA-1345), an mRNA-based vaccine for respiratory syncytial virus (RSV), to protect adults aged 60 and over from lower respiratory tract infections caused by RSV. This approval, granted under a breakth...
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May 28, 2024
AstraZeneca’s Tropion-Lung01 Phase III Trial Positive Outcomes; Biogen’s LEQEMBI South Korea Approval; AltruBio’s $225M Series B Funding; GSK’s Depemokimab Positive Phase III Severe Asthma Results; Roche’s Inavolisib FDA Breakthrough Therapy Designation
The Tropion-Lung01 Phase III Trial Reveals that Datopotamab Deruxtecan Significantly Enhanced Overall Survival in Advanced Nonsquamous NSCLC Patients Compared to Chemotherapy The high-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which had previously met the dual primary endpoint o...
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May 21, 2024
Amgen’s IMDELLTRA FDA Approval; J&J’s Proteologix Acquisition; Bristol Myers Squibb’s BREYANZI FDA Approval; AbbVie and Gilgamesh Pharmaceuticals’ Agreement; Eisai’s LEQEMBI FDA Fast Track Status
IMDELLTRA Receives FDA Approval as the First T-Cell Engager Therapy for Advanced Small Cell Lung Cancer Amgen has reported that the FDA has approved IMDELLTRA™ (tarlatamab-dlle) for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following pl...
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May 14, 2024
Takeda and AC Immune’s Alzheimer’s Deal; Eli Lilly’s Donanemab FDA Review; Bristol Myers Squibb’s Phase III CheckMate -73L Trial Result; Regeneron Pharmaceuticals’ Dupixent sBLA; Excision BioTherapeutics’ EBT-101 Phase I/II Trial Results
Takeda and AC Immune Ink Exclusive Deal for Active Immunotherapy in Alzheimer’s, Focusing on Amyloid Beta Takeda and AC Immune SA have unveiled an exclusive global option and licensing pact concerning AC Immune’s active immunotherapies directed at harmful variants of amyloid beta (Abeta), notably ACI-24.060, int...
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May 07, 2024
Boehringer Ingelheim’s Diabetic Macular Ischemia Study; Novartis’ Mariana Oncology Acquisition; Astellas and Poseida Therapeutics Partnership; Prime Medicine’s PM359 IND; Pfizer’s TIVDAK FDA Approval
Boehringer Ingelheim Announces Promising Findings From Groundbreaking Study on Diabetic Macular Ischemia Boehringer Ingelheim released encouraging results from the HORNBILL Phase I/IIa trial of BI 764524, marking the pioneering investigation into a potential therapy for individuals with diabetic macular is...
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Apr 30, 2024
X4 Pharmaceuticals’ XOLREMDI FDA Approval; ONO to Acquire Deciphera Pharmaceuticals; Johnson & Johnson’s SIRTURO CHMP Approval; BeiGene’s Tislelizumab EC Approval; Sanofi’s Rilzabrutinib LUNA 3 Phase III Trial
FDA Greenlights XOLREMDI Capsules from X4 Pharmaceuticals for WHIM Syndrome Treatment X4 Pharmaceuticals has declared that the FDA has granted approval for XOLREMDI™ (mavorixafor) capsules to be utilized in individuals aged 12 and above who have WHIM syndrome (characterized by warts, hypogammaglobulinemia, infec...
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Apr 23, 2024
Ipsen and Skyhawk Therapeutics Partnership; SynOx Therapeutics’ Phase III Trial; Roche’s Alecensa FDA Approval; AbbVie’s RINVOQ Phase III SELECT-GCA Trial; AskBio’s AB-1002 FDA Fast Track Designation
Ipsen Partners with Skyhawk Therapeutics for RNA-Focused Research in Rare Neurological Disorders Ipsen and Skyhawk Therapeutics have entered into an exclusive global partnership to explore and create new small molecules that can influence RNA for rare neurological conditions. Under this agreement, Ipsen has the ...
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