Roche to Acquire Poseida Therapeutics in Strategic Move to Advance Off-the-Shelf CAR-T Cell Therapies

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it has entered into a definitive merger agreement to acquire Poseida Therapeutics, Inc. (“Poseida&r...

November 27, 2024 | Wednesday | News
Alnylam's Vutrisiran sNDA Accepted by FDA for Priority Review in ATTR-CM with March 2025 Decision Expected

 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced that the U.S. Food and Drug Administration&n...

November 26, 2024 | Tuesday | News
GSK’s Blenrep Combination Therapy Accepted for FDA Review in Relapsed Multiple Myeloma

GSK plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep&...

November 26, 2024 | Tuesday | News
Kedrion Biopharma's Bolognana Facility FDA-Approved to Manufacture RYPLAZIM® for PLGD-1 Treatment

 Kedrion Biopharma Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the company's manufacturing facility in B...

November 22, 2024 | Friday | News
Merck CEO Belén Garijo Declares Strong Q3 2024 Growth, Reaffirms Path to Profitable 2024 Finish

Net sales up organically by 3.8% to € 5.3 billion EBITDA pre up organically by 16.9% to € 1.6 billion EBITDA ...

November 21, 2024 | Thursday | Company results
Quotient Sciences Installs World’s First GMP Biofoundry-in-a-Box for Accelerated RNA Manufacturing

" Quotient Sciences, in collaboration with Centillion, has installed the revolutionary Biofoundry-in-a-Box (BiaB™) at its Alnwick site, marking a n...

November 20, 2024 | Wednesday | News
Abzena Expands Analytical Capabilities with GMP Cell-Based Potency Assays at Cambridge and San Diego Facilities

" Abzena, a leading CDMO/CRO, now offers GMP cell-based potency assays at its UK and US sites, enhancing its support for complex biologics and ADC programs...

November 20, 2024 | Wednesday | News
Ardena Secures Full GMP Approval for Expanded Nanomedicine Facility in Oss, Netherlands

" Ardena, a leading CDMO, has received full GMP approval for its advanced nanomedicine facility in Oss. This €20 million investment, featuring state...

November 20, 2024 | Wednesday | News
AstraZeneca’s Tagrisso (osimertinib) Recommended for EU Approval in Unresectable EGFR-Mutated Lung Cancer

AstraZeneca’s Tagrisso (osimertinib) has been recommended for approval in the European Union (EU) for the treatment of adult patients with ...

November 19, 2024 | Tuesday | News
European Commission Approves OPUVIZ™ (SB15), a Biosimilar to Eylea, for Treatment of Retinal Disorders

Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has approved OPUVIZ™ 40 mg/mL solution...

November 19, 2024 | Tuesday | News
Tirzepatide Significantly Reduces Heart Failure Risk in Obese Patients with Preserved Ejection Fraction, New Data Show

Eli Lilly and Company (NYSE: LLY) announced detailed results from the SUMMIT Phase 3 trial showing tirzepatide significantly reduced the risk of worsening ...

November 18, 2024 | Monday | News
EMA Committee Recommends Approval of Opdivo® + Yervoy® for First-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer

 Bristol Myers Squibb (NYSE: BMY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...

November 18, 2024 | Monday | News
EMA CHMP Issues Positive Opinion for Lecanemab in Early Alzheimer’s Disease

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusett...

November 15, 2024 | Friday | News
GSK’s Blenrep Combination Demonstrates Significant Survival Benefit in Relapsed/Refractory Multiple Myeloma

GSK plc (LSE/NYSE: GSK) announced positive headline results from a planned interim analysis of the DREAMM-7 head-to-head phase III trial evaluating Bl...

November 15, 2024 | Friday | News

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