November 22nd 2024
The company officially launched new production suites, a revamp of its development labs, and more at its Thousand Oaks, Calif., cell therapy manufacturing facility.
With this $3.6 million investment, the CDMO will strengthen its advanced labeling, automated visual inspection, and fill/finish technology.
November 21st 2024
The investment will allow Sanofi to strengthen antibody bioproduction at its Lyon Gerland site in France.
November 20th 2024
Under the collaboration, the companies will create and test circVec DNA–LNP formulations with an eye toward potential therapeutic applications.
November 19th 2024
Under a £15.7 million (US$20.7 million) investment, SEKISUI has expanded its UK site for clinical-grade drug substance manufacturing.
Moderna and ILCM Announce Collaboration to Develop mRNA Therapeutic for CN-1
Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.
Element Acquires Impact Analytical
Element’s acquisition of Impact Analytical expands their life sciences footprint in North America.
The NIST Proposes Clarifications to Bayh-Dole March-in Rights Regulations
Proposed changes to rules governing the commercialization of technologies developed with federal funding prompts significant stakeholder feedback.
Immutep Granted a Chinese Patent for LAG-3 Antagonist Antibody
Immutep was granted a Chinese patent for LAG525, a LAG-3 antagonist antibody, under evaluation for cancer treatment.
Reevaluating Cell and Gene Therapy Development
The industry considers applying automation and digitalization lessons learned during the COVID-19 pandemic to enhance workflows.
Incyte and MorphoSys Receive EC Approval for Minjuvi in Combination Therapy for Lymphoma
The European Commission has granted marketing authorization to Incyte and MorphoSys for Minjuvi (tafasitamab) in combination therapy with lenalidomide to treat relapsed or refractory DLBCL.
Aadi Bioscience and Aerpio Pharmaceuticals Close Merger and $155 Million Private Placement
Aadi Bioscience has closed its previously announced merger with Aerpio Pharmaceuticals and a concurrent $155-million PIPE investment.
Trends Affecting Biopharmaceutical Manufacturing
Almost half of pharmaceutical industry profits continue to come from biopharmaceuticals.
Catalent Acquires Nutraceutical for $1 Billion
Catalent’s acquisition of Bettera paves the way for growth in the softgel and oral dose formulation and manufacturing market for nutraceuticals.
FDA and Industry Map New R&D Initiatives under Next User Fee Program
FDA formally unveiled its plan for revising and renewing its fee program for drugs and biologics.
FSD Pharma to Acquire Lucid Psycheceuticals
FSD Pharma has entered a definitive agreement to acquire all of the issued and outstanding shares of Lucid Psycheceuticals for approximately US$9 million (CAD$11.3 million) in FSD Pharma stock.
Next-Gen Automation Lab Aims to Speed Up Drug Discovery Process
Eli Lilly and Company and industry partners, including Ziath, are focused on speeding up the drug discovery process with a fully automated lab.
BioAgilytix Acquires Australian-Based CRO 360biolabs
BioAgilytix, a US-based contract research laboratory focused on large-molecule drug development, has agreed to purchase 360biolabs, an Australia-based contract research organization specializing in virology and immunology.
AGC Biologics Breaks Ground on New Multipurpose Facility in Denmark
AGC Biologics has broken ground on a new multipurpose facility in Copenhagen, Denmark, that will increase capacity.
NGM Bio Pinpoints Fourth Antibody Drug Candidate for Oncology Therapy Development
NGM Biopharmaceuticals has disclosed a fourth antibody drug candidate, NGM831, for development into an oncology therapeutic.
Pfizer to Acquire Trillium Therapeutics in $2.26-Billion Deal
Pfizer’s proposed $2.26-billion acquisition of Trillium Therapeutics will add next-generation hematology-targeted immuno-therapeutics to its oncology pipeline.
Lonza Invests in Drug Product Manufacturing Services in China
Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.
Merck KGaA and Telix Partner on Pan-Cancer Clinical Combination Studies
Merck KGaA has partnered with Telix Pharmaceuticals to conduct combination clinical studies for cancer therapy.
Werewolf Therapeutics Announces Clinical Trial Collaboration with Merck
The collaboration will focus on the interactions between WTX-124 indukine and KEYTRUDA (pembrolizumab).
Patent Office Grants BlueAllele Patent for Advanced Gene Editing Technology
BlueAllele has been granted a US patent for its advanced gene-editing technology, PALIDON, which is compatible with existing gene editing nucleases and delivery systems.
Artiva Biotherapeutics Builds New US Cell Therapy R&D and Manufacturing Facility
Artiva Biotherapeutics’s new R&D and GMP manufacturing center in San Diego, Calif., for NK cell therapies is expected to open in 2022.
Lykan Bioscience and Vineti Partner to Advance Cell Therapies from Clinic to Commercialization
Lykan Bioscience and Vineti will combine their capabilities to streamline process development and manufacturing to move cell therapies through clinical phases to commercialization.
Biden Highlights Drug Pricing Reforms to Advance Legislative Agenda
The President calls for granting Medicare authority to negotiate drug prices and penalties for pharma companies that raise prices faster than inflation.
KGI Team Adapts Vaccine Development Work to Address COVID-19
A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.
Aldevron and Ginkgo Bioworks Collaboration Yields mRNA Manufacturing Enhancement
A collaboration between Aldevron and Ginkgo Bioworks has resulted in a manufacturing enhancement that can improve production of an enzyme used for mRNA therapeutics.
Lonza and Sheba Medical Center Demonstrate Successful Cell Therapy Results with Cocoon Automated Platform
Lonza and Sheba Medical Center have successfully dosed four patients with a CD19 autologous CAR-T cell therapy using Lonza’s Cocoon automated manufacturing platform.
AGC Biologics Acquires Cell and Gene Therapy Commercial Manufacturing Facility
AGC Biologics has acquired Novartis’ Longmont, Colorado, manufacturing facility for the commercial production of cell and gene therapies.
Novavax and European Commission Finalize COVID-19 Vaccine Purchase Agreement
Novavax and European Commission have finalized an agreement to purchase up to 200 million doses of a COVID-19 vaccine.
BeiGene to Build New Manufacturing and Clinical R&D Facility in New Jersey
BeiGene plans to build a new campus for R&D and commercial-scale biopharmaceutical manufacturing in Hopewell, NJ.
Catalent Finalizes RheinCell Therapeutics Acquisition
Catalent finalizes their acquisition of iPSC developer and manufacturer RheinCell Therapeutics.