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Syngene Adds Biologics Drug Substance Manufacturing Capacity with Facility Acquisition
Syngene has acquired a multi-modal biologics drug substance manufacturing facility in Bangalore, India, from Stelis Biopharma.
FDA Approves BioMarin’s Roctavian, the First Gene Therapy for Treating Severe Hemophilia A
FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.
New Deal on the Horizon
The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.
Innovation Idolatry
If we view a change opposite of one’s interest as antithetical to innovation, we risk losing sight of our ultimate goal.
Drug Pricing’s Static Changes
The debate surrounding drug pricing changes rages on.
Frontrunner in Therapies for Complement-Mediated Diseases
A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.
Donaldson Company Acquires Univercells Technologies for €136 Million
Donaldson Company’s €136 million (US$148 million) acquisition of Univercells is designed to broaden its portfolio of biomanufacturing solutions.
FDA Approves UCB Generalized Myasthenia Gravis Treatment
UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.
Tower Cold Chain Expands to American Center of Excellence
Tower Cold Chain will soon open its new headquarters in Philadelphia.
GSK Acquires BELLUS Health
This arrangement was approved by the shareholders at BELLUS on June 16, 2023, according to a company press release.
FDA Approves Pfizer Human Growth Hormone Analog
FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.
NCI Launches Persistent Poverty Initiative
The persistent poverty initiative aims to fight the cumulative effects of persistent poverty on cancer outcomes.
Sobi and CTI BioPharma Complete $1.7 Billion Acquisition Deal
Sobi has officially acquired CTI, a biopharma company focused on blood related cancers and rare diseases, in a merger valued at approximately $1.7 billion.
Gene Therapy for Duchenne Muscular Dystrophy Approved by FDA
The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.
Maurice Michel of Sweden Wins 2023 Eppendorf Award for Young European Investigators
The prestigious award, worth €20,000 (US$22,000), goes to Maurice Michel of the Science for Life Laboratory at Karolinska Institutet, Stockholm, Sweden.
SCTbio and Cyto-care Collaborate to Improve Cell Therapy Cryopreservation
The companies hope address the need for efficient collection, cryopreservation, quality control, and logistics capabilities of leukapheresis materials to support various aspects of the cell therapy workflow.
Oliva Therapeutics to Partner with Rio Biopharmaceuticals
This collaboration is the first commercialization into the United States and Canadian markets for Rio Biopharmaceuticals.
NIH Develops Novel Tumor Identification Technology
The Segmentation by Exogenous Perfusion system uses a cell’s location in the tumor to find differences in gene activity.
FDA Releases Psychedelic Drugs Draft Guidance
FDA’s new draft guidance outlines key considerations for psychedelic drug development programs.
Sanofi Consumer Healthcare Opens Suggestion Portal
Sanofi’s Open Innovation Portal is designed to promote community feedback and propose novel solutions to various problems in the healthcare landscape.
Aenova Opens New Building for Highly Potent Drugs
Aenova has opened a new building for the production of highly potent APIs in Germany.
SandboxAQ Launches Molecular Simulation Division
Sandbox AQ’s molecular simulation division is collaborating with companies like AstraZeneca and Sanofi to develop novel treatments for various disorders.
FDA Releases Draft Guidance for Section 505G of Food, Drug, and Cosmetic Act
The guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.
Andelyn Biosciences Opens New CGT Manufacturing Headquarters
The new headquarters located in Columbus, Ohio, more than triples Andelyn Biosciences’ footprint to meet growing demand for CGT services.
FDA Releases Updated COVID-19 Vaccine Guidelines
The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.
FDA Launches Pilot Program Using Cancer Biomarkers to Mitigate Risk
FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.
Saudi Arabia’ PIF Launches Lifera, a New CDMO
PIF has established Lifera, a new manufacturing entity that will manufacture, stockpile, and supply bio/pharmaceuticals both locally and through partnerships.
Enzene Biosciences Invests $50 Million into New Jersey Biomanufacturing Facility
India’s Enzene Biosciences is investing $50 Million into a new biopharma manufacturing plant in Hopewell, NJ.
Eli Lilly Set to Acquire DICE Therapeutics
The transaction is expected to close in the third quarter of 2023.
University of Waterloo Researchers Announce Sustainable Encapsulation Technology
Researchers at the University of Waterloo have developed a liquid-liquid encapsulation system for use in sustainable encapsulation processes.
