Novartis expands Zolgensma® manufacturing capacity with approval of multi-product North Carolina facility The FDA has granted commercial licensure approval for Novartis' Durham, N.C. site, a multi-product gene therapy manufacturing facility. This approval allows the state-of-the-art, 170,000 square-foot facility to make, test and release commercial Zolgensma®, as well as produce…..
On World Bipolar Day ALCEDIAG announces EIT Health supported EDIT-B Consortium validating innovative blood diagnostic test for bipolar disorder ALCEDIAG announced the launch of the EDIT-B Consortium, supported by the European Institute of Innovation and Technology for Health (EIT Health). This newly formed European public-private partnership aims at advancing…..
Nanoparticle-based COVID-19 vaccine could target future infectious diseases Just one dose of a new nanoparticle-based COVID-19 vaccine was enough to produce an immune response in animals on track with vaccines currently in clinical use. And with minor changes, Northwestern University researchers hope the same vaccine platform could target other…..
CordenPharma Chenôve increases lipid manufacturing capacity to support mRNA vaccine strategy CordenPharma, a full-service CDMO, has kicked off a major investment project to increase lipid manufacturing capacity at its Chenôve facility, near Dijon, France. This strategic decision was a result of the greatly increased demand to supply millions of…..
Touchlight and Versameb announce GMP manufacturing supply agreement to support the development of novel mRNA-based therapeutics Touchlight, a UK biotechnology company pioneering enzymatic DNA production to enable the genetic medicine revolution, has concluded a development and manufacturing pipeline agreement with Versameb, a Swiss pre-clinical stage company focused on discovering and…..
MaaT Pharma and SkyePharma to establish the first microbiome-based therapeutics manufacturing facility in France MaaT Pharma and Skyepharma have entered a partnership agreement to build SkyeHub Bioproduction, a new manufacturing facility near Lyon. This new plant will be France’s largest specialized cGMP manufacturing facility for ecosystem microbiome-based therapeutics. SkyeHub Bioproduction…..
« L’innovation en bioproduction n’est pas un champ aride en France » Le Grand Défi « Biomédicaments : améliorer les rendements et maîtriser les coûts de production » a maintenant sélectionné 10 projets retenus dans le cadre de ses premiers appels à projets. Alors qu’une nouvelle vague de lauréats va être annoncée prochainement,…..
Bacthera and Seres Therapeutics Collaborate for Commercial Manufacturing of SER-109, a Potential Treatment Against Recurrent C. difficile Infection SER-109 has the potential to be the first-ever live biotherapeutic product (LBP) to be produced commercially; the collaboration with Seres Therapeutics is a critical milestone for Bacthera, a joint venture between a…..
GTP Bioways is acquiring IDBiotech and invests €12M in two GMP biopharmaceutical production units Acquisition of CRO IDBiotech GTP Bioways, a French CDMO (Contract Development and Manufacturing Organization) specializing in the production of biotherapies and nanotherapies, has acquired IDBiotech. Based in Issoire (France), this CRO specialises in the development…..
Second phase II study for zilebesiran, an RNAi therapeutic for the treatment of hypertension Alnylam Pharmaceuticals, a leading RNAi therapeutics company, has initiated KARDIA-2 (NCT05103332), a global Phase 2 study to evaluate the efficacy and safety of zilebesiran (formerly known as ALN-AGT), an investigational subcutaneous RNAi therapeutic targeting liver-expressed angiotensinogen…..
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