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Abzena secures ADC manufacturing services contract
Abzena plc has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate…
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Roche lymphoma drug drives high remission rate, longer survival
An experimental Roche Holding AG drug, added to standard therapy, led to a far higher rate of remission and helped patients with an advanced, aggressive blood cancer live significantly…
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GSK submits US regulatory application for single-dose tafenoquine for P. vivax malaria
GSK and Medicines for Malaria Venture (MMV) announced the submission of a new drug application (NDA) by GSK to the United States Food and Drug Administration (FDA), seeking approval of…
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Brammer Bio Launches Gene Therapy Product Manufacturing Operations in Massachusetts
Brammer Bio announced the completion of renovations and launch of its late-stage clinical capacity and commercial-ready cGMP manufacturing site in Cambridge, Massachusetts for gene…
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Fresenius Kabi to Expand Pharmaceutical Manufacturing in North Carolina
Fresenius Kabi, a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition, will expand its manufacturing operations in…
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Arvinas expands strategic license agreement with Genentech
Arvinas LLC announced it has expanded its ongoing license agreement with Genentech, a member of the Roche Group, for the development of new therapeutics using Arvinas' novel PROTAC…
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Avista Pharma Solutions Doubles API Manufacturing Capacity at Colorado Facility
Avista Pharma Solutions, Inc. has completed facility upgrades that effectively double the company’s API manufacturing capacity at its Longmont, Colorado site. During this expansion, the…
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Cambrex invests in new small scale capacity at its Charles City, Iowa facility
Cambrex Corporation announced that it has completed an expansion of cGMP small scale capacity at its Charles City, Iowa plant.
The project has seen the installation of two 500…
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Neurimmune collaborates with Ono Pharma in Neurodegenerative Diseases Field
Neurimmune announced that it has entered into a collaboration with Ono Pharmaceutical Co., Ltd. focused on the development of human antibodies against a novel therapeutic target for…
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Almirall opts for Werum’s PAS-X Manufacturing Execution System
Spanish pharmaceutical company Almirall opted for Werum’s PAS-X Manufacturing Execution System to be installed in the German plant in Reinbek near Hamburg. Almirall is the market leader…
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Fujifilm expands Biopharmaceutical Contract Development & Manufacturing Business
FUJIFILM Corporation is to invest a total of 3.2 billion yen on its CDMO sites in the U.S.A. and the U.K. in order to accelerate the expansion of the company's business for developing…
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STELARA (ustekinumab) shows positive results in treatment of Lupus in Phase 2 Trial
Janssen Research & Development, LLC (Janssen) announced positive results from a randomized, placebo-controlled Phase 2 study investigating the anti-interleukin (IL)-12/23 monoclonal…
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AstraZeneca provides update on tralokinumab Phase III programme in severe, uncontrolled asthma
AstraZeneca and its global biologics research and development arm, MedImmune, today announced the top-line results of the Phase III STRATOS 2 and TROPOS trials for tralokinumab, an…
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Teva Announces Completion of PARAGARD Divestiture to CooperSurgical
Teva Pharmaceutical Industries announced that it has completed the divestiture of PARAGARD (intrauterine copper contraceptive) to CooperSurgical in a $1.1 billion cash transaction. This…
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MilliporeSigma and Samsung BioLogics to Extend Strategic Alliance
MilliporeSigma today announced the signing of a Memorandum of Understanding (MoU) with Samsung BioLogics for a strategic alliance on biopharmaceutical manufacturing and biologics…
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Saudi FDA approves Sobi’s Alprolix for the treatment of haemophilia B
Swedish Orphan Biovitrum AB (publ) (Sobi™) announces that the Saudi Food & Drug Authority (SFDA) in the Kingdom of Saudi Arabia has approved Alprolix (eftrenonacog alfa), for the…
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AbbVie receives FDA Priority Review for elagolix
AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted priority review for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH)…
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Charles River Announces Expansion of In Vitro Oncology Services
Charles River Laboratories International, Inc. announced its partnership with InSphero AG, a leading supplier of 3D solutions for in vitro drug discovery and development.
Through…
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Ortek Therapeutics receives FDA clearance for ECD Device
Ortek Therapeutics announced that the Ortek ECD™ received 510(k) clearance from the U.S. Food and Drug Administration. The ECD is a patented lightweight tabletop device designed as an…
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Servier CDMO Expands Chromatography Platform in Normandy
Servier CDMO announces that the company has invested $7.5 million USD in intensified technology included continuous chromatography with simulated moving beds (SMB) and super critical…
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