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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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Teva Announces Submission of BLA for Fremanezumab to the U.S. FDA
Teva Pharmaceutical announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for fremanezumab, an anti-calcitonin gene-related…
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GSK receives WHO Prequalification for Synflorix pneumococcal vaccine four-dose vial
GSK announced that the World Health Organization (WHO) has awarded prequalification for the new four-dose vial presentation of Synflorix pneumococcal vaccine targeted mainly for…
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Merz and Teijin Announce Partnership to Bring Xeomin (incobotulinumtoxinA) to Japan
Merz and Teijin Limited announced that they have entered into a strategic license and co-development agreement for the commercialization of Xeomin (incobotulinumtoxinA) for Japan.…
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MilliporeSigma Opens New Life Science Center in Massachusetts
MilliporeSigma today officially opened its new Life Science Center in Burlington, Massachusetts. The new center serves as a regional hub for scientific advancement and customer…
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Moffitt Researchers Discover New Targets for Approved Cancer Drug
Developing new drugs to treat cancer can be a painstaking process taking over a decade from start to Food and Drug Administration approval. Scientists are trying to develop innovative…
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AbbVie & Turnstone announces collaboration on Viral Immunotherapies in Oncology
AbbVie announced a research, option and license agreement whereby AbbVie obtained an exclusive option to license up to three of Turnstone's next-generation oncolytic viral…
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Astellas Pharma and Seattle Genetics Initiate Pivotal Trial of Enfortumab Vedotin
Astellas Pharma and Seattle Genetics announced dosing of the first patient in EV-201, a registrational phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or…
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FDA grants Priority Review to Gilotrif for uncommon EGFR mutations in advanced NSCLC
Boehringer Ingelheim announced that the supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and…
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EMA accepts Marketing application for Imfinzi to treat NSCLC patients
AstraZeneca, along with MedImmune, its global biologics research and development arm, has announced that the European Medicines Agency (EMA) has accepted a Marketing…
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