News

The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent,…
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AstraZeneca announced that the European Commission (EC) has granted full marketing authorisation for Tagrisso (osimertinib) 40mg and 80mg once-daily tablets for the treatment of adult…
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Recipharm, the contract development and manufacturing organisation (CDMO), has opened a newly built GMP suite for clinical trial material (CTM) manufacture at its facility in Research…
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Amcor Rigid Plastics expands its relationship with long-time customer Campbell Soup Co. with the opening of an on-site bottle manufacturing operation in Paris, Texas. Amcor’s new…
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Novartis announced an expanded commercialization agreement with Amgen for AMG 334 (erenumab), which is being investigated for the prevention of migraine. This agreement builds on a 2015…
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Ge announced that United BioPharma Inc. (UBP) has selected GE Healthcare’s FlexFactory manufacturing platform for its new facility in Hsinchu Industrial Park, Taiwan focusing on…
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The Feinstein Institute for Medical Research, and TheraSource LLC, a Long Island-based biotech company, announce today that they have received a Phase I Small Business Technology…
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NGM Bio’s NGM282 has met the primary and key secondary endpoints in a Phase 2 trial in nonalcoholic steatohepatitis (NASH) patients. NGM282, which is a non-tumorigenic, engineered…
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Tiziana Life Sciences plc, a clinical stage biotechnology company developing targeted drugs for cancer and autoimmune diseases, today announces the approval in Israel of a phase II…
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Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for…
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Recipharm, the contract development and manufacturing organisation (CDMO), has delivered its first batch of serialised drug products to Saudi Arabia, following the introduction of new…
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DePuy Synthes Products, Inc., part of the Johnson & Johnson Family of Companies, has acquired 3D printing technology from Tissue Regeneration Systems, Inc. (TRS). The 3D printing…
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Novartis announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CTL019, an investigational chimeric antigen receptor T cell (CAR-T)…
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Agenus Inc. announced that the first patient has been dosed in a Phase 1/2 clinical trial of its anti-PD-1 antibody, AGEN2034. The open-label, dose-escalation portion of the trial is…
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uniQure N.V. announced that it will not pursue the renewal of the Glybera (alipogene tiparvovec) marketing authorization in Europe when it is scheduled to expire on October 25, 2017.…
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H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of precision medicines for oncology and a member of Eisai’s global Oncology…
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Sawai Pharmaceutical Co. Ltd., a leading Japanese generic pharmaceuticals manufacturer, and Upsher-Smith Laboratories, Inc., ("Upsher-Smith"), an established generics manufacturer based…
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ReForm Biologics, a pharmaceutical technology company that develops proprietary excipients to improve biologic formulations, announced that the Company’s Board of Directors has…
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A certified CDISC provider and leader in pharmacometrics, Certara has developed a new solution which will enable sponsors to achieve new compliance requirements effortlessly
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Veeva Systems announced Veeva Vault SiteExchange, a cloud application that allows life sciences companies, CROs, and sites to easily access and exchange information during clinical…
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