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Allele Receives Tissue Bank License for Manufacturing and Distribution of cGMP-compliant iPSCs
Allele Biotechnology & Pharmaceuticals Inc. has received a Tissue Bank License from the California Department of Public Health, making it the world’s first establishment to collect…
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Ferring Acquires Innovative Biotechnology Company and Microbiome Pioneer Rebiotix
Ferring Pharmaceuticals and Rebiotix Inc. announce that they have agreed to the acquisition of Rebiotix by Ferring. This acquisition brings together two innovative healthcare companies…
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Boehringer Ingelheim and OSE Announce Global Immuno-Oncology Partnership
Boehringer Ingelheim and OSE Immunotherapeutics announced a collaboration and exclusive worldwide collaboration and license agreement to jointly develop OSE-172, a SIRP-alpha antagonist…
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FDA accepts BLA for moxetumomab pasudotox in hairy cell leukaemia
AstraZeneca and MedImmune announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox, an investigational…
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Abide and Celgene Enter Worldwide License Agreement for ABX-1772
Abide Therapeutics announced that it has granted Celgene an exclusive worldwide license for ABX-1772, a preclinical drug candidate discovered by Abide. In connection with the license,…
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PPD Expands GMP Biologics Testing Capacity
Pharmaceutical Product Development, LLC (PPD) has expanded its GMP (good manufacturing practices) analytical laboratory in Middleton, Wisconsin. PPD Laboratories’ new 32,000-square-foot…
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Facility Remodelling Completed for Abzena’s New ADC GMP Manufacturing Suite
Abzena plc, the life sciences group providing services and technologies to enable the design, development and manufacture of biopharmaceutical products, has announced the completion of…
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GSK reaches agreement with Novartis to acquire full ownership of Consumer Healthcare Business
GlaxoSmithKline plc announces that it has reached an agreement with Novartis for the buyout of Novartis’ 36.5% stake in their Consumer Healthcare Joint Venture for $13 billion (£9.2…
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ViiV Healthcare gains CHMP Positive Opinion for Juluca (dolutegravir/rilpivirine) in Europe
ViiV Healthcare announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca…
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Teva Announces the Launch of a Generic Version of Lialda in the United States
Teva Pharmaceutical Industries Ltd. announced the launch of a generic version of Lialda (mesalamine) delayed-release tablets, 1.2 g, in the U.S.
Mesalamine delayed-release tablets…
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Sandoz receives positive CHMP opinion for proposed biosimilar infliximab
Sandoz announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of…
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FDA approves inclusion of data from safety outcomes trial in the Tresiba label
Novo Nordisk announced that the US Food and Drug Administration (FDA) approved updates to the prescribing information (PI) for Tresiba (insulin degludec injection) 100 U/mL, 200 U/mL to…
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Pfizer Reports Top-Line Results from a Study of CHANTIX/CHAMPIX (varenicline) in Adolescent Smokers
Pfizer Inc. announced results from a Phase 4 study evaluating the efficacy and safety of CHANTIX/CHAMPIX (varenicline) for smoking cessation in nicotine dependent adolescents 12-19…
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3P Biopharmaceuticals and Intervacc complete manufacturing agreement
3P Biopharmaceuticals and Intervacc complete manufacturing agreement for new vaccine against equine strangles
3P Biopharmaceuticals and the Swedish company Intervacc have now…
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Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for Enfortumab Vedotin in…
Astellas Pharma and Seattle Genetics announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug…
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Shire and NanoMedSyn Enter Into Research Agreement for Potential Lysosomal Storage Disorder…
Shire plc and NanoMedSyn announced that the companies have entered into a preclinical research collaboration to evaluate a potential ERT using NanoMedSyn's proprietary synthetic…
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Teva Announces the Launch of a Generic Version of ALOXI in the United States
Teva Pharmaceutical Industries Ltd., announced the launch of a generic version of ALOXI®1 (palonosetron HCI) injection, 0.25 mg/5 mL, in the United States. Palonosetron hydrochloride…
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Regeneron and Alnylam to Discover New Treatments for Nonalcoholic Steatohepatitis
Regeneron Pharmaceuticals and Alnylam Pharmaceuticals announced a collaboration to identify RNAi therapeutics for the chronic liver disease nonalcoholic steatohepatitis (NASH) and…
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Seattle Genetics Announces FDA Approval of ADCETRIS (Brentuximab Vedotin)
Seattle Genetics announced that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) in combination with chemotherapy in adult patients with…
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Saladax Receives Approval to Sell a New Line of Psychiatry Tests on the European Market
Saladax Biomedical Inc., a diagnostics company providing kits to test drug levels for adherence and personalized dose management, announced that it has received CE mark (Conformité…
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