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Bydureon receives positive EU CHMP opinion for EXSCEL cardiovascular outcomes data
AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a Type-II variation update…
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Seattle Genetics Announces ADCETRIS (Brentuximab Vedotin) Approval in Japan for Frontline Hodgkin…
Seattle Genetics announced that its collaborator, Takeda Pharmaceutical Company Limited (Takeda), has received approval from the Japanese Ministry of Health, Labour and Welfare for…
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BeiGene Selects GE Healthcare’s Off-the-Shelf Biologics Factory to Boost its Manufacturing Capacity…
BeiGene, Ltd., a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer,…
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PMI BioPharma Solutions Launches Research and Manufacturing Facilities
PMI BioPharma Solutions officially formed in January of 2018, has established complete research and manufacturing operations at multiple sites located in both Nashville and Celina…
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PCI Pharma Services to Acquire Sherpa Clinical Packaging
Sherpa Clinical Packaging (Sherpa) has announced an agreement to be acquired by PCI Pharma Services (PCI). Sherpa, headquartered in San Diego, CA, provides clinical trial material…
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Gilead and Galapagos Announce TORTUGA Phase 2 Study of Filgotinib in Ankylosing Spondylitis Achieves…
Gilead Sciences and Galapagos announced that the randomized, placebo-controlled Phase 2 TORTUGA study of filgotinib, an investigational, selective JAK1 inhibitor, achieved its primary…
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LEO Pharma Closes Acquisition of Bayer’s Prescription Dermatology Business in the United States
LEO Pharma and Bayer announced the completion of the relevant closing conditions to allow the transfer of Bayer’s prescription dermatology business to LEO Pharma in the United States.…
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Novartis to divest the Sandoz US dermatology business and generic US oral solids portfolio to…
Novartis announced it has agreed to sell selected portions of its Sandoz US portfolio, specifically the Sandoz US dermatology business and generic US oral solids portfolio, to Aurobindo…
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Tetraphase Announces FDA Approval of XERAVA (Eravacycline) for cIAI
Tetraphase Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted approval of XERAVA (eravacycline) for the treatment of complicated intra-abdominal…
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PCI Expands Cold Chain Infrastructure with Dedicated -40°C Facility
PCI announced the completion of a purpose built -40°C storage and distribution facility at our North American Clinical Services Center of Excellence.
The site, located in Rockford,…
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FDA Approves Merck’s two new HIV-1 medicines DELSTRIGO and PIFELTRO
Merck announced that the U.S. Food and Drug Administration (FDA) has approved two new HIV-1 medicines: DELSTRIGO, a once-daily fixed-dose combination tablet of doravirine (100 mg),…
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Novartis receives EC approval of its CAR-T cell therapy, Kymriah (tisagenlecleucel)
Novartis announced that the European Commission (EC) has approved Kymriah (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young…
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Tolero Announces Clinical Research Collaboration with AbbVie for Acute Myeloid Leukemia Trial
Tolero Pharmaceuticals has entered into a clinical research collaboration with AbbVie, a research-based global biopharmaceutical company, exploring the potential of combination therapy…
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CNDA grants rapid approval of Roche’s Alecensa (alectinib) as a treatment for ALK-positive lung…
Roche announced that the China National Drug Administration (CNDA) has granted marketing authorisation for Alecensa (alectinib) as a monotherapy treatment for patients with anaplastic…
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Eisai And Merck Announce FDA Approval Of LENVIMA Capsules For Treatment Of Unresectable HCC
Eisai Inc. and Merck, known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor LENVIMA …
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BioNTech Signs Collaboration Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of…
BioNTech AG announced that it has entered into a multi-year research and development (R&D) collaboration with Pfizer Inc. to develop mRNA-based vaccines for prevention of influenza…
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NIH-funded researchers reverse congenital blindness in mice
Researchers funded by the National Eye Institute (NEI) have reversed congenital blindness in mice by changing supportive cells in the retina called Müller glia into rod photoreceptors.…
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Janssen Reports Positive Topline Results for ATLAS Phase III Study of a Novel, Long Acting…
The Janssen Pharmaceutical Companies of Johnson & Johnson confirmed positive topline results from the global, Phase III Antiretroviral Therapy as Long-Acting Suppression (ATLAS)…
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Almac Discovery, Elasmogen and Innovate UK Collaborate to Develop VNAR Based Oncology Platform
Almac Discovery, a biopharmaceutical company focused on discovering and identifying innovative therapeutics for the treatment of cancer, and Elasmogen, an SME focused on the development…
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Solid Tumors Targeted in New CAR T-Cell Immunotherapy Trial
Seattle Children’s has opened a chimeric antigen receptor (CAR) T-cell immunotherapy trial for children and young adults with relapsed or refractory non-central nervous system…
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