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Mission Therapeutics and AbbVie Sign DUBs Collaboration in Alzheimer’s and Parkinson’s Disease
Mission Therapeutics and AbbVie announced a collaboration in the research and preclinical development of specified DUB inhibitors for the treatment of Alzheimer’s Disease and…
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Aerie Pharmaceuticals Establishes GMP PRINT Production Facility in an Expanded Global Headquarters
Aerie Pharmaceuticals announced that it has built and commenced operation of its GMP (Good Manufacturing Practices)-validated manufacturing facility for production of ophthalmic…
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Vetter Further Expands Secondary Packaging
Vetter is a leading solution provider of prefilled drug-delivery systems and a specialist for a wide range of packaging solutions. In addition to labelling, blister packing, cartoning…
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Almac Group Announces Successful HSA Inspection of Singapore Facility
Almac Group announced that it has received a renewal of its GMP/GDP certification following the successful regulatory inspection by the Health Sciences Authority (HSA) of its facility…
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Janssen Submits European Marketing Authorisation Application for Esketamine Nasal Spray
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking…
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Recipharm completes acquisition of Sanofi inhalation contract manufacturing business
Recipharm and Sanofi have completed the acquisition of Sanofi’s inhalation contract manufacturing business including a manufacturing facility located in Holmes Chapel, UK.
The…
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Novartis licenses three novel anti-infective programs to Boston Pharmaceuticals
Novartis announced that it has entered into a licensing and equity agreement with Boston Pharmaceuticals for the development of three novel anti-infective drug candidates that are part…
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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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