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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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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 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 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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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 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, 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 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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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 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 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 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 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 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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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 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 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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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 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 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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