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Lilly R&D Center Opens in Seaport

  • Posted by ISPE Boston
  • On August 15, 2024
Eli Lilly has opened its Lilly Seaport Innovation Center (LSC), a research and development facility in the Seaport dedicated to advancing Lilly’s efforts in RNA and DNA-based therapies as well as discovering new drug targets across several disease states, including diabetes, obesity, cardiovascular diseases, neurodegeneration and chronic pain. “The opening of LSC expands upon Lilly’s […]
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Moderna Wins $176 Million from U.S. for Late-Stage Testing of Bird Flu Vaccine

  • Posted by ISPE Boston
  • On August 2, 2024
Moderna is receiving $176 million through the Rapid Response Partnership Vehicle (RRPV) to accelerate the development of mRNA-based pandemic influenza vaccines. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS). The project award will support late-stage development for an […]
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FDA Approves Eli Lilly’s Alzheimer’s Drug

  • Posted by ISPE Boston
  • On August 2, 2024
The FDA has approved Kisunla, Eli Lilly’s Alzheimer’s treatment for adults with early symptomatic Alzheimer’s disease (AD), which includes people with mild cognitive impairment as well as people with the mild dementia stage of AD, with confirmed amyloid pathology.  Once-monthly Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when […]
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Celsius Acquired by AbbVie for $250 million

  • Posted by ISPE Boston
  • On July 17, 2024
AbbVie has announced the acquisition of privately held Cambridge biotech Celsius Therapeutics. Celsius is pioneering new therapies for patients with inflammatory disease. Celsius’ lead investigational asset is CEL383, a potential first-in-class anti-TREM1 antibody that has completed a Phase 1 clinical study for the treatment of inflammatory bowel disease (IBD). TREM1 has been identified as a key […]
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Alnylam Reports Positive Results from Phase 3 Study

  • Posted by ISPE Boston
  • On July 17, 2024
RNAi therapeutics company Alnylam has announced positive topline results from its Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM), a rare heart condition that is both progressive and fatal. Transthyretin amyloidosis (ATTR) is an underdiagnosed, rapidly progressive, debilitating and fatal disease caused by […]
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Sarepta Wins FDA Approval for Muscular Dystrophy Drug

  • Posted by ISPE Boston
  • On July 17, 2024
Sarepta Therapeutics has received FDA approval of an expansion to the labeled indication for Elevidys, a single-dose, adeno-associated virus (AAV)-based gene transfer therapy designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene […]
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Moderna Receives FDA Approval for RSV Vaccine

  • Posted by ISPE Boston
  • On June 7, 2024
Moderna has announced that the FDA has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna which has filed […]
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Biogen to Acquire Human Immunology Biosciences for $1.15 Billion

  • Posted by ISPE Boston
  • On June 7, 2024
Biogen has agreed to acquire Human Immunology Biosciences (HI-Bio) for $1.15 billion upfront and up to $650 million in potential milestone payments. HI-Bio is a privately-held clinical-stage biotech focused on targeted therapies for patients with severe immune-mediated diseases. The transaction is subject to customary closing conditions, including receipt of necessary regulatory approvals and is currently […]
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Novavax and Sanofi Ink Vaccine Licensing Deal

  • Posted by ISPE Boston
  • On May 16, 2024
Vaccine developer Novavax has entered into an agreement with Sanofi that includes: a co-exclusive license to co-commercialize Novavax’s current COVID-19 vaccine worldwide; a sole license to Novavax’s COVID-19 vaccine for use in combination with Sanofi’s flu vaccines; and a non-exclusive license to use Novavax’s COVID-19 vaccine in combination with non-flu vaccines. Outside of the collaboration, each […]
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Novartis to Acquire Mariana Oncology

  • Posted by ISPE Boston
  • On May 9, 2024
Mariana Oncology of Watertown has announced it will be acquired by Novartis for $1 billion upfront and up to $750 million in potential milestone payments. The acquisition brings together Mariana Oncology’s innovative radiopharmaceutical pipeline and platform with the proven clinical development and commercialization expertise of Novartis. Mariana Oncology has developed a robust portfolio of novel […]
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