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Featured Image

Novartis’ AveXis Inks Vaccine Manufacturing Agreement

  • Posted by ISPE Boston
  • On June 4, 2020
Mass Eye and Ear and Mass General Hospital have entered into a manufacturing agreement to produce their novel genetic vaccine with AveXis, a Novartis company. AveXis will begin manufacturing the vaccine this month while the vaccine, known as AAVCOVID, undergoes further safety and efficacy testing in preclinical studies. AveXis, will lead the manufacturing efforts of […]
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AstraZeneca Proceeding with At-Risk Vaccine Development

  • Posted by ISPE Boston
  • On June 4, 2020
AstraZeneca is advancing its ongoing response to address the unprecedented challenges of COVID-19, collaborating with a number of countries and multilateral organizations to make the University of Oxford’s COVID-19 vaccine, formerly called ChAdOx1 and now known as AZD1222, widely accessible around the world in an equitable manner. The company has concluded the first agreements for […]
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Merck Triples Efforts to Combat COVID-19

  • Posted by ISPE Boston
  • On June 4, 2020
Merck is embarking on three significant scientific initiatives to combat COVID-19: two agreements to develop potential vaccines and a research collaboration to advance the development of a novel antiviral candidate: Merck to acquire Themis Bioscience, a company focused on vaccines and immune-modulation therapies for infectious diseases, including COVID-19; IAVI and Merck collaborate to develop COVID-19 […]
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AstraZeneca and Merck Win FDA Approval for Ovarian Cancer Treatment

  • Posted by ISPE Boston
  • On May 21, 2020
AstraZeneca and Merck have announced that the FDA has approved Lynparza in combination with bevacizumab as a first-line maintenance treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in certain adult patients whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by BRCA mutation and/or genomic instability. Regulatory reviews are […]
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WuXi Biologics to Build Biologics Plant in Worcester

  • Posted by ISPE Boston
  • On May 21, 2020
WuXi Biologics and the Worcester Business Development Corporation (WBDC) have announced the successful signing of a land deal for WuXi Biologics’ clinical and commercial manufacturing facility (MFG11) in Worcester at The Reactory, a 46-acre master-planned biomanufacturing campus. The approximately 107,000-square-foot, two-story facility will be operational in 2022 and create 150 new jobs. Craig Blais, the […]
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AbbVie Completes Allergan Acquisition

  • Posted by ISPE Boston
  • On May 14, 2020
AbbVie has completed its acquisition of Allergan plc following receipt of regulatory approval from all government authorities required by the transaction agreement and approval by the Irish High Court. “We are pleased to reach this important milestone for the Company, its employees, shareholders and the patients we serve,” said Richard A. Gonzalez, chairman and chief […]
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AstraZeneca Drug Wins Breakthrough Therapy Designation

  • Posted by ISPE Boston
  • On May 14, 2020
AstraZeneca and Daiichi Sankyo drug Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of certain patients with HER2-positive metastatic gastric cancer. In March 2019, AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialize Enhertu worldwide, except in Japan where Daiichi Sankyo maintains […]
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Moderna Receives FDA Fast Track Designation for Coronavirus Vaccine

  • Posted by ISPE Boston
  • On May 14, 2020
The FDA has granted Fast Track designation for Moderna’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2). In explanation, Moderna’s Chief Medical Officer Tal Zaks said, “Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus. As we await the full set of clinical data from the NIAID-led Phase 1 […]
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Join ISPE Now for Added Benefits

  • Posted by ISPE Boston
  • On May 14, 2020
During times like these ISPE Boston recognizes the vital role our members play in our development and mission. We’d like to show our appreciation by rolling out some membership incentives starting May 15th, 2020 through July 15th, 2020. Anyone who renews their membership or is joining the Boston Area Chapter for the first time will […]
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Moderna and Lonza in Deal to Manufacture Moderna’s Coronavirus mRNA Vaccine

  • Posted by ISPE Boston
  • On May 6, 2020
Moderna and Lonza have announced a 10-year strategic collaboration agreement to enable larger scale manufacture of Moderna’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) and additional Moderna products in the future. Under the terms of the agreement, the companies plan to establish manufacturing suites at Lonza’s facilities in the U.S. and Switzerland for the […]
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