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 […]

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 […]

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 […]

Apply Today for a Joel Goldenberg Memorial Scholarship

Posted by H. Steven Kennedy
On June 3, 2020

Are you interested in pursuing a career in biotechnology and pharmaceutical manufacturing? Are you an undergraduate or graduate student enrolled in an accredited college or university located in New England or the Albany/Schenectady area? Are you pursuing a certification or an associate, bachelor, master, or a doctoral degree in any of the STEM disciplines? Do […]

Trends and Investments in BioPharma: The Impact of COVID-19

Posted by Kevin Chronley
On May 28, 2020

Historically, our global community has long prioritized the value of health. This is the basis for today’s biopharma industry with its primary growth derived from on-going innovation and most recently by the ability of biologics to treat challenging diseases. The industry has attracted investment to support the trend toward innovation which in turn fuels the […]

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 […]

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 […]

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 […]

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 […]

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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