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Moderna and Vertex in New Collaboration to Treat CF Using Gene Editing

  • Posted by ISPE Boston
  • On October 1, 2020
Moderna and Vertex have announced a new strategic research collaboration and licensing agreement aimed at the discovery and development of lipid nanoparticles (LNPs) and mRNAs for the delivery of gene-editing therapies for the treatment of cystic fibrosis (CF). The three-year research collaboration initially will focus on the discovery and optimization of novel LNPs and mRNAs that […]
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Ironwood to Reduce Workforce Based on Phase III Trial Results

  • Posted by ISPE Boston
  • On October 1, 2020
Following confirmation that the Phase III trial of GERD drug IW-3718 failed to achieve the primary endpoint of achieving a statistically significant improvement in heartburn severity, Ironwood has announced plans to implement an organizational restructuring, reducing headcount by approximately 100 full-time employees, or nearly 35% of the current workforce. Following the changes, Ironwood expects to […]
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More About Lilly’s mAb Therapy for COVID-19

  • Posted by ISPE Boston
  • On September 30, 2020
Eli Lilly has announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with SARS-CoV-2 neutralizing antibody LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555 for the treatment of symptomatic COVID-19 in the outpatient setting. LY-CoV555 is a potent, neutralizing […]
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Lilly and Amgen Announce Manufacturing Collaboration for COVID-19 mAb Therapies

  • Posted by ISPE Boston
  • On September 30, 2020
Eli Lilly and Amgen have entered into a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly’s potential COVID-19 therapies. Lilly is currently studying several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination. Through this collaboration, the two companies will have the ability to quickly scale up […]
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13 Tips for Writing Effective Quality System Investigative Reports

  • Posted by ISPE Boston
  • On September 24, 2020
By: Howard Sneider Completing an investigation is one of the most strenuous responsibilities of individuals that work in quality system compliance. The investigation usually includes an investigative report to document the events and analysis of the proceedings. The investigative report is, with few exceptions, an irrevocable account of what has occurred and will largely determine […]
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Update Your Clean Room Knowledge with Industry Pros

  • Posted by ISPE Boston
  • On September 16, 2020
Join us at our next webinar on September 24, 12-1 pm, with presentations by two industry experts followed by a live Q&A session. This program is perfect for professionals working in validation, quality control, quality assurance, operations, cleanroom management, regulatory affairs or production and those who test and monitor cleanroom environmental conditions, airflow and the accuracy […]
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Over 160 CEOs Sign MassBio’s Pledge to Create a More Equitable and Inclusive Life Sciences Industry

  • Posted by ISPE Boston
  • On September 14, 2020
The Massachusetts Biotechnology Council today announced that 164 CEOs representing the breadth of the life sciences have signed its Open Letter 2.0 – The CEO Pledge for a More Equitable and Inclusive Life Sciences Industry. This pledge serves as a call to action for CEOs across the life sciences to create change within their respective […]
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Cambridge Biotechs Attract Venture Financing

  • Posted by ISPE Boston
  • On September 10, 2020
Cambridge-based startups Korro Bio and Casma Therapeutics have secured financing of $91.5 million and $50 million, respectively, in recent funding rounds. Both companies were launched in 2018. The funding will enable Korro to advance its novel platform for precise, single-base, RNA editing to modulate protein function for therapeutic applications, including advancing its lead program to […]
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Biotech Leaders Outline Principles to Ensure “Public’s Trust” in COVID-19 Treatments

  • Posted by ISPE Boston
  • On September 10, 2020
As America’s researchers race to develop the scientific solutions needed to eradicate COVID-19, leaders within the Biotechnology Innovation Organization (BIO) released an open letter to their biopharmaceutical colleagues that articulates key principles to ensure the “integrity, transparency, and objective assessment” of COVID-19 clinical data and secure public trust in new medical products developed in response to the […]
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Top COVID-19 Vaccine Makers Vow to Follow Regulatory Guidelines

  • Posted by ISPE Boston
  • On September 10, 2020
The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi have signed a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines. All nine CEOs signed the following pledge: We, […]
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