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Through the agreement, Takeda will handle securing the regulatory approvals before distributing the doses, while Moderna will supply the finished product.

Takeda, Moderna, and the Government of Japan to Collaborate to Distribute 50 Million COVID-19 Vaccine Doses

Novartis and Molecular Partners are collaborating on the development, manufacture, and commercialization of Molecular Partners’ anti-COVID-19 DARPin program.

Novartis Collaborates with Molecular Partners on Two Anti-COVID-19 Therapies 

The UK BIA Antibody Taskforce has identified differentiated antibody combinations that will be taken into development as COVID-19 antibody therapy candidates.

UK BIA Antibody Taskforce Identifies Novel COVID-19 Antibody Therapy Candidates

The companies have signed a Statement of Intent with Gavi to make 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine available for distribution. 

Sanofi and GSK Agree to Support COVAX with 200 Million COVID-19 Vaccines Doses

The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.

FDA Vaccine Committee Meets About COVID-19 Vaccines

200 employees will be hired by the end of 2020, with 300 more planning to be hired by 2023. 

Roche Canada to Invest $500 Million and Create 500 New Jobs at its Canadian Global Pharma Technical Operations Site

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.

FDA Finds CGMP Violations at Canadian Facility 

FDA issued guidance for applicants that must report annually on the status of postmarketing studies and clinical trials under section 506B of the FD&C Act.

Guidance on Annual Status Reports of Postmarketing Studies 

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The much-anticipated meeting of FDA’s vaccine advisory committee this week is slated to address a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection.

Early Vaccine Authorization Raises Ethical and Logistical Challenges for Trial Sponsors

Recent data, from BIA and Clarivate, has revealed that investment in UK biotech continues to be strong.

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