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With the presentation of research supporting the use of PTA technology, BioSkryb also launched its ResolveDNA platform for commercial use at ASHG 2020, held virtually on Oct. 27–30, 2020.

Novel Single-Cell Whole Genome Amplification Technology Made Commercially Available at ASHG 2020

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.

UK Biotech Investment Continues to be Strong, According to Data

The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.

MHRA Joins the Australia-Canada-Singapore-Switzerland Consortium

The approval comes after a Phase III trial that showed Keytruda reduced the risk of disease progression or death by 35%.

Merck’s Keytruda Approved for Expanded Indication in Classical Hodgkin Lymphoma

Regeneron will distribute Inmazeb treatment doses over the course of six years to BARDA.

FDA Approves Regeneron’s Inmazeb as the First Treatment for Ebola

The unexplained illness in a study participant is being reviewed and evaluated by an independent data safety monitoring board and internal clinical and safety physicians. 

J&J Pauses COVID-19 Vaccine Candidate Clinical Trials Due to Unexplained Illness 

The companies are entering into an agreement for the late-stage development and large-scale manufacturing of AZD7442, AstraZeneca’s investigational product for treatment and prevention of COVID-19.

HHS, DoD, AstraZeneca Enter into $486-Million Agreement for COVID-19 Investigational Product

The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.

FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

First Participant Dosed in CureVac’s COVID-19 Vaccine Clinical Trial

Experts fear confusion over allocation process, cold-chain requirements, IT systems. 

COVID-19 Vaccine Distribution Raises Multiple Challenges

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

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