Biopharma News

The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.

The companies are entering into a license agreement to provide CSL Behring with exclusive global rights to etranacogene dezaparvovec, uniQure’s investigational gene therapy for patients with hemophilia B.

The company’s oral COVID-19 vaccine has been chosen to participate in a non-human primate challenge study organized and funded by Operation Warp Speed.

The test results could potentially be used in the development of COVID-19 vaccines and the screening of convalescent plasma for prophylactic and therapeutic use.

The company has expanded its laboratory test portfolio with five new molecular, serology, and functional assays for COVID-19 vaccine and therapy development programs.

Inovio received a $71-million contract from the US Department of Defense to scale up manufacture of its Cellectra smart device to deliver its DNA vaccine.

The company will invest EUR 610 million (USD$682 million) into a new vaccine production site and research center in France.

Valneva will manufacture the Sabin vaccine strains for clinical trials in its manufacturing facility in Solna, Sweden, using Batavia’s process.

Citing clinical trial data that hydroxychloroquine did not show benefits for COVID-19 patients, FDA removes emergency use authorization for the drug as a treatment for the novel coronavirus.

The Biomedical Catalyst has been relaunched, meaning that innovative biotech companies will have the opportunity to access a share of £30 million (US$38 million) in grant funding.

The candidates will be used by the Vaccine Research Center, part of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

The companies have entered into a development and manufacturing agreement for Anthos Therapeutics’ abelacimab for treating thrombotic disorders.

Novavax announces DoD contract to produce 10 million doses of COVID-19 vaccine candidate.

The protocol on Northern Ireland (NI) once Brexit has been completed has received mixed opinions in industry, according to various press releases.

The European Commission has granted marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for Darzalex (daratumumab) subcutaneous formulation to treat adults with multiple myeloma.

The collaboration will focus on novel therapeutics targeting RNA-modifying proteins for cancer treatment.

Johnson & Johnson’s Janssen Pharmaceutical Companies has received a positive opinion in Europe for its two-dose Ebola vaccine regimen.

The investment will give the company the opportunity to accelerate the development of proprietary boron-10 target drugs while it develops its neutron beam accelerator technology for Boron Neutron Capture Therapy.

The new vaccine would be made with a Newcastle disease virus vector that expresses the immunogenic spike protein of SARS-CoV-2

The Gavi advance market commitment for COVID-19 vaccines is a new financing instrument aimed at incentivizing vaccine manufacturers to produce sufficient and affordable quantities of COVID-19 vaccines.

The medicine is the first outcome of the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19.

The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19.

The acquisition gives Novovax an annual operating capacity of more that one billion doses of COVID-19 vaccine antigen.

Incyte and MorphoSys have revealed that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for tafasitamab, an anti-CD19 antibody.

The UK BioIndustry Association has stated its support of a government led funding initiative, Future Fund, which will support innovative companies in the United Kingdom that will help to ensure the country’s leading position in science, innovation, and technology.

Biopharmaceutical company, Atriva Therapeutics, has announced, in a May 28, 2020 press release, that it will develop ATR-002, an oral small molecule, for treatment of patients with moderate-to-severe COVID-19 that require hospitalization in a Phase II study.

Merck will use Themis’s vector platform to develop a vaccine to prevent COVID-19.

Advent manufactured the vaccine doses for the Phase 2/3 clinical trial.