Biopharma News

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.

The company announced that participants have enrolled in a Phase 1/2 clinical trial of its COVID-19 vaccine candidate, NVX‑CoV2373, a prefusion protein made using Novavax’s proprietary nanoparticle technology.

CanSinoBIO will license-in Precision NanoSystems' proprietary RNA vaccine platform technology while the latter leads the development of the RNA vaccine formulation.

The companies have formed a collaboration to develop a novel human recombinant protein as a therapeutic candidate against COVID-19.

Participants in two dosing cohorts in Moderna’s mRNA-1273 study reached or exceeded neutralizing antibody titers generally seen in convalescent sera.

The Center for iPS Cell Research and Application Foundation and the Cell and Gene Therapy Catapult have announced the launch of a new collaborative research project that will focus on induced pluripotent stem cell characterization.

Santen Pharmaceutical has concluded a licensing agreement with jCyte for the development, registration, and commercialization rights to jCell, an investigational retinitis pigmentosa therapy, in Japan, Asia, and Europe.

Hitachi Chemical Advanced Therapeutics Solutions and apceth Biopharma entered into long-term development and manufacturing services agreements for the clinical and commercial supply of multiple bluebird bio therapies.

The Coalition for Epidemic Preparedness Innovations will invest up to $384 million of additional funding, in addition to the $4 million it invested in March, to advance the clinical development of NVX-CoV2373, Novavax’s COVID-19 vaccine candidate.

Boehringer Ingelheim will use the partnership to reveal novel insights into the complexities of various inflammatory diseases, which opens the potential for a clearer understanding of potential candidate biomarkers.

AbbVie and Allergan have satisfied all required antitrust clearances for the acquisition.

Catalent will manufacture a mRNA-based COVID-19 vaccine for clinical trials and potential commercialization.

Trial begins in the US for the Pfizer-BioNTech mRNA COVID-19 vaccine; manufacturing plans announced.

The companies have entered into a manufacturing agreement to supply leronlimab, an investigational new drug currently being used in clinical trial protocols for COVID-19.

FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.

The goal of the collaboration is to manufacture up to one billion does per year of mRNA-1273, Moderna’s vaccine against the novel coronavirus.

Catalent and Johnson & Johnson announce joint investment and tech transfer to prepare for rapid scale-up and segregated cGMP commercial manufacturing capacity.

AstraZeneca and the University of Oxford have announced that they will collaborate on the global development and distribution of the university’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection.

ILC Therapeutics, a biotech company based in the United Kingdom, has discovered two separate novel treatments for patients suffering with COVID-19 prior to needing ventilators.

With funding from the Bill & Melinda Gates Foundation, Batavia’s low-cost vaccine manufacturing process will be used to produce Wistar’s drug substance and drug product formulations, to be distributed to vaccine manufacturers.

NIH trial shows remdesivir accelerates recovery; Gilead study shows similar efficacy for 5- and 10-day dosing.

A report into the Swiss biotech sector has shown that there is continued growth in the sector, which has received investments from public and private companies worth CHF 1.2 billion (US$1.2 billion).

MicrofluidX has raised £1.4 million (US$1.7 million) in seed funding, which it will use to develop its novel cell bioprocessing technology for cell and gene therapy.

A UK BioIndustry Association industry-led vaccine manufacturing group has welcomed a recent announcement by the government of the UK, that it will receive £14 million (US$17.3 million) in investment to rapidly scale up the development of vaccines for COVID-19.

The approval was based off of positive results from a Phase III study that showed patients 70 years or younger treated with the BTK inhibitor lived longer without disease progression.

US government and industry partners will coordinate to bring the most promising COVID-19 vaccine and treatment candidates to clinical trials.