News

The company has expanded capabilities for aggregate analytics to include dynamic light scattering.

The statement, published by the International Coalition of Medicines Regulatory Authorities, outlined its commitment to a strengthening of global collaboration in the fight against COVID-19.

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

The companies will work to accelerate the development of CytoAgents’ lead COVID-19 drug candidate, GP168, into human clinical trials.

Merck will provide funding and will work with researchers at the Institute for Systems Biology to identify targets for therapeutic intervention and vaccine development.

The decision is part of the Takeda’s goal to divest $10 billion in non-core assets and focus on its key business areas.

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.

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 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).

Technical services and regulatory affairs consulting group, Diamond Pharma Services, has announced its acquisition of PharmaCentral-a pharmacovigilance services and medical affairs business based in Dublin, Ireland.

A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.

The vaccine will be based on a ReiThera-proprietary simian adenoviral vector with strong immunological potency and low pre-existing immunity in humans.

Emergent will offer up its drug substance manufacturing services with support by investments from Johnson & Johnson starting in 2020.

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.

Bayer will provide CAD $1.5 million (USD$1 million) toward two studies to evaluate its chloroquine and interferon beta-1b combination therapies.

Wavelength Pharmaceuticals expanded production of APIs for certain pharmaceutical products needed to manage respiratory critical care patients in the COVID-19 pandemic.

Catalent Biologics increased capacity at its Bloomington, IN Facility.

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

The company is recalling the product because of out-of-specification results for high molecular weight polymers.

The company is voluntarily recalling 13 lots of the product because of particulate matter found in reserve sample vials.

The companies will collaborate on the discovery and development of next-generation drug and engineered cell therapies focused on natural killer cells.

With hundreds of clinical trials for potential coronavirus therapies in the works concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.

The phase-II, randomized, double-blind, placebo-controlled trial will study the efficacy and safety of the live biotherapeutic in 90 individuals with COVID-19 symptoms.

The company will build an additional commercial-scale, contract manufacturing facility for viral vectors and gene therapies near its existing site in Carlsbad, CA.

Through the agreement, BARDA will support the advancement of the vaccine candidate to FDA licensure and will handle all late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020.

The report outlines the company’s approaches to product quality, safety, environmental sustainability, and diversity and inclusion.

The company is recalling Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles because of failed dissolution specifications.

The International Safe Transit Association’s Pharma Committee published a guideline on the passive thermal packaging qualification process.

The Commission of Human Medicines Expert Working Group has concluded that there is insufficient evidence to link ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), with susceptibility for contracting COVID-19 or worsening symptoms.

Medical dermatology company based in Denmark, Leo Pharma, has entered into a license agreement with two Eastern-Asian companies for the development and commercialization of FB825, a novel atopic dermatitis and allergic asthma drug candidate.