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AstraZeneca received approval from FDA for Fasenra Pen, a pre-fillled auto-injector pen that allows for self-administration of its asthma biologic therapy, Fasenra (benralizumab).

The companies will collaborate to identify and develop in-vivo genome editing therapeutic candidates for genetic diseases, including hemophilia.

The collaboration aims to reduce “vein-to-vein” time for patients and to optimize manufacturing and supply operations.

Following the publication of a statement from the United Kingdom’s Secretary of State for Health and Social Care, Matt Hancock, on the continuity of medicines supply in a ‘no-deal’ Brexit scenario, the UK BioIndustry Association (BIA) has issued a response on Oct. 9, 2019.

In an Oct. 10, 2019 press release, ChargePoint Technology announced that its smart monitoring system, Verifi, is now available for the biopharma market.

Biotechnology company, Avacta Group, and clinical-stage oncology-focused biotech, ADC Therapeutics, have entered into a collaboration and option agreement focused on the development of potent Affimer-drug conjugates.

MilliporeSigma will now be the first company to make acoustic technology available for cell therapy manufacturing.

The new facility raises production capacity by an additional 19,100 m2 and creates 200 new full-time jobs.

The collaboration focuses on baculovirus/Sf9 expression system for Prevail's pipeline of novel AAV9-based gene therapy programs neurodegenerative diseases.

The new services provide rapid production of antibody drug conjugates (ADCs) for best candidate selection.

The increased capacity will enable the company to guarantee short production timelines.

Under a collaboration potentially worth more than $1.5 billion, the companies aim to develop the antisense therapy to treat patients with certain cardiovascular and metabolic diseases.

GSK invested $139 million to its Rockville, MD site to support demand for Benlysta.

The agency has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for reducing the risk of HIV-1 infection.

The tables can be used for new drug applications, biologics license applications, and supplements to these applications.

The new joint venture, named Oerth Bio, will use Arvinas’ Protac technology to develop innovative new agricultural products. As part of its collaboration with Arvinas, Bayer is also using this technology to develop human therapeutics.

The companies are working together with Japanese clients to outline projects from early clinical stage up to commercial launch.

Manufacturing of the cell line will take place at Lonza’s GMP facility in Geleen, Netherlands.

Data showed that the drug candidate activated T regulatory cells, believed to serve a crucial role in protecting the body from uncontrolled inflammation or autoimmunity.

The companies agreed to a multi-year research and development collaboration that will focus on AI empowerment and exploration.

Researchers used advanced animal model lab tests to determine the new vector is 10 times more efficient at incorporating corrective genes into bone marrow stem cells than traditional vectors.

The new incubators are set to be operational starting in 2021.

The agency seeks comments on a draft guidance designed to make the process conform to its original intent as a communication tool, rather than a roadblock to competition and innovation.

The partnership combines global CDMO services with a cellular orchestration platform.

The project will focus on the development of an influenza vaccine that protects against multiple strains of the influenza virus in a single dose.

After months of planning and explaining, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs.

The companies plan to collaborate for the advancement of an optical system for on-line analysis of mammalian cells during a bioprocess.

PPD is expanding its bioanalytical lab in Richmond, VA, to enhance its immunochemistry, biomarker, and chromatography services.

Cellink’s BIO X6, a six-printhead bioprinting platform, offers the capability to combine more materials, cells, and tools to enhance research applications across the bioprinting field.

A new educational platform by Quality Executive Partners offers on-demand digital courses with technical content, virtual reality, and real-time coaching with an initial focus on sterile product manufacturing and microbiology.