News

The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.

PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.

Catalent will offer materials from its gene therapy facilities in Maryland to support IND-enabling studies and a Phase I/II clinical trial of the product.

Through the acquisition, Jazz will gain access to GW’s novel cannabinoid platform, including Epidiolex, a plant-derived cannabinoid medicine for the treatment of high-growth childhood-onset epilepsy.

Scientists at the company learned that deagglomeration techniques lose efficacy through equipment wear over time and developed a tactic that makes up for the wear and prepares an ideal sample for each particle size test.

Both companies will provide resources and expertise to research, develop, and manufacture multiple mRNA vaccine candidates, including multi-valent and monovalent approaches.

The companies have entered into a research collaboration and license agreement for the potential treatment of rheumatoid arthritis via Imcyse’s RA program based on its Imotope technology.

As demand for COVID-19 vaccines increases, Big Pharma offers its manufacturing capacity and expertise.

The companies previously entered into a collaboration in November 2020 with the goal of producing more than 100 million doses of the CureVac vaccine per year at Rentschler’s Laupheim, Germany facility.

WuXi STA will acquire the site’s operations and assets, including the plant, equipment, and workforce.

The deal, which is set to close by the end of the first quarter of 2021, will provide Horizon with access to Viela’s rare disease medicine portfolio.

The new board will join the company’s co-founder and chairman, Jay Walker, and company CEO, Franco Negron.

FDA puts applications on hold as the agency limits alternative oversight methods.

Bayer will support CureVac by providing the company with further development, supply, and territory operations via its clinical operations, regulatory affairs, pharmacovigilance, medical information, and supply chain management expertise.

Cytiva acquired Vanrx Pharmasystems, a Canadian manufacturer of robotic aseptic filling equipment.

With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies.

The vaccine met the primary endpoint with a vaccine efficacy of 89.3% in its Phase III trial in the United Kingdom and a vaccine efficacy of 49% in HIV-positive participants and 60% in HIV-negative participants in a South African Phase IIb trial.

FDA published guidance that includes risk-based recommendations for minimizing the potential transmission of COVID-19.

The vaccine is 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination.

The European Medicines Agency has recommended granting conditional marketing authorization for AstraZeneca’s COVID-19 vaccine.

Biotechnology company, Polyplus-transfection, has started construction of a new facility in France to meet growth in the cell and gene therapy market.

BIA has welcomed the announcement from the UK government that genomics expertise and capacity will be offered globally to help identify new variants of the virus that cause COVID-19.

The dispute between the European Commission (EC) of the European Union and pharmaceutical company AstraZeneca continues.

The European Medicines Agency (EMA) has issued the first safety update on a COVID-19 vaccine—Comirnaty (Pfizer/BioNTech vaccine).

Nexelis’ recent acquisition of GSK’s Marburg, Germany-based vaccines clinical bioanalytical laboratory expands its bioanalytical capabilities.

The £500,000 (US$686,294)-investment in mass spectrometry support will accelerate biologics development and approval.

The launch of HiScreen Fibro PrismA, the company’s newest product for early mAb purification process development strengthens Cytiva’s new fiber-based Protein A platform.