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.

Through the acquisition, Element will have access to Avomeen’s expertise in formulation chemistry, product manufacturing, extractables and leachables, and large molecule testing.

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

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.

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

The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.

COVID-19 vaccine supplies are breaking news headlines, in both ‘good’ and ‘not so good’ ways.

Viewpoint: Mike Hennessy, Sr., founder and chairman of MJH Life Sciences, commends the leadership of the pharmaceutical industry in combatting the COVID-19 pandemic.

A complicated vaccination rollout and mixed messages may derail the pandemic endgame.

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

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.

Open communication and transparency coupled with technical expertise foster strong long-term manufacturing partnerships.

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.

Contract development and manufacturing organizations provide vital services to rush COVID-19 vaccines to patients.

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.

The vaccine will be developed using Gritstone’s proprietary prime-boost vaccine platform, which includes self-amplifying mRNA and adenoviral vectors, with antigens formulated by Gilead.

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

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