Moderna’s mRNA vaccine to prevent COVID-19 disease is granted FDA Emergency Use Authorization and CDC recommendation.

The guidance provides information on review timelines during the COVID-19 pandemic.

A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.

The new guidance provides information on how sponsors should interact with the agency regarding complex innovative trial design proposals.

The agency is answering frequently asked questions about the Pfizer–BioNTech COVID-19 vaccine on its website.

FDA is expected to issue Emergency Use Authorization for Moderna’s vaccine, enabling immediate distribution.

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.

The films are now available in three options of varying thickness for added protection against moisture and oxygen.

Due to a packaging error, the company is voluntarily recalling one lot of sildenafil 100 mg tablets for the treatment of erectile dysfunction and one lot of trazodone 100mg tablets for the treatment of major depressive disorder.

John Rim, the company’s former executive vice-president, has been named its new president and CEO.

The HERALD trial will involve participants 18 years and older who will receive a two-dose schedule of CVnCoV or placebo at multiple sites is Europe and Latin America.

The companies are entering into a license and collaboration agreement for the development and commercialization of Relay’s investigational cancer treatment, RLY-1971, a potent inhibitor of SHP2, a molecule that plays a role in cancer cell survival.

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations.

The company will expand its clinical supply chain services by establishing two new facilities in Rheinfelden and Weil am Rhein, Germany.

Freezers, shipping containers, and tracking systems aid distribution of COVID-19 vaccines.

Through the acquisition, Eli Lilly will have access to Prevail’s portfolio of clinical-stage and preclinical neuroscience assets.

Trixeo Aerosphere—AstraZeneca’s triple-combination COPD therapy—has been approved for use in the European Union (EU).

Sterling Pharma Solutions has formed a new strategic partnership with ADC Bio.

A report, launched by Takeda UK, has shown that despite the increase in media attention, COVID-19 has had little positive impact on the perception of pharmaceutical companies.

EUA marks a milestone in COVID-19 vaccine development and is hailed as a turning point in pandemic fight.

The company will expand the site to include six new containment isolators and a product development manufacturing laboratory.

Through the acquisition, AstraZeneca will work with Alexion’s R&D team to build up Alexion's pipeline of 11 molecules across more than 20 clinical-development programs in several indications.

Through the acquisition Gilead will gain access to Hepcludex (bulevirtide) for the treatment of chronic HDV infection in adults with compensated liver disease.

Success in combatting the pandemic depends on the ability of manufacturers to quickly and efficiently produce and distribute the huge quantities of vaccines demanded by the United States government and public health organizations around the world.

The acquisition will enhance Boehringer Ingelheim’s cancer cell-directed therapies portfolio and will complement its existing capabilities in antigen discovery and antibody and T-cell engager technologies.

Committee recommends Emergency Use Authorization of first mRNA-based COVID-19 vaccine; FDA approval is pending.

ISPE and Gilead Sciences have partnered up for the establishment of an internship program.