BioPharm International Editors

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

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

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

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.

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.

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 company has formed an agreement with the Ministry of Health of Singapore to supply mRNA-1273, Moderna’s COVID-19 vaccine candidate, to the people of Singapore.

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

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

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.

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

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

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.

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

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

The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.

Celltrion Healthcare has announced that EMA's CHMP has issued a positive opinion for the marketing authorization of CT-P17—an adalimumab biosimilar.

The European Commission has granted a license for the use of inclisiran (Leqvio) as a treatment of primary hypercholesterolemia or mixed dyslipidaemia in adult patients.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint strategy for medicines regulation in Europe over the next five years.

Evonik offers lipid nanoparticles for gene-based drug development and manufacturing.

With the acquisition, Evonik will expand its life science division and its portfolio of functional excipients and biomaterials.

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

The collaboration includes the development, commercialization, and supply of Orgenesis’ pipeline in South Korea and Japan and the development and commercialization of Cure Therapeutics’ pipeline on a global basis.

The company has received $500 million in funding from Sino Biopharmaceutical for further development, capacity expansion, and manufacturing of CoronaVac, its COVID-19 vaccine candidate.

CDMO HALIX will manufacture the drug substance for AstraZeneca’s COVID-19 vaccine candidate, AZD1222, at commercial scale at its cGMP facility in the Netherlands.