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.

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.

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

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

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.

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

The European Medicines Agency has launched a full investigation into a cyberattack.

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.

Cytiva is adding process development, media and assay development, and contract development services at its facilities in Korea, Japan, Sweden, and the UK.

Through the acquisition, PTI will gain access to LDA’s lead product, the SIMS 1915+, a helium leak test system that combines its helium leak detection technology with its SIMS software for data collection and analysis.

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.

Piramal Pharma Solutions invests in expanded potent and non-potent API development and manufacturing at its Riverview, MI facility.

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.

Dr. Marcus Michel will take over the role from Richard Stedman, who has served as CEO for the past three years, as he transitions to a special advisor role for the company.

The company will expand its micronization abilities for highly potent drug compounds through this investment.

Pfizer-BioNTech details its case for Emergency Use Authorization for "highly effective" COVID-19 vaccine.

The product is being recalled because of Burkholderia cepecia contamination.

A development agreement will study inhaled formulations of cannabinoid-based drug product for central nervous system diseases.

The new guidance document is intended to minimize medication errors and avoid violations of the FD&C Act.

The agency published guidance on how sponsors of combination products can obtain feedback from FDA on scientific and regulatory concerns.

The virtual showroom will provide real-time construction updates, various specs, and services that its new super plant, Plant 4, will offer upon completion.

The companies have entered into an agreement for next-generation, mesothelin-directed CAR-T cell therapies for the treatment of solid tumors.

Startup company Vivlion has signed a non-exclusive license agreement with ERS Genomics granting access to CRISPR/Cas9 patent portfolio.

New data from CGT Catapult has demonstrated progression by the industry toward commercialization of therapies and an increase in GMP manufacturing space.