News

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.

A contract from the US government will help fund domestic US production of small-molecule APIs and finished dosage forms and will be the first GMP facility using ICM technology.

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

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.

The company is recalling one lot of Cisatracurium Besylate Injection, USP 10mg per 5mL because of mislabeling.

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

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

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

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 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.

Evozyne’s evolution-based protein design technology will be used to research and develop proteins that could be used in the next generation of gene therapies.

The new division will provide system solutions and individual machines and components.

The project is aimed at discovering novel transport mechanisms in the human intestinal tract that could be used for oral delivery of diverse therapeutic modalities.

Sanofi will offer access to its infrastructure and expertise to help BioNTech produce over 125 million doses of its COVID-19 vaccine in Europe.

Emergent will use its CDMO services to manufacture drug product batches to support the increased supply of the therapeutic candidate in anticipation of a potential emergency use authorization in the first quarter of 2021.

Clinical material for a Theratechnologies product in development will be produced at PPS’ manufacturing facility in Lexington, KY.

The site, which is set to be operational in three years, will feature disposable technology and advanced technology filling lines to produce 90 million vials and 50 million pre-filled syringes a year.

The two facilities consist of 260 and 130 permanent staff members respectively and produce liquid-filled hard capsules and softgels for the pharmaceutical market as well as other markets.

The companies have entered into an advance purchase agreement with COVAX to provide up to 40 million doses of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, to lower-middle-income countries.

Woodcock will serve as acting commissioner of FDA, taking over for Stephen Hahn, FDA’s previous acting commissioner.

The company is discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, to focus on advancing its two SARS-CoV-2/COVID-19 therapeutic candidates, MK-4482 and MK-7110.

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

The broader national strategy sets seven goals, some fairly general, such as building public trust, safely reopening schools and businesses, advancing racial and ethnic equity, and restoring US global leadership.

The drug offers immediate post-exposure protection against the virus and will serve as a counterpart to the vaccine during its early phases.

Verquvo is a soluble guanylate cyclase stimulator for the reduction of the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure.

Estonia, Hungary, and Iceland have signed up to take part in a pilot of Guardtime's VaccineGuard—a newly developed platform aimed at supporting the global COVID-19 vaccination program.