Pharmaceutical Technology Editors

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.

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.

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 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.

A new report from the University of Strathclyde’s Fraser of Allander Institute has demonstrated the strength of the pharmaceutical sector in Scotland.

DHL Global Forwarding has expanded its life sciences and healthcare facility in Leipzig, Germany.

CPhI China event organizers are encouraged by the success of the recent event and claim that it demonstrates a reassuring return to form for pharma events in 2021, which will also fuel a boom for the industry.

GlaxoSmithKline (GSK) and Novartis have announced the launch of a collaboration to support scientific research into genetic diversity in Africa and the potential impact in response to drugs.

The approval was based on positive results from a single-arm Phase II trial where the treatment demonstrated significant antitumor activities in patients with the disease.

Through the acquisition, Thermo Fisher will have access to Mesa’s PCR-based rapid point-of-care testing platform for detecting infectious diseases.