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

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.

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.

The companies will develop up to three CD3-engaging T-cell redirecting bispecific antibody therapies using Merus' proprietary Biclonics platform.

ReFIBE sterile cleanroom wipes are sustainable polyester wipes made from recycled post-consumer plastic bottles.

Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far.

The CPhI event, which was originally scheduled for Aug. 31–Sept. 2, 2021 at the Fiera Milano in Milan, Italy, will be rescheduled for Nov. 9–11, 2021 at the same venue.

The new US offices will give the company the ability to support its US-based customers on site while continuing to collaborate with its global team.

Henogen will be integrated into Thermo Fisher’s Pharma Services business within its Laboratory Products and Services segment.

The 40,000-ft.2 facility will feature eight cleanrooms with configurations for the production of cell and viral vector products.

This new agreement covers 1.25 million additional doses of the antibody cocktail containing casirivimab and imdevimab for the treatment of COVID-19.

The collaboration will focus on up to three types of lung and gastrointestinal cancers.

The first four investments of the new program will support clinical-stage biotechnology companies while new investments will include companies focused on oncology, rare disease, and inflammation and immunology.

The acquisition significantly expands Precision Medicine Group’s cell and gene therapy expertise.

The fill line will work to manufacture high-value APIs for drug product manufacturing to meet the needs of the COVID-19 pandemic.

A report on the FDA PREPP initiative’s work in 2020 aims to strengthen the Agency’s response to future public health emergencies.