Industry News

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.

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.

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.

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

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 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.

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

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

A longer-than-expected scale up of raw materials forces Pfizer to cut 2020 vaccine production in half.

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

A novel PTA technology captures more than 95% of the genomes of single cells, providing more uniform, accurate, and reproducible single-cell analysis data.

CGT Catapult has launched the Advanced Therapies Skills Training Network, designed to open career opportunities and upskill staff in advanced therapy and vaccine manufacturing in the UK.

The grant will support the advancement of glycoengineering technology for plant-derived proteins developed by a University of Alberta scientist partnered with PlantForm.

MHRA has granted a temporary authorization for emergency use to Pfizer and BioNTech for the mRNA vaccine against COVID-19.

FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19.

The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

The Trump administration unveiled a new drug price control policy, drawing opposition from pharma manufacturers and pharmacy benefit managers.

When administered together in clinical trials, casirivimab and imdevimab were shown to lessen COVID-19 hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

Following an EUA application from Pfizer and NioNTech, FDA outlines the process for committee and agency review.

Almac Sciences has been granted an award by the COVID-19 Therapeutics Accelerator for the development of an efficient and scalable production process for remdesivir.

Researchers concluded that the nasal spray should catch and coat the virus inside the nose, preventing it from spreading throughout the body, and it is then removed by nose-blowing or swallowing.

A second global Phase III clinical trial investigating the safety and efficacy of a two-dose regimen of JNJ-78436735 has been initiated by Johnson & Johnson.