PharmTech Europe News

EMA is providing support via its Innovation Task Force (ITF) for developers to help them reduce, replace, and refine animal use in drug development.

GSK has received a positive recommendation from the EMA’s CHMP for Nucala (mepolizumab) to be used as a treatment in three additional eosinophil-driven diseases.

The first part of the 2021 CPhI Annual Report has been published and predicts a strong outlook for CDMOs over the next few years.

The organizers of Pharmapack Europe have released the results of its global drug delivery and packaging survey, demonstrating the continuation of the United States’ lead in innovation.

Celltrion Group has been granted approval for regdanvimab (CT-P59) to be used as a treatment for COVID-19 by the Korean Ministry of Food and Drug Safety (MFDS).

ProductLife Group (PLG) and Juuka Advisory have teamed up to form a new consulting offering, ProductLife Consulting.

BMG Pharma has signed an agreement with HTL for the development and commercialization of injectable products with sodium hyaluronate lipoate formate.

Symbiosis Pharmaceutical Services has successfully completed an on-site inspection, performed by the MHRA, of its expanded facility in Stirling, UK.

SGS has selected the European Centre for Clinical Research Training (ECCRT) for the provision of good manufacturing practice (GMP) training of its pharmacy team.

Exscientia has entered into a four-year agreement with the Bill & Melinda Gates Foundation for the development of small-molecule therapeutics that can tackle coronavirus and other viruses with pandemic potential.

GeneQuine Biotherapeutics has chosen Exothera to advance the development of its osteoarthritis gene therapy product candidate, GQ-303.

ABPI has announced that eight leaders from the patient and health charity sector have been chosen to join its new Patient Advisory Council.

ILC Therapeutics, has successfully closed a £3.5 million (US$4.9 million) pre-initial public offering (IPO) funding round.

NICE has reconsidered its decision on Janssen's Erleada (apalutamide), issuing two positive final appraisal determinations (FADs) on the therapy.

NICE has recommended tofacitinib (Xeljanz, Pfizer)as an option for treating active polyarticular juvenile arthritis and juvenile psoriatic arthritis.

Sterling Pharma Solutions has invested in a center of excellence for research into commercial applications of continuous flow chemistry at its site in Dudley, UK.

Nanoform and Herantis Pharma's proof of concept project evaluating the application of the nanoforming process has been successful.

Avantor has acquired the Masterflex bioprocessing business and related assets of Antylia Scientific.

The European Commission has granted marketing authorization to Incyte and MorphoSys for Minjuvi (tafasitamab) in combination therapy with lenalidomide to treat relapsed or refractory DLBCL.

The European Commission has approved UCB's treatment for adults with moderate-to-severe plaque psoriasis, BIMZELX (bimekizumab).

Insilico Biotechnology has joined the Inno4vac project—an innovative European public-private partnership aimed at accelerating vaccine R&D timelines.

Signal Rx Pharmaceuticals, Crystec, and ADYA Consulting are collaborating on the development of an inhaled dry powder formulation of SF2523 to treat pulmonary fibrosis, lung cancer, and SARS-CoV-2 related illnesses.

Aptamer Group and Bio-Works Technologies are partnering up to develop a new affinity resin for improved purification and scale-up of gene therapy vectors.

MHRA has approved Scancell’s clinical trial application for the initiation of the first-in-human Phase I/II study of Modi-1—a therapeutic vaccine candidate from the company's Moditope platform.

CC Bio has raised £890,000 (US $1.2 million) in seed funding from CMS Ventures to accelerate the development of an innovative approach to infection treatment and prevention.

AGC Biologics has broken ground on a new multipurpose facility in Copenhagen, Denmark, that will increase capacity.

MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.

ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.

EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.

Bristol Myers Squibb has exercised the option to in-license an immune-modulating drug candidate developed by Exscientia.