PharmTech Europe News

After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.

EMA's safety committee, PRAC, has concluded that there is no evidence linking the viral vector in Zynteglo to a blood cancer known as acute myeloid leukemia (AML).

Exscientia has been given funding from the COVID-19 Therapeutics Accelerator to accelerate the optimization of a new class of COVID-19 drugs created using its AI drug design platform.

MHRA has granted marketing authorization for Diurnal Group’s Efmody as a treatment of adult and adolescent patients with CAH in Great Britain.

V. Ashok has been appointed as ACG's new group chief financial officer.

Novasep and Exelixis have signed a manufacturing services agreement for the CGMP clinical manufacturing of a next-generation ADC candidate.

Recipharm has signed a memorandum of understanding (MOU) with His Majesty the King of Morocco, the Moroccan government, and a consortium of leading banks from the country, for fill/finish capacity in the country.

The recently published Life Sciences Sector Vision, from the UK government, has been welcomed by the UK BioIndustry Association (BIA).

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

Five therapeutic candidates for the treatment of COVID-19 are identified as promising by the European Commission.

Chalmers University researchers have developed a method to label and track mRNA molecules.

CDMO Yposkesi will increase its current gene therapy vector capacity through French government’s “Plan de Relance” scheme.

CatSci has opened its new Dagenham, UK-based laboratory, which is dedicated to analytical excellence.

The Cell and Gene Therapy Catapult will establish offices and laboratories in Edinburgh, Scotland.

Evonik has released an innovative green technology that can enable the large-scale synthesis of APIs in water.

Pharmapack Europe event organizers have revealed increased levels of innovation in drug delivery across the industry, substantiated by the level of regulatory approvals.

The Council of Europe has appointed Petra Dörr, PhD, as the future director of the European Directorate for the Quality of Medicines and Healthcare (EDQM).

EMA's CHMP has adopted a positive opinion recommending the approval of UCB’s bimekizumab (Bimzelx) for the treatment of plaque psoriasis.

Otsuka Pharmaceuticals Europe has filed an initial marketing authorization application to the European Medicines Agency for voclosporin.

The University of Birmingham has been confirmed as the third National Training Centre in the Advanced Therapies Skills Training Network (ATSTN) initiative

The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.

Ilya Pharma has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.

EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.

Vectura has signed an agreement with Incannex Healthcare for the pre-clinical development of IHL-216A, an inhaled drug product for the treatment of traumatic brain injury.

Exscientia has entered into a binding agreement to acquire the artificial intelligence precision-based medicines company, Allcyte.

RECOVERY trial results have shown that Regeneron’s investigational antibody combination therapy reduces the mortality risk for seronegative hospitalized patients with severe COVID-19.

CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis.

Recent analysis has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.

BIA has published a report presenting the findings of a survey on the public attitudes toward equal access to medicines for those living with rare diseases.

Horiba has joined a consortium aimed at accelerating the development of process analytical technologies for cell and gene therapy manufacturing