PharmTech Europe News

3P Innovation has won a Princess Royal Training Award for its Graduate Development Programme (GDP).

UK's ABPI responds to the latest revisions being made to NICE methods for assessment of drugs and devices.

The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.

The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.

EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.

BMG Pharma's clinical trial has demonstrated positive results in the efficacy of BMG0705 Nasal Spray and BMG0703A Mouth Rinse as treatments for asymptomatic COVID-19 patients.

Evonik has acquired the German biotech company JeNaCell, expanding its biomaterials portfolio.

Nanoform and Boehringer Ingelheim have executed a master services agreement in relation to pre-clinical development projects.

EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.

WuXi STA has finalized its acquisition of Bristol Myers Squibb’s drug product manufacturing facility based in Couvet, Switzerland.

Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.

Bioiberica has received certification of its CSR management system as aligned with the United Nations Sustainable Development Goals.

The University of Sheffield has launched an innovative gene therapy program that could pave the way for novel treatments for neurodegenerative diseases.

A global safety database analysis has demonstrated no increased incidence of thrombosis with TTS after the second dose of Vaxzevria.

CMA fines Advanz and investors for more than £100 million (approximately US$139 million) after the company increased the price of thyroid tablet packs from £20 (US$23.74) in 2009 to £248 (approximately US$295) in 2017.

The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.

Kineret (anakinra) is under evaluation by EMA's CHMP as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.

EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.

ERS Genomics and Japan SLC have signed a non-exclusive license agreement, allowing Japan SLC access to ERS Genomics’ CRISPR/Cas9 patent portfolio.

Byondis and Glycotope have formed an agreement to discover and develop antibodies that target specific glyco-epitopes.

Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.

Exscientia and GT Apeiron Therapeutics have entered into a strategic R&D oncology collaboration agreement.

Specialty pharmaceutical company, Advanz Pharma, has launched a generic version of lanreotide, MYTOLAC, in Germany.

Catalent commences the first phase of a $100-million expansion program Anagni site to increase its manufacturing capabilities for biologics drug substance.

The European Commission has granted marketing authorization to bluebird bio for its gene therapy SKYSONA for the treatment of early CALD.

A new report by Radnor Capital Partners and commissioned by the BIA has shown that international investors are being drawn toward the biotech sector of the UK.

Aptamer Group has signed a contract with a global pharmaceutical company to use Optimers to support innovative vaccine development for neurodegenerative disease.

CDMO Idifarma has launched a new service aimed at delivering an accelerated pathway for complex drugs.

EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.