PharmTech Europe News

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended that Givlaari (givosiran) be granted marketing authorization in the European Union.

The UK BioIndustry Association (BIA) has issued a statement welcoming the publication of the Life Sciences 2030 Skills Strategy, a report setting out how the life sciences sector in the United Kingdom will develop future talent.

Abcam has purchased Applied StemCell’s (ASC’s) gene editing platform and oncology product portfolio, adding comprehensive cell editing capabilities and engine to support expansion of existing “off-the-shelf” cell lines.

The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.

Propess (dinoprostone) from Ferring Pharmaceuticals has achieved approval from the Minister of Health, Labour, and Welfare (MHLW) in Japan, making it the first pharmacological treatment for cervical ripening to be approved in the country for more than 20 years.

As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced.

The amount was the third highest year recorded and investment has increased more than 400% since 2012.

The drug treats adult patients with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity.

Fios Genomics, a spin-out bioinformatics company from Edinburgh University, has entered into a strategic partnership with Charles River Laboratories.

Mereo BioPharma Group and Oncologie have entered a global licensing agreement for the development and commercialization of navicixizumab.

The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health.

The UK’s MHRA has been recognized for its support of the development of an on-demand educational platform leveraging the power of virtual reality (VR), Virtuosi, from Quality Executive Partners (QxP).

Inflazome, a biotech company based in Dublin, Ireland, has announced that the United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO) will grant its patent applications in January 2020.

The UK government announced it will be collaborating with Novartis on the launch of a clinical trial for the company’s new cholesterol treatment, Inclisiran.

Horizon Discovery Group and Mammoth Biosciences have signed a collaboration and license agreement aimed at the development of the next generation of engineered Chinese hamster ovary (CHO) cell lines to improve biotherapeutics production.

The Cell and Gene Therapy Catapult (CGT Catapult) has revealed that the United Kingdom is a favorable environment for cell and gene therapy clinical trials.

ProBioGen and Lava Therapeutics have closed the cell line development and manufacturing agreement for Lava’s novel bispecific antibody lead candidate.

BioMed X and Merck have extended their ongoing collaboration with the commencement of a new joint research group, bringing the total joint projects being undertaken at the BioMed X Innovation Center to six.

Generic pharmaceutical company, Hikma Pharmaceuticals, and biopharmaceutical company, Arecor, have entered into an exclusive agreement for the development and commercialization of a ready-to-use injectable medicine.

Phillips-Medisize has announced that it is expanding its current Global Innovation and Development (GID) site in Struer, Denmark, to include a dedicated manufacturing development and clinical build unit.

Privately owned global pharmaceutical company, Galen, has announced the completion of its acquisition of a boutique healthcare company, POA Pharma.

PhoreMost, a biopharma company based in the United Kingdom, and Boehringer Ingelheim have entered into a multi-project drug discovery collaboration agreement, it was revealed.

A selection of interesting conferences, technical presentations, and Learning Lab presentations as chosen by the editorial team of Pharmaceutical Technology Europe.

Sartorius and the German Research Center for Artificial Intelligence have established a research laboratory for AI in the biopharmaceutical industry.

The divestment of the pharma and food ingredients business is in line with Ferrer’s new strategy to focus on the core business of branded pharmaceuticals.

The European Medicines Agency and its European partners have launched a pilot program for cooperation in the inspection of facilities that manufacture sterile drug products.

Newron Pharmaceuticals has received communications from the United States Food and Drug Administration (FDA) suggesting it discusses its proposed statistical plan in a Type A meeting.

Life science and healthcare business accelerator, Start Codon, and membership organization, One Nucleus, have partnered up to support the life science ecosystem in the United Kingdom.

Swiss-based specialist pharma R&D company, MetP Pharma, has been granted a Notice of Allowance from the Unites States Patent and Trademark Office (USPTO) for its patent titled, “Treatment of Demyelineating Diseases.”

Galderma, a Swiss-based dermatology company that the United States Food and Drug Administration (FDA) has granted breakthrough therapy designation to its investigational therapy, nemolizumab.