PharmTech Europe News

EMA, along with its partners across the European medicines regulatory network, are keeping a close watch on the pharmaceutical supply chains in the European Union as a result of the potential impact of COVID-19.

European Union and national authorities are continuing to work on the prevention and management of nitrosamine impurities in medicines.

The Indian government has issued a notification of the restriction on the export of 26 APIs and formulations, including paracetamol, progesterone, and vitamin B12, as a result of the outbreak of COVID-19.

The global safety organization of Novartis is in the process of conducting a comprehensive review of a limited number of cases where patients treated with Beovu (brolucizumab) have experienced severe vision loss, inflammation, and potential retinal vasculitis.

The conference, which was originally scheduled for March 31–April 3, 2020 at the Messe München in Germany, will be rescheduled for Oct. 19–22, 2020 at the same location.

The technology enables the rapid production of large numbers of recombinant antibodies at 80-mL scale.

Thermo Fisher Scientific has announced that its acquisition proposal for Qiagen has been unanimously approved by the company’s managing board and board of directors.

CN Bio Innovations has raised $9 million (£6.9 million) in investment funding that will be used to support commercial development and strengthen market position in the United States

GW Pharmaceuticals and Bayer have revealed that GW will regain the exclusive commercialization rights for Sativex (delta-9-tetrahydrocannabinol [THC] and cannabidiol [CBD]) in the UK.

Full-service contract research organization, Pivotal, has announced its acquisition of Akcelis, a Belgian company that specializes in patient engagement, recruitment, and retention.

A study finds a potential risk of persistent visual side-effects in male patients taking the highest recommended dose of sildenafil.

Outsourcing stability testing to full-service providers can offer comprehensive benefits to bio/pharma companies.

The huge potential of biopharma is presenting an important epoch for outsourcing partners that can support the development and manufacture of biologics in an efficient way.

Generic pharmaceutical company, Hikma Pharmaceuticals, and the Swiss subsidiary of Glenmark Pharmaceuticals, Glenmark Specialty, have signed an exclusive license agreement for the commercialization of Ryaltris in the United States.

German-based company, Insilico Biotechnology, has announced that it has opened its first subsidiary in the United States, specifically in Boston, MA, which is a biopharmaceutical hub in the country.

Water Street Healthcare Partners, a strategic investor that is focused on the healthcare industry, has agreed to invest in Solvias, a global pharmaceutical laboratory services business.

ABPI has issued a statement noting that it shares the ambition of the United Kingdom’s government, as set out in its published approach to the negotiations for the future relationship with the European Union (EU).

The All-Party Parliamentary Group (APPG) for Life Sciences, aimed at raising awareness of the United Kingdom’s life sciences among parliamentarians and to explore the challenges and opportunities facing the sector, was relaunched on Feb. 27, 2020.

Kyowa Kirin has announced that its treatment for X-linked hypophosphatemia (XLH), Crysvita (burisumab), has been approved by Swissmedic for use in adults, adolescents, and children (1 year and older).

Researchers at the Technical University of Munich (TUM) have discovered a way of continuously and precisely dosing active agents using an oil-hydrogel mixture.

The Office for Life Sciences of the government of the United Kingdom has designated six new locations in the country as ‘Life Sciences Opportunity Zones’, of which the Harwell Science and Innovation Campus is one.

Bio-chromatography development and manufacturing company, BIA Separations, has signed a license agreement with the University of Zagreb to commercialize a novel elution method for virus and viral vector purification.

The European Commission (EC) has approved Pfizer’s treatment for wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), Vyndaqel (tafamidis).

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended that the use of cyproterone be restricted as a result of the potential risk of meningioma.

ERS Genomics revealed that the European Patent Office (EPO) has rejected arguments filed in opposition to patent EP2800811, which is directed to the single-guide CRISPR/Cas9 gene editing system and covers uses in cellular and non-cellular settings.

The Native Antigen Company has commercially introduced antigens that have been specifically derived from the Wuhan strain of novel coronavirus, now named Covid-19.

According to executive search firm Odgers Berndtson, its recent poll has highlighted that senior executives in life sciences believe there is a positive future for the United Kingdom’s sector outside the European Union.

The National Institute for Health and Care Excellence (NICE) has issued guidance in Feb. 2020 stating that it does not recommend the combination therapy of pembrolizumab with axitinib for the treatment of advanced renal cell carcinoma in adults.

The UK and Europe are entering a transitional period, which will involve negotiations across the board, including those on the pharma regulatory landscape.

Amid the rapidly rising cases of a novel coronavirus, concerns are being raised over preparedness and potential disruptions to the pharma supply chain.