PharmTech Europe News

The agency is advising healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine for potential side effects.

Incyte and MorphoSys have revealed that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for tafasitamab, an anti-CD19 antibody.

SeraNovo and Carna Biosciences have announced a second license agreement that will expand the existing partnership to include joint development of an oral formulation of Carna’s kinase inhibitor.

The UK BioIndustry Association has stated its support of a government led funding initiative, Future Fund, which will support innovative companies in the United Kingdom that will help to ensure the country’s leading position in science, innovation, and technology.

Biopharmaceutical company, Atriva Therapeutics, has announced, in a May 28, 2020 press release, that it will develop ATR-002, an oral small molecule, for treatment of patients with moderate-to-severe COVID-19 that require hospitalization in a Phase II study.

The Health Products Regulatory Authority (HPRA) has granted Wasdell Group an Investigational Medicinal Product (IMP) license for its European headquarters based in Dundalk, Ireland.

Global pharmaceutical company, Advanz Pharma, has closed its acquisition of specialty pharmaceutical company, Correvio Pharma.

The European Medicines Agency is emphasizing the need for the research community to pool resources to determine which COVID-19 treatments and preventions are safe and effective.

The International Coalition of Medicines Regulatory Authorities held a virtual meeting of regulators from around the world to discuss policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic.

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events met on May 13, 2020 to discuss measures the European Union is taking to ensure the availability of medicines during the COVID-19 pandemic.

Vibalogics is contracted to manufacture Janssen's COVID-19 candidate vaccine at its GMP-accredited facility in Cuxhaven, Germany.

The CHMP has issued a recommendation that the compassionate use of remdesivir be expanded in the treatment of more patients with severe COVID-19 symptoms.

The Center for iPS Cell Research and Application Foundation and the Cell and Gene Therapy Catapult have announced the launch of a new collaborative research project that will focus on induced pluripotent stem cell characterization.

Santen Pharmaceutical has concluded a licensing agreement with jCyte for the development, registration, and commercialization rights to jCell, an investigational retinitis pigmentosa therapy, in Japan, Asia, and Europe.

In light of the current social distances measures, in place as a result of COVID-19, IMA Digital, part of IMA Group, has been providing virtual experiences for those interested in packaging and processing.

A rolling review of data on the use of remdesivir, an investigational antiviral medicine, for the treatment of COVID-19 has been started by EMA’s Committee for Medicinal Products for Human Use.

A high-level meeting on COVID-19 policies, organized by EMA under the auspice of the International Coalition of Medicines Regulatory Authorities (ICMRA), has brought together global regulators to ensure a coordinated pandemic response.

CMO Evonik begins capacity expansion of APIs and intermediates at its sites in Dossenheim and Hanau Germany to increase EU supply security for drug products.

EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.

Supplier of punches and dies to tablet producers, I Holland, has reported that it will be revisiting its webinar series, investigating best practices in tablet manufacture, for those currently working from home.

Private equity firm, Ampersand Capital Partners, has made a majority investment into contract packaging organization (CPO), Tjoapack.

The Cambridge Design Partnership and the Stevanato Group have announced a partnership that will see the development of a new pen-injector based on the Axis-D technology and IP licensed from Haselmeier in 2019.

ILC Therapeutics, a biotech company based in the United Kingdom, has discovered two separate novel treatments for patients suffering with COVID-19 prior to needing ventilators.

AstraZeneca and the University of Oxford have announced that they will collaborate on the global development and distribution of the university’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection.

The statement, published by the International Coalition of Medicines Regulatory Authorities, outlined its commitment to a strengthening of global collaboration in the fight against COVID-19.

A UK BioIndustry Association industry-led vaccine manufacturing group has welcomed a recent announcement by the government of the UK, that it will receive £14 million (US$17.3 million) in investment to rapidly scale up the development of vaccines for COVID-19.

MicrofluidX has raised £1.4 million (US$1.7 million) in seed funding, which it will use to develop its novel cell bioprocessing technology for cell and gene therapy.

A report into the Swiss biotech sector has shown that there is continued growth in the sector, which has received investments from public and private companies worth CHF 1.2 billion (US$1.2 billion).

Technical services and regulatory affairs consulting group, Diamond Pharma Services, has announced its acquisition of PharmaCentral-a pharmacovigilance services and medical affairs business based in Dublin, Ireland.

The Commission of Human Medicines Expert Working Group has concluded that there is insufficient evidence to link ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), with susceptibility for contracting COVID-19 or worsening symptoms.