PharmTech Europe News

Medical dermatology company based in Denmark, Leo Pharma, has entered into a license agreement with two Eastern-Asian companies for the development and commercialization of FB825, a novel atopic dermatitis and allergic asthma drug candidate.

Dutch company HALIX has announced it is joining a consortium of partners that are all under the guidance of the University of Oxford to provide good manufacturing practice (GMP) manufacturing services for a COVID-19 vaccine.

Biopharmaceutical company, TScan Therapeutics, has entered into a collaboration agreement with Novartis that is aimed at the discovery and development of novel T-cell receptor (TCR) therapies for solid tumors.

Late-stage pharmaceutical company based in San Diego, MEI Pharma, and Japanese drug discovery company, Kyowa Kirin, have entered into a global license, development, and commercialization agreement for ME-401.

AstraZeneca has announced it will be commencing a randomized, global clinical trial to assess the efficacy and safety of Calquence (acalabrutinib) in treating the exaggerated immune response of patients with COVID-19.

Sanofi and GlaxoSmithKline (GSK) have revealed that they are joining forces to develop an adjuvanted vaccine using their respective technologies that can be used to fight COVID-19.

The task force will assist in the developing, authorizing, and monitoring of treatments of COVID-19.

The guidance answers questions on changes made to the regulatory framework to address challenges during the COVID-19 pandemic.

EMA's CHMP has recommended the use of remdesivir, an investigational antiviral medicine, in compassionate use programs across the European Union.

Horizon Discovery has announced that it has expanded its cell-based clustered regularly interspaced short palindromic repeats (CRISPR) screening services to include primary human B cells, which complements the T cell screening service.

Belgian biopharmaceutical company, UCB, has successfully completed its acquisition of Ra Pharmaceuticals, which is now a wholly-owned subsidiary of the company.

The agency has been tasked with coordinating efforts to mitigate shortages of medicines within Europe during the COVID-19 pandemic.

Specialty pharmaceutical company, Diurnal, has announced that the marketing authorization application (MAA) for Chronocort has passed validation with the European Medicines Agency (EMA).

N4 Pharma will be undertaking a proof-of-concept research project using a COVID-19 DNA plasmid to demonstrate the ability of its delivery system, Nuvec, to collaborative partners developing DNA or RNA vaccines.

Prior to the global market downturn, data from the United Kingdom BioIndustry Association (BIA) and Informa Pharma Intelligence have revealed that biotech companies in the UK had raised £309 million (US$379 million).

AstraZeneca has announced that it has achieved approval in Japan for Lokelma (sodium zirconium cyclosilicate) for the treatment of patients with hyperkalemia (elevated blood potassium levels).

Mylan and Pfizer announced a postponement of the transaction that would see Mylan and Upjohn Combined until the second half of the year as a result of the current COVID-19 pandemic.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the latest statement by the members of the European Council on efforts to tackle COVID-19.

AstraZeneca has revealed that it will collaborate with Silence Therapeutics on the discovery, development, and commercialization of small interfering RNA (siRNA) therapeutics for the treatment of cardiovascular, renal, metabolic, and respiratory diseases.

Grifols has entered into a formal collaboration with US Federal public health agencies, including the Biomedical Advanced Research Development Authority (BARDA) and the Food and Drug Administration (FDA), to produce a treatment that specifically targets COVID-19.

In light of the current COVID-19 pandemic, the agencies co-chaired the first global regulators meeting to facilitate development of vaccines against SARS-CoV-2, which causes COVID-19.

Belgian-based bioprocessing provider, Univercells, has launched a CDMO, Exothera, that will support developers of cell and gene therapies through process development and production of viral vectors.

In a daily press briefing on March 18, 2020, the World Health Organization (WHO) announced that, along with its partners, it will be organizing a large international study that will compare various untested treatments for COVID-19.

Synairgen, a respiratory drug discovery and development company, has announced that it has received expedited approvals to conduct a trial of its inhaled formulation of interferon-beta-1a, SNG001, in COVID-19 patients.

The partners have initiated an observational case-control study of siltuximab in patients with COVID-19 who have developed serious respiratory complications.

Evonik has announced that it has developed a collagen platform that has been made with fermentation-based processes and does not use any animal or human-derived materials.

The Pharmacovigilance Risk Assessment Committee (PRAC) of EMA has recommended that women stop taking 5-mg ulipristal acetate (Esmya and generic medicines) for the treatment of uterine fibroids while a safety review into potential liver injury risk is performed.

Following reports, that are particularly circulating social media, questioning whether non-steroidal anti-inflammatories (NSAIDs), such as ibuprofen, worsen COVID-19, the European Medicines Agency (EMA) has issued advice.

On March 11, 2020, Chancellor Rishi Sunak delivered the 2020 Budget to the government of the United Kingdom, revealing the proposed spending and tax plans for the conservative government for the coming year.

The National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Teva Pharmaceutical’s migraine therapy, Ajovy (fremanezumab).