PharmTech Europe News

Sandoz, a Novartis division, announced  that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and  etanercept in Europe, for the same indications as the respective reference medicines.

The new suite will be used to produce non-sterile dosage forms, such as metered dose inhalers and semisolid topical products, for clinical studies up to Phase II.

Cobra will increase capacity in response to customer demand for DNA and viral vector production.

The two companies will develop translational biomarkers for fibrotic diseases, including non-alcoholic steatohepatitis (NASH).

The project will foster the translation of nanomedicine applications for the treatment of cardiovascular diseases.

The agency issued its recommendation for the influenza virus strains European vaccine manufacturers should include for 2017.

The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.

Carglumic acid is used in the management of rare, life-threatening inborn metabolic disorders affecting the urea cycle.

GW Pharmaceuticals plans to submit a regulatory filing to FDA and EMA following two positive Phase III trials of Epidiolex in patients with Lennox-Gastaut Syndrome.

The company has secured an additional facility in Hampton, Middlesex, as part of a project to expand its UK-based operations by 15% in 2017.

The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.

The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs

The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.

The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.

The company made a €42 million investment in a new building at its Reinbek site to support the production of biopharmaceuticals.

Having an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.

The agency’s CHMP recommended six drugs for market approval, including one orphan drug, during its February meeting.

The agency’s CHMP recommended conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism.

Under the agreement, Abzena will manufacture magacizumab, an antibody created using the ‘Abzena inside’ Composite Human Antibody technology.

BPS-804, which is being developed for the treatment of osteogenesis imperfecta (brittle bone disease), has been granted orphan drug designation by both FDA and the European Commission.

Sartorius and EMBL have entered into a corporate partnership program to foster advanced training.

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

Baricitinib (Olumiant) is the first JAK inhibitor licensed to treat rheumatoid arthritis in Europe.

EMA announces that the European Union’s PAS Register has received its 1000th upload.

Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.

The £14-million research project aims to better understand adverse drug reactions through a variety of modeling approaches.

The company announced an investment in a new facility in Dundalk, County Louth, Ireland. On Jan. 26, 2017 Almac Group announced that as part of its ongoing global expansion, the company has secured a new facility in Dundalk, County Louth, Ireland. The new facility will be located at IDA Business Park. The new facility will increase the group’s European footprint by 32,000 ft2. The Dundalk facility will be utilized by Almac Pharma Services and Almac Clinical Services.

Novo Nordisk entered a research collaboration with the University of Oxford focused on Type 2 diabetes.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

The companies will split Actellion’s drug discovery and early-stage clinical development assets into a new Swiss biopharmaceutical company.