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Marketing Authorisation (MA)

The first allogenic stem cell therapy — Alofisel (darvadstrocel) from TiGenix and Takeda Pharmaceutical Company — has received marketing authorisation approval from the EC for the treatment of complex perianal fistulas in Crohn’s disease more

News

Amgen and Allergan have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorisation of ABP 980, a biosimilar to Herceptin (trastuzumab). more

News

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Juluca treatment for HIV-1. more

News

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the marketing authorisation of Lynparza (olaparib) tablets for patients with platinum-sensitive relapsed ovarian, fallopian tube, or primary perito more

News

The European Commission (EC) has revealed its decision to grant conditional marketing authorisation to Kyowa Kirin for Crysvita (burosumab) to treat X-linked hypophosphatemia (XLH) with radiographic evidence of bone disease in children & adolescents more

The European Medicines Agency (EMA) has accepted the conditional marketing authorisation application for avacopan in the treatment of patients with anti-neutrophil cytoplasmic antibody associated vasculitis. more

News

GlaxoSmithKline (GSK) has announced that its once-daily single inhaler triple therapy, Trelegy Ellipta, for the treatment of chronic obstructive pulmonary disease (COPD) has been granted marketing authorisation by the European Commission. more

Technology

The US Food and Drug Administration (FDA) has granted marketing authorisation to an electric stimulation device aimed at helping to reduce the symptoms associated with opioid withdrawal. more

Technology

Global pharmaceutical company, Mylan, has announced that its partner Synthon has received European marketing authorisation approval for its generic, Glatiramer Acetate injection, to treat patients with relapsing forms of multiple sclerosis (MS). more

News

The European Commission (EC) has granted marketing authorisation to Sanofi and Regeneron Pharmaceuticals for dupilumab (Dupixent) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. more

News

Science and technology company, Merck, has announced the availability of Mavenclad (cladribine tablets) in the UK and Ireland for the treatment of adults with highly active relapsing multiple sclerosis (MS). more

News

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the marketing authorisation in the EU for Janssen-Cilag International’s guselkumab — a treatment for moderate to severe plaque psoriasis. more

News

Dr Rajendra Wable, subject matter expert-medical writing and regulatory affairs at ‎Sciformix Corporation, discusses how marketing authorisation applications across Europe, Australia and other countries can be supported with non-clinical overviews more

Opinion

Dermatology specialist, LEO Pharma, has announced that the European Commission (EC) has granted marketing authorisation for its new biologic, Kyntheum (brodalumab), for the treatment of moderate-to-severe plaque psoriasis in adults within the EU. more

News

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion, recommending that biosimilar Imraldi be granted marketing authorisation. more

News

Sanofi and Regeneron Pharmaceuticals have announced that the European Commission (EC) has granted marketing authorisation of Kevzara in combination with methotrexate for the treatment of moderately to severely active rheumatoid arthritis in adults more

News

Veltassa (patiromer), developed by Relypsa, has received a recommendation for marketing approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of hyperkalaemia. more

News

Sanofi and Regeneron have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the marketing authorisation of Kevzara (sarilumab). more

News

The CHMP has given a positive opinion recommending that Biogen’s treatment for patients with spinal muscular atrophy (SMA), SPINRAZA (nusinersen), be granted marketing authorisation. more

News

It is very important to work with experienced US/EU-based regulatory and market intelligence partners. more

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