The UK’s referendum decision to leave the EU in May 2016 undoubtedly sent shockwaves throughout Europe. European countries are still struggling to interpret what ‘Brexit’ will mean for them. Ireland,
Tag "European Medicines Agency"
A retrospective cohort study, published in the British Medical Journal, has found no conclusive evidence that most oncology treatments approved for use by the European Medicines Agency (EMA) offered survival
The publication on Saturday of the EU Commission’s unranked and unshortlisted assessment of the 27 bids from member states to host the London-based European Banking Authority (EBA) and the European
Losing valuable staff is the major concern in the impending relocation of the European Medicines Agency. The agency which is responsible for the evaluation, authorisation and pharmacovigilance of all medicines
The Brexit-inspired need to move the London HQ of the European Medicines Agency will throw up two major risks when it comes to patients and the approval of new medicines,
UCB has announced that the European Commission (EC) has approved expanding the use of its anti-epileptic drug (AED) Vimpat (lacosamide) as monotherapy and adjunctive therapy in the treatment of partial-onset
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) discussed the safety reviews of a variety of medications during its June 2017 meeting. The medicines in review included treatments for
The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. Biosimilars are biological medicines that are highly similar in all essential aspects
European regulators have accepted for review Sandoz’ marketing applications for biosimilars to AbbVie’s Humira (adalimumab) and Janssen’s Remicade (infliximab). The company is seeking approval for its biosimilars for use in
The European Medicines Agency (EMA) has approved Aptar Pharma’s integrated electronic nasal lockout device (e-Lockout) following a multi-year development with Takeda Pharmaceuticals International. Aptar Pharma agreed to supply Takeda with its
The European Medicines Agency (EMA) has approved Zebinix (eslicarbazepine acetate) for use as once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy. It is already indicated in Europe as an
The European Medicines Agency (EMA) met with a delegation from the East African Community (EAC) from May 18–19, 2017 as part of the agency’s collaboration with African regulators. The meeting
On May 22, 2017, the European Medicines Agency (EMA) announced that its Pharmacovigilance Risk Assessment Committee has completed an audit and evaluation of the new EudraVigilance information system for tracking
Even before European officials present the groundwork for relocating the bloc’s drug regulator, a fight has emerged between countries vying for the economic lift and status that come with hosting the
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval to expand the use of Novartis’ Zykadia (ceritinib) in anaplastic lymphoma kinase (ALK)-positive non-small cell
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
Cinfa Biotech announced trial results for a biosimilar of Amgen’s Neulasta, a multi-billion blockbuster to treat chemotherapy-induced neutropenia. Cinfa Biotech is a Spanish company specialized in developing biosimilars. The biotech
The European Medicines Agency’s (EMA) 2016 annual report focuses on the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and
Ireland has stepped up its bid to host the European Medicines Agency (EMA) with the official announcement being delivered and reiterated by Minister of Health, Simon Harris over the past
The European Commission has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC). The
The European Medicines Agency (EMA) wants to suspend around 300 marketed generic meds (and applications) coming out of Indian CRO Micro Therapeutic Research Labs due to concerns over “misrepresentation of
Apeiron Biologics has announced that the EMA’s CHMP has recommended the approval of APN311 for immunotherapy of high risk neuroblastoma.
The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic
The move by Great Britain to step away from the European Union may be sending chills of uncertainty to many
Representatives from the European Medicines Agency (EMA) met with medicines regulators from Africa last week to discuss how to improve
Abeona Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing gene therapies for life-threatening rare diseases, announced today that the
Mundipharma is gearing up to launch biosimilar Truxima in seven European markets for the treatment of certain cancers and inflammatory
UK-based rare and speciality diseases group Mereo BioPharma says its brittle bone disease drug BPS-804 has been accepted to participate
Johnson & Johnson is counting on new buy Actelion’s pulmonary arterial hypertension (PAH) meds to provide a top-line boost once
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