EMA
Amicus Therapeutics’ Fabry disease drug gets European regulatory support
April 4, 2016Research and Development, Sales and Marketing Amicus Therapeutics, EMA, Fabry disease, genetic disorder, rare disease
Shares in biotechnology firm Amicus Therapeutics (Nasdaq: FOLD) rose to close up nearly 3% after the European regulators announced backing …
EMA to review Pfizer’s Xeljanz for patients with rheumatoid arthritis
March 24, 2016Research and Development, Sales and Marketing EMA, Pfizer, Xeljanz, approval, authorisation, marketing, review, rheumatoid arthritis
Pfizer (NYSE: PFE) has announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) …
European Medicines Agency elects Christa Wirthumer-Hoche as new chair of management board
March 21, 2016Medical Communications, Research and Development Christa Wirthumer-Hoche, EMA, European Medicines Agency, chair, chairperson, wirthumer-hoche
Christa Wirthumer-Hoche has been elected chair of the management board of the European Medicine’s Agency. She has served as vice …
Celator’s shares jump on positive late-stage trials for leukaemia drug
March 16, 2016Business Services, Research and Development, Sales and Marketing Celator Pharmaceuticals, EMA, US FDA, Vyxeos, drug trials, phase III
Shares in trial-stage Celator Pharmaceuticals (Nasdaq: CPXX) soared gaining over four times in value as the company announced late-stage trials …
FDA approves Pfizer sNDA for Xalkori
March 14, 2016Research and Development, Sales and Marketing Cancer, EMA, NSCLC, Pfizer, Xalkori (crizotinib)
The US FDA has approved Pfizer’s supplemental new drug application (sNDA) for its kinase inhibitor Xalkori in treating patients with …
EMA starts review of Gilead Sciences’ Zydelig following safety concerns
March 14, 2016Research and Development, Sales and Marketing EMA, Gilead Sciences, blood cancer, clinical trials, zydelig
Regulators in Europe have initiated a safety review of Gilead Sciences’ (Nasdaq: GILD) blood cancer drug Zydelig (idelalisib) following reports …
EMA launches PRIME scheme
March 8, 2016Manufacturing and Production, Research and Development EMA, Guido Rasi, PRIME
The European Medicines Agency (EMA) has launched its new PRIME (priority medicines) scheme, which aims to strengthen support to medicines …
EMA recommends AZ/Acerta drug for orphan status in three indications
February 25, 2016Research and Development AstraZeneca, EMA, Orphan Drugs
The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has recommended AstraZeneca and Acerta’s acalabrutinib (ACP-196) for designation …
Lundbeck gets go-ahead for US and EU licence expansions
February 4, 2016Medical Communications, Sales and Marketing Abilify, EMA, FDA, Lundbeck, Otsuka, Takeda, aripiprazole, brintellix, vortioxetine
Lundbeck has earned two recommendations from regulatory committees of the FDA and the EMA, which both recommended the company’s drugs …
Actelion’s Uptravi and rare bleeding disorder drug get positive EMA decisions
February 1, 2016Sales and Marketing CHMP, EMA, Uptravi, pulmonary arterial hypertension, selexipag
The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMA, has issued positive opinions on …
EMA fast-tracks BMS multiple myeloma drug
February 1, 2016Sales and Marketing AbbVie, BMS, Bristol-Myers Squibb, EMA, Empliciti, myeloma
The EMA has recommended granting a marketing authorisation for Bristol Myers-Squibb and AbbVie’s immunotherapy Empliciti for the treatment of multiple myeloma. The …
Samsung beats pharma to develop first EU-approved Enbrel biosimilar
January 18, 2016Manufacturing and Production Benepali, CHMP, EMA, Enbrel, Samsung, Samsung Bioepis, etanercept, positive opinion
Samsung Bioepis – the collaboration between Samsung Biologics and Biogen Idec, has become the first company to have a biosimilar …
Eisai submits new cancer combo to EMA for approval
January 12, 2016Sales and Marketing Afinitor, EMA, Eisai, Lenvima, MAA, Novartis, everolimus, lenvatinib
Eisai has submitted a new Marketing Authorisation Application to the EMA for the combination of Lenvima and Novartis’ Afinitor for …
EMA adds warning label to Novartis’ MS treatment Gilenya
December 22, 2015Manufacturing and Production EMA, European Medicines Agency, FDA, Novartis, PML, basal cell carcinoma, fingolimod, gilenya
Drug safety regulators in Europe have said they will add warnings to the label and prescribing information of Gilenya (fingolimod), …
EMA management board chair stands down
December 21, 2015Manufacturing and Production, Sales and Marketing EMA, European Medicines Agency, Sir Kent Woods
Sir Kent Woods will step down as chair of the board at the EMA from the end of December 2015. …
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