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EMA

Showing 15 posts of 400 posts found.

EMA to review Pfizer’s Xeljanz for patients with rheumatoid arthritis

March 24, 2016
Research 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) …

News
christa_wirthumer-hoche

European Medicines Agency elects Christa Wirthumer-Hoche as new chair of management board

March 21, 2016
Medical 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 …

Appointment
celatorpharmalogo

Celator’s shares jump on positive late-stage trials for leukaemia drug

March 16, 2016
Business 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 …

News
xalkori

FDA approves Pfizer sNDA for Xalkori

March 14, 2016
Research 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 …

News
gilead-sciences

EMA starts review of Gilead Sciences’ Zydelig following safety concerns

March 14, 2016
Research 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 …

News
ema_logo

EMA launches PRIME scheme

March 8, 2016
Manufacturing 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 …

News
ema_logo

EMA recommends AZ/Acerta drug for orphan status in three indications

February 25, 2016
Research 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 …

News
Lundbeck HQ

Lundbeck gets go-ahead for US and EU licence expansions

February 4, 2016
Medical 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 …

News
EMA inside

Actelion’s Uptravi and rare bleeding disorder drug get positive EMA decisions

February 1, 2016
Sales 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 …

News
Empliciti pack shot

EMA fast-tracks BMS multiple myeloma drug

February 1, 2016
Sales 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 …

News

Samsung beats pharma to develop first EU-approved Enbrel biosimilar

January 18, 2016
Manufacturing 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 …

News
Eisai

Eisai submits new cancer combo to EMA for approval

January 12, 2016
Sales 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 …

News
Gilenya

EMA adds warning label to Novartis’ MS treatment Gilenya

December 22, 2015
Manufacturing 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), …

News
sir_kent_woods

EMA management board chair stands down

December 21, 2015
Manufacturing 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. …

Appointment
EU flag

Three AstraZeneca drugs recommended by EMA committee

December 21, 2015
Sales and Marketing AstraZeneca, Brilique, CHMP, EMA, Portrazza, Tagrisoo, lesinurad, lilly

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended several new drugs in its latest meeting, including …

News
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