EMA

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EMA set to also revise guidelines of Alzheimer’s trials

February 28, 2018
Medical Communications Alzheimer's, EMA, FDA, biotech, drugs, pharma, pharmaceutical

The EMA, following on from the FDA’s lead earlier this month, has announced that it will revise its guidelines on …

Novo’s Ozempic secures European approval in type 2 diabetes

February 12, 2018
Sales and Marketing EC, EMA, Europe, Novo Nordisk, diabetes, pharma

Novo Nordisk has revealed that its drug Ozempic (semaglutide) has received approval from the European Commission (EC) as a monotherapy …

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New Year, new goals

February 8, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CRUK, Cancer Research UK, Chiesi, EMA, FDA, Genetic Alliance, pharma

With the New Year begun in earnest, Pharmafocus speaks to a range of players in pharma and the life sciences …

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Italy refuses to give up hope on EMA HQ

January 30, 2018
Medical Communications, Research and Development EMA, amsterdam, biotech, drugs, pharma, pharmaceutical

It is no secret that Milan was not best pleased that it was pipped to the post to host the …

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Santhera’s Raxone rejected in Europe for Duchenne muscular dystrophy

January 29, 2018
Sales and Marketing Duchenne Muscular Dystrophy, EMA, Europe Santhera, pharma

While the EMA’s Committee for Medicinal products for Human Use (CHMP) recommended a spree of treatments over the past week, …

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Novartis’ CAR T therapy Kymriah scores accelerated approval in both Europe and US

January 17, 2018
Research and Development, Sales and Marketing CAR T, CAR-T, EMA, Europe, FDA, Kymriah, Novartis, US, pharma

Following up last year’s ground-breaking news that CAR T therapy Kymriah had become the first such treatment to be approved …

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Samsung Bioepis’ Ontruzant becomes first Herceptin biosimilar approved in Europe

November 20, 2017
Sales and Marketing EMA, Herceptin, Roche, Samsung Bioepis

Samsung Bioepis has announced that Ontruzant, the company’s biosimilar version of Roche’s Herceptin, has been awarded marketing authorisation in Europe …

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EMA Headquarters: There’s no place like home

November 13, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, biotech, brexit, drugs, pharma, pharmaceutical

With the result of the Brexit referendum, the future of the EMA’s London headquarters was cast in doubt. Now, 19 …

MSD withdraws European application of Keytruda combo in lung cancer

October 30, 2017
Sales and Marketing EMA, MSD, keytruda

MSD has been forced to withdraw its EU marketing application for Keytruda (pembrolizumab) in combination with pemetrexed and carboplatin as …

EMA responds to criticism of its cancer drug approvals

October 17, 2017
Manufacturing and Production, Medical Communications Cancer, EMA, biotech, drugs, oncology, pharma, pharmaceutical

The EMA received a broadside just less than two week ago from a group of researchers that had studied data …

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57% of cancer drugs uses approved by EMA show no benefit

October 5, 2017
Sales and Marketing EMA, biotech, drugs, oncology, pharma, pharmaceutical

A new study conducted by King’s College London and LSE has found that of 48 treatments approved between 2009 and …

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