EMA
Three AstraZeneca drugs recommended by EMA committee
December 21, 2015Sales 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 …
EMA sets out new five-year plan
December 9, 2015Research and Development EMA, Guido Rasi
The European Medicines Agency’s (EMA) new executive director, Professor Guido Rasi, outlined his vision for his five-year mandate at the …
Janssen submits Stelara for EU approval for Crohn’s
December 9, 2015Sales and Marketing Crohn’s disease, EMA, European Medicines Agency, Janssen, Stelara, crohn's disease, ustekinumab
Janssen today announced that it has submitted an application to the European Medicines Agency, seeking approval of Stelara in Crohn’s …
Gilead awaits EU decision on hep C combo treatment
December 8, 2015Research and Development EMA, Gilead, SOF/VEL, accelerated assessment, hepatitis C, sovaldi, velpatasvir
The EMA has granted Gilead Sciences an accelerated assessment for its application for a new Sovaldi combination treatment.The combination contains …
New regulatory submissions for AbbVie and Novo Nordisk
December 4, 2015Medical Communications AbbVie, EMA, FDA, Novo Nordisk, Viekira Pak, insulin aspart
AbbVie and Novo Nordisk have submitted new drug applications to the US FDA and European Medicines Agency (EMA) respectively. The …
EMA concludes HPV vaccines do not cause CRPS or POTS
November 9, 2015Sales and Marketing EMA, HPV, HPV vaccine, PRAC, complex regional pain syndrome, drug safety, postural orthostatic tachycardia syndrome
The European Medicines Agency says there is no evidence from a detailed scientific review of reports linking complex regional pain …
EMA launches scheme to prioritise medicines access for patients
October 27, 2015Manufacturing and Production EMA, European Medicines Agency, medicines access
The EMA has launched a public consultation on a scheme which aims to enable access to more medicines.The PRIME scheme …
GSK’s Volibris gets pulmonary arterial hypertension approval in Europe
October 26, 2015Research and Development, Sales and Marketing EMA, GSK
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion …
EMA appoints Guido Rasi as executive director
October 9, 2015Medical Communications, Sales and Marketing EMA, Guido Rasi
The European Medicines Agency’s (EMA’s) Management Board has nominated Professor Guido Rasi as the Executive Director of the Agency. The …
UCB plots new Vimpat submissions after positive monotherapy results
October 8, 2015Research and Development EMA, European Medicines Agency, UCB, carbamazepine, epilepsy, lacosamide, phase III, vimpat
A Phase III non-inferiority study comparing UCB’s Vimpat with carbamazepine suggests the two drugs can be used as monotherapy treatments. …
EMA launches project to boost early patient access to drugs
September 8, 2015Research and Development EMA, European Medicines Agency, MAPPs, adaptive pathways, drug development, market access
The EMA is launching an adaptive pathway project to bring new medicinal products to market in Europe. The ADAPT SMART …
Standardising the pharma benefit-risk assessment process
September 1, 2015Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, FDA, benefit-risk analysis, pharmacoepidemiology, pharmacovigilance
Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view …
Abbvie and Roche report success in Phase II leukaemia trial
August 13, 2015Research and Development AbbVie, Breakthrough Therapy Designation, CLL, EMA, FDA, Roche, chronic lymphocytic leukaemia, leukaemia, venetoclax
AbbVie plans to submit regulatory applications for its leukaemia drug venetoclax to the FDA and the EMA before the end …
FDA and EMA approve heart drug Praluent
July 27, 2015Sales and Marketing EMA, FDA, PCSK9, Regeneron, Sanofi, high cholesterol, praluent
The FDA and the EMA have both approved Sanofi and Regeneron’s new high cholesterol drug Praluent. Regulators on both sides …
EMA backs GSK’s malaria vaccine for use in Africa
July 24, 2015Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CHMP, Committee for Medicinal Products for Human USE, EMA, European Medicines Agency, GSK, WHO, malaria, world health organization
GSK has taken a significant step forward toward being the first company to bring a malaria vaccine to market, after …
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