EU
EU-US reach landmark deal on mutual recognition of manufacturing inspection
March 3, 2017Medical Communications EMA, EU, FDA, US
The European Union and the US has announced that an agreement has been made to mutually recognise inspection of drug …
Myelofibrosis market to increase to be worth over $1 billion by 2025
November 16, 2016Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EU, US, myelofibrosis
The myelofibrosis market is expected to grow from $545.2 million in 2015 to $1.02 billion by 2025, almost doubling in …
Pfizer’s breast cancer drug gets EU approval
November 10, 2016Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, EU, Novartis, Pfizer, ibrance
Pfizer is celebrating the approval by the European Union of its breast cancer drug Ibrance, following a positive recommendation from …
Adents and Microsoft pool resources to create new cloud platform
October 27, 2016Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Adents, EU, France, Microsoft
Adents, a French software developer for unique production identification and ‘Track & Trace’ solutions, and Microsoft have developed, with an …
EMA opens clinical trial data to public
October 25, 2016Manufacturing and Production Amgen, AstraZeneca, EMA, EU, Kyprolis, clinical reports, clinical trials
The European Medicine Agency has begun to release to the public data on clinical trial via their own website. The …
€10.2 billion lost every year across the EU due to fake medicines
September 30, 2016Manufacturing and Production, Medical Communications EU, European Union Intellectual Property Office, France, Germany, Italy, Spain, united kingdom
A report commissioned by the European Union Intellectual Property Office has shown that a staggering amount of money, €10.2 billion, …
European Commission approves new RA treatment from BMS
September 6, 2016Research and Development, Sales and Marketing BMS, Bristol-Myers Squibb, EMA, EU, Orencia, RA, abatacept, approval, rheumatoid arthritis
Bristol-Myers Squibb has received approval from the European Commission for rheumatoid arthritis (RA) treatment Orencia (abatacept), making it the first …
Gilead gets EU approval for HIV-prevention treatment Truvada
August 23, 2016Manufacturing and Production, Sales and Marketing EU, Gilead, HIV, PrEP, Truvada, prevention
Gilead Sciences has received marketing authorisation from the European Commission for once-daily Truvada (emtricitabine/tenofovir disoproxil), in combination with safer sex …
EU grants marketing authorisation for Teva’s asthma drug Cinqaero
August 19, 2016Medical Communications, Sales and Marketing EU, Teva, approval, asthma, cinqaero, eosinophilic
The European Commission has granted marketing authorisation for Teva’s Cinqaero (reslizumab), as an odd-on therapy in adult patients with severe …
MSD scores EU approval for Keytruda in lung cancer
August 3, 2016Research and Development, Sales and Marketing EU, MSD, Merck, approval, keytruda, lung cancer
MSD, called Merck in the US and Canada, has announced that the European Commission has approved Keytruda (pembrolizumab) for patients …
IBS-D treatment Truberzi receives positive opinion from CHMP
July 26, 2016Manufacturing and Production, Sales and Marketing Allergan, EU, Truberzi, diarrhoea. CHMP, irritable bowel syndrome
Global pharmaceutical company Allergan has announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of …
AbbVie scores EU recommendation for shorter treatment of Viekirax in hepatitis C
July 25, 2016Research and Development, Sales and Marketing EU, Gilead, Viekirax, hepatitis C
AbbVie has received an EU recommendation for a shorter treatment duration of Viekirax (ombitasvir/paritaprevir/ritonavir) plus ribavirin in genotype 4 chronic …
EU recommends PrEP in Gilead’s HIV prevention treatment
July 25, 2016Research and Development, Sales and Marketing EU, Gilead, HIV, PrEP, prevention
Gilead has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines …
Shire receives positive EU opinion for pancreatic cancer drug
July 25, 2016Research and Development, Sales and Marketing CHMP, EU, Pancreatic cancer, Shire
Shire has announced that the EU regulator’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion …
Opdivo to go before EU, US regulators in head and neck cancer
July 19, 2016Manufacturing and Production, Research and Development EMA, EU, FDA, US, head and neck cancer, opdivo
Bristol-Myers Squibb has announced that its lead oncology drug, Opdivo (nivolumab), is set to go before regulators in the US …
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