European Commission
Europe approves first therapy for haemophilia A with inhibitors in over 20 years
March 1, 2018Research and Development Europe, European Commission, Hemlibra, Roche, haemophilia, pharma
Roche has revealed that its bispecific factor IXa- and factor X-directed antibody Hemlibra (emicizumab) has been approved by the European …
Eli Lilly’s Taltz get EU approval in psoriatic arthritis subgroup
January 24, 2018Research and Development, Sales and Marketing EU, Eli Lilly, Europe, European Commission, Taltz, pharma, psoriatic arthritis
Eli Lilly has revealed that its IgG4 monoclonal antibody Taltz (ixekizumab) has been awarded marketing approval from the European Commission …
Shire scores European approval for Adynovi in haemophilia A
January 15, 2018Sales and Marketing Adynovi, Europe, European Commission, Shire, haemophilia, haemophilia a, pharma
Shire has revealed that the European Commission has approved Adynovi (antihaemophilic factor (recombinant), PEGylated) for on-demand and prophylactic use in …
Roche’s Ocrevus gets the go ahead in Europe for two forms of MS
January 12, 2018Medical Communications, Sales and Marketing Europe, European Commission, Ocrevus, Roche, multiple sclerosis, pharma
Roche has revealed that its multiple sclerosis (MS) drug Ocrevus (ocrelizumab) has been awarded marketing approval in Europe by the …
AZ’s Fasenra approved in Europe as an add-on for severe eosinophilic asthma
January 11, 2018Research and Development AstraZeneca, European Commission, Fasenra, MedImmune, asthma, pharma
AstraZeneca and its biologics R&D unit MedImmune have announced that their drug Fasenra (benralizumab) has received approval from the European …
Pharmafile.com’s top ten stories of 2017
December 22, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Abbott, Actelion, Amgen, AstraZeneca, Cyber attack, EMA, European Commission, Humira, J&J, JJ, Johnson & Johnson, MSD, Sanofi, Shire, Teva, biosimilar, brexit
After a packed year that has flown by, we’ve reached the final top ten of 2017. Below you can find …
Tesaro secures EU approval in specific ovarian cancer population
November 23, 2017Sales and Marketing Europe, European Commission, Tesaro, Zejula, pharma
The European Commission has granted Tesaro’s Zejula (niraparib) marketing approval in Europe, it has emerged. Zejula is a poly (ADP-ribose) …
Boehringer celebrates EU approval of Humira biosimilar
November 14, 2017Manufacturing and Production, Sales and Marketing Boehringer, Boehringer Ingelheim, Cyltezo, EU, Europe, European Commission, Humira, biosimilar
Boehringer Ingelheim has announced that Cyltezo, its biosimilar of Abbvie’s Humira, has received marketing authorisation approval from the European Commission, …
Roche’s Tecentriq scores approvals in metastatic lung and bladder cancer
September 27, 2017Research and Development, Sales and Marketing Cancer, EMA, EU, European Commission, Roche, bladder cancer, immunotherapy, lung cancer, pharma, tecentriq
It’s good news for Roche as the company’s immunotherapy drug Tecentriq secures approval from the European Commission to be used …
Leo Pharma gets European approval for unique plaque psoriasis drug
July 20, 2017Sales and Marketing EU, European Commission, biotech, drugs, pharma, pharmaceutical, psoriasis
The European Commission has announced that it has decided to approve Leo Pharma’s Kyntheum (brodalumab), making it the first and …
New Pfizer EU approval offers first treatment option for leukaemia subtype
July 3, 2017Sales and Marketing AstraZeneca, Besponsa, EU, European Commission
Pfizer has revealed that its drug Besponsa (inotuzumab ozogamicin) has received approval from the European Commission as a monotherapy for …
Regulators get aggressive on matters excessive
June 29, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CMA, Drug pricing, European Commission, Pfizer, aspen
Gustaf Duhs, Partner at Stevens & Bolton, discusses the recent cases of regulators becoming firmer with drug companies over their …
Novartis gains first-line approval for Zykadia in lung cancer
June 29, 2017Research and Development EMA, European Commission, NSCLC, Novartis
The European Commission has followed the EMA’s CHMP positive opinion by approving Novartis’ Zykadia for first-line treatment of patients with …
Servier fights fine over antitrust breaches
June 7, 2017Manufacturing and Production, Research and Development, Sales and Marketing European Commission, Servier, generic
Servier, a French pharmaceutical firm, has sought to lower the fine it received from the European Commission for breaching antitrust …
BMS’ Opdivo scores eighth approval in Europe for bladder cancer
June 5, 2017Research and Development, Sales and Marketing Bristol-Myers Squibb, Cancer, Europe, European Commission, bladder cancer, immunotherapy
Bristol-Myers Squibb has announced that its flagship immunotherapy treatment Opdivo (nivolumab) has secured its eighth approval in Europe as the …
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FibroFind appoints Lee Borthwick as CEO
