Europe
Novartis’ Sandoz scores EU approval for Remicade biosimilar
May 24, 2018Sales and Marketing EU, Europe, Novartis, Remicade, Sandoz, Zessly, pharma
The European Commission has given its approval to Sandoz, Novartis’ generics and biosimilars unit, for its biosimilar version of Janssen’s …
ViiV’s two-drug regimen gets EU approval for HIV-1
May 22, 2018Manufacturing and Production, Sales and Marketing EMA, EU, Europe, HIV, Juluca, ViiV Healthcare, pharma
ViiV Healthcare has announced that its HIV therapy Juluca (dolutegravir/rilpivirine) has been awarded marketing authorisation in the EU from the …
EMA review confirms risks of Abbvie and Biogen’s Zinbryta outweigh benefits
May 21, 2018Research and Development, Sales and Marketing EMA, Europe, European Commission, PRAC, multiple sclerosis, pharma, zinbryta
The EMA has judged that the benefits offered by Zinbryta (daclizumab), Abbvie and Biogen’s humanised IgG1 monoclonal antibody for the …
European approval for tablet formulation of Lynparza in ovarian cancer
May 8, 2018Research and Development, Sales and Marketing AstraZeneca, Cancer, EMA, Europe, MSD, lynparza, ovarian cancer, pharma
AstraZeneca and MSD’s poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib) has been approved for use in Europe, it has emerged, …
Takeda and TiGenix’s Alofisel becomes first donor-derived stem cell therapy approved in Europe
March 26, 2018Sales and Marketing Crohn’s disease, EU, Europe, European Commission, Takeda, TiGenix, crohn's disease, pharma
The European Commission has awarded approval to Takeda and TiGenix’s allogeneic expanded adipose-derived stem cell (eASC) therapy Alofisel (darvadstrocel) for …
GSK’s shingles vaccine secures EU and Japan approvals
March 26, 2018Sales and Marketing EU, Europe, GSK, Japan, Shingrix, pharma, shingles
GlaxoSmithKline has announced that its shingles vaccine Shingrix has secured approval in two new regions: in Europe, for the prevention …
Abbvie and Biogen pull MS drug Zinbryta following urgent EMA safety review
March 5, 2018Sales and Marketing AQbbvie, Biogen, EMA, Europe, mulyiple sclerosis, pharma, zinbryta
Biogen and Abbvie have announced their intention to voluntarily withdraw their multiple sclerosis therapy Zinbryta (daclizumab) from all global markets …
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 …
Celltrion’s Herceptin biosimilar seals EU approval
February 15, 2018Sales and Marketing EU, Europe, Herceptin, Herzuma, celltrion, pharma
Herzuma, Celltrion’s biosimilar version of Roche/Genentech’s blockbuster immunotherapy Herceptin, has been awarded approval from the European Commission, the company has …
Novo’s Ozempic secures European approval in type 2 diabetes
February 12, 2018Sales 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 …
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 …
Novartis’ CAR T therapy Kymriah scores accelerated approval in both Europe and US
January 17, 2018Research 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 …
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 …
European biotechs outperform US for investment return, report claims
November 29, 2017Medical Communications, Sales and Marketing EU, Europe, US, investment, pharma
A new report from RSA Group has revealed that European biotech companies are “significantly outperforming” their US counterparts in terms …
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