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Showing 15 posts of 198 posts found.

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Novartis’ Sandoz scores EU approval for Remicade biosimilar

May 24, 2018
Sales 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 …

News
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ViiV’s two-drug regimen gets EU approval for HIV-1

May 22, 2018
Manufacturing 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 …

News
european_commission_web

EMA review confirms risks of Abbvie and Biogen’s Zinbryta outweigh benefits

May 21, 2018
Research 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 …

News
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European approval for tablet formulation of Lynparza in ovarian cancer

May 8, 2018
Research 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, …

News
european_commission_web

Takeda and TiGenix’s Alofisel becomes first donor-derived stem cell therapy approved in Europe

March 26, 2018
Sales 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 …

News
gsk_boronia_australia

GSK’s shingles vaccine secures EU and Japan approvals

March 26, 2018
Sales 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 …

News

Abbvie and Biogen pull MS drug Zinbryta following urgent EMA safety review

March 5, 2018
Sales 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 …

News

Europe approves first therapy for haemophilia A with inhibitors in over 20 years

March 1, 2018
Research 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 …

News
celltrion1

Celltrion’s Herceptin biosimilar seals EU approval

February 15, 2018
Sales 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 …

News

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 …

News
lilly_entrance_web

Eli Lilly’s Taltz get EU approval in psoriatic arthritis subgroup

January 24, 2018
Research 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 …

News
novartis_outside_1

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 …

News
shire_image_4

Shire scores European approval for Adynovi in haemophilia A

January 15, 2018
Sales 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 …

News
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Roche’s Ocrevus gets the go ahead in Europe for two forms of MS

January 12, 2018
Medical 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 …

News
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European biotechs outperform US for investment return, report claims

November 29, 2017
Medical 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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