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Showing 15 posts of 39 posts found.

Ameluz approved by European Commission for treatment for actinic keratosis

March 11, 2020
Research and Development EC, EMA, Europe, Lesions

Biofrontera AG has announced the European Commission has approved the use of their drug Ameluz in combination with photodynamic therapy …

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AbbVie granted EU marketing authorisation for new arthritis drug

December 19, 2019
Business Services AbbVie, EC, EU, arthritis, rheumatoid arthritis

AbbVie have announced that the European Commission (EC) have granted marketing authorisation for RINVOQ (upadacitnib). It’s a daily selective reversible …

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Roche scores two EU approvals in haemophilia and rare autoimmune disease

March 15, 2019
Medical Communications EC, EU, Europe, Roche, haemophilia, rare diseases

The European Commission (EC) has approved Roche’s haemophilia treatment Hemlibra (emicizumab). The approval comes as the EC approved Roche’s MabThera …

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 …

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Eisai says European Commission backs Halaven to treat of advanced Liposarcoma in Europe

May 5, 2016
Research and Development, Sales and Marketing EC, Eisai, US FDA, oncology, regulation, soft tissue sarcoma

The European Commission has backed marketing for the Japanese drug major Eisai’s (TYO: 4523) Halaven (eribulin) to treat advanced soft …

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Eli Lilly gets European marketing authorisation for psoriasis drug

April 26, 2016
EC, EU, Eli Lilly, drug trial, psoriasis, regulation

US pharma firm Eli Lilly and Co (NYSE: LLY) on Tuesday said the European Commission backed marketing authorisation for its …

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Alexion scores double EU approval

September 1, 2015
Manufacturing and Production, Sales and Marketing Alexion, EC, European Commission, Kanuma, Strensiq, asfotase alfa, sebelipase alfa, ultra rare disease, ultra-rare disease

Two treatments developed by ultra-rare disease specialists Alexion Pharmaceuticals are now approved for use in Europe. The European Commission approved …

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European Imbruvica approval for Janssen

July 20, 2015
Medical Communications, Sales and Marketing B-cell lymphoma, EC, European Commission, Janssen, Waldenström’s Macroglobulinemia, imbruvica, rare cancer

Janssen has received final European sign-off for its oncology treatment Imbruvica (ibrutinib) as a treatment option for adult patients with …

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AbbVie hep C drug gets priority review in Japan

April 16, 2015
Sales and Marketing AbbVie, EC, EU, Europe, Exviera, FDA, Japan, Viekira Pak, Viekirax, hepatitis C, ombitasvir/paritaprevir/ritonavir

AbbVie’s combination hepatitis C treatment looks set to be approved in yet another country after being granted priority review in …

EU widens indications for Pfizer vaccine

March 4, 2015
Research and Development, Sales and Marketing EC, EMA, Pfizer, pneumococcal polysaccharide conjugate vaccine, prevenar

Pfizer has gained approval from the European Commission which has signed off on an EMA decision to recommend Prevenar 13 …

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Chiesi’s stem cell therapy approved in Europe

February 23, 2015
Research and Development, Sales and Marketing Chiesi, EC, Europe, Holoclar, Holostem Advanced Therapies, LSCD, stem cell

Chiesi’s Holoclar has become the first stem cell therapy to get the green light in Europe, gaining conditional approval from …

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GSK buys bacteria vaccine firm

February 11, 2015
Research and Development, Sales and Marketing EC, GSK, GlaxoSmithKline, GlycoVaxyn, Novartis, vaccines

GlaxoSmithKline is continuing the significant expansion of its vaccine business with the purchase of Swiss biopharma company GlycoVaxyn. The UK …

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GSK Ebola vaccine gets EU support

December 17, 2014
Research and Development, Sales and Marketing EC, EU, Ebola, Europe, GSK, Merck, Takeda, Vaccine, WHO, johnson

A newly-formed European consortium is to help advance the development of GlaxoSmithKline’s promising Ebola vaccine. The consortium is backed by …

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EMA in turmoil as top job ‘annulled’

November 17, 2014
Sales and Marketing EC, EMA, EU, Europe, Guido Rasi, Rasi, transparency

The future of Guido Rasi, head of Europe’s drugs regulator, is up in the air after a legal ruling which …

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AZ oncology drug a ‘Phoenix from the flames’

October 27, 2014
Sales and Marketing AstraZeneca, CHMP, EC, lynparza, olaparib, oncology

As the possibility of a deal with Pfizer fades, AstraZeneca is continuing its argument for independence as a key cancer …

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