EU

Showing 15 posts of 244 posts found.

Sandoz announces €150 million investment in antibiotic production

May 18, 2021
Manufacturing and Production EU, manufacturing, production

Sandoz, a division of Novartis, has announced plans to develop its European antibiotics manufacturing network by expanding the production capabilities …

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Janssen submits MAA to EMA for novel CAR-T cell therapy

May 5, 2021
Research and Development EMA, EU, Janssen, multiple myeloma

Janssen have submitted a Marketing Authorisation Application (MAA) to the EMA seeking approval of cilta-cel, an investigational B cell maturation …

EC approves Kaftrio as combination treatment for cystic fibrosis

April 29, 2021
EU, European Commission, cystic fibrosis

Vertex Pharmaceuticals has been granted European Commission approval for the label extension of Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with …

NICE to join GetReal Institute alongside nine key healthcare players

April 28, 2021
Research and Development EU, NICE, rwe

NICE has announced it will join with nine other organisations to form the GetReal Institute, a not-for-profit multi-stakeholder enterprise, as …

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European Commission sues AstraZeneca over COVID-19 jab supplies

April 27, 2021
Manufacturing and Production AstraZeneca, AstraZeneca vaccine, COVID-19, EU, European Commission, covid 19 news, covid-19 news, european union, pharma, pharma news

The European Commission (EC) announced yesterday that it was suing AstraZeneca for failing to respect its contract to supply COVID-19 …

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LEO Pharma receives positive CHMP opinion for dermatitis treatment

April 26, 2021
Sales and Marketing CHMP, EMA, EU, dermatitis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion …

Phoenix Cardiac gains CE Mark for “game-changer” MR device

April 26, 2021
Sales and Marketing CE Mark, EU, cardiovascular

Phoenix Cardiac Devices have received CE Mark certification for its BACE (basal annuloplasty of the cardia externally) device, a novel …

GW Pharma’s cannabidiol gains EC approval

April 21, 2021
Research and Development EC, EU, cannabis

GW Pharmaceuticals has received European Commission (EC) approval for the type II variation application for Epidyolex (cannabidiol), as an adjunctive …

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BioVersys receives €20 Million EU Financing to develop new antibiotics

April 14, 2021
Research and Development EU

The European Investment Bank (EIB) and BioVersys AG, a clinical-stage pharmaceutical company, have today announced the signing of a €20 …

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Incyte receives EC approval for Pemazyre

March 30, 2021
Manufacturing and Production EU

Incyte have received approval from the European Commission (EC) for Pemazyre (pemigatinib), the first new treatment for adults with locally …

Novavax delays 100 million vaccines to the EU

March 26, 2021
Medical Communications COVID-19, EU, Vaccine

Novavax is delaying the signing of a contract to supply COVID-19 vaccines to the EU, as the company warned it …

eTheRNA awarded €6.9 million TIGER Grant by European Commission

March 22, 2021
Sales and Marketing Cancer, EU

eTheRNA immunotherapies, a clinical-stage company, has been awarded a grant of €6.9 million by the European Commission to develop a …

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Netherlands suspends AstraZeneca vaccine despite safety assurances

March 15, 2021
Medical Communications, Sales and Marketing AstraZeneca, COVID-19, EMA, EU, WHO

The Netherlands has become the latest country to suspend the use of the Oxford-AstraZeneca vaccine amid concerns it may cause …

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Dynavax’s hepatitis B vaccine gets EU approval

February 23, 2021
Manufacturing and Production EU, Vaccine, hepatitis B

The European Commission (EC) has granted marketing authorisation Dynavax Technologies Corporation’s HEPLISAV B vaccine for the active immunisation against hepatitis …

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ViiV gets EU approval for children’s HIV treatment

January 13, 2021
Research and Development EU, HIV, ViiV

ViiV Healthcare, the global specialist HIV company, has received marketing authorisation from the European Commission for Tivicay (dolutegravir) 5mg dispersible …

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