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Showing 15 posts of 252 posts found.

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Samsung Bioepis & Biogen receive positive CHMP opinion for ranibizumab biosimilar

June 28, 2021
Sales and Marketing EC, EMA, EU, biosimilars

Samsung Bioepis and Biogen have announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a …

News
sanofi_hq__boetie_hall_small_

Sanofi’s NSCLC drug gains EC approval

June 25, 2021
Medical Communications EC, EU, NSCLC, Sanofi

The European Commission (EC) has approved Sanofi and Regeneron’s PD-1 inhibitor, Libtayo (cemiplimab), for the first-line treatment of adults with …

News

Exscientia buys Austrian cancer cell screening company for €50 million

June 17, 2021
AI, EU, deal, marketing, sales

UK-based AI pioneers Exscientia has announced the purchase of rival AI firm Allcyte for €50 million. The multimillion deal, paid …

News
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MHRA approves venetoclax as acute myeloid leukemia treatment

June 8, 2021
Manufacturing and Production EC, EU, MHRA, leukemia

The MHRA has announced its approval for AbbVie’s venetoclax, in combination with a hypomethylating agent, for the treatment of newly …

News
covid_cell_1_20

MHRA confirms registration of Avacta’s lateral flow test

June 7, 2021
Sales and Marketing COVID-19, EU, MHRA, lateral flow test

Avacta has announced that the MHRA has confirmed registration of the AffiDX SARS-CoV-2 antigen lateral flow test, which allows the …

News
moderna_norwood_plant

Moderna submits BLA with FDA for COVID vaccine

June 2, 2021
Research and Development COVID-19, EU, FDA, Lonza, Moderna, production

Moderna has initiated the rolling submission process with the FDA for a Biologics License Application (BLA) for the licensure of …

News
az

AstraZeneca’s lung cancer drug gains EU approval

May 28, 2021
Medical Communications AstraZeneca, EU, lung cancer, oncology

AstraZeneca’s Tagrisso (osimertinib) has been approved in the EU for the adjuvant treatment of adult patients with early-stage (IB, II …

News

BD unveils plan for €165 million Spanish manufacturing plant

May 19, 2021
Research and Development EU, manufacturing

BD has announced plans to build a new €160 million manufacturing plant in Zaragoza, located in the Aragon region of …

News

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 …

News
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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 …

News

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 …

News

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 …

News
EU building with flags outside it

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 …

News
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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 …

News

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 …

News
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