EU
Samsung Bioepis & Biogen receive positive CHMP opinion for ranibizumab biosimilar
June 28, 2021Sales 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 …
Sanofi’s NSCLC drug gains EC approval
June 25, 2021Medical 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 …
MHRA approves venetoclax as acute myeloid leukemia treatment
June 8, 2021Manufacturing 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 …
MHRA confirms registration of Avacta’s lateral flow test
June 7, 2021Sales 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 …
Moderna submits BLA with FDA for COVID vaccine
June 2, 2021Research 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 …
AstraZeneca’s lung cancer drug gains EU approval
May 28, 2021Medical 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 …
BD unveils plan for €165 million Spanish manufacturing plant
May 19, 2021Research and Development EU, manufacturing
BD has announced plans to build a new €160 million manufacturing plant in Zaragoza, located in the Aragon region of …
Sandoz announces €150 million investment in antibiotic production
May 18, 2021Manufacturing 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 …
Janssen submits MAA to EMA for novel CAR-T cell therapy
May 5, 2021Research 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, 2021EU, 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, 2021Research 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 …
European Commission sues AstraZeneca over COVID-19 jab supplies
April 27, 2021Manufacturing 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 …
LEO Pharma receives positive CHMP opinion for dermatitis treatment
April 26, 2021Sales 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, 2021Sales 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 …
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Five Facts about cardiovascular disease
