EMA
FDA accepts Ipsen’s NDA for ultra-rare genetic disorder drug
June 1, 2021Manufacturing and Production EMA, FDA, FOP, NDA, ipsen
The FDA have accepted Ipsen’s New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the prevention …
Takeda: Dengue vaccine successful in long-term trials & set for global distribution
May 25, 2021Manufacturing and Production EMA, Vaccine, dengue
Japanese pharma company Takeda has announced long-term safety and efficacy results for its dengue vaccine candidate, TAK-003, and has successfully …
Vertex applies to expand indication of cystic fibrosis drug
May 20, 2021EMA, MHRA, cystic fibrosis
Vertex has announced that the EMA and MHRA have validated the post marketing applications for an expanded indication of Kaftiro …
Self-administered Crysvita receives positive CHMP opinion
May 10, 2021Sales and Marketing CHMP, EMA
Kyowa Kirin’s drug for a rare metabolic bone disease, Crysvita, has received a positive opinion from the EMA’s Committee for …
EMA begin review of GSK & Vir COVID-19 treatment
May 10, 2021Sales and Marketing COVID-19, EMA, GSK, covid-19 treatment, pharma, pharma news, vir
The EMA has begun a rolling review of GSK and Vir’s sotrovimab treatment for COVID-19, which will continue until there …
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 …
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 …
EMA to begin review of GSK and Vir’s COVID-19 treatment
April 16, 2021Medical Communications COVID-19, EMA, GSK, covid-19 treatment, pharma, pharma news, vir
The EMA have begun a review of GSK and Vir Biotechnology’s investigational COVID-19 antibody (VIR-7831) for patients at high risk …
EMA launch investigation into J&J’s COVID-19 vaccine amid US blood clot reports
April 12, 2021Sales and Marketing COVID-19, EMA, J&J, JJ, Vaccine
The EMA is reviewing reports of rare blood clots in four people in the US who received Johnson & Johnson’s …
Roche’s SMA treatment Evrysdi approved by European Commission
March 30, 2021Manufacturing and Production EMA, European Commission, PTC Therapeutics, Roche, sma, spinal muscular atrophy
The European Commission has granted marketing authorisation to Roche and PTC Therapeutics’ Evrysdi, for the treatment of patients aged 2 …
Janssen’s multiple sclerosis treatment recommended by EMA
March 29, 2021Sales and Marketing CHMP, EMA, Janssen, Johnson & Johnson, PONVORY, multiple sclerosis
Janssen’s PONVORY therapy for the treatment of adults with relapsing forms of multiple sclerosis (MS) has been recommended by the …
Astellas Pharma and Seagen cancer treatment gets MAA acceptance from EMA
March 26, 2021Medical Communications EMA, oncology
Astellas Pharma and Seagen Inc. have announced that the EMA has accepted their marketing authorisation application (MAA) for enfortumab vedotin, …
Incyte biliary tract cancer treatment approved in Japan
March 23, 2021Manufacturing and Production EMA, Japan, oncology
The Japanese Ministry of Health, Labour, and Welfare (MHLW) have approved Incyte’s Pemazyre (pemigatinib) for the treatment of patients with …
AstraZeneca COVID-19 vaccine deemed “safe and effective” by EMA
March 19, 2021Medical Communications AstraZeneca, COVID-19, EMA, Vaccine
AstraZeneca’s COVID-19 vaccine has been cleared for continued use by the EMA following an investigation into the reports of 37 …
Netherlands suspends AstraZeneca vaccine despite safety assurances
March 15, 2021Medical 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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