Blog
RSS FeedPosted by Michael Wonder on 20 Dec 2021
EMA adopts a positive CHMP opinion for Pfizer’s and OPKO’s somatrogon, a long-acting treatment for paediatric growth hormone deficiency
17 December 2021 - If approved by the European Commission, somatrogon will offer children and adolescents living with growth hormone ...
Posted by Michael Wonder on 20 Dec 2021
Saphnelo recommended for approval in the EU by CHMP for the treatment of patients with systemic lupus erythematosus
20 December 2021 - Saphnelo is a first-in-class type I interferon receptor antibody shown to reduce overall disease activity in ...
Posted by Michael Wonder on 20 Dec 2021
CHMP issues positive opinion for Pfizer’s 20 valent pneumococcal conjugate vaccine for the prevention of vaccine type pneumococcal pneumonia in adults
17 December 2021 - Pfizer announced today that the CHMP of the EMA has issued a positive opinion to recommend the ...
Posted by Michael Wonder on 19 Dec 2021
Pfizer receives positive CHMP opinion for Lorviqua (lorlatinib) as first-line treatment for ALK positive advanced lung cancer
17 December 2021 - Recommendation based on results from the Phase 3 CROWN trial, which showed Lorviqua reduced the risk of ...
Posted by Michael Wonder on 18 Dec 2021
New treatment for sickle cell disease
17 December 2021 - EMA has recommended granting a marketing authorisation in the EU for Oxbryta (voxelotor) for the treatment of ...
Posted by Michael Wonder on 18 Dec 2021
Astellas and Seagen receive positive CHMP opinion for Padcev (enfortumab vedotin) in locally advanced or metastatic urothelial cancer
17 December 2021 - If approved, PADCEV would be the first medicine for patients in the EU who have received prior ...
Posted by Michael Wonder on 18 Dec 2021
Tepmetko (tepotinib) receives positive CHMP opinion for patients with advanced NSCLC with METex14 skipping alterations
17 December 2021 - Tepmetko is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe ...
Posted by Michael Wonder on 16 Dec 2021
AVT02, Alvotech’s biosimilar to high concentration formulation of adalimumab (Humira) approved for use in European Union
15 December 2021 - Alvotech received approval for AVT02 (100 mg/mL), the company’s high concentration biosimilar to Humira (adalimumab), from the ...
Posted by Michael Wonder on 16 Dec 2021
COVID-19: EMA recommends authorisation of antibody medicine Xevudy
16 December 2021 - EMA’s CHMP has recommended authorising the monoclonal antibody Xevudy (sotrovimab) for the treatment of COVID-19. ...
Posted by Michael Wonder on 16 Dec 2021
EMA recommends approval for use of Kineret in adults with COVID-19
16 December 2021 - EMA’s CHMP has recommended extending the indication of Kineret (anakinra) to include treatment of COVID-19 in ...
Posted by Michael Wonder on 16 Dec 2021
Apellis and Sobi Announce EU approval of Aspaveli (pegcetacoplan) for treatment of PNH
15 December 2021 - The first targeted C3 therapy approved in the EU. ...
Posted by Michael Wonder on 15 Dec 2021
COVID-19 Vaccine Janssen: EMA recommendation on booster dose
15 December 2021 - EMA’s CHMP has concluded that a booster dose of COVID-19 Vaccine Janssen may be considered at ...
Posted by Michael Wonder on 13 Dec 2021
European Commission approves Pfizer's Cibinqo (abrocitinib) for the treatment of adults with moderate to severe atopic dermatitis
10 December 2021 - Cibinqo is a once daily oral treatment with proven efficacy demonstrated in a large scale clinical ...
Posted by Michael Wonder on 13 Dec 2021
Janssen EMEA receives conditional marketing authorisation for Rybrevant (amivantamab), the first treatment approved for patients with advanced non-small-cell lung cancer with EGFR exon 20 insertion mutations
10 December 2021 - Janssen EMEA receives conditional marketing authorisation for Rybrevant (amivantamab), the first treatment approved for patients with advanced ...
Posted by Michael Wonder on 08 Dec 2021
Novavax COVID-19 vaccine could be approved very soon, says EMA chief
8 December 2021 - The head of the EMA on Tuesday said that it could soon approve the COVID-19 vaccine ...