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RSS FeedPosted by Michael Wonder on 14 Dec 2020
Janssen receives positive CHMP opinion for Spravato (esketamine nasal spray) for the rapid reduction of depressive symptoms in a psychiatric emergency for patients with major depressive disorder
11 December 2020 - Positive opinion is based on results from two Phase 3 ASPIRE studies in adult patients with moderate ...
Posted by Michael Wonder on 14 Dec 2020
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) as first-line treatment in adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
11 December 2020 - Opinion granted based on significant progression-free survival benefit demonstrated with Keytruda monotherapy compared to standard of ...
Posted by Michael Wonder on 14 Dec 2020
Trastuzumab deruxtecan recommended for approval in the EU by CHMP for HER2 positive metastatic breast cancer
14 December 2020 - Recommendation based on positive results from the DESTINY-Breast01 trial, which showed durable responses in patients with ...
Posted by Michael Wonder on 13 Dec 2020
ViiV Healthcare announces positive CHMP opinion for Rukobia (fostemsavir), a first-in-class attachment inhibitor for the treatment of adults with multidrug-resistant HIV with few treatment options available
11 December 2020 - Findings from pivotal phase III BRIGHTE study demonstrated that the majority (60%) of heavily treatment-experienced adults randomised ...
Posted by Michael Wonder on 13 Dec 2020
Bristol Myers Squibb receives positive CHMP opinion for Inrebic (fedratinib) for adult patients with newly diagnosed and previously treated myelofibrosis
11 December 2020 - If approved, Inrebic will become the first new therapy for myelofibrosis in Europe in nearly a decade. ...
Posted by Michael Wonder on 13 Dec 2020
Seagen announces positive CHMP opinion for Tukysa (tucatinib) for the treatment of patients with locally advanced or metastatic HER2 positive breast cancer
11 December 2020 - Recommendation for approval in the European Union based on results of pivotal HER2CLIMB trial. ...
Posted by Michael Wonder on 12 Dec 2020
CHMP recommends the approvals of Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis and ankylosing spondylitis
10 December 2020 - If approved, Rinvoq will be the first oral, selective and reversible JAK inhibitor approved in three rheumatologic ...
Posted by Michael Wonder on 11 Dec 2020
Bavencio (avelumab) receives positive CHMP opinion for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
11 December 2020 - Merck and Pfizer today announced that the CHMP of the EMA adopted a positive opinion recommending approval ...
Posted by Michael Wonder on 10 Dec 2020
Hackers steal Pfizer/BioNTech COVID-19 vaccine data in Europe, companies say
10 December 2020 - U.S. drug maker Pfizer and its German partner BioNTech said on Wednesday that documents related to development ...
Posted by Michael Wonder on 09 Dec 2020
Albireo submits for U.S. FDA and EMA product approval of once daily odevixibat for PFIC
8 December 2020 - Data on PFIC types 1, 2, 3 submitted to support use across a wide range of patients. ...
Posted by Michael Wonder on 08 Dec 2020
Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025
8 December 2020 - The EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy for ...
Posted by Michael Wonder on 07 Dec 2020
EMA publishes agenda for 7-10 December CHMP meeting
7 December 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 07 Dec 2020
Janssen seeks EU approval for twice yearly schizophrenia treatment
7 December 2020 - Janssen has submitted a marketing authorisation extension application to the EMA for paliperidone palmitate six monthly ...
Posted by Michael Wonder on 01 Dec 2020
Mirum Pharmaceuticals announces European Medicines Agency validation of the marketing authorisation application for maralixibat in patients with PFIC2
30 November 2020 - Five-year transplant-free survival data from the Phase 2 INDIGO study used as the basis for the MAA ...
Posted by Michael Wonder on 01 Dec 2020
ARS announces acceptance of market authorisation application submission to European Medicines Agency for Neffy (ARS-1; epinephrine nasal spray)
30 November 2020 - ARS Pharmaceuticals announced today that the EMA has accepted a marketing authorisation application submission for review of ...