Blog
RSS FeedPosted by Michael Wonder on 14 Dec 2020
ExCellThera receives Priority Medicines (PRIME) designation from European Medicines Agency for ECT-001 cell therapy
11 December 2020 - ExCellThera announced today that ECT-001 cell therapy has been granted PRIority MEdicines (PRIME) designation by the EMA ...
Posted by Michael Wonder on 14 Dec 2020
Trixeo Aerosphere approved in the EU for maintenance treatment of COPD
14 December 2020 - Fourth major approval for AstraZeneca’s triple-combination therapy which is marketed as Breztri Aerosphere in the US, ...
Posted 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 14 Dec 2020
Advicenne receives positive CHMP opinion recommending approval of ADV7103 (sibnayal) for the treatment of distal renal tubular acidosis
11 December 2020 - Advicenne today announces the CHMP of the EMA adopted a positive opinion recommending approval of its lead ...
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 13 Dec 2020
Walgreens statement regarding FDA emergency use authorisation of COVID-19 vaccine
11 December 2020 - Walgreens is preparing to immediately bring vaccines to high priority populations, as determined by the Centers ...
Posted by Michael Wonder on 13 Dec 2020
First coronavirus vaccines head to states, starting historic effort
12 December 2020 - Distributing supplies is a daunting logistical challenge, involving sophisticated tracking equipment, military contingencies and tight security. ...
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 12 Dec 2020
FDA takes key action in fight against COVID-19 by issuing emergency use authorisation for first COVID-19 vaccine
11 December 2020 - Action follows thorough evaluation of available safety, effectiveness, and manufacturing quality information by FDA career scientists, input ...
Posted by Michael Wonder on 12 Dec 2020
Lexicon Pharmaceuticals receives fast track designation from the FDA for LX9211 for diabetic peripheral neuropathic pain
11 December 2020 - Lexicon Pharmaceuticals announced today that it has received Fast Track designation from the U.S. FDA for ...
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 ...