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RSS FeedPosted by Michael Wonder on 26 Apr 2021
EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe
26 April 2021 - The EMA and the European Centre for Disease Prevention and Control today kicked off a new ...
Posted by Michael Wonder on 26 Apr 2021
Vertex and CRISPR Therapeutics announce Priority Medicines (PRIME) designation granted by the European Medicines Agency to CTX001 for transfusion-dependent beta thalassaemia
26 April 2021 - Vertex Pharmaceuticals and CRISPR Therapeutics today announced the EMA has granted Priority Medicines (PRIME) designation to ...
Posted by Michael Wonder on 26 Apr 2021
Axsome Therapeutics announces FDA acceptance and priority review of new drug application for AXS-05 for treatment of major depressive disorder
26 April 2021 - FDA grants priority review and sets PDUFA action goal date of 22 August 2021. ...
Posted by Michael Wonder on 26 Apr 2021
Selumetinib recommended for approval in the EU by CHMP as the first medicine for paediatric patients with neurofibromatosis type 1 and plexiform neurofibromas
26 April 2021 - Recommendation based on the SPRINT Phase 2 trial, which showed selumetinib reduced tumour volume in children. ...
Posted by Michael Wonder on 26 Apr 2021
Tagrisso recommended for approval in the EU by CHMP for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
26 April 2021 - Opinion based on unprecedented results from the ADAURA Phase 3 trial where Tagrisso reduced the risk of ...
Posted by Michael Wonder on 26 Apr 2021
European Commission approves GSK’s Jemperli (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer
23 April 2021 - The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe. ...
Posted by Michael Wonder on 26 Apr 2021
Global sarcoma therapy now approved for Australian patients
23 April 2021 - Globally regarded soft tissue sarcoma therapy has been approved by the Therapeutic Goods Administration for Australian patients. ...
Posted by Michael Wonder on 26 Apr 2021
LEO Pharma receives positive CHMP opinion of Adtralza (tralokinumab) for the treatment of adults with moderate-to-severe atopic dermatitis
23 April 2021 - The CHMP opinion is primarily supported by data from ECZTRA 1, 2, and 3 trials included in ...
Posted by Michael Wonder on 26 Apr 2021
FDA to scrutinise unproven cancer drugs after 10 year gap
26 April 2021 - U.S. regulators are convening a meeting to consider clawing back approvals from several cancer drugs that have ...
Posted by Michael Wonder on 26 Apr 2021
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) as first-line treatment for unresectable malignant pleural mesothelioma
23 April 2021 - Recommendation based on positive results from the Phase 3 CheckMate-743 trial, in which Opdivo plus Yervoy demonstrated ...
Posted by Michael Wonder on 26 Apr 2021
Bristol Myers Squibb receives positive CHMP opinion for Onureg (azacitidine tablets; CC-486) as frontline oral maintenance therapy for adults with acute myeloid leukaemia in first remission
23 April 2021 - In the pivotal Quazar AML-001 study, Onureg demonstrated significant overall survival and showed a relapse-free survival benefit ...
Posted by Michael Wonder on 25 Apr 2021
AbbVie receives positive CHMP opinion for Venclyxto (venetoclax) as a combination regimen for adult patients with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy
23 April 2021 - Positive opinion based on data from the VIALE-A and M14-358 trials, which evaluated the safety, efficacy and ...
Posted by Michael Wonder on 24 Apr 2021
Highlights from the April 19-22 CHMP meeting
23 April 2021 - EMA’s CHMP recommended eight medicines for approval at its April 2021 meeting. ...
Posted by Michael Wonder on 24 Apr 2021
AstraZeneca’s COVID-19 vaccine: benefits and risks in context
23 April 2021 - Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) is authorised in the EU to prevent COVID-19, which can cause ...
Posted by Michael Wonder on 24 Apr 2021
FDA and CDC lift recommended pause on Johnson & Johnson (Janssen) COVID-19 vaccine use following thorough safety review
23 April 2021 - Agencies underscore confidence in vaccine’s safety and effectiveness following data assessment; available data suggest potential blood clots ...