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RSS FeedPosted by Michael Wonder on 31 May 2020
Nabriva Therapeutics receives positive EU CHMP opinion for Xenleta (lefamulin) for the treatment of community-acquired pneumonia
29 May 2020 - If approved, Xenleta has the potential to be a first-in-class pleuromutilin antibiotic for the intravenous and ...
Posted by Michael Wonder on 31 May 2020
Johnson & Johnson receives positive CHMP opinion for Janssen’s investigational preventive Ebola vaccine regimen
29 May 2020 - The investigational Ebola vaccine regimen leverages Janssen’s established AdVac and PER.C6 technologies and Bavarian Nordic’s MVA-BN technology. ...
Posted by Michael Wonder on 31 May 2020
CHMP recommends EU approval of Roche’s Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer
29 May 2020 - Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain, ...
Posted by Michael Wonder on 31 May 2020
Novartis Piqray receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation
29 May 2020 - Piqray (alpelisib) in combination with fulvestrant will become first and only targeted treatment for advanced breast ...
Posted by Michael Wonder on 31 May 2020
FDA approves Genentech’s Tecentriq in combination with Avastin for people with the most common form of liver cancer
29 May 2020 - Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 31 May 2020
Highlights from the May 25-28 CHMP meeting
29 May 2020 - Eight new medicines recommended for approval. ...
Posted by Michael Wonder on 31 May 2020
COVID-19: reminder of the risks of chloroquine and hydroxychloroquine
29 May 2020 - The EMA is reminding health care professionals to closely monitor patients with COVID-19 who are receiving ...
Posted by Michael Wonder on 31 May 2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3
28 May 2020 - As part of its coordinated response to the pandemic, the International Coalition of Medicines Regulatory Authorities ...
Posted by Michael Wonder on 31 May 2020
FDA approves the first oral medication for the management of heavy menstrual bleeding due to uterine fibroids in pre-menopausal women
29 May 2020 - Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is expected to be available in the U.S. ...
Posted by Michael Wonder on 31 May 2020
Lilly's Cyramza (ramucirumab) receives FDA approval as first-line treatment for metastatic EGFR mutated non-small cell lung cancer
29 May 2020 - Cyramza, in combination with erlotinib, now approved for the treatment of people with untreated metastatic non-small cell ...
Posted by Michael Wonder on 29 May 2020
Roche’s Ocrevus (ocrelizumab) shorter 2 hour infusion time approved in Europe
28 May 2020 - Reduces infusion time to 2 hours from the conventional 3.5 hours for patients with relapsing or primary ...
Posted by Michael Wonder on 29 May 2020
FDA approves first drug to image tau pathology in patients being evaluated for Alzheimer’s disease
28 May 2020 - Today, the U.S. FDA approved Tauvid (flortaucipir F18) for intravenous injection, the first drug used to help ...
Posted by Michael Wonder on 29 May 2020
FDA accepts for review Fresenius Kabi’s first biosimilar regulatory submission for MSB11455, a biosimilar candidate of pegfilgrastim
27 May 2020 - Fresenius Kabi announced today that the U.S. FDA has accepted for review the company’s biologics license ...
Posted by Michael Wonder on 28 May 2020
Fauci warns about hydroxychloroquine
27 May 2020 - Top administration expert airs differences with Trump on pandemic response. ...
Posted by Michael Wonder on 28 May 2020
‘Vaccine nationalism’: a new dynamic in the race to quash coronavirus
27 May 2020 - International pursuit for a shot is shifting into a contest of which world power can immunise its ...