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RSS FeedPosted by Michael Wonder on 05 Nov 2019
Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo (pegfilgrastim-bmez)
5 November 2019 - Ziextenzo is indicated to decrease the incidence of febrile neutropenia, one of the most serious side effects ...
Posted by Michael Wonder on 05 Nov 2019
RedHill Biopharma announces FDA approval of Talicia for treatment of H. pylori in adults
4 November 2019 - RedHill plans to launch Talicia in the U.S. in Q1/2020 for the treatment of H. pylori infection ...
Posted by Michael Wonder on 05 Nov 2019
FDA verdict on Biogen’s Alzheimer’s drug likely to be a ‘political decision,’ analyst says
4 November 2019 - Federal regulators may buckle to public and political pressure to approve Biogen’s experimental Alzheimer’s drug, according to ...
Posted by Michael Wonder on 01 Nov 2019
Vertex announces EMA marketing authorisation application validation for VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination treatment in cystic fibrosis
31 October 2019 - Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages ...
Posted by Michael Wonder on 31 Oct 2019
FDA grants appeal to Recro Pharma for IV meloxicam new drug application
31 October 2019 - Received positive response from FDA regarding IV meloxicam formal dispute resolution request. ...
Posted by Michael Wonder on 31 Oct 2019
Where were the women? Gender parity in clinical trials
30 October 2019 - On October 3, the FDA approved co-formulated tenofovir alafenamide and emtricitabine (F/TAF) for HIV prevention in at-risk ...
Posted by Michael Wonder on 31 Oct 2019
Janssen announces Health Canada approval of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are transplant ineligible
30 October 2019 - This Darzalex combination regimen reduced the risk of disease progression or death by 44% in newly ...
Posted by Michael Wonder on 30 Oct 2019
Democrats ‘continue to have concerns’ about FDA program to streamline regulation of medical software
30 October 2019 - A trio of Democrats on the Senate health committee, led by presidential candidate Elizabeth Warren, is ...
Posted by Michael Wonder on 30 Oct 2019
Biogen and Alkermes announce FDA approval of Vumerity (diroximel fumarate) for multiple sclerosis
30 October 2019 - Vumerity, a new oral treatment option for relapsing forms of multiple sclerosis, offers a combination of well-characterised ...
Posted by Michael Wonder on 30 Oct 2019
Model assisted designs for early phase clinical trials: simplicity meets superiority
30 October 2019 - Drug development enterprise is struggling because of prohibitively high costs and slow progress. ...
Posted by Michael Wonder on 30 Oct 2019
EMA and FDA accept marketing applications for Chugai's satralizumab in neuromyelitis optica spectrum disorder
30 October 2019 - The applications will be reviewed under accelerated assessment by EMA. ...
Posted by Michael Wonder on 30 Oct 2019
Dupixent (dupilumab) now approved in European Union for severe chronic rhinosinusitis with nasal polyposis
29 October 2019 - First biologic approved in the European Union for adults with severe chronic rhinosinusitis with nasal polyposis. ...
Posted by Michael Wonder on 30 Oct 2019
Intravenous Benlysta is the first biologic treatment to be approved for children with lupus in Europe
29 October 2019 - GlaxoSmithKline today announced that the European Commission has adopted a decision to extend to children five years ...
Posted by Michael Wonder on 29 Oct 2019
Terns Pharmaceuticals receives fast track designation from the FDA for TERN-101, an FXR agonist for the treatment of NASH
29 October 2019 - Terns Pharmaceuticals today announced that TERN-101, an investigational farnesoid X receptor (FXR) agonist, has been granted fast ...
Posted by Michael Wonder on 29 Oct 2019
In generic drug plants in China and India, data falsification is still a problem
29 October 2019 - As the generic drug industry faces allegations of data manipulation, headlines about carcinogen-tainted blood pressure medicine, ...