Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2019
Janssen announces U.S. FDA breakthrough therapy designation granted for niraparib for the treatment of metastatic castration-resistant prostate cancer
3 October 2019 - Niraparib, an orally-administered PARP inhibitor, is currently being investigated for the treatment of patients with metastatic castration-resistant ...
Posted by Michael Wonder on 03 Oct 2019
FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic
3 October 2019 - The U.S. FDA today approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk ...
Posted by Michael Wonder on 03 Oct 2019
Novartis Entresto receives FDA approval for paediatric heart failure, helping to address critical unmet need for treatment options
1 October 2019 - Entresto is now approved for the treatment of paediatric patients aged 1 year and older with symptomatic ...
Posted by Michael Wonder on 03 Oct 2019
Janssen submits supplemental new drug application to U.S. FDA for Spravato (esketamine) CIII nasal spray for the rapid reduction of depressive symptoms in adults with major depressive disorder who have active suicidal ideation with intent
2 October 2019 - If approved, Spravato would be the first treatment for this severely ill population who historically have been ...
Posted by Michael Wonder on 03 Oct 2019
FDA approves labeling supplement for Puma Biotechnology’s Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer
2 October 2019 - Interim data from the Phase II CONTROL Trial showed that the addition of prophylactic treatment with loperamide ...
Posted by Michael Wonder on 02 Oct 2019
Trump set to nominate Stephen Hahn as FDA commissioner, pending vetting process
1 October 2019 - President Trump is set to nominate Dr. Stephen Hahn to lead the Food and Drug Administration, ...
Posted by Michael Wonder on 02 Oct 2019
The real impact of drug price legislation on biopharmaceutical R&D
2 October 2019 - As outcry around drug prices rages, arguments continue to surface that limiting corporate revenues via price controls ...
Posted by Michael Wonder on 02 Oct 2019
U.S. FDA submission of new drug application for NS-065/NCNP-01 (viltolarsen)
2 October 2019 - Nippon Shinyaku announced that it has completed the submission of its rolling new drug application to the ...
Posted by Michael Wonder on 02 Oct 2019
GSK submits filing to FDA for Trelegy Ellipta use in patients with asthma
2 October 2019 - GSK and Innoviva today announced the filing of a supplemental new drug application to the US ...
Posted by Michael Wonder on 02 Oct 2019
FDA accepts two applications for Merck’s Dificid (fidaxomicin) to treat children aged six months up to 18 years with Clostridium difficile infections
2 October 2019 - Dificid paediatric filings receive priority review classification. ...
Posted by Michael Wonder on 02 Oct 2019
Trade agreement drug monopoly is obsolete given faster, better drug discovery
2 October 2019 - For decades, the brand-name drug industry has relentlessly promoted the message that any reduction in its ...
Posted by Michael Wonder on 02 Oct 2019
Evolus receives approval for Nuceiva in the European Union
1 October 2019 - Evolus today announced that the European Commission has approved the marketing of Nuceiva (prabotulinumtoxinA). ...
Posted by Michael Wonder on 02 Oct 2019
Progressing the long-term plan for stem cell research
2 October 2019 - This is the next step in the $150 million Stem Cell Therapies Mission, helping world-class Australian researchers ...
Posted by Michael Wonder on 02 Oct 2019
How to ensure that novel analytic methods are fit for decision-making
2 October 2019 - The past decade has seen the increased generation and availability of new data sources such as ...
Posted by Michael Wonder on 01 Oct 2019
Novartis and Microsoft announce collaboration to transform medicine with artificial intelligence
1 October 2019 - Multi-year alliance underpins the Novartis commitment to leverage data & artificial intelligence to transform how medicines are ...