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RSS FeedPosted by Michael Wonder on 21 Jan 2020
Genprex receives U.S. FDA fast track designation for gene therapy that targets lung cancer
21 January 2020 - Genprex today announced that the U.S FDA has granted fast track Designation for Genprex’s Oncoprex immunogene ...
Posted by Michael Wonder on 21 Jan 2020
US FDA grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma
21 January 2020 - Belantamab mafodotin has potential to be the first anti-BCMA treatment available to patients. ...
Posted by Michael Wonder on 21 Jan 2020
The biosimilar solution to expensive cancer care
20 January 2020 - In a recent column in Evidence-Based Oncology, Kathy Oubre, MS, chief operating officer of Pontchartrain Cancer ...
Posted by Michael Wonder on 21 Jan 2020
Will the FDA give the go-ahead to a prescription video game? The wait goes on, as new data come in.
21 January 2020 - In mid 2018, the startup Akili Interactive Labs asked the Food and Drug Administration to let ...
Posted by Michael Wonder on 21 Jan 2020
European Commission approves Roche’s Polivy for people with previously treated aggressive lymphoma
21 January 2020 - Novel combination regimen includes first-in-class antibody-drug conjugate that specifically targets CD79b. ...
Posted by Michael Wonder on 21 Jan 2020
Janssen seeks expanded use of Imbruvica (ibrutinib) in combination with rituximab for patients with previously untreated chronic lymphocytic leukaemia
20 January 2020 - Application supported by the Phase 3 E1912 study evaluating the use of ibrutinib in combination with rituximab, ...
Posted by Michael Wonder on 21 Jan 2020
European Commission approves Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are transplant eligible
20 January 2020 - Janssen announced today that the European Commission has granted marketing authorisation for Darzalex (daratumumab) in combination with ...
Posted by Michael Wonder on 21 Jan 2020
Jazz Pharmaceuticals receives EU marketing authorisation for Sunosi (solriamfetol) for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea
20 January 2020 - Sunosi is the only licensed therapy in Europe for the treatment of excessive daytime sleepiness in adults ...
Posted by Michael Wonder on 20 Jan 2020
FDA delays decision on Intercept's NASH drug by three months
20 January 2020 - Action date pushed back to 26 June. ...
Posted by Michael Wonder on 20 Jan 2020
Novartis announces EU approval of Mayzent (siponimod) for adult patients with secondary progressive multiple sclerosis with active disease
20 January 2020 - Mayzent (siponimod) is the first and only oral treatment specifically indicated for patients with secondary progressive multiple ...
Posted by Michael Wonder on 20 Jan 2020
Lynparza regulatory submission granted priority review in the US for HRR-mutated metastatic castration-resistant prostate cancer
20 January 2020 - Submission based on PROfound, the first positive Phase III trial testing a targeted treatment in biomarker-selected ...
Posted by Michael Wonder on 20 Jan 2020
Ten recommendations to unlock the potential of big data for public health in the EU
20 January 2020 - The joint Big Data Task Force of EMA and the Heads of Medicines Agencies proposes ten ...
Posted by Michael Wonder on 20 Jan 2020
Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study
17 January 2020 - Failure to report the results of a clinical trial can distort the evidence base for clinical practice, ...
Posted by Michael Wonder on 20 Jan 2020
Fees and charges proposal 2020-21
20 January 2020 - The TGA is undertaking a consultation through its website to seek stakeholder's views on TGA’s proposed fees ...
Posted by Michael Wonder on 20 Jan 2020
New science strategy prepares regulatory scientists for the future
20 January 2020 - The Health Products Regulation Group in the Department of Health has published a new regulatory science ...