Blog
RSS FeedPosted by Michael Wonder on 04 Sep 2018
Janssen submits esketamine nasal spray new drug application to U.S. FDA for treatment-resistant depression
4 September 2018 - Janssen today announced the submission of a new drug application to the U.S. FDA for esketamine ...
Posted by Michael Wonder on 04 Sep 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for the treatment of Merkel cell carcinoma, a rare form of skin cancer
4 September 2018 - Application based on data from Phase 2 KEYNOTE-017 trial. ...
Posted by Michael Wonder on 04 Sep 2018
Biosimilar medicines are the key to success
3 September 2018 - The lives of more than 10 million Americans — those with rheumatoid arthritis, psoriatic arthritis, ankylosing ...
Posted by Michael Wonder on 03 Sep 2018
You’ll never guess which company is reinventing health benefits
31 August 2018 - Frustrated with insurers, some large companies — including a certain cable behemoth — are shedding long-held practices ...
Posted by Michael Wonder on 03 Sep 2018
Cablivi (caplacizumab) approved in Europe for adults with acquired thrombotic thrombocytopenic purpura
3 September 2018 - In addition, U.S. FDA to conduct priority review of caplacizumab with a target action date of ...
Posted by Michael Wonder on 03 Sep 2018
FDA grants Insys Therapeutics ‘fast track’ designation for epinephrine nasal spray as investigational treatment for anaphylaxis
30 August 2018 - Insys Therapeutics announced today that the U.S. FDA has granted fast track designation to the company’s epinephrine ...
Posted by Michael Wonder on 01 Sep 2018
FDA issues a complete response letter for new drug application for dasatroline for the treatment of ADHD
31 August 2018 - Sunovion Pharmaceuticals today announced that the U.S. FDA issued a complete response letter for the new ...
Posted by Michael Wonder on 31 Aug 2018
Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: a systematic review
1 September 2018 - Although patient-reported outcomes, such as health-related quality of life, are important endpoints in randomised controlled trials, there ...
Posted by Michael Wonder on 31 Aug 2018
Choice of control group in randomised trials of cancer medicine: are we testing trivialities?
31 August 2018 - Several trials in cancer medicine over the past 5 years share two common features: first, they were ...
Posted by Michael Wonder on 30 Aug 2018
FDA approves Merck’s Delstrigo (doravirine with lamivudine and tenofovir disoproxil fumarate), a once daily fixed-dose combination tablet as a complete regimen and Pifeltro (doravirine), an NNRTI, both for the treatment of HIV-1 in appropriate patients
30 August 2018 - Approvals based on findings from the pivotal Phase 3 DRIVE-AHEAD and DRIVE-FORWARD trials evaluating the efficacy and ...
Posted by Michael Wonder on 30 Aug 2018
FDA’s comprehensive effort to advance new innovations: initiatives to modernise for innovation
29 August 2018 - Our longstanding goal for medical care is to ensure that the right drug or device is delivered ...
Posted by Michael Wonder on 30 Aug 2018
Bayer receives US approval for modern haemophilia A treatment Jivi with a step-wise prophylaxis dosing regimen
30 August 2018 - Jivi’s extended half-life allows for twice-weekly initial dosing / May be adjusted to every five days and ...
Posted by Michael Wonder on 30 Aug 2018
U.S. Food and Drug Administration accepts Bristol-Myers Squibb’s application for Sprycel (dasatinib) in paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia
30 August 2018 - Application based on results from Phase 2 CA180-372 study. ...
Posted by Michael Wonder on 30 Aug 2018
FDA accepts resubmission of new drug application for Duobrii (halobetasol propionate and tazarotene) lotion
29 August 2018 - Ortho Dermatologics today announced that the U.S. FDA has accepted the resubmitted new drug application for Duobrii ...
Posted by Michael Wonder on 29 Aug 2018
Surprise! Trump might actually lower drug prices.
29 August 2018 - Surprise! The Trump administration is actually making progress to reduce drug prices, and not just by ...