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RSS FeedPosted by Michael Wonder on 28 Jun 2018
The biopharmaceutical industry provides 75% of the FDA's drug review budget. Is this a problem?
28 June 2018 - Caroline Chen of ProPublica has written a provocative article challenging the objectivity of the FDA in its ...
Posted by Michael Wonder on 28 Jun 2018
Statement from FDA Commissioner on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug
28 June 2018 - As a physician, I understand how important it can be for health care providers to treat ...
Posted by Michael Wonder on 28 Jun 2018
Medicines Australia welcomes shortages legislation
28 June 2018 - Medicines Australia welcomes the introduction of the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018 ...
Posted by Michael Wonder on 28 Jun 2018
Bias, operational bias, and generalisability in Phase II/III trials
27 June 2018 - Adaptive clinical trial designs improve the efficiency of the drug development process by allowing treatment decisions to ...
Posted by Michael Wonder on 28 Jun 2018
AcelRx receives European Commission approval for Dzuveo
27 June 2018 - AcelRx's Dzuveo receives EU approval for management of acute moderate to severe pain in medically monitored ...
Posted by Michael Wonder on 28 Jun 2018
Jazz Pharmaceuticals announces FDA acceptance of supplemental new drug application for Xyrem (sodium oxybate) to treat cataplexy and excessive daytime sleepiness in paediatric narcolepsy patients
27 June 2018 - Jazz Pharmaceuticals today announced that the U.S. FDA accepted for priority review its supplemental new drug application ...
Posted by Michael Wonder on 28 Jun 2018
Sunovion announces Health Canada approval of Aptiom (eslicarbazepine acetate) as monotherapy to treat partial-onset seizures in adults with epilepsy
27 June 2018 - Aptiom now provides a once-daily monotherapy treatment option for adults with partial-onset seizures. ...
Posted by Michael Wonder on 27 Jun 2018
Metastasis-free survival — a new end point in prostate cancer trials
27 June 2018 - Earlier this year, the FDA approved apalutamide, an androgen receptor inhibitor, for treatment of patients with non-metastatic ...
Posted by Michael Wonder on 27 Jun 2018
U.S. FDA grants priority review for Pfizer's new drug application for glasdegib in patients with previously untreated acute myeloid leukaemia
27 June 2018 - Submission based on data from randomised Phase 2 trial, which showed glasdegib in combination with chemotherapy nearly ...
Posted by Michael Wonder on 27 Jun 2018
Array BioPharma announces FDA approval of Braftovi (encorafenib) in combination with Mektovi (binimetinib)
27 June 2018 - Approval based on Phase 3 COLUMBUS trial which demonstrated nearly 15 months median progression-free survival. ...
Posted by Michael Wonder on 27 Jun 2018
Health Canada offers HTA aligned reviews for drugs and biologics
25 June 2018 - Sponsors of biologics and new drug submissions now have the option of requesting aligned regulatory reviews ...
Posted by Michael Wonder on 27 Jun 2018
Gottlieb calls on payers to share data to aid drug innovation
25 June 2018 - The FDA is working to modernize the clinical trial process in order to answer the right ...
Posted by Michael Wonder on 27 Jun 2018
Puma Biotechnology announces results of CHMP re-examination of MAA for neratinib for extended adjuvant treatment of HER2 positive early stage breast cancer
26 June 2018 - Puma Biotechnology announced that the CHMP of the EMA has adopted a positive trend vote recommending the ...
Posted by Michael Wonder on 27 Jun 2018
Sandoz restrained from selling MabThera biosimilar in Australia
21 June 2018 - Australia's first biosimilar interlocutory injunction. ...
Posted by Michael Wonder on 27 Jun 2018
Zemdri (plazomicin) approved by FDA for the treatment of adults with complicated urinary tract infections
26 June 2018 - Zemdri is a new treatment for patients with cUTI, including pyelonephritis, due to certain Enterobacteriaceae. ...