Blog
RSS FeedPosted by Michael Wonder on 26 Aug 2019
Developing real-world data and evidence to support regulatory decision-making
26 August 2019 - On 3 October, the FDA and the Duke-Margolis Center for Health Policy will hold a conference, ...
Posted by Michael Wonder on 26 Aug 2019
FDA encourages inclusion of male patients in breast cancer clinical trials
26 August 2019 - The draft guidance, Male Breast Cancer: Developing Drugs for Treatment, includes draft recommendations for inclusion of males ...
Posted by Michael Wonder on 26 Aug 2019
Lilly receives U.S. FDA approval for Taltz (ixekizumab) for the treatment of active ankylosing spondylitis (radiographic axial spondyloarthritis)
26 August 2019 - Eli Lilly and Company announced today that the U.S. FDA has approved Taltz (ixekizumab) injection 80 ...
Posted by Michael Wonder on 26 Aug 2019
Don’t give up on biosimilars—Congress can give them a boost
25 August 2019 - Drugs grown in live cells are hard to replicate. But policy changes can help accelerate the process. ...
Posted by Michael Wonder on 25 Aug 2019
Medipost’s Pneumostem gets FDA’s fast-track designation
23 August 2019 - Medipost said that the U.S. FDA has given a fast- track designation for Pneumostem, a bronchopulmonary ...
Posted by Michael Wonder on 25 Aug 2019
Time for FDA to release complete responses letters? Debate reignites.
23 August 2019 - The idea of the US FDA releasing complete response letters resurfaced this week as Sarepta Therapeutics ...
Posted by Michael Wonder on 24 Aug 2019
Life changing drugs almost nobody can afford
23 August 2019 - Patients suffering from rare diseases who had little hope for a treatment now have access to ...
Posted by Michael Wonder on 23 Aug 2019
FDA focuses on Novartis delay in reporting drug-test data manipulation
22 August 2019 - Regulators zeroing in on the company’s two-month delay in launching a formal inquiry. ...
Posted by Michael Wonder on 22 Aug 2019
EMA publishes agenda for 19-22 August CHMP meeting
19 August 2019 - Agenda of CHMP written procedure. ...
Posted by Michael Wonder on 22 Aug 2019
AstraZeneca agrees to buy US FDA priority review voucher from Sobi
22 August 2019 - AstraZeneca today announced that it has agreed to buy a US FDA priority review voucher for ...
Posted by Michael Wonder on 22 Aug 2019
Gilead files challenge to government patents for HIV prevention pill
21 August 2019 - Gilead Sciences took the unusual step of mounting a challenge to U.S. government patents on Wednesday, ...
Posted by Michael Wonder on 22 Aug 2019
Fiasp approved in Europe for the management of diabetes in adolescents and children aged one year and above
22 August 2019 - Novo Nordisk today announced that the European Commission has granted an extension of the indication for ...
Posted by Michael Wonder on 22 Aug 2019
Mundipharma announces the licence extension submission for Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin) to the European Medicines Agency
22 August 2019 - The CREDENCE renal outcomes study, which was stopped early due to positive efficacy findings, served as the ...
Posted by Michael Wonder on 22 Aug 2019
U.S. FDA grants Xtandi (enzalutamide) application priority review for the treatment of men with metastatic hormone-sensitive prostate cancer
21 August 2019 - Xtandi supplemental new drug application seeks to add an indication for men with prostate cancer that has ...
Posted by Michael Wonder on 21 Aug 2019
BeiGene announces U.S. FDA acceptance and grant of priority review for its new drug application of zanubrutinib in patients with relapsed/refractory Mantle cell lymphoma
21 August 2019 - BeiGene today announced that the U.S. FDA has accepted the company’s new drug application for zanubrutinib for ...