Blog
RSS FeedPosted by Michael Wonder on 23 Aug 2018
Case-control studies: using “real world” evidence to assess association
23 August 2018 - Associations between patient characteristics or treatments received and clinical outcomes are often first described using observational data, ...
Posted by Michael Wonder on 23 Aug 2018
FDA's new generic EpiPen approval exemplifies progress on drug price reform
23 August 2018 - Last week, FDA Commissioner Scott Gottlieb announced the approval of the first generic version of EpiPen, an ...
Posted by Michael Wonder on 23 Aug 2018
FDA adds four tropical diseases to priority review voucher program to encourage drug development in areas of unmet need
23 August 2018 - Today, the U.S. FDA announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis ...
Posted by Michael Wonder on 23 Aug 2018
U.S. FDA accepts for priority review BMS’ application for Empliciti (elotuzumab) plus pomalidomide and low dose dexamethasone in patients with relapsed or refractory multiple myeloma
23 August 2018 - Application based on results from Phase 2 ELOQUENT-3 study. ...
Posted by Michael Wonder on 23 Aug 2018
Novimmune submits marketing authorisation application in Europe for its lead drug emapalumab
22 August 2018 - Novimmune today announced that it has successfully submitted a marketing authorisation application to the EMA seeking marketing ...
Posted by Michael Wonder on 23 Aug 2018
Y-mAbs receives breakthrough therapy designation for naxitamab for the treatment of high risk neuroblastoma
21 August 2018 - Y-mAbs Therapeutics today announced that the company has received a breakthrough therapy designation for naxitamab, in combination ...
Posted by Michael Wonder on 22 Aug 2018
FDA approves first drug for neurotrophic keratitis, a rare eye disease
22 August 2018 - The U.S. FDA today approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a ...
Posted by Michael Wonder on 22 Aug 2018
Mallinckrodt confirms receipt of stannsoporfin complete response letter
22 August 2018 - Mallinckrodt confirmed today that it has received a complete response letter from the U.S. FDA related ...
Posted by Michael Wonder on 22 Aug 2018
Statement by FDA Commissioner on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics
22 August 2018 - As we all work to confront the staggering human and economic toll created by the opioid crisis, ...
Posted by Michael Wonder on 22 Aug 2018
Allergan receives complete response letter from the U.S. FDA for ulipristal acetate new drug application
21 August 2018 - Allergan today announced it received a complete response letter from the U.S. FDA in response to the ...
Posted by Michael Wonder on 21 Aug 2018
Audentes announces regenerative medicine advanced therapy designation granted by the FDA to AT132 for the treatment of X-linked myotubular myopathy
21 August 2018 - Designation granted based on positive interim data from ASPIRO clinical trial. ...
Posted by Michael Wonder on 21 Aug 2018
Paving the way for biosimilars
21 August 2018 - The FDA’s recently announced Biosimilars Action Plan will take steps to increase access for patients who ...
Posted by Michael Wonder on 21 Aug 2018
United States FDA approves Teva's generic epinephrine injection auto-injector
16 August 2018 - Teva is pleased with the US FDA's approval of its generic versions of EpiPen and EpiPen ...
Posted by Michael Wonder on 21 Aug 2018
FDA takes additional action to mitigate shortages of EpiPen by extending expiration date for specific lots of medication
21 August 2018 - The U.S. FDA today took additional action to mitigate shortages of EpiPen (epinephrine) auto-injector by extending ...
Posted by Michael Wonder on 21 Aug 2018
FDA analysis shows similar success rates for paediatric trials using clinical and surrogate outcomes
21 August 2018 - An analysis by US FDA officials published earlier this month finds that there is a similar ...