Blog
RSS FeedPosted by Michael Wonder on 25 Jan 2019
Using the E value to assess the potential effect of unmeasured confounding in observational studies
24 January 2019 - Randomised trials serve as the standard for comparative studies of treatment effects. ...
Posted by Michael Wonder on 24 Jan 2019
FDA statement from Commissioner announcing efforts to improve the quality of the information used to assess the effectiveness of REMS programs in supporting the safe use of medications
24 January 2019 - In making decisions about whether the benefits of a drug outweighs its risks, there are many ...
Posted by Michael Wonder on 24 Jan 2019
BMS announces voluntary withdrawal of U.S. application for Opdivo plus low dose Yervoy for treatment of first-line lung cancer in patients with tumor mutational burden ≥10 mutations/megabase, following discussions with the U.S. FDA
24 January 2019 - Following recent discussions with the U.S. FDA, the company today announced the voluntary withdrawal of the ...
Posted by Michael Wonder on 24 Jan 2019
U.S. FDA accepts sNDAs for Pifeltro (doravirine) and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate)
23 January 2019 - Potential new indication would expand use to allow treatment-experienced adults living with HIV-1 whose virus is suppressed ...
Posted by Michael Wonder on 24 Jan 2019
Genmab announces initiation of U.S. FDA regulatory submission for label expansion of daratumumab in combination with lenalidomide and dexamethasone in front line multiple myeloma
22 January 2019 - First part of regulatory package submitted to the U.S. FDA for label expansion of daratumumab in combination ...
Posted by Michael Wonder on 24 Jan 2019
FDA approves use of 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) in children as young as 6 months of age
23 January 2019 - The 0.5 mL dose is now approved for use in children 6 months through 35 months of ...
Posted by Michael Wonder on 24 Jan 2019
Toward an effective innovation agenda
23 January 2019 - Digital technologies have transformed the U.S. and global economies, offering tremendous benefits to consumers and financial success ...
Posted by Michael Wonder on 23 Jan 2019
Modernising clinical trials for patients with cancer
23 January 2019 - Clinical trials involve evaluating and validating new therapies in humans and represent the fundamental means of making ...
Posted by Michael Wonder on 23 Jan 2019
Physicians’ perspectives on FDA approval standards and off-label drug marketing
22 January 2019 - Recently, two fundamental aspects of the US FDA’s pharmaceutical market oversight have become controversial. ...
Posted by Michael Wonder on 23 Jan 2019
EMA relocation updates
23 January 2019 - The EMA will physically relocate to the Netherlands in early March 2019. ...
Posted by Michael Wonder on 23 Jan 2019
No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life
23 January 2019 - Preliminary results from the ANNOUNCE study show that Lartruvo (olaratumab) in combination with doxorubicin is not ...
Posted by Michael Wonder on 23 Jan 2019
European Commission approves Blincyto (blinatumomab) in patients with Philadelphia chromosome negative minimal residual disease-positive B-cell precursor acute lymphoblastic leukaemia
22 January 2019 - Approval based on data from the Phase 2 BLAST study, the largest prospective trial in minimal residual ...
Posted by Michael Wonder on 23 Jan 2019
Random-effects meta-analysis: summarising evidence with caveats
22 January 2019 - Questions involving medical therapies are often studied more than once. For example, numerous clinical trials have been ...
Posted by Michael Wonder on 23 Jan 2019
TG Therapeutics receives breakthrough therapy designation from the U.S. FDA for umbralisib for the treatment of marginal zone lymphoma
22 January 2019 - Breakthrough therapy designation granted based on interim data from the marginal zone lymphoma cohort of the UNITY-NHL ...
Posted by Michael Wonder on 22 Jan 2019
Celgene, sold for $74 billion, leaves a legacy of chutzpah in science and drug pricing
22 January 2019 - Nina Kjellson was just two years out of college, working as a research associate at Oracle ...