Blog
RSS FeedPosted 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
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 ...
Posted by Michael Wonder on 22 Jan 2019
Shutdown risks delaying FDA approval of potentially life-saving drugs and therapies
22 January 2019 - It's not accepting new applications or fees during the shutdown. ...
Posted by Michael Wonder on 22 Jan 2019
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on latest steps to strengthen FDA’s 510(k) program for premarket review of medical devices
22 January 2019 - In 2018, the FDA’s Center for Devices and Radiological Health achieved several new milestones, including a ...
Posted by Michael Wonder on 22 Jan 2019
FDA chief Scott Gottlieb warns 'we have many hard decisions ahead of us' if government shutdown persists
18 January 2019 - "We are in uncharted territory. This is a watershed moment in the life of this agency," he ...
Posted by Michael Wonder on 21 Jan 2019
FDA's banner year for approvals: will market access to new drugs follow suit?
21 January 2019 - It's not hyperbolic to say that 2018 was a sensational year for FDA approvals of new drugs ...
Posted by Michael Wonder on 19 Jan 2019
Samsung Bioepis biosimilar to Roche's Herceptin wins FDA nod
19 January 2019 - The U.S. FDA said on Friday it had approved a biosimilar to Roche’s blockbuster breast cancer ...
Posted by Michael Wonder on 18 Jan 2019
Lilly reports results of Phase 3 soft tissue sarcoma study of Lartruvo
18 January 2019 - Lartruvo in combination with doxorubicin previously showed an overall survival benefit in soft tissue sarcoma in a ...
Posted by Michael Wonder on 18 Jan 2019
Immunomedics receives complete response letter from FDA for sacituzumab govitecan biologics license application
17 January 2019 - Immunomedics today announced it has received a complete response letter from the U.S. FDA for the ...
Posted by Michael Wonder on 18 Jan 2019
Actelion receives complete response letter from U.S. FDA for Opsumit (macitentan) supplemental new drug application
16 January 2019 - Actelion today announced it has received a complete response letter from the U.S. FDA for its supplemental ...
Posted by Michael Wonder on 18 Jan 2019
FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-small cell lung cancer
17 January 2019 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application for Tecentriq ...
Posted by Michael Wonder on 17 Jan 2019
FDA issues letter about paclitaxel coated balloons and eluting stents
17 January 2019 - Today the FDA issued a letter to health care providers about a recent publication in the Journal ...