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RSS FeedPosted by Michael Wonder on 14 Apr 2021
PhRMA's three part approach to build a better health care system
13 April 2021 - Our plan is based on three key pillars: ending the pandemic and building a more resilient system, ...
Posted by Michael Wonder on 14 Apr 2021
Moleculin awarded new rare paediatric disease designation from U.S. FDA for WP1066 for the treatment of ependymoma
14 April 2021 - Moleculin Biotech announced today that the U.S. FDA has granted rare paediatric disease designation to its ...
Posted by Michael Wonder on 13 Apr 2021
U.S. FDA to scrutinise vaccine design behind COVID-19 shots linked to blood clots
13 April 2021 - With two COVID-19 vaccines now under scrutiny for possible links to very rare cases of blood ...
Posted by Michael Wonder on 13 Apr 2021
Atossa Therapeutics announces ovarian cancer patient has begun treatment with oral endoxifen under FDA’s Expanded Access Pathway
13 April 2021 - Atossa Therapeutics today announced that an ovarian cancer patient has begun treatment with Atossa’s proprietary oral endoxifen. ...
Posted by Michael Wonder on 13 Apr 2021
FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer
13 April 2021 - Today the Food and Drug Administration granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics) for patients ...
Posted by Michael Wonder on 13 Apr 2021
vTv Therapeutics receives FDA breakthrough therapy designation for TTP399 for the treatment of type 1 diabetes
13 April 2021 - Designation offers potential for expedited development pathway and reinforces TTP399’s potential to provide a substantial clinical benefit. ...
Posted by Michael Wonder on 13 Apr 2021
Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine
13 April 2021 - The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation ...
Posted by Michael Wonder on 13 Apr 2021
Avenue Therapeutics announces that the FDA is still reviewing its NDA resubmission for IV tramadol
13 April 2021 - The FDA has not provided a decision regarding the new drug application. ...
Posted by Michael Wonder on 13 Apr 2021
Adamis Pharmaceuticals provides an update on Zimhi
12 April 2021 - Adamis Pharmaceuticals today provided an update on the status of the company’s new drug application relating ...
Posted by Michael Wonder on 12 Apr 2021
International reference pricing for prescription drugs in the United States: administrative limitations and collateral effects
12 April 2021 - Many countries use international (or external) reference pricing—benchmarking prices against those in other countries—to manage spending ...
Posted by Michael Wonder on 12 Apr 2021
Cavazzoni to take over influential spot atop FDA drug center
12 April 2021 - Patrizia Cavazzoni has been named the permanent leader of the FDA’s Center for Drug Evaluation and ...
Posted by Michael Wonder on 12 Apr 2021
ICER publishes research protocol for assessing the unsupported price increases on prescription drugs that occurred in 2020
12 April 2021 - Final assessment to be published on 16 November; through 10 May, ICER is accepting public Input ...
Posted by Michael Wonder on 12 Apr 2021
CBO report shows enacting drug pricing legislation will result in fewer new drugs
12 April 2021 - If there was a silver lining in the COVID-19 pandemic, it was the response of the biopharmaceutical ...
Posted by Michael Wonder on 12 Apr 2021
Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental new drug application for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in idiopathic hypersomnia
12 April 2021 - Final FDA decision anticipated by 12 August. ...
Posted by Michael Wonder on 12 Apr 2021
ICER to use Aetion observational RWE to update value assessment of treatments for hereditary angioedema
12 April 2021 - New ICER pilot will incorporate more than 24 months of observational real world demographic, utilisation, and cost ...