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, ...

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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 ...

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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 ...

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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.  ...

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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 ...

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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. ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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