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RSS FeedPosted by Michael Wonder on 22 Jul 2020
Jazz Pharmaceuticals announces U.S. FDA approval of Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for cataplexy or excessive daytime sleepiness associated with narcolepsy
22 July 2020 - Xywav is the first FDA approved new treatment option indicated for both cataplexy and excessive daytime sleepiness ...
Posted by Michael Wonder on 22 Jul 2020
Pfizer vaccine deal at $20 a dose sets ceiling for rivals
22 July 2020 - U.S. agrees to pay Pfizer, BioNTech $1.95 billion on approval. ...
Posted by Michael Wonder on 22 Jul 2020
Coronavirus: pharmaceutical giants split on vaccine profits
22 July 2020 - Pharmaceutical companies are split on how they would price their potential COVID-19 vaccines, with some pledging ...
Posted by Michael Wonder on 21 Jul 2020
Aurinia announces U.S. FDA acceptance of the filing of new drug application and priority review for voclosporin for the treatment of lupus nephritis
21 July 2020 - FDA grants priority review and sets PDUFA date of 22 January 2021 . ...
Posted by Michael Wonder on 21 Jul 2020
Harnessing real world data for regulatory use and applying innovative applications
22 July 2020 - A vast quantity of real world data are available to health care researchers. ...
Posted by Michael Wonder on 21 Jul 2020
Use of risk evaluation and mitigation strategies by the US Food and Drug Administration, 2008-2019
21 July 2020 - The US FDA Amendments Act of 2007 gave the FDA authority to require a Risk Evaluation and ...
Posted by Michael Wonder on 21 Jul 2020
Grünenthal and Averitas Pharma announce U.S. FDA approval of Qutenza for the treatment of neuropathic pain associated with diabetic peripheral neuropathy of the feet
21 July 2020 - Qutenza is the first and only topical, non-systemic, non-opioid pain treatment of its kind to deliver prescription ...
Posted by Michael Wonder on 21 Jul 2020
Pharma execs say FDA will not lower standards for coronavirus vaccine
21 July 2020 - Drug company executives sought to reassure House Democrats that the federal government is not lowering its ...
Posted by Michael Wonder on 20 Jul 2020
Trials of a vaccine and new drug raise hope of beating COVID-19
20 July 2020 - The latest tests with Oxford University’s vaccine, and interferon beta, look promising. ...
Posted by Michael Wonder on 20 Jul 2020
Many drug companies working on COVID-19 vaccines and treatments are lobbying harder than usual
20 July 2020 - Pharmaceutical companies racing to develop coronavirus treatments and vaccines have upped their lobbying presence in the ...
Posted by Michael Wonder on 20 Jul 2020
Gene therapy shows promise for haemophilia, but could be most expensive U.S. drug ever
20 June 2020 - Jack Grehan, who was born with hemophilia, used to inject himself every couple of days with ...
Posted by Michael Wonder on 20 Jul 2020
Osmotica Pharmaceutical announces FDA user fee goal date of 29 December 2020 for arbaclofen extended release tablets
20 July 2020 - Osmotica Pharmaceuticals, through its subsidiary Osmotica Pharmaceutical US, announced today that the U.S. FDA considers the Company’s ...
Posted by Michael Wonder on 20 Jul 2020
Acadia Pharmaceuticals announces U.S. FDA accepted for filing the supplemental new drug application for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis
20 July 2020 - If approved, Nuplazid would be the first and only treatment indicated for dementia-related psychosis. ...
Posted by Michael Wonder on 20 Jul 2020
Rare disease drove two women on a mission to change FDA drug review process
19 July 2020 - Melissa Goetz and Lindsey Sutton are campaigning to improve the US drug review process for rare diseases. ...
Posted by Michael Wonder on 20 Jul 2020
Orphazyme completes rolling submission of new drug application to U.S. FDA for arimoclomol for Niemann-Pick disease type C
20 July 2020 - Company expects to submit marketing authorisation application for arimoclomol for Niemann-Pick disease type C to European Medicines Agency ...