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Ipsen : Palovarotene FDA acceptance – 28 May 2021.pdf


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Ipsen confirms U.S. FDA accepts New Drug Application for palovarotene as the first potential treatment worldwide for fibrodysplasia ossificans progressiva (FOP)
New Drug Application granted Priority Review status, with a decision anticipated on 30 November
2021
Authorization Application (MAA) for palovarotene with Swissmedic granting palovarotene a priority
review
PARIS, FRANCE, 28 May 2021 - Ipsen (Euronext: IPN; ADR: IPSEY) today announced that its New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification (new bone formation) as a potential treatment option for people living with the progressive disabling and ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP), has been accepted by the U.S. Food and Drug Administration ( ....

France General , United States , United Kingdom , Robertj Pignolo , Jess Smith , Maryann Quinn , Howard Mayer , Ipsen Euronext , Al Mukaddam , Global Communications , Product Communications , Head Of Research , Mayo Clinic College Of Medicine , Drug Administration , Data Monitoring Committee , Drug Development Forum , Ipsen Biopharmaceuticals Inc , European Medicines Agency , Proc Intl Clin Council , New Drug Application , Drug Application , Priority Review , Medicines Agency , Executive Vice President , Geriatric Medicine , Mayo Clinic College ,

BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver | McDonnell Boehnen Hulbert & Berghoff LLP


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One year ago, World Health Organization Director-General Tedros Adhanom declared the COVID-19 outbreak to be a pandemic. At the time of the announcement, the WHO noted that there were 118,000 cases reported globally, but in its most recent situation report, the WHO indicated that as of March 7, 2021 there have been 116,166,652 cases globally.
The response to the COVID-19 pandemic by the global biopharmaceutical industry over the past fourteen months has been unprecedented. From December 30, 2019, when SARS coronavirus was first detected in a patient sample, and January 10, 2020, when the complete genome of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was released, multiple treatments and vaccines have been developed and approved for use in combating COVID-19. And the rapid development of these treatments and vaccines has, as the Pharmaceutical Research and Manufacturers of America (PhRMA) recen ....

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