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New appointments in the biopharmaceutical industry: March 2021


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AbbVie : Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Adults with Active Psoriatic Arthritis


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NORTH CHICAGO, Ill., March 17, 2021 /PRNewswire/ AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for upadacitinib in the treatment of adult patients with active psoriatic arthritis. The updated Prescription Drug User Fee Act (PDUFA) action date has been extended three months to late Q2 2021.
AbbVie recently received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in psoriatic arthritis. AbbVie responded to the request and the FDA will require additional time for a full review of the submission. ....

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Takeda and IDT Support Manufacturing of Johnson & Johnson's COVID-19 Vaccine


Takeda and IDT Support Manufacturing of Johnson & Johnson’s COVID-19 Vaccine
Monday, March 15, 2021 5:35PM IST (12:05PM GMT)
− Takeda will make manufacturing capacity available at IDT’s facilities in Germany
 
Takeda Pharmaceutical Company Limited
(TSE:4502/NYSE:TAK) (“Takeda”) today announced a mutual agreement with IDT Biologika GmbH (“IDT”), a contract development and manufacturing organization, to utilize capacity at IDT previously reserved for Takeda’s dengue vaccine candidate (TAK-003) to manufacture the single-shot COVID-19 vaccine developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. At the end of a three-month period, the capacity will be returned to Takeda to resume critical manufacturing for the planned launch of its dengue vaccine, subject to regulatory approvals. ....

United States , Rachel Wiese , Kazumi Kobayashi , Biologika Gmb , Rajeev Venkayya , Plasma Alliance , Takeda Pharmaceutical Company Limited , German Center , Janssen Pharmaceutical Companies Of Johnson , Care Alliance , Takeda Pharmaceutical Company , Exchange Commission , Covid Rd Alliance , Government Of Japan Ministry Health Labour , Vaccine Research , Pharmaceutical Company Limited , Janssen Pharmaceutical Companies , Global Vaccine Business Unit , Health Labour , Rare Genetic , Plasma Derived Therapies , Annual Report , Media Contact , Outside Japan , Takeda Pharmaceutical , Idt Biologika Gmbh ,

Covid 19 coronavirus: Australia considers funding vaccine maker to curb reliance on imports


Covid 19 coronavirus: Australia considers funding vaccine maker to curb reliance on imports
12 Mar, 2021 12:00 AM
4 minutes to read
Canberra seeks allies in its campaign to dissuade the EU from blocking jab shipments. Photo / Getty Images
Financial Times
By: Jamie Smyth
Canberra is considering co-funding a A$1 billion ($1.07b) biopharmaceutical plant to reduce its dependence on imports of critical medicines in the wake of Italy s decision to block a shipment of Covid-19 vaccine to Australia.
It
is also embarking on a diplomatic push to build a coalition of countries , including New Zealand, Japan, Norway and Canada, aimed at preventing the EU from obstructing vaccine exports. ....

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