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RSS FeedPosted by Michael Wonder on 19 Jul 2021
G1 Therapeutics receives fast track designation from U.S. Food and Drug Administration for Cosela (trilaciclib) in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer
19 July 2021 - G1 Therapeutics today announced that the U.S. FDA has granted fast track designation to Cosela (trilaciclib) ...
Posted by Michael Wonder on 19 Jul 2021
BlueRock Therapeutics receives FDA fast track designation for DA01 in the treatment of advanced Parkinson’s disease
19 July 2021 - BlueRock Therapeutics announced that the U.S. FDA has granted fast track designation for DA01 for advanced Parkinson’s ...
Posted by Michael Wonder on 19 Jul 2021
Making sense of the FDA’s ‘indefensible’ decision to approve Aduhelm
19 July 2021 - There are three sides to every story that defies logic: the defenders’ side, the critics’ side and ...
Posted by Michael Wonder on 19 Jul 2021
EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure
19 July 2021 - EMA has started evaluating an application to extend the use of Kineret (anakinra) to include treatment ...
Posted by Michael Wonder on 19 Jul 2021
Lilly and Incyte provide update on supplemental new drug application for baricitinib for the treatment of moderate to severe atopic dermatitis
16 July 2021 - Eli Lilly and Incyte announced today that the U.S. FDA will not meet the Prescription Drug User ...
Posted by Michael Wonder on 19 Jul 2021
AbbVie provides update regarding Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in the U.S.
16 July 2021 - AbbVie today announced the U.S. FDA did not meet the Prescription Drug User Fee Act action ...
Posted by Michael Wonder on 18 Jul 2021
U.S. FDA grants priority review for the biologics license application for Pfizer-BioNTech COVID-19 vaccine
16 July 2021 - Pfizer and BioNTech today announced that the U.S. FDA granted priority review designation for the biologics license ...
Posted by Michael Wonder on 17 Jul 2021
Merck announces U.S. FDA approval of Vaxneuvance (Pneumococcal 15 valent conjugate vaccine) for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes
16 July 2021 - Clinical data supporting approval demonstrated non-inferior immune responses for the serotypes shared with PCV13 (1, 3, 4, ...
Posted by Michael Wonder on 16 Jul 2021
FDA approves new use of transplant drug based on real world evidence
16 July 2021 - Today, the U.S. Food and Drug Administration approved a new use for Prograf (tacrolimus) based on a ...
Posted by Michael Wonder on 16 Jul 2021
FDA approves belumosudil for chronic graft versus host disease
16 July 2021 - On 16 July 2021, the FDA approved belumosudil (Rezurock, Kadmon Pharmaceuticals), a kinase inhibitor, for adult ...
Posted by Michael Wonder on 16 Jul 2021
International regulators work towards alignment on development and authorisation of second generation COVID-19 vaccines
16 July 2021 - Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 ...
Posted by Michael Wonder on 16 Jul 2021
Ocugen announces initiation of rolling submission to Health Canada for Covaxin
15 July 2021 - Ocugen today announced that it had initiated a rolling submission to Health Canada for Covaxin, the ...
Posted by Michael Wonder on 16 Jul 2021
EMA validates BioMarin's marketing authorisation application for valoctocogene roxaparvovec to treat severe haemophilia A
15 July 2021 - Potential first gene therapy in Europe for treatment of haemophilia A. ...
Posted by Michael Wonder on 16 Jul 2021
HutchMed’s marketing authorisation application for surufatinib submitted and validated by the European Medicines Agency
15 July 2021 - EMA commences review of surufatinib for the treatment of advanced neuroendocrine tumours. ...
Posted by Michael Wonder on 15 Jul 2021
ATAGI update following weekly COVID-19 meeting (14 July 2021)
15 July 2021 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 14 ...