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RSS FeedPosted by Michael Wonder on 13 May 2021
Long waits for life saving drugs harming Canadians: report
13 May 2021 - Canadians wait 15 months longer on average for new and potentially life-saving medications compared to Americans ...
Posted by Michael Wonder on 13 May 2021
Strongbridge Biopharma announces U.S. FDA filing acceptance of new drug application for Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome
13 May 2021 - FDA Sets Prescription Drug User Fee Act target action date of 1 January 2022. ...
Posted by Michael Wonder on 13 May 2021
Palisade Bio receives FDA fast track designation for LB1148 for reduction of adhesions following abdominal and pelvic surgery
13 May 2021 - LB1148 was previously granted fast track designation from the U.S. FDA for the treatment of post-operative GI ...
Posted by Michael Wonder on 13 May 2021
Heron Therapeutics announces U.S. FDA approval of Zynrelef for the management of post-operative pain for up to 72 hours
13 May 2021 - Full U.S. commercial launch of Zynrelef is planned for July 2021. ...
Posted by Michael Wonder on 13 May 2021
Eisai Korea to stop supply of blood cancer drug Symbenda this year
13 May 2021 - Symbenda (bendamustine), a treatment for blood cancer, is expected to become unavailable in Korea within this ...
Posted by Michael Wonder on 13 May 2021
Daiichi Sankyo submits application for additional indication of mirogabalin in Japan
13 May 2021 - Daiichi Sankyo today announced that it has submitted a supplemental new drug application for mirogabalin besylate ...
Posted by Michael Wonder on 13 May 2021
Fulcrum Therapeutics announces U.S. FDA grants fast track designation to losmapimod for the potential treatment of facioscapulohumeral muscular dystrophy
12 May 2021 - Fulcrum Therapeutics today announced that the U.S. FDA has granted fast track designation to losmapimod for ...
Posted by Michael Wonder on 12 May 2021
Agenda items scheduled for review by the PBAC under the process for reviewing recommendations not accepted by applicants
13 May 2021 - The revised agenda for the July 2021 PBAC meeting notes seven medicines/medicinal preparations for review under ...
Posted by Michael Wonder on 12 May 2021
BioCryst receives UK approval of Orladeyo (berotralstat), first oral, once daily therapy to prevent attacks in hereditary angioedema patients
12 May 2021 - BioCryst Pharmaceuticals today announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency has granted ...
Posted by Michael Wonder on 12 May 2021
Allow Medicare to negotiate on behalf of patients to lower drug prices
12 May 2021 - President Biden’s speech announcing his American Families Plan reaffirmed his strong support for legislation to lower ...
Posted by Michael Wonder on 12 May 2021
Evofem Biosciences receives fast track designation for EVO100 for prevention of gonorrhoea in women
12 May 2021 - Potential for expedited NDA review of EVO100 by FDA. ...
Posted by Michael Wonder on 12 May 2021
Liquidia resubmits new drug application for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension
10 May 2021 - Liquidia Corporation announced today that on 7 May 2021, it resubmitted its new drug application for LIQ861 ...
Posted by Michael Wonder on 12 May 2021
Astellas’ Xtandi bags additional MHRA approval in prostate cancer
12 May 2021 - Japanese pharma company Astellas has announced that its prostate cancer therapy Xtandi has gained an approval ...
Posted by Michael Wonder on 12 May 2021
NICE rejects Pfizer’s rare heart disease treatment Vyndaqel
12 May 2021 - Pfizer’s Vyndaqel has been rejected by NICE as a treatment for the rare heart condition transthyretin ...
Posted by Michael Wonder on 12 May 2021
Public availability of results of ClinicalTrials.gov registered expanded access studies
10 May 2021 - Expanded access is the use of investigational treatments outside of clinical trials. Results of expanded access studies ...