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RSS FeedPosted by Michael Wonder on 14 Oct 2020
Harmony Biosciences receives FDA approval for expanded use of Wakix (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy
13 October 2020 - Wakix is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult ...
Posted by Michael Wonder on 14 Oct 2020
Bayer submits supplemental new drug application to the FDA for intrauterine device Mirena (levonorgestrel releasing intrauterine system) 52 mg
14 October 2020 - Application seeks to extend duration of use up to seven years for Mirena. ...
Posted by Michael Wonder on 14 Oct 2020
CTI BioPharma initiates rolling submission of new drug application for pacritinib in myelofibrosis patients with severe thrombocytopenia
13 October 2020 - Completion of submission expected in first quarter 2021. ...
Posted by Michael Wonder on 13 Oct 2020
Daewoong's antipyretic unable to get insurance benefits
13 October 2020 - Daewoong Pharmaceutical has failed to list Fiblast (trafermin), a burn treatment drug developed by Japan's Kaken ...
Posted by Michael Wonder on 13 Oct 2020
PMV Pharma granted FDA fast track designation of PC14586 for the treatment of advanced cancer patients that have tumours with a p53 Y220C mutation
13 October 2020 - PMV Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to its lead product ...
Posted by Michael Wonder on 13 Oct 2020
Top Democrats call for watchdog to review Trump Medicare drug cards
13 October 2020 - Top-ranking Democrats want an independent watchdog to expedite a review of the Trump administration's plans to ...
Posted by Michael Wonder on 13 Oct 2020
Oxular receives rare paediatric disease and orphan drug designations for retinoblastoma treatment
12 October 2020 - Provides furthered momentum for OXU-003 development programme. ...
Posted by Michael Wonder on 13 Oct 2020
Stage 2 PBS process improvements – consultation closed
13 October 2020 - On 21 September 2020, the department hosted a webinar to provide information to industry on the ...
Posted by Michael Wonder on 12 Oct 2020
EMA publishes agenda for 12-15 October CHMP meeting
12 October 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 12 Oct 2020
SMC accepts Bavencio (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced or metastatic renal cell carcinoma
12 October 2020 - Merck and Pfizer announced today that the Scottish Medicines Consortium has accepted the immunotherapy Bavencio (avelumab) for ...
Posted by Michael Wonder on 12 Oct 2020
Alexion receives FDA approval for new advanced formulation of Ultomiris (ravulizumab-cwvz) with significantly reduced infusion time
12 October 2020 - New 100 mg/mL formulation will reduce infusion time by approximately 60 percent, lessening the burden on patients. ...
Posted by Michael Wonder on 12 Oct 2020
SMC - October 2020 decisions
12 October 2020 - The Scottish Medicines Consortium, which advises on newly licensed medicines for use by NHSScotland, has today ...
Posted by Michael Wonder on 12 Oct 2020
NICE proposes simplifying how medicines and medical devices are selected for evaluation
12 October 2020 - As part of the work underway to review the methods and processes NICE uses to develop guidance ...
Posted by Michael Wonder on 12 Oct 2020
Innovent and Lilly jointly announce the NMPA granted marketing approval for Halpryza (rituximab injection) in China
9 October 2020 - Innovent Biologics and Eli Lilly and Company today jointly announce that Halpryza (rituximab injection), a recombinant human/murine ...
Posted by Michael Wonder on 12 Oct 2020
PHARMAC apologises for contraceptive pill shortages
10 October 2020 - Pharmac is apologising to thousands of women who will be forced to change oral contraceptives because ...