Blog
RSS FeedPosted by Michael Wonder on 17 Nov 2020
Amazon jumps into the pharmacy business with online prescription fulfilment, free delivery for Prime members
17 November 2020 - Amazon is making its biggest move yet into the pharmacy space. ...
Posted by Michael Wonder on 17 Nov 2020
UCB’s Vimpat (lacosamide) now approved by FDA in U.S. for primary generalised tonic-clonic seizures and expanded paediatric use for people living with epilepsy
17 November 2020 - All three Vimpat formulations, including injection for intravenous use, are now indicated for the treatment of partial-onset ...
Posted by Michael Wonder on 17 Nov 2020
PHARMAC and Diabetes Foundation Aotearoa locked in stand-off over drug funding decision
17 November 2020 - The Diabetes Foundation Aotearoa is calling on drug funding agency PHARMAC to release the submissions it ...
Posted by Michael Wonder on 17 Nov 2020
PLx Pharma submits supplemental new drug applications for Vazalore 325 mg and 81 mg to U.S. FDA
16 November 2020 - FDA sets estimated completion review date for the end of February 2021. ...
Posted by Michael Wonder on 17 Nov 2020
Kiniksa announces breakthrough therapy designation granted to vixarelimab for the treatment of pruritus associated with prurigo nodularis
16 November 2020 - Kiniksa Pharmaceuticals today announced that the U.S. FDA granted breakthrough therapy designation to vixarelimab for the ...
Posted by Michael Wonder on 16 Nov 2020
Trump officials preparing to move forward with major step to lower Medicare drug prices
16 November 2020 - The Trump administration is preparing to move forward with a major proposal to lower drug prices, ...
Posted by Michael Wonder on 16 Nov 2020
Apellis announces FDA acceptance and priority review of the new drug application for pegcetacoplan for the treatment of PNH
16 November 2020 - FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss ...
Posted by Michael Wonder on 16 Nov 2020
Lupin announces FDA filing acceptance of supplemental new drug application for Solosec (secnidazole) for the treatment of trichomoniasis
16 November 2020 - Lupin Pharmaceuticals announced today that the U.S. FDA has accepted their supplemental new drug application for ...
Posted by Michael Wonder on 16 Nov 2020
CHMP adopted positive opinion for Elzonris (tagraxofusp) for the treatment of blastic plasmacytoid dendritic cell neoplasm
13 November 2020 - The CHMP recommended approval of Elzonris for the first line treatment of adult patients with blastic plasmacytoid ...
Posted by Michael Wonder on 16 Nov 2020
CHMP recommends EU approval of Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2 positive breast cancer
13 November 2020 - Phesgo offers faster and less invasive delivery of standard of care treatment with Perjeta and Herceptin, under ...
Posted by Michael Wonder on 16 Nov 2020
The CHMP has adopted a negative opinion for emapalumab in Europe for the treatment of primary HLH
13 November 2020 - Sobi today announced that the CHMP has adopted a negative opinion recommending a refusal of the ...
Posted by Michael Wonder on 16 Nov 2020
Emer Cooke takes office as head of EMA
16 November 2020 - Emer Cooke has begun her mandate as Executive Director of the European Medicines Agency today. ...
Posted by Michael Wonder on 16 Nov 2020
Adamis Pharmaceuticals receives a complete response letter from the FDA regarding Zimhi
16 November 2020 - Adamis Pharmaceuticals today announced that after the close of business and the U.S. markets on 13 ...
Posted by Michael Wonder on 16 Nov 2020
Eisai receives approval for indication expansion of anti-epileptic agent Fycompa for use in paediatric patients
16 November 2020 - Eisai announced that it has been received approval from the European Commission for the use of its ...
Posted by Michael Wonder on 16 Nov 2020
How will Brexit affect the supply of medicines?
6 November 2020 - Starting from day one, 1 January 2021, the government expects new checks and bureaucracy at the short ...