Blog
RSS FeedPosted by Michael Wonder on 10 Jan 2021
2020: a strong year for new drug therapy approvals – despite many COVID-19 challenges
8 January 2021 - Throughout 2020, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research was challenged ...
Posted by Michael Wonder on 08 Jan 2021
Praxis Precision Medicines receives rare paediatric disease and orphan drug designations for severe paediatric epilepsy programs
7 January 2021 - FDA grants RPD and ODD for PRAX-222 for treatment of SCN2A-DEE. ...
Posted by Michael Wonder on 08 Jan 2021
Extra dose from vials of Comirnaty COVID-19 vaccine
8 January 2021 - EMA’s human medicines committee (CHMP) has recommended updating the Product Information for Comirnaty to clarify that ...
Posted by Michael Wonder on 08 Jan 2021
FDA statement on following the authorised dosing schedules for COVID-19 vaccines
4 January 2021 - Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease ...
Posted by Michael Wonder on 08 Jan 2021
Inversago Pharma receives rare paediatric disease designation from the FDA for INV-101 for the treatment of Prader-Willi syndrome
7 January 2021 - Inversago Pharma today announced the U.S. FDA granted a rare paediatric disease designation to the Company’s lead ...
Posted by Michael Wonder on 07 Jan 2021
Gemini Therapeutics announces FDA fast track designation granted for GEM103 for the treatment of dry age-related macular degeneration in patients with complement factor H loss of function gene variants
7 January 2020 - Gemini Therapeutics today announced that GEM103, the Company’s investigational treatment for dry age-related macular degeneration, has been ...
Posted by Michael Wonder on 07 Jan 2021
Merus granted FDA fast track designation of zenocutuzumab for the treatment of patients with neuregulin 1 fusion cancers
7 January 2021 - NRG1 fusions are rare mutations in many types of solid tumours, including non-small cell lung cancer and ...
Posted by Michael Wonder on 07 Jan 2021
Warning of shortages, researchers look to stretch vaccine supply
5 January 2021 - The N.I.H. and Moderna are examining whether doses of Moderna’s coronavirus vaccine can be halved to double ...
Posted by Michael Wonder on 07 Jan 2021
Most governments are not yet on track to hit their vaccine roll-out targets
6 January 2021 - Some countries aim to inoculate millions of people a day. So far, most are falling short. ...
Posted by Michael Wonder on 07 Jan 2021
Adalimumab biosimilars face product obsolescence before launch
6 January 2021 - Product differentiation by concentration is a threat to the multiple adalimumab biosimilars approved but not yet ...
Posted by Michael Wonder on 07 Jan 2021
RedHill Biopharma's RHB-204 granted FDA fast track designation for non-tuberculous mycobacteria disease
6 January 2021 - FDA Fast Track designation, together with previously granted QIDP designation, provides RHB-204 with eligibility for rolling NDA ...
Posted by Michael Wonder on 06 Jan 2021
EMA recommends Moderna COVID-19 vaccine for authorisation in the EU
6 January 2021 - EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent coronavirus disease ...
Posted by Michael Wonder on 06 Jan 2021
FDA accepts for priority review the new drug application for mirabegron for oral suspension and supplemental new drug application for Myrbetriq (mirabegron) tablets in paediatric patients
6 January 2021 - Astellas Pharma announced today that the U.S. FDA accepted priority review for its new drug application for ...
Posted by Michael Wonder on 06 Jan 2021
Farxiga granted priority review in the US for the treatment of patients with chronic kidney disease
6 January 2021 - Farxiga could become the first SGLT2 inhibitor approved to treat patients with chronic kidney disease, with ...
Posted by Michael Wonder on 06 Jan 2021
MorphoSys and Incyte announce the acceptance of the Swissmedic marketing authorisation application for tafasitamab
5 January 2021 - The Swissmedic marketing authorisation application seeks approval for tafasitamab in combination with lenalidomide for the treatment ...