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RSS FeedPosted by Michael Wonder on 10 Jan 2021
U.S. FDA approves addition of overall survival and other secondary outcome data to Nubeqa (darolutamide) Prescribing Information
8 January 2021 - Phase 3 data showed treatment with Nubeqa resulted in a 31% reduction in risk of death, with ...
Posted 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 09 Jan 2021
Health Canada postpones overhaul of drug pricing for 6 months
8 January 2021 - Changes meant to bring down price of prescription drugs pushed to 1 July 2021. ...
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
NICE no for BMS’ Opdivo for head and neck cancer
8 January 2021 - The UK’s NICE has turned down Bristol Myers Squibb’s immunotherapy Opdivo (nivolumab) for recurrent or metastatic ...
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
Drug prices increase and biopharma bashing returns
5 January 2021 - It’s an annual ritual. In the first week of January, drug companies announce their annual price increases. ...
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
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 ...
Posted by Michael Wonder on 06 Jan 2021
KYE Pharmaceuticals announces approval of Corzyna in Canada (ranolazine extended release tablets)
5 January 2020 - KYE Pharmaceuticals today announced an important milestone, Corzyna (ranolazine extended release tablets) has now been approved by ...