Blog
RSS FeedPosted by Michael Wonder on 05 Apr 2022
Bristol Myers Squibb receives European Commission approval for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for certain forms of relapsed or refractory large B-cell lymphoma
5 April 2022 - Approval of Breyanzi is based on results from TRANSCEND WORLD, and TRANSCEND NHL 001, the largest pivotal ...
Posted by Michael Wonder on 05 Apr 2022
Curium announces FDA approval of a generic version of DaTscan (Ioflupane I 123 injection) in the U.S.
5 April 2022 - Curium announced today that its generic version of DaTscan (Ioflupane I 123 injection) was approved on 30 ...
Posted by Michael Wonder on 05 Apr 2022
FDA updates sotrovimab emergency use authorisation
5 April 2022 - Sotrovimab is no longer authorised to treat COVID-19 in any U.S. region due to increases in ...
Posted by Michael Wonder on 05 Apr 2022
Watchdog urged to probe McKinsey over work with FDA, opioid manufacturers
5 April 2022 - The consulting firm was getting paid by opioid makers while working for the FDA. ...
Posted by Michael Wonder on 05 Apr 2022
Janssen announces Health Canada approval of Rybrevant (amivantamab), the first and only targeted treatment for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations
4 April 2022 - Targeting both cancer driving and resistance mechanism pathways, Rybrevant offers a unique treatment approach for an ...
Posted by Michael Wonder on 05 Apr 2022
European Commission approves Kimmtrak (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
4 April 2022 - Kimmtrak demonstrated statistically and clinically meaningful overall survival benefit, hazard ratio of 0.51, with median overall ...
Posted by Michael Wonder on 04 Apr 2022
Locally made medicines
4 April 2022 - The Morrison Government is supporting new local jobs in Australia’s innovative medical sector and investing to secure ...
Posted by Michael Wonder on 04 Apr 2022
FDA shuts out its own experts in authorising another vaccine booster
3 April 2022 - Decisions like this only reinforce the perception that Covid policy is driven by groupthink and politics. ...
Posted by Michael Wonder on 04 Apr 2022
Novartis announces European Commission approval of Beovu for people living with diabetic macular oedema
31 March 2022 - Approval is based on year one data from the Phase 3 KESTREL and KITE trials investigating Beovu ...
Posted by Michael Wonder on 04 Apr 2022
Precigen receives fast track designation for PRGN-3006 UltraCAR-T in patients with relapsed or refractory acute myeloid leukaemia
4 April 2022 - PRGN-3006 UltraCAR-T previously received orphan drug designation in patients with acute myeloid leukaemia by the US FDA. ...
Posted by Michael Wonder on 04 Apr 2022
FDA approves Nobelpharma's Hyftor (sirolimus 0.2% topical gel)
4 April 2022 - Hyftor is the first topical treatment approved by the FDA for facial angiofibroma in individuals with tuberous ...
Posted by Michael Wonder on 04 Apr 2022
Alnylam announces three month extension of review period for new drug application for vutrisiran
4 April 2022 - New PDUFA goal date scheduled for 14 July 2022. ...
Posted by Michael Wonder on 04 Apr 2022
Acer Therapeutics’ Edsivo (celiprolol) granted FDA breakthrough therapy designation for vascular Ehlers-Danlos syndrome
4 April 2022 - Discussions on-going with FDA through special protocol assessment seeking agreement on planned pivotal Phase 3 DiSCOVER trial ...
Posted by Michael Wonder on 04 Apr 2022
Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
1 April 2022 - Celerity Pharmaceuticals Uses Biocon Biologics’ Insulin Drug Substance to Develop the Product. ...
Posted by Michael Wonder on 04 Apr 2022
U.S. FDA grants priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults
4 April 2022 - If approved, Actemra/RoActemra would be the first U.S. FDA approved immunomodulator for the treatment of COVID-19 in ...