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RSS FeedPosted by Michael Wonder on 16 Dec 2021
The wild west of checkpoint inhibitor development
15 December 2021 - Although immunotherapy development has improved overall survival among patients with common cancers and has led to important ...
Posted by Michael Wonder on 16 Dec 2021
CSL Behring receives accelerated CHMP assessment for etranacogene dezaparvovec for European patients living with haemophilia B
15 December 2021 - CSL Behring today announced that the CHMP, the chief scientific body of the EMA accepted its ...
Posted by Michael Wonder on 15 Dec 2021
Sapience Therapeutics receives FDA fast track designation for ST101 for advanced cutaneous melanoma
15 December 2021 - Sapience Therapeutics announced today that the U.S. FDA has granted fast track designation to its lead program, ...
Posted by Michael Wonder on 15 Dec 2021
Nuvation Bio receives FDA fast track designation for NUV-422 for the treatment of high grade gliomas, including glioblastoma multiforme
15 December 2021 - Nuvation Bio today announced that the U.S. FDA has granted fast track designation to NUV-422, a cyclin-dependent ...
Posted by Michael Wonder on 15 Dec 2021
U.S. FDA grants priority review for spesolimab for the treatment of flares in patients with generalised pustular psoriasis, a rare, life-threatening skin disease
15 December 2021 - Additionally, FDA granted breakthrough therapy designation for spesolimab in the treatment of generalised pustular psoriasis flares. ...
Posted by Michael Wonder on 15 Dec 2021
EMA launches the Regulatory Science Research Needs initiative
15 December 2021 - For the first time, EMA has issued a list of regulatory science topics that need further research ...
Posted by Michael Wonder on 15 Dec 2021
FDA approves first drug to prevent graft versus host disease
15 December 2021 - Today, the U.S. FDA approved Orencia (abatacept) for the prophylaxis of acute graft versus host disease, a ...
Posted by Michael Wonder on 15 Dec 2021
COVID-19 Vaccine Janssen: EMA recommendation on booster dose
15 December 2021 - EMA’s CHMP has concluded that a booster dose of COVID-19 Vaccine Janssen may be considered at ...
Posted by Michael Wonder on 15 Dec 2021
Califf sails through confirmation hearing for FDA job, despite tensions over opioids
14 December 2021 - Robert Califf escaped largely unscathed from a two-hour hearing Tuesday vetting him to be commissioner of ...
Posted by Michael Wonder on 15 Dec 2021
TGA approves new medicine for paediatric cancer
15 December 2021 - Another new cancer medicine from AstraZeneca. ...
Posted by Michael Wonder on 15 Dec 2021
Alnylam submits regulatory applications to the U.S. FDA and EMA to support label expansion for Oxlumo for the treatment of advanced primary hyperoxaluria type 1
14 December 2021 - Findings from the ILLUMINATE-C Phase 3 study showed substantial reductions in plasma oxalate in PH1 patients with ...
Posted by Michael Wonder on 15 Dec 2021
Incyte announces acceptance and priority review of sNDA for ruxolitinib cream (Opzelura) as a treatment for patients with vitiligo
14 December 2021 - Incyte today announced that the U.S. FDA has accepted for priority review the supplemental new drug application ...
Posted by Michael Wonder on 15 Dec 2021
U.S. FDA approves Pfizer’s Xeljanz (tofacitinib) for the treatment of active ankylosing spondylitis
14 December 2021 - Pfizer announced today that the U.S. FDA has approved the supplemental new drug application for Xeljanz/Xeljanz XR ...
Posted by Michael Wonder on 15 Dec 2021
Rinvoq (upadacitinib) receives U.S. FDA approval for active psoriatic arthritis
14 December 2021 - Milestone marks the second FDA approved indication for Rinvoq following rheumatoid arthritis in 2019. ...
Posted by Michael Wonder on 14 Dec 2021
Heterogeneity of treatment effect; estimating how the effects of interventions vary across individuals
14 December 2021 - ...