GlobalData’s Investigative News team reviews recent events that impacted a drug’s path to regulatory approval.
Regulatory roundup: Servier, Pfizer and Debiopharm gather gains with oncology trial updates; Karyopharm poses a loss
GlobalData’s Investigative News team reviews oncology and nononcological events that impacted drugs’ paths to approval.
With blood cancer oncologists inexperienced with Pepaxto, they will wait for the FDA on guidance on how to mitigate death risk.
Medicare’s National Coverage Determination could boost chances of limited Aduhelm coverage despite backlash
Could Medicare’s rare move to determine Aduhelm’s coverage nationally be a positive sign for Biogen?
Roche recently announced that its product Evrysdi (risdiplam) was recommended for approval for the treatment of spinal muscular atrophy (SMA) in patients two months of age and older by the European Medicines Agency (EMA).
Another domestic Chinese PD-1 inhibitor enters the race for US approval following Coherus BioSciences’ deal with Shanghai Junshi Biosciences
On 1 February, Coherus Biosciences announced that it will pay $150m to Shanghai Junshi Biosciences for the rights to Junshi’s PD-1 inhibitor Tuoyi (toripalimab) in the US and Canada. Junshi…