Regulatory roundup: Ology, MaxCyte make moves in women’s cancer with divergent approval chances
GlobalData’s Investigative News team reviews recent events that impacted a drug’s path to regulatory approval.
Brands
Gilead’s lenacapavir: HIV prospects strongest in long-acting combos with Merck’s islatravir
Gilead’s lenacapavir will find its strongest niche as a long-acting HIV combination treatment, experts said.
Akebia and GSK will grapple with heightened scrutiny of HIF PHIs after roxadustat concerns
The firms may struggle to convince regulators that their HIF PHIs don't share roxadustat’s safety...
Regulatory roundup: Sanofi/Regeneron, J&J and Eyenovia boost approval chances with Phase III updates
Trial updates and data releases across the pharma space moved the needle when it came...
Trial of AbbVie’s NASH drug against severe Covid-19 enrols 25% of patients after a year
The investigator-led trial has so far recruited 45 out of 183 patients despite enrolment opening...
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.
After Covid-19, mRNA technology aims to revolutionise the flu shot
After developing Covid-19 vaccines based on mRNA, pharma is now looking to improve seasonal flu shots using the same science.
Pepaxto’s US uptake to stall in multiple myeloma until FDA provides advice to address death risk
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’s Evrysdi is a strong contender for SMA market share following EMA nod
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…
