Ampio obtains DCGI approval for Phase II Covid-19 trial of inhaled drug
In the trial, inhaled Ampion will be used to treat patients with respiratory distress associated with Covid-19.
Approvals
Waning Covid-19 vaccine efficacy: what does the data show?
While Covid-19 vaccines’ protection does appear to wane, most experts agree that universal booster rollouts...
Promising therapeutics on horizon for recurrent and metastatic cervical cancer
Alternative treatment options for recurrent and metastatic cervical cancer can transform the landscape and satisfy...
Ferring draws closer to a microbiome breakthrough
Ferring and subsidiary Rebiotix are developing a microbiota-based live biotherapeutic, RBX2660, against recurrent C. diff.
Multiple myeloma: first bispecific mAb to secure r/r approval will have biggest market bite
Market latecomers will likely struggle to demonstrate value-added edge so early strategic decisions are critical.
Leading regenerative medicine advocacy group leverages GlobalData’s datasets to highlight a record year
The Alliance for Regenerative Medicine’s report reveals the data behind a “year of firsts and records” for the sector.
Regulatory roundup: Alexion ALS drug sees approval prospects plummet
GlobalData’s Investigative News team reviews recent events that impacted a drug’s path to regulatory approval.
FDA requests additional study for first-in-class drug tenapanor
Tenapanor has the potential to capture a slice of the hyperphosphataemia market by targeting certain dialysis-dependent patients.
ObsEva’s Yselty: EDELWEISS III endpoint data readout and likelihood of market success
Yselty offers promise in the endometriosis market because of its ability to alleviate pain while minimising other adverse effects.
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 concerns in CKD.
