Fears that US regulators would take issue with AstraZeneca's decision to change the endpoints of a second pivotal trial for anifrolumab were unfounded and the first-in-class type I interferon inhibitor is the first new treatment for systemic lupus erythematosus in more than 10 years.
AstraZeneca PLC's commercial teams are all set for the US launch of anifrolumab, the first medicine to be approved in over a decade for lupus, at the end of August, the company's biopharmaceuticals head has told Scrip.
Ruud Dobber said that the US Food and Drug Administration's approval of anifrolumab, which has the brand name Saphnelo, for...
The US FDA approved Insmed’s second product, the DPP1 inhibitor Brinsupri (brensocatib) for non-cystic fibrosis bronchiectasis. The company launched the drug immediately with a list price of $88,000 per year.
The US FDA approved Hernexeos for previously treated HER2-mutant NSCLC, making it the first oral option in a setting where drugs like AstraZeneca/Daiichi Sankyo’s Enhertu dominate.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The company will start shipping its newly launched phenylketonuria drug within two weeks and has bought back global net sales obligations for the treatment.
The microbiome-based company’s trial of VE202 in ulcerative colitis has failed in Phase II, but its ongoing Phase III study in C difficile infection is more promising.
Public Company Edition: OrbiMed partners Carter Neild and Matthew Rizzo spoke with Scrip about the firm’s fifth royalty and credit fund. Also, Ligand sold $400m worth of notes, BridgeBio’s oncology spinout went public via SPAC merger and raised $261m and Assembly raised $175m.
Also deals involving Xspray/Handa, Fosun/Expedition, Kaken/Astria, Orchid/Allecra, Sanofi/Visirna, KKR/Healthcare Royalty Partners, Viridian/Kissei, Sandoz/Evotec, Dx&Vx, Dr. Falk/Allianthera, Madrigal/CSPC and Lilly/LTZ.
