The race is firmly on to be the first PARP inhibitor approved for metastatic castration-resistant prostate cancer, with the FDA giving a speedy review to AstraZeneca and Merck & Co's Lynparza just days after granting the same to Clovis Oncology's Rubraca.
AstraZeneca PLC's hopes of having a fourth tumor type approved for Lynparza have received a big boost with US regulators agreeing to a quicker evaluation of the firm's PARP inhibitor for prostate cancer.
The UK major and partner Merck & Co. Inc. have announced that a supplemental new drug application for Lynparza...
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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.
