The first HIV single-tablet regimen anchored by a protease inhibitor, Symtuza’s prospects are challenged by competitors already on the market and treatment guidelines that prefer integrase inhibitor regimens.
Johnson & Johnson has obtained US approval for the first protease inhibitor-containing single-tablet regimen for HIV, but Symtuza faces cloudy commercial prospects due to US treatment guidelines that prefer regimens anchored by integrase inhibitors and concerns about eventual generic availability of its components.
Symtuza, which combines J&J’s protease inhibitor darunavir (Prezista/Prezcobix) with three agents licensed from HIV leader Gilead Sciences Inc., was...
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.
Madrigal and Syndax update investors on their key launches, while Merck KGaA weighs in on the possibility of direct-to-consumer sales in the US.
The Swiss drugmaker’s BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate has chalked up another win in late-stage development, further strengthening its pipeline-in-a-product bid.
The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.
