Approvals

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 approval of Wegovy HD brings a more effective version to the lower-dose version and the oral formulation, but the company has struggled to compete with obesity rival Eli Lilly.

The drug is the first oral IL-23 receptor antagonist to clear the US FDA. Johnson & Johnson and partner Protagonist Therapeutics are banking on its convenience as well as efficacy and safety to make the drug competitive.

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.

Biocon’s FDA approval and Cipla’s US launch – via partner Orbicular – add momentum to the early generic market for Novo Nordisk’s Saxenda.

Clinigen's CEO and senior executives outline how the services company navigated Japan’s rigorous regulatory framework to secure approval for Prolacta’s human milk–based fortifier as a prescription biological product.

South Korea starts development of AI-supported system to dramatically shorten drug approval reviews and announces new national strategy for AI in biopharma targeting 10x expansion in the country’s new drug pipeline.

Previously known only as AMP-007, the generic Atrovent HFA inhaler is now set for a Q2 launch with six months of exclusivity.

With J&J’s CAR-T Carvykti also approved for second-line disease, an oncologist told Scrip multiple factors will determine who gets which therapy option.

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.

Glenmark says it plans to launch imminently the first US generic fluticasone propionate rival to Flovent, for which it has just received FDA approval – with an added bonus of 180 days of Competitive Generic Therapy exclusivity.

At its February meeting, the EMA’s CHMP issued positive opinions for six biosimilars – including the first rival to Perjeta.