The latest approval for Johnson & Johnson's monoclonal antibody therapy Darzalex in multiple myeloma keeps the product firmly on course as a much-needed new option in relapsed/refractory patients but competition in the market is hotting up all the time.
The European Commission has now granted conditional approval to Janssen-Cilag's (Johnson & Johnson) first-in-class anti-CD38 antibody Darzalex (daratumumab; licensed form Genmab) for use in melanoma following a CHMP positive opinion in April. (Also see "Accelerated EU Committee Nod for J&J/Genmab's Darzalex " - Scrip, 2 April, 2016.)
The approval, the second for the novel product after it was given an earlier-than-expected go-ahead by the US FDA last...
Trial setbacks and extra regulatory scrutiny have hit the progress of some new drugs towards expected approvals this year, but early successes have boosted the commercial prospects of others. Fears of disruption from changes at the US FDA are so far unfounded.
Dizal's EGFR inhibitor Zegfrovy approved in US as new once-daily oral option for second-line NSCLC with EGFR exon 20 insertion mutations, at lower dose than in China.
The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.
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.
Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.
Emerging Company Profile: Early-stage biotech Eolo will seek cash and deals for its novel obesity drug SANA after positive Phase I results for weight loss, lean muscle mass preservation and fat mass reduction.
Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.
