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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.
Swiss major confident that new oncology drugs will fill revenue gap.
Stelara revenues declined 42.7% in the quarter due to biosimilars, but innovative medicines grew 4.9%, surpassing $15bn for the quarter. Although pharma tariffs could be coming, the firm said the impact continues to be hard to predict.
Sun’s Leqselvi goes up against Lilly's Olumiant and Pfizer's Litfulo, which currently has the broadest label, in the US alopecia market. Can it shake things up early, amid growing activity in the space with several new mechanisms of action being investigated?
Nanoscope’s experimental gene therapy, MCO-010, is designed to target the broader retinitis pigmentosa population, regardless of the underlying gene mutation, with a completed US regulatory submission expected in early 2026.
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 for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.
Lynkuet will compete with Astellas's Veozah/Veoza
Soleno Therapeutics will raise about $200m gross proceeds from an offering of 2.35m of its common stock to fund the commercialization of Vykat XR, which became the first drug for Prader-Willi syndrome to gain US approval on March 26.
Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.
The company is expecting US FDA approval of the drug in a bigger indication, major depressive disorder, later this year.
Coartem Baby to be rolled out in eight African countries in the autumn.
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.
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.
Many assets underperform their pre-launch sales predictions, which can be disastrous to their developers and marketers. In this article, Scrip highlights several historic examples and the factors that influenced their poorer-than-expected performance.
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.
Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.