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Pipeline Watch: Five Approvals And Twelve Phase III Readouts

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.

Novartis Upbeat Even With Entresto Expiry Looming

 
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Swiss major confident that new oncology drugs will fill revenue gap.

J&J Delivers In Q2 Despite Stelara Drop, Raising Guidance

 

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 Alopecia Treatment Debuts In US - Can It Make Up For Lost Time?

 

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?


In Brief: Nanoscope Ploughs Forward With FDA Application For Retinitis Pigmentosa Gene Therapy

 
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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: Ten Approvals And Two Phase III Readouts

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.

Moderna’s Spikevax Wins Pediatric Approval, But With Narrower Label

 

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.

Bayer Bags First Global Okay For Hot Flashes Therapy

 
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Lynkuet will compete with Astellas's Veozah/Veoza


In Brief: Soleno To Raise $200m To Boost Vykat XR Launch

 
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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 Firms Snag Global First-In-Class Approvals In China

 

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.

J&J Seeks Schizophrenia Relapse Indication For Caplyta

 

The company is expecting US FDA approval of the drug in a bigger indication, major depressive disorder, later this year.

Novartis Secures Approval For First Malaria Therapy for Babies

 
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Coartem Baby to be rolled out in eight African countries in the autumn.


Pipeline Watch: Ten Approvals And Eleven Phase III Readouts

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.

2025’s Biggest Launches – Half-Year Progress Report

 

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 Zegfrovy Wins US NSCLC Approval, At Lower Dose Than In China

 

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.

Regeneron Wins Long-Sought FDA Nod For Lynozyfic In Myeloma

 

The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.


Pipeline Watch: Eleven Approvals And ADA Readouts 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.

Empty Promises: Five Drugs That Fell Short Of Their Sales Forecasts

 

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: Ten Approvals And Seventeen Phase III Readouts

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.

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 

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.