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Sep 17, 2024

Novartis heaps pressure on Lilly with broad FDA approval for Kisqali in early breast cancer

Merck, Daiichi rack up phase 3 ADC lung cancer win but report 2 deaths, immature OS data

FDA clears Senseonics’ 365-day Eversense CGM implant

Coherus' cancer biosimilar faces supply squeeze after company's contract manufacturer overextends itself

Ascendis’ dwarfism drug accelerates growth in phase 3, teeing up challenge to BioMarin

Lupus landscape 'poised for evolution' as US doctors eagerly await new entrants

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Novartis heaps pressure on Lilly with broad FDA approval for Kisqali in early breast cancer

By Angus Liu

An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis' Kisqali and Eli Lilly's Verzenio in early breast cancer.

Merck, Daiichi rack up phase 3 ADC lung cancer win but report 2 deaths, immature OS data

By Nick Paul Taylor

A phase 3 trial of Daiichi Sankyo and Merck & Co.’s HER3-directed antibody-drug conjugate has hit its primary endpoint, boosting plans to take a second shot at FDA approval. But two more people died after developing interstitial lung disease, and the overall survival data are immature.

FDA clears Senseonics’ 365-day Eversense CGM implant

By Conor Hale

Developed by Senseonics and Ascensia Diabetes Care, the Eversense 365 implant got the go-ahead for adults with Type 1 or Type 2 diabetes.

Coherus' cancer biosimilar faces supply squeeze after company's contract manufacturer overextends itself

By Fraiser Kansteiner

Thanks to “over-commitments and capacity constraints” facing the U.S.-based contractor in charge of final packaging for Coherus' Udenyca, the copycat cancer med will suffer a “temporary” supply interruption, the company said last week.

Ascendis' dwarfism drug accelerates growth in phase 3, teeing up challenge to BioMarin

By Nick Paul Taylor

Ascendis Pharma has emerged as a potential threat to BioMarin’s Voxzogo, reporting phase 3 growth disorder data that exceeded analyst expectations and positions the biotech to file for approval next year.

Lupus landscape 'poised for evolution' as US doctors eagerly await new entrants

By Ben Adams

New biologics such as GSK's Benlysta and AstraZeneca's Saphnelo, along with off-label drugs, have been the mainstay for systemic lupus erythematosus treatment for many years. However, the landscape may be about to change with the introduction of new medicines and indications from other approved treatments.

FDA elevates recall as Zimmer Biomet phases out hip replacement implant

By Conor Hale

The FDA is getting the word out regarding a recall effort from Zimmer Biomet, related to its discontinued CPT hip implant and its potential link to fractures of the thigh bone after placement.

J&J talc appeal upends $260M award to Oregon woman with mesothelioma

By Kevin Dunleavy

Three months after a jury awarded $260 million to an Oregon woman who claimed that her use of Johnson’s Baby Powder caused her to develop mesothelioma, a state judge has overturned the verdict and granted the company a new trial.

Alkeus’ oral eye disease asset fails to significantly reduce lesion growth in phase 3

By Gabrielle Masson

Though Alkeus Pharmaceuticals’ oral eye disease asset failed to significantly reduce geographic atrophy (GA) lesion growth, the biotech is citing "clinically meaningful" results and a secondary endpoint win as reasons to pursue further development.

GSK makes Brooke Shields the star of shingles vaccination push

By Nick Paul Taylor

GSK has turned to Brooke Shields to get the message out about shingles vaccination. The drugmaker has worked with the model and actor to talk to female celebrities and patients aged 50 years and up about the power that comes from aging and how shingles threatens their health.