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Research & Development

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Pipeline Watch: Eight Approvals As CTAD Dominates Phase III Updates

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.

Pipeline Watch Approvals

Y-mAbs Shifts Focus To Approved Drug, Pipeline After Omburtamab CRL

The FDA’s thumbs-down was largely expected after a negative advisory committee review and the path forward for the drug remains unclear – but the company is prioritizing other programs.

Complete Response Letters ImmunoOncology

Lundbeck And Axsome Rival Candidate Data Raise Prospects For First Alzheimer’s Agitation Approvals

The firms unveiled positive Phase III data from their respective assets for treating the agitation seen in Alzheimer’s disease with Lundbeck’s candidate set to become first-to-market for the challenging behavioral symptom.

Clinical Trials Companies

Frontline Success Bolsters IO ‘Backbone’ Hopes For GSK’s Jemperli

GSK’s PD-1 inhibitor will not be able to make up much ground on Keytruda, but new studies suggest it is a match for the market-leading PD-1 inhibitors.

Clinical Trials Companies

Alzheimer’s Experts: Lecanemab Is A Win, But Also Just The Beginning

While Phase III results for Eisai and Biogen’s lecanemab show amyloid clearance provides benefit and Roche’s Phase III gantenerumab data are supportive, more data and certainty of access to treatment are needed.

Clinical Trials Drug Approval Standards

Sanofi Makes Big Strides In Eradicating Sleeping Sickness

The positive Phase II/III results for acoziborole have led researchers to claim that the goal of eliminating sleeping sickness by 2030 is now very much a reality.

Infectious Diseases Clinical Trials

How Much Amyloid Clearance, How Fast Is Needed To Slow Alzheimer’s?

Lilly’s donanemab showed faster, deeper amyloid clearance versus Biogen/Eisai’s Aduhelm and Roche’s failed Phase III gantenerumab studies showed the importance of deep, rapid removal.

Clinical Trials Neurology

Nimbus Nips At BMS’s Heels With Psoriasis Results For TYK2 Inhibitor

Without disclosing data, Nimbus announced positive Phase IIb results for NDI-034858 in psoriasis. The company plans to initiate a Phase III trial next year.

Clinical Trials Business Strategies

Acousia To Refresh Stagnant Hearing Loss Space With New Potassium Channel Approach

The German biotech plans to prevent chemotherapy-induced hearing loss and treat chronic hearing loss by targeting a potassium channel in the ear’s sensory hair cells as it tackles a widespread but side-lined area.

Emerging Company Profile Companies

Megadeal Ahead? Horizon In Takeover Talks With Big Pharma For $20bn+ Deal

The Irish firm revealed it was in early conversations with Amgen, J&J and Sanofi regarding a possible takeover, with some experts touting the potential for a deal far surpassing the $20bn mark.

M & A Companies

Vision Possible: Why Eyestem Is 'Bullish' About Its Dry AMD Candidate

Eyestem founder and CEO talks to Scrip about progress made by the firm’s experimental treatment for dry age-related macular degeneration, cell and gene therapy pricing considerations and the wider competitive landscape. The company is also developing treatments for retinitis pigmentosa and idiopathic pulmonary fibrosis.

Research & Development Regenerative Medicine

Eisai/Biogen’s Lecanemab Effective Across Endpoints, But Will Safety Limit Use?

Alzheimer’s patients treated with the amyloid protofibril-clearing antibody had slower disease progression compared to placebo, with differences increasing over time. Safety concerns, however, are growing. 

Clinical Trials Drug Safety
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