Vertex Pain Drug Fast-Tracked by FDA; Keytruda Reaches Sales Milestone

Here's a brief update on recent developments involving Vertex Pharmaceuticals, Merck & Co., FibroGen, Intellia Therapeutics, and Biogen.

The Food and Drug Administration has granted Vertex Pharmaceuticals an expedited review for its promising pain relief tablet. This decision means the approval could come as soon as January 30. Unlike current pain medications, Vertex’s tablet targets a microscopic cell tunnel that controls nerve cell communication, making it a potentially valuable non-opioid option for pain management. Wall Street analysts predict that annual sales of the drug could eventually surpass $5 billion.

In other news, Merck & Co.'s immunotherapy drug Keytruda has achieved a significant milestone. According to the latest earnings report, quarterly sales of Keytruda have exceeded $7 billion for the first time. Additionally, Keytruda clinched its 40th approved indication in the U.S. during the same three-month period, marking another achievement for the company.

FibroGen has announced a significant reduction in its U.S. workforce, laying off 75% of its staff. This restructuring follows disappointing outcomes from a Phase 2/3 trial of its drug pamrevlumab for pancreatic cancer. The San Francisco-based biotech firm has been struggling with multiple trial failures and regulatory setbacks in recent years. Consequently, shares of FibroGen plummeted by half in early Wednesday trading.

Gene editing company Intellia Therapeutics has received approval from the U.K.'s Medicine and Healthcare products Regulatory Agency to initiate a Phase 1/2 clinical trial for its treatment NTLA-3001, aimed at alpha-1 antitrypsin deficiency. NTLA-3001 is designed to insert a healthy copy of the gene responsible for producing the AAT protein directly into patients. This is Intellia’s third medicine to reach clinical trials, following treatments for transthyretin amyloidosis and hereditary angioedema.

Lastly, Biogen is collaborating with two diagnostics developers to identify biological markers for Alzheimer's disease. The goal of this partnership is twofold: to discover and then develop tests for blood-based markers that indicate the presence of diseased tau protein in the brain. Tau, although essential for brain health, can sometimes form toxic clumps that harm neurons. Earlier this year, Biogen announced plans to accelerate the development of an experimental therapy targeting tau, known as BIIB080. This move aims to bolster Biogen's Alzheimer’s treatment portfolio.

These updates reflect a dynamic period in the pharmaceutical and biotechnology sectors, featuring significant advancements and challenges across various companies.

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