Management & Regulatory

Compass Pathways Cuts Workforce and Refocuses on Psilocybin Program
Management & Regulatory Compass Pathways Cuts Workforce and Refocuses on Psilocybin Program

In a significant move, Compass Pathways has announced its decision to lay off 30% of its workforce, streamline its research efforts, and explore selling its digital technologies. This decision comes in response to delays in the development of its lead drug, a synthetic form of psilocybin aimed at

Viking's Obesity Drug Shows Promising Results Amid Competitive Market
Management & Regulatory Viking's Obesity Drug Shows Promising Results Amid Competitive Market

The recent results of a clinical trial for an oral obesity drug developed by Viking Therapeutics have generated significant interest. The drug has shown promise in early-phase trials, capturing the attention of Wall Street analysts and investors alike. The study results, revealed at a medical

Choosing Between BizDevOps and CoE Models for Pharma IT Efficiency
Management & Regulatory Choosing Between BizDevOps and CoE Models for Pharma IT Efficiency

In the pharmaceutical industry, IT organizations face a critical decision when managing unified clinical development platforms: whether to adopt a product-centric BizDevOps model or a centralized Center of Excellence (CoE) model. This choice is pivotal as pharmaceutical companies strive to bring

What Are the Latest Challenges and Triumphs in Big Pharma?
Management & Regulatory What Are the Latest Challenges and Triumphs in Big Pharma?

Recent developments in the pharmaceutical industry underscore the volatile nature of advancements and market dynamics affecting prominent companies. The latest updates reveal a mix of struggles and achievements that highlight how pharmaceutical giants are navigating the complexities of drug

Can LakeShore Biopharma Sustain Growth After Regaining Nasdaq Compliance?
Management & Regulatory Can LakeShore Biopharma Sustain Growth After Regaining Nasdaq Compliance?

LakeShore Biopharma Co., Ltd (NASDAQ: LSB), a prominent biopharmaceutical company, has successfully regained compliance with Nasdaq's minimum bid price requirement after experiencing non-compliance due to a prolonged period of its share price falling below $1.00. As of October 21, 2024, the company

Michelle Tarver Leads FDA's CDRH Amid AI, Recall, and Safety Challenges
Management & Regulatory Michelle Tarver Leads FDA's CDRH Amid AI, Recall, and Safety Challenges

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is experiencing a transformative period marked by the recent appointment of Michelle Tarver as its new director. Tarver, a clinical ophthalmologist with extensive experience within the FDA, steps into her

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