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Following Peter Marks’ appointment, Lilly executive remains unfazed by the FDA’s frequent leadership changes.

Key Takeaways Eli Lilly’s recent hiring of a former FDA official raises questions about potential conflicts of interest. Critics worry that such moves could undermine public trust and decision-making at the FDA. Eli Lilly’s chief scientific officer argues that industry involvement can enhance medicine development and contribute positively to society. In the world of pharmaceuticals, …

Biotech Leaders Warn That FDA Turmoil Is Stifling Innovation

Key Takeaways Replimune and Capricor Therapeutics face significant delays in FDA drug approvals. Leaders emphasize the need for a consistent and transparent FDA for drug development. Uncertainty at the FDA could hinder the development of innovative treatments. Navigating Drug Approval Challenges In the biotech industry, getting a drug approved is no small feat. For companies …

FMLA Enhances Protections for Patients in Clinical Trials

Understanding Clinical Trials: The FMLA’s New Impact on Patients When faced with a diagnosis of a complex disease like sarcoidosis, patients often confront overwhelming decisions. A patient of mine had to choose between taking steroids or enrolling in a clinical trial. She chose the trial, hoping for better treatment options. However, as the trial unfolded, …

Former FDA official Peter Marks partners with Eli Lilly.

Peter Marks Takes on New Role at Eli Lilly: What It Means for Public Health Former FDA vaccine chief Peter Marks has moved to Eli Lilly. This role focuses on molecule discovery and infectious diseases. His transition raises concerns about the revolving door between government and industry. Marks expresses excitement about contributing to public health. …

Leading FDA official’s unexpected critique of treatment raises eyebrows on Wall Street.

Key Takeaways FDA regulator George Tidmarsh raised alarms about the lupus drug voclosporin. He highlighted concerns over the drug’s toxicity and lack of clinical benefits. Tidmarsh’s comments sparked speculation about personal motivations behind his statements. Is There a Personal Grudge Behind FDA Comments on Voclosporin? Have you ever had a situation where a colleague made …

Strategies for the FDA to Increase Domestic Medicine Production

Key Takeaways America is at a crucial point in advancing science and public health. Changes in the drug development process can accelerate patient access to lifesaving therapies. The FDA’s new PreCheck program is designed to streamline drug manufacturing and approval. Industry collaboration is essential for improving the pharmaceutical supply chain. Modernizing regulations can transform how …

Crinetics’ Palsonify Receives FDA Approval as the Latest Treatment for Acromegaly

Key Takeaways Crinetics Pharmaceuticals received FDA approval for Palsonify, a new treatment for acromegaly. The drug is considered safe and effective, lowering growth hormone levels significantly. Palsonify is aimed at adults who cannot undergo surgery or didn’t respond to it effectively. The annual cost for Palsonify will be approximately $290,000. Crinetics views this approval as …