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Robertson discusses the trends shaping the future of oncology commercialization.

In today's Pharmaceutical Executive Daily, Cam Olig of Prescryptive Health touches on the results of a new market access survey, Eli Lilly and Ascidian Therapeutics announce a global research collaboration worth up to $1.9 billion to develop RNA exon editors for inherited kidney diseases, and the FDA issues new draft guidance to reduce the submission burden for gene therapy developers.

Eli Lilly moves to deny 340B discounts to hospitals refusing to submit claims data under its documentation policy, escalating a months-long standoff with the American Hospital Association and prompting calls for federal intervention.

FDA's CBER details a framework for sponsors to apply existing CMC, nonclinical, and clinical data to genome-editing-based product development and regulatory filings.

Ascidian Therapeutics has entered a global research and licensing deal with Eli Lilly to develop RNA exon-editing therapies for monogenic kidney diseases, a class of genetic conditions with an unmet need for treatment.

Prescryptive Health’s chief commercial officer discusses the results of a market access survey that asked industry executives about DTC models, affordability, and patient access.

In today's Pharmaceutical Executive Daily, FDA has accepted a new drug application for giredestrant under priority review, FDA also issues a complete response letter for Cingulate's CTx-1301, and Dan Troy, former FDA Chief Counsel, explains the roadblocks and hurdles facing the FDA's efforts to bring stricter oversight to direct-to-consumer prescription drug advertising.

FDA has accepted Roche's NDA for giredestrant under Priority Review, moving the investigational oral SERD closer to potential approval .

FDA has issued a Complete Response Letter to Cingulate’s ADHD candidate CTx-1301 over manufacturing-related deficiencies, delaying approval of the once-daily therapy while leaving its clinical safety and efficacy profile unchallenged.

The former lead counsel discusses FDA’s efforts to bring about strict oversight on DTC drug ads and the difficulties the agency faces in doing so.

In today's Pharmaceutical Executive Daily, the FDA approves Shionogi's Xocova, a pharma M&A roundup covers Servier's acquisition of Edgewise Therapeutics' muscular dystrophy, Eli Lilly's licensing of Hanmi's long-acting GLP-2 therapy, and the merger of Rallybio and Avenzo Therapeutics, finally Sean Werner examines why breakthrough cell and gene therapies continue to fail at the regulatory finish line.

FDA approves Shionogi’s Xocova as First Oral Post-Exposure Covid-19 Prevention Therapy, marking a major milestone for Covid-19 prevention treatments.

A trio of deals from Eli Lilly, Servier, and Avenzo highlights continued industry investment in rare diseases and oncology, spanning gastrointestinal disorders, muscular dystrophy, and next-generation cancer therapeutics.