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worth up to $1.9 billion to develop RNA exon editors for inherited kidney diseases, and the FDA issues new draft guidance to reduce the submission burden for gene therapy developers.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.
Between 2026 and 2030, billions of dollars in revenue will be at risk due to expiring patents and periods of exclusivity.
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.
As FDA complete response letters continue to impact nearly half of cell and gene therapy submissions, manufacturing strategy and process design are emerging as the industry’s most persistent regulatory vulnerabilities.
With recent leadership shakeups, many are wondering how FDA will change its approach to regulating DTC pharma advertisements.
In today’s Pharmaceutical Executive Daily, Harpreet Singh discusses the evolving regulatory landscape for biopharma, the World Health Organization identifies three priority treatment candidates for the Bundibugyo strain of Ebola virus disease, and this week’s pharma roundup highlights new findings on Mounjaro and long COVID-related immune system changes.
WHO identifies experimental therapies from Mapp Biopharmaceutical, Regeneron, and Gilead as leading candidates for the Bundibugyo strain of Ebola virus disease, as the agency pushes for urgent clinical trials amid a growing outbreak.
Research published this week highlights tirzepatide outperforming other GLP-1 therapies in early type 2 diabetes treatment while separate studies identified autoantibodies as a likely biological driver behind persistent neurological symptoms in some long Covid patients.
Former chief counsel for FDA Dan Troy explains why there is no firm timeline for regulatory reform or update at FDA for DTC pharma advertisements.
In today’s Pharmaceutical Executive Daily, an FDA advisory committee weighs recommendations for the composition of the 2026–2027 Covid-19 vaccines, CVS Health restores coverage for Eli Lilly’s Zepbound while adding the company’s newly approved obesity pill Foundayo, and experts discuss how treatment expectations are evolving in lupus care.
CVS Health is restoring coverage of Eli Lilly’s Zepbound and adding oral obesity drug Foundayo to its formulary, signaling shifting payer dynamics as lower-cost GLP-1 therapies expand access for patients.
FDA advisors are set to meet this week to determine whether Covid-19 vaccines should be updated to target the emerging XFG variant, a decision that could shape the composition of the 2026–2027 immunization season amid ongoing viral evolution.
Dan Troy, former FDA chief counsel, explains limits on what regulations FDA can put on DTC advertisements.
The Lupus Research Alliance’s CEO and president discusses how recent treatment breakthroughs are changing the patient experience in Lupus treatment.
Harpreet Singh, former FDA Oncology Division Director and current chief medical officer at Precision for Medicine notes how evolving FDA review standards, expedited approval programs, and emerging AI tools are reshaping the regulatory landscape for biopharma companies.
Former FDA chief counsel Dan Troy discusses the motivation behind potential DTC pharma ad bans.
Harpreet Singh, MD, notes that FDA’s internal AI system could improve efficiency in drug review by helping reviewers aggregate and synthesize complex data.
A fragmented approach to drug discovery created structural inefficiencies that drive up R&D costs.
In today’s Pharmaceutical Executive Daily, Eli Lilly announces three acquisitions totaling roughly $3 billion, the FDA approves Hepcludex as the first treatment for chronic hepatitis delta virus infection in the United States, and biotech finance leaders reflect on the lessons learned from navigating two decades of volatile markets.
FDA approves Gilead’s Hepcludex as the first treatment for chronic hepatitis delta virus in the U.S., marking a major milestone for a severe liver disease with limited therapeutic options.
