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FDA Approves Xocova as First Oral Post-Exposure Covid-19 Prevention Therapy

Pharma M&A Roundup: Servier Acquiring Edgewise Therapeutics' Muscular Dystrophy Business, Hanmi Enters Licensing Agreement with Eli Lilly, Avenzo Enters Merger Agreement with Rallybio

Why Breakthrough Cell and Gene Therapies Still Fail at the Finish Line

How Leadership Changes at FDA Impact its Strategy on DTC Drug Advertisements

Pharmaceutical Executive Daily: WHO Identifies Priority Treatment Candidates for Ebola

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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’s Advisory Panel Votes in Favor of Updating Covid-19 Vaccine Shots to Target XFG Variant
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.

Eli Lilly enters three separate acquisitions totaling $3.83 billion in a push into vaccines and infectious diseases, signaling a strategic expansion into prevention-focused medicines.

























