Economic Challenges, Strategic Investments: Reshaping the Women's Health Landscape
This discussion features BioSpace's head of insights Lori Ellis, Kearney partner Martin Hadosi, and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine emphasizing the need for collaboration to improve women's health.This discussion features Lori Ellis, Martin Hadosi, and Melissa Laitner, who emphasize the need for collaborative effort across multiple sectors including industry, healthcare organizations, researchers, and patient advocacy groups. Regarding investment challenges, they acknowledge the current difficult economic environment affects all biomedical research, not just women's health specifically.This episode is presented in partnership with DIA, in support of their 2025 Global Annual Meeting taking place June 15-19 in Washington DC.HostLori Ellis, Head of Insights, BioSpaceGuestsMartin Hodosi, Partner, KearneyMelissa Laitner, Director of Strategic Initiatives, National Academy of MedicineDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
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10:34
Makary’s First Interview, US Manufacturing Push and Lilly vs. Novo in Obesity Pill Race
While much of the country was off celebrating Easter and Passover this weekend, the FDA—and its new leader Marty Makary—were busy making news. Makary, who was confirmed as FDA commissioner last month, gave his first major interview, where he unveiled a new regulatory pathway for rare disease therapies and addressed the “epidemic of distrust” he feels is imperiling the agency. Makary also shared his thoughts on the conflicts of interest he sees between the FDA and pharma industry, highlighting a new directive to ban industry representatives from serving on the agency’s advisory committees—a move experts believe will have minimal impact in reducing COIs.Makary also touched on vaccines and what he believes to be the cause of autism. On this, he was more restrained than his boss, HHS Secretary Robert F. Kennedy Jr., who continues to insist on re-investigating what he believes is a link between autism and vaccines. The interview comes as more former FDA officials sound the alarm about the changes happening within the agency.Elsewhere on the policy front, President Donald Trump continues to threaten tariffs on pharma products. In response, two more companies, Roche and Regeneron, are committing billions of dollars to enhance their U.S. footprints. They join Novartis, J&J and Eli Lilly in this regard, with the latter additionally promising to manufacture its investigational oral obesity drug orforglipron in the U.S.That announcement followed the news that orforglipron generated “injectable-like efficacy” in a Phase III diabetes trial. Lilly intends to submit for approval of the pill for weight management by the end of this year and diabetes in 2026. Not to be outdone, chief rival Novo Nordisk revealed Saturday that it has already filed for FDA approval of an oral formulation of its own blockbuster, semaglutide, for overweight and obesity.Finally, make sure to check out this week’s edition of BioPharm Executive where we take a deep dive into another sizzling space—transthyretin amyloid cardiomyopathy (ATTR-CM)—and find out which pharma CEO has the biggest golden parachute.
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18:16
Tariff Turmoil, FDA’s Future, Pfizer’s Obesity Setback and CEO Salaries Revealed
It’s all about tariffs again this week. No sooner had Donald Trump announced that “major” tariffs on the pharmaceutical industry would be coming “very shortly”—sending stocks spiraling—the president announced a 90-day pause on most taxes for imports from countries not named China. But this respite was not to last. On Sunday, Secretary of Commerce Howard Lutnick told ABC News that tariffs would be coming for pharma in the next month or two, according to Leerink. A Federal Register Notice revealing an investigation into pharmaceutical product imports and the associated potential national security threats additionally signaled that tariffs might be imminent. Accordingly, tariffs were a major theme as Johnson & Johnson kicked off Q1 earnings season on Tuesday, where CEO Joaquin Duato urged President Donald Trump to consider tax policy changes instead. Last week, Novartis joined J&J and Eli Lilly in preparing for said tariffs with a $23 billion pledge to expand its own U.S. R&D and manufacturing. And amid all of these trade tensions, the National Security Commission on Emerging Biotechnology released a report warning that China is “dangerously close” to overtaking U.S. biotech. Meanwhile, after unprecedented cuts to its workforce, the FDA is looking toward a future of drug review delays and increased executive oversight, according to experts. Industry watchers have also expressed concern that the cuts could trigger a little-known mechanism built into the Prescription Drug User Fee Act that could potentially cost the FDA nearly half of its funding and set the agency—and U.S. patients—back 35 years. Also fighting for headlines on Monday morning was Pfizer’s announcement that it is ending development of its lead obesity candidate danuglipron after detecting a potential case of drug-induced liver injury. Pfizer’s loss could be Viking Therapeutics’ gain, however, as analysts immediately floated the idea of a marriage between the two companies. Viking has long been a top takeover target, and the biotech’s shares rose 13% upon Pfizer’s announcement. Finally, it’s that time of year again: In BioPharm Executive this week, BioSpace looked at the top paid CEOs in biopharma. Who is this year’s highest paid CEO? Click here to find out.
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Bonus: Q1 2025 Job Market Update
In this bonus episode, BioSpace’s vice president of marketing Chantal Dresner and careers editor Angela Gabriel take a look at job market performance in the first quarter of 2025. They discuss job posting trends, application rates and layoffs. Also discussed are recent decisions of the Trump administration and how they are impacting the workforces of the private sector, HHS and academia.Want to receive our latest quarterly job market reports? Subscribe to Career Insider for our job market updates, job trends, career advice and more.
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9:18
Breaking Down Barriers: The Nuanced Approach to Women's Representation in Medical Research
This discussion features BioSpace's head of insights Lori Ellis, Kearney partner Martin Hadosi, and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine examining the underrepresentation of women in clinical trials. They stress that rather than waiting for regulatory guidance, the industry should proactively improve trial accessibility and inclusivity, as there's mutual benefit in faster enrollment and more diverse participation.This episode is presented in partnership with DIA, in support of their 2025 Global Annual Meeting taking place June 15-19 in Washington DC.HostLori Ellis, Head of Insights, BioSpaceGuestsMartin Hodosi, Partner, KearneyMelissa Laitner, Director of Strategic Initiatives, National Academy of MedicineDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
Unravel the business of science with BioSpace. We dive into biopharma's top stories and biggest challenges, whether it’s layoffs, pipeline shake-ups, acquisitions, new FDA approvals or how to regulate AI in drug development.
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