BioSpace

• Eroding Immunity: Vaccine Hesitancy and Cynicism

  Paul Offit, MD, Director of the Vaccine Education Center at the Children's Hospital of Philadelphia and the Maurice R. Hilleman Professor of Vaccinology, Professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania, identifies himself as a "vaccine skeptic"–someone who demands data and evidence–which he believes is the appropriate stance for medical professionals and regulators.After the Cutter incident in 1955, which resulted in 250 cases of polio caused by batches of polio vaccine containing live polio virus given to the public, the FDA took up this mantle in evaluating vaccines. He warns that public discourse has moved dangerously past healthy skepticism into harmful cynicism, particularly through conspiracy theorists who dismiss scientific evidence by claiming researchers are "in the pocket of Big Pharma." This cynicism threatens public health as vaccine-preventable diseases like measles and pertussis are re-emerging due to declining vaccination rates, with polio potentially following if immunization continues to decrease.Host⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestsPaul Offit, MD, Director of the Vaccine Education Center, Children's Hospital of Philadelphia; Maurice R. Hilleman Professor of Vaccinology and a Professor of Pediatrics, Perelman School of Medicine, University of PennsylvaniaDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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• Trump’s US Manufacturing Push, New Vaccine Policy, Novo’s Weight Loss Pill up for FDA Review

  In his effort to onshore manufacturing, President Donald Trump issued an executive order on Monday afternoon ordering the FDA to ease permitting processes for new and expanded U.S. facilities. The announcement comes as more and more Big Pharma companies commit billions to expanding their U.S. footprints. Bristol Myers Squibb CEO Christopher Boerner announced this week that the company will pump $40 billion into its stateside operations over the next five years, even as the pharma executes a massive cost-cutting effort that involves shaving $3.5 billion from expenses by 2027 and cutting thousands of jobs, including another 516 in New Jersey, according to a May WARN notice.  In other policy news, the Department of Health and Human Services on Wednesday said it will require all new vaccines to be tested in placebo-controlled trials to earn FDA approval but some vaccine experts have raised concerns about this approach. Meanwhile, turmoil still envelopes the FDA, with staff cuts and rehires continuing at a dizzying pace. On Monday, several states sued HHS, saying that the cuts offload critical functions and costs onto the states and impede public health efforts.  As Q1 earnings season for Big Pharma begins to wind down, there are still headlines coming from the biotech sector. Vertex revealed last week that it is abandoning all of its adeno-associated virus vector work, while BioNTech on Monday announced that tariffs could get in the way of its ambitious plans for a closely watched PD-L1-VEGF therapy. Moderna, meanwhile, continues its fall from COVID grace, missing Q1 revenue expectations and announcing plans to reduce operating expenses by around $1.5 billion by 2027.   In the weight loss space, Novo Nordisk announced on Friday that the FDA has accepted the application for a pill version of Wegovy, with a decision expected this fall. Novo has also struck partnerships with CVS and Hims & Hers pharmacies to market injectable Wegovy, drawing the attention of Eli Lilly CEO David Ricks.   Also this week, check out BioSpace’s deep dives into advances in base editing—a technology that’s been touted as a “safer” CRISPR—and Summit Therapeutics’ push to bring closely watched PD-1/VEGF immunotherapy ivonescimab to the U.S. market after its recent approval in China. 

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• Tariffs Continue to Dominate Q1 Earnings, AACR Excites Cancer Space, CEO Pay Gaps, More

  Policy issues—particularly tariffs—loom large as Q1 2025 earnings season rolls on, with Pfizer , Novartis, AstraZeneca and many more all reporting this week. On Pfizer’s call, CEO Albert Bourla called the Trump administration’s national security concerns “legitimate,” but objected to the proposed tariffs in general. Meanwhile, Novartis CEO Vas Narasimhan brushed off the tariff risk but expressed concern over President Donald Trump’s desire to bring back the ‘Most Favored Nations’ rule.  Meanwhile, cancer conference season is in full swing, with the American Association for Cancer Research’s annual event continuing in Chicago. Merck, GSK, Boehringer Ingelheim, Roche and others have presented highly anticipated data from some of their cornerstone cancer drugs and other candidates.  Turning to the latest news out of the FDA, newly minted Commissioner Marty Makary gave his first two big press interviews last week, making statements that both jibed with and contradicted recent reporting. And in the midst of the ongoing Novavax vaccine saga, many have raised concerns that the FDA could become politicized under the watch of HHS Secretary RFK Jr.  Finally, check out this week’s BioPharm Executive stories, including a deep dive into the trend toward mining innovative therapies from China and BioSpace’s annual report on pharma CEO-to-employee pay ratios. 

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• 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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• 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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