BioSpace

• Lilly’s Obesity Pill Heads to the FDA, AbbVie Bets on Psychedelics, HHS Unveils More Change

  Eli Lilly posted data Tuesday from a second Phase III trial of its oral weight loss therapy orforglipron, providing the company with all it needs to head to the FDA with a new drug application. For more in-depth discussion on the oral weight-loss space, check out a special episode of The Weekly. And stay tuned to BioSpace for more unique coverage of this market as we learn which investigational assets will make it across the regulatory finish line and which will join the weight-loss wasteland. On the business side of biopharma, AbbVie turned back to neuropsychiatric therapies this week, acquiring partner Gilgamesh Pharmaceuticals’ lead depression candidate for $1.2 billion. The deal is a display of resilience for AbbVie in the neuropsychiatric space as well, after the stunning failure last November of schizophrenia asset emraclidine—picked up in its nearly $9 billion acquisition of Cerevel Therapeutics. And is the cooler late summer weather thawing the IPO market? Neuropsych-focused LB Pharma revealed in an SEC filing on Friday that it plans to take the plunge, ending a six-month stalemate in biotech IPOs.  Finally, the Department of Health and Human Services (HHS) has been busy this past week. On Monday, the CDC named Retsef Levi—a known vaccine critic—to head the agency’s COVID-19 immunization working group, just as reports surfaced that the Trump administration could be “within months” of banning the COVID-19 vaccine in the U.S. Meanwhile, the FDA issued new draft guidance for cancer drug developers that prioritizes the use of survival data, and the agency began publishing drug-related adverse event reports daily.   HHS itself has also been the subject of recent headlines, announcing that it will no longer recognize employee unions, and last week, hundreds of HHS staffers penned an open letter calling on Secretary Kennedy to tone down what they called “dangerous and deceitful statements” that have fostered distrust against federal health workers, exposing them to physical harm. This followed the Aug. 8 shooting at CDC headquarters in Atlanta.   Finally, multinational pharmaceutical companies spent more than $48 billion on partnerships with China in the first half of 2025 alone, according to a new report from IQVIA—more than in all of 2024.  

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• Oral Weight-Loss Race Heats Up as New Data From Lilly, Viking Reset Expectations

  Oral therapies are projected to account for 25% of the anti-obesity medication market by 2030—but first returns have largely disappointed. This month, shares of both Eli Lilly and Viking Therapeutics took a hit as investors reacted negatively to highly anticipated Phase III and Phase II results for their respective candidates.While the 9.1% placebo-adjusted weight loss generated by Lilly’s orforglipron over 72 weeks was an efficacy miss by most analyst accounts, tolerability tripped up oral VK2735’s otherwise best-case efficacy scenario—10.9% weight loss after just 13 weeks. These murky results have left observers wondering, just how game-changing these pills will be and which ones will be most effective?In such a hot space, Lilly’s and Viking’s results—which follow Novo Nordisk’s new drug application for an oral form of Wegovy in May—are only the tip of the iceberg. Stay tuned to BioSpace for further in-depth coverage of the space as we learn which investigational assets will make it across the regulatory finish line and which will join the weight-loss wasteland.

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• Why AI Won't Save the 90% of Clinical Trials That Still Fail

  While AI represents a significant advancement in efficiency for early-stage drug discovery, it won't dramatically change the 90% clinical trial failure rate. Most failures stem from fundamental gaps in biological understanding rather then the processes where AI is able to have the most impact.The discussion highlights AI's strengths and ability to reduce preclinical costs. However, they caution that AI faces significant limitations in predicting complex biological properties like toxicity due to insufficient data, and regulatory acceptance of AI-only safety assessments remains unlikely, meaning traditional clinical trials will continue to be necessary.This episode is presented in partnership with ⁠Cresset⁠.Host⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuests⁠Mutlu Dogruel⁠, VP of AI, Cresset⁠Mark Mackey⁠, CSO, CressetDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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• MAHA Report Emphasizes Vaccines, Safety Vexes Viking’s Obesity Win, Novo Gains Momentum

  Three months after taking heat over an error-riddled first report, Health Secretary Robert F. Kennedy’s Make America Healthy Again Commission was due to submit a new strategy report to President Donald Trump last week. While the report is delayed—for disputed reasons— Politico obtained a draft copy, which homes in on creating a new vaccine framework and streamlining access to investigational drugs, specifically for children. The new strategy also touches on pharma lobbying, with plans to address alleged conflicts of interest within HHS—which, incidentally, a new JAMA study found have dropped dramatically over the past 25 years. In other HHS news, Kennedy is reviving the Task Force on Safer Childhood Vaccines—which has been dormant for 30 years, and the secretary voiced his support of mRNA vaccines for cancer.   Meanwhile, weight loss continues to coral the headlines. Viking Therapeutics reported greater than 12% weight loss after 13 weeks for its obesity pill VK2735, but tolerability tanked the biotech’s stock. As Viking, Eli Lilly and Novo Nordisk begin to report data from these oral options, manufacturing comes into focus, and Novo’s pending approval of an oral form of Wegovy specifically puts the spotlight on the variability of high-dose peptides.  Speaking of Novo, the Danish pharma appears to be sucking in some oxygen after a difficult run. Last week, the FDA approved Wegovy as just the second drug for metabolic dysfunction-associated steatohepatitis (MASH), and on Monday, Novo teamed up with GoodRx to offer Wegovy and Ozempic and $499 per month if patients skip insurance. Not to be outdone, fellow weight loss warrior Lilly announced a $1.3 billion partnership with AI/ML startup Superluminal Medicines to advance new small molecules for cardiometabolic diseases and obesity. Lilly has also been active on the policy front, saying that it will soon announce higher prices for its drugs in markets like Europe in an effort to “align prices across developed countries.”  Always a contentious topic, pricing plays a key role in why the pharmaceutical industry fails to command the same respect as steelworkers or other all-American pursuits. Also in BioPharm Executive this week, BioSpace takes a deep dive into how the Trump administration is using Most Favored Nation pricing to target pharma companies and pursue a broader trade war.  

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• The Hidden Patent Crisis That Could Break Biotech: What Every CEO Needs to Know

  In this Denatured discussion, the conversation revolves around unpacking the patent policy changes that could make or break biotech companies. Guests Aaron Cummings and Anne Li of Brownstein Hyatt Farber Schreck highlight critical issues posed by the Patent Office including recent changes to the Inter Partes Review (IPR) such as discretionary denial and a proposed patent property tax.Cummings and Li also discuss how biopharma can work with the administration as changes are being proposed and evaluated and stress the importance of individual advocacy and engagement.Host⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestsAaron CummingsAnne Elise Herold Li, Shareholder, Brownstein Hyatt Farber SchreckDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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