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Feb 18, 2026
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Gottlieb cites a Wall Street Journal editorial noting FDA leader Vinay Prasad rejected Moderna's (MRNA) mRNA vaccine without a cursory review. This "arbitrary" regulatory behavior increases the cost of capital and unpredictability for the entire sector. Gottlieb notes investment in vaccines and cell/gene therapies is drying up in the US and shifting to China (where half of the global mRNA pipeline now sits). The regulatory environment in the US has become hostile to innovation, making the sector uninvestable in the medium term until leadership changes. A change in FDA administration or successful appeals by pharma companies could reverse sentiment. |
CNBC
Squawk Pod: Baby Formula, A Tax Hike, & The L...
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Feb 09, 2026
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Gottlieb warns that the environment for developing new vaccines has become toxic for investors. The regulatory bar at the FDA has risen, and the CDC's advisory committee has shown reluctance to recommend new vaccines even after approval. Consequently, venture capital firms are pulling funding from early-stage vaccine research because the path to commercialization is blocked by political and regulatory skepticism. Gottlieb notes that research money is actively leaving the space, specifically citing pulled funding for Epstein-Barr Virus (EBV) vaccines. A shift in public health policy or a new pandemic forcing a regulatory reversal. |
CNBC
Squawk Pod: Super Bowl ads & GLP-1 competitio...
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Feb 09, 2026
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SHORT
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Hims & Hers (HIMS) paused sales of its copycat weight-loss pill after the FDA and Novo Nordisk (NVO) threatened action. The stock dropped ~15.8%. Novo has filed a lawsuit seeking damages and a permanent ban. Gottlieb explains that HIMS claimed to use a "liposomal" delivery system to mimic Novo's patented oral absorption technology. If true, this technically makes it an "unapproved new drug," not just a compounded copy. The FDA referred the case directly to the DOJ, which is highly unusual; typically, the FDA sends a warning letter first. A DOJ referral implies the regulator is seeking an immediate injunction or seizure of products. Novo Nordisk spent ~$1.8B acquiring the specific technology to make oral semaglutide absorbable. HIMS attempted to bypass this with a novel formulation without going through the drug approval process. HIMS could theoretically settle, though Gottlieb views them as a "bad actor" unlikely to secure partnerships with big pharma. |
CNBC
Squawk Pod: Super Bowl ads & GLP-1 competitio...
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Feb 09, 2026
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Investment capital is fleeing the vaccine research sector. Gottlieb notes that research into vaccines for Epstein-Barr Virus (EBV), MS, and cancer prevention is being pulled back. The political and regulatory environment has become hostile. It is increasingly difficult to get vaccines through the FDA due to policy changes, and even if approved, the CDC is showing reluctance to recommend them due to anti-vaccine sentiment. Gottlieb states that as a Venture Capital partner, he sees it is "very hard to get a new vaccine program funded" right now. A shift in political sentiment or a new public health crisis forcing a regulatory pivot. |
CNBC
Dr. Scott Gottlieb on Novo Nordisk vs. Hims &...
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Feb 09, 2026
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LONG
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Novo Nordisk (NVO) and Eli Lilly (LLY) retain tight control over the GLP-1 market. Novo specifically spent ~$1.8B to acquire the "SNAC" technology that allows their oral drug to survive stomach acid. The regulatory crackdown on Hims validates the "moat" around Big Pharma's IP. While compounding exists, the incumbents will only partner with "compliant" telehealth platforms (like Ro) that respect regulatory boundaries, freezing out aggressive actors like Hims. Novo's patent on the absorption technology prevents generic oral versions from working effectively without infringing IP or triggering FDA "new drug" rules. Continued compounding of the *injectable* versions (which is legally distinct from the oral pill issue). |
CNBC
Dr. Scott Gottlieb on Novo Nordisk vs. Hims &...
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Feb 09, 2026
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Hims & Hers attempted to launch a compounded oral GLP-1 using a "liposomal" delivery system to bypass Novo Nordisk's patents. The FDA immediately referred the case to the DOJ, and Hims withdrew the product. Gottlieb argues this wasn't just compounding; by creating a new delivery mechanism to survive stomach acid, Hims effectively created an "unapproved new drug" which requires years of trials. The immediate referral to the DOJ (rather than a standard FDA warning letter) suggests regulators were preparing for a seizure or injunction. The Department of Health and Human Services (HHS) General Counsel made a rare, direct referral to the DOJ before the FDA even took enforcement action. Hims could pivot to standard compounding, though Gottlieb believes their reputation is damaged. |
CNBC
Dr. Scott Gottlieb on Novo Nordisk vs. Hims &...
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