Your Weekly Biotech News Fix | Ep. 974
The week of 3.30.2026
Hello Avatar! Another week of biotech news is in the history books. We are proud to bring you the latest edition of our weekly biotech news fix. The content is designed to be consumed as a quick scroll to bring readers up to speed on key events from the week. For those of you interested to read a bit more, we provide links to the source articles.
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BIOTECH NEWS UPDATES FOR THE WEEK 3/30
Trump Hits Drugmakers With 100% Tariff but Carve-outs Soften the Blow
The Trump administration has imposed a 100% tariff on imports of patented pharmaceutical products and ingredients from 17 large companies, set to take effect in 120 days, and will extend to smaller companies in 180 days. The tariffs follow a Section 232 investigation and are intended to bolster national security and public health. However, numerous carve-outs and company-specific agreements are expected to significantly mitigate the impact. Companies that have secured Most Favored Nation (MFN) and onshoring agreements with the administration will be subject to a 0% tariff rate through January 20, 2029, while those with only onshoring deals will face a 20% rate. Despite these agreements, some major firms like Pfizer, Johnson & Johnson, and GSK are still listed as facing near-term tariffs, either due to gaps in finalized agreements or public disclosure. Trade agreements also provide a 15% tariff rate for imports from the EU, Japan, Korea, Switzerland, and Liechtenstein, with the UK securing a 0% rate due to a separate arrangement.
Additional carve-outs exempt products such as orphan drugs, cell and gene therapies, and antibody-drug conjugates, and generic and biosimilar medicines are fully exempt, though this exemption will be reviewed in a year. Analysts expect the existing deals to serve as a framework, enabling more companies to negotiate favorable terms and potentially avoid the full tariff. The Biotechnology Innovation Organization (BIO) warned that these tariffs could increase costs, hinder domestic manufacturing, and delay treatment development, while also citing concerns about policy uncertainty and the MFN framework stifling investment in U.S. biotech. In contrast, the Association for Accessible Medicines praised the exclusion of generics and biosimilars. Despite the headline 100% tariff, the numerous carve-outs and ongoing negotiations are expected to soften the broader clinical and financial impact for much of the pharmaceutical industry.
Approvals in Hand, Lilly and Novo Obesity Pills Will Battle It Out on Hairline Differences
Eli Lilly and Novo Nordisk are set to compete for dominance in the growing oral obesity medication market following the FDA approvals of Lilly’s orforglipron (Foundayo) and Novo’s oral semaglutide (Wegovy pill). Foundayo achieved 11.2% mean weight loss over 72 weeks in the Phase 3 ATTAIN-1 trial, while oral Wegovy demonstrated a higher average weight loss of 16.6% in the Phase 3 OASIS 4 trial. However, no direct head-to-head clinical trials have compared the two drugs; Novo’s claim of superiority is based on a simulated treatment comparison. Lilly’s Foundayo comes with a clean label for broad patient use and more convenient dosing, as it can be taken with or without food, unlike the Wegovy pill, which must be taken on an empty stomach with a 30-minute waiting period. Financially, both products have set similar starting prices ($149/month self-pay), but escalate with dose, with Foundayo reaching $349 and Wegovy pill reaching $299 for higher doses; William Blair gave Novo the pricing edge due to its maintenance cost advantage.
The commercial launches have been quick, with Novo reporting over 600,000 prescriptions filled since January, and Lilly preparing to ship Foundayo in tablet, not capsule, form for greater manufacturing efficiency and lower costs. Strategic distinctions include Foundayo being a small-molecule drug, generally easier and less costly to manufacture than peptide-based oral Wegovy. Market strategists predict factors such as dosing convenience, manufacturing scalability, and pricing structure will be critical to uptake and patient adherence. While both companies are deploying aggressive marketing and data strategies to highlight their drugs’ strengths, analysts expect injectable GLP-1 products will continue to dominate the U.S. obesity market due to their higher potency and greater efficacy in populations with high BMI. Regardless of which oral therapy leads, analysts agree that broader availability of oral options benefits patients, potentially expanding the overall market.
Eli Lilly’s Oral Obesity Pill Approved, Kicking Off Renewed Novo Rivalry
The FDA has approved Eli Lilly’s oral obesity drug Foundayo (orforglipron), marking an acceleration in the competition with Novo Nordisk’s oral Wegovy. Foundayo, supported by Phase 3 clinical data showing significant weight loss and cardiometabolic improvements, will be available immediately via LillyDirect, priced at $25 per month with commercial insurance and $149 for self-pay. The approval—granted just 50 days after submission under the FDA’s new Commissioner’s National Priority Voucher (CNPV) program—highlights the agency’s priority review process for drugs addressing national health priorities. Foundayo’s approval was based on results from the ATTAIN-1 trial, where the highest dose produced an average weight loss of 27.3 pounds at 72 weeks; however, no head-to-head trials have directly compared it to Novo’s oral option. The label carries a boxed warning for thyroid C-cell tumors, restricting its use in certain patient populations at heightened risk.
Strategically, the addition of Foundayo bolsters Lilly’s weight loss and diabetes franchise, which already includes Mounjaro and Zepbound, and is projected by Truist Securities to generate up to $101 billion in peak global revenue. Foundayo’s small-molecule formulation offers manufacturing advantages over Novo’s peptide-based oral drug, potentially allowing for broader market access. Financially, the launch follows a pricing agreement involving the White House that initially set Foundayo’s price at $150, comparable to oral Wegovy’s launch price. With Mounjaro already outpacing Novo’s Ozempic in annual sales, Foundayo’s entry further intensifies the rivalry in the obesity therapeutics market, although meaningful direct efficacy comparisons await formal head-to-head studies.
FDA approves Lilly obesity pill, triggering battle with Novo Nordisk
The U.S. Food and Drug Administration has approved Eli Lilly’s once-daily oral obesity medication, Foundayo (orforglipron), marking a direct challenge to Novo Nordisk’s recently launched oral version of Wegovy. Both drugs target the GLP-1 pathway and compete within a rapidly expanding obesity market projected to reach $100 billion annually by 2030. In clinical trials, Foundayo led to roughly 11% body weight loss for people with obesity but without diabetes, and 10% for those with obesity and diabetes, while Wegovy’s pill achieved average weight loss of 14%. There have been no head-to-head trials, and company executives have disputed claims of relative efficacy, with Novo emphasizing the numerical superiority in weight loss results for oral Wegovy and Lilly promoting the convenience advantage of Foundayo, which does not need to be taken on an empty stomach.
The commercial landscape is shaped by insurance coverage challenges and high patient demand, with both companies offering introductory cash-pay pricing at $149 per month as part of a pricing deal with the White House, and Lilly additionally providing starter doses to the insured for $25 per month. The approval and launch of Foundayo continue a broader competitive battle in the metabolic drugs sector, where Lilly has already disrupted Novo’s earlier dominance through injectable products such as Zepbound and Mounjaro. Analysts anticipate significant uptake for Foundayo, with RBC Capital Markets projecting $1.7 billion in U.S. sales in 2024 and a potential peak of $36 billion annually. Both the clinical and commercial outcomes of this rivalry will depend on access, ongoing efficacy perceptions, and further regulatory developments.
Pharma’s M&A Train Is on Track for Record Highs With More Deals To Come: Analysts
Pharmaceutical M&A activity surged in the first quarter of 2026, reaching nearly $47 billion on the strength of major deals such as Merck’s $6.7 billion buyout of Terns Pharmaceuticals, Eli Lilly’s $6.3 billion acquisition of Centessa Pharmaceuticals, and Biogen’s $5.6 billion purchase of Apellis Pharmaceuticals. Analysts at BMO Capital Markets and Jefferies note that both large-scale transactions (over $5 billion) and smaller $1–$3 billion “tuck-ins” are increasing as big pharma companies including Gilead, Novartis, and Servier actively pursue targets. Deal premiums have been significant, ranging from 38% to 140%—for example, Biogen paid an 86% premium for Apellis amid concerns about upcoming patent expirations, while Merck’s Terns deal left room for rival bidders. Contingent value rights (CVRs) are also appearing more frequently; three of the last five deals included CVRs that tie additional payments to future milestones, such as Lilly’s Centessa acquisition with a potential $1.5 billion CVR tied to FDA approval.
Looking forward, analysts expect M&A momentum to persist, with potential record-breaking activity in 2026 that could total up to $172 billion if the current pace continues, surpassing the $111 billion spent in 2025. Companies like Novartis (with $53 billion in deal capacity), AbbVie, Amgen, Bristol Myers Squibb, and Gilead are cited as likely acquirers, with Novartis notably active in immunology and expected to target cardiometabolic and rare disease areas. Oncology and immunology/inflammation remain anticipated hot spots for future deals due to their commercial opportunities and alignment with existing pharma pipelines. Overall, analysts view the robust deal-making environment as beneficial for the sector, potentially unlocking further investment into biopharma and boosting public market activity, including IPOs and secondary offerings.
Biopharma M&A Heats Up, Rare Diseases Win Three Approvals, Wave Crashes
The biopharma sector experienced a surge in major M&A activity, with Biogen, Eli Lilly, and Merck collectively spending over $20 billion in a single week, marking three of the year’s four largest takeovers. Merck acquired Terns Pharmaceuticals for $6.7 billion, targeting a mid-stage leukemia drug, while Lilly and Biogen acquired Centessa Pharmaceuticals and Apellis Pharmaceuticals, respectively. Additional transactions included Novartis’ up to $2 billion acquisition of Excellergy and Gilead’s $2.1 billion deal for Ouro Medicines. In parallel, Aurinia Pharmaceuticals’ CEO Kevin Tang pursued another takeover attempt of Kezar Life Sciences, offering $50 million. These transactions reflect strategic positioning around both approved products and late-stage pipeline assets.
Regulatory progress was notable in the rare disease arena, as the FDA approved three therapies: Denali Therapeutics’ Avlayah for Hunter syndrome—addressing neurological complications—and Rocket Pharmaceuticals’ Kresladi for leukocyte adhesion deficiency-I, along with a high-dose formulation of Biogen’s Spinraza for spinal muscular atrophy. Biogen also achieved a Phase 2 win for its lupus candidate litifilimab. In contrast, the obesity drug development space showed volatility; Wave Life Sciences’ shares were halved after disappointing Phase 1 data for obesity candidate WVE-007. Investor attention remains fixed on the upcoming FDA decision on Lilly’s oral obesity drug orforglipron, expected by April 10.
FDA Ties Amgen’s Rare Inflammatory Disease Drug to Eight Deaths, Dozens of Liver Injuries
The FDA has identified eight deaths and 76 cases of drug-induced liver injury (DILI), including biopsy-confirmed vanishing bile duct syndrome, linked to Amgen’s rare disease therapy Tavneos. Of the liver injury cases, 74 required hospitalization and three of the seven patients with vanishing bile duct syndrome died. The safety concerns were detailed in a June 2024 alert, citing both FDA surveillance and Amgen-provided postmarketing data, and are described as new safety findings despite existing hepatotoxicity warnings in Tavneos’ product labeling. The agency recommended enhanced liver function monitoring for patients and advised discontinuation of Tavneos if significant liver enzyme elevations are detected.
Tavneos, approved in 2021 for severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, was acquired by Amgen through its $3.7 billion purchase of ChemoCentryx in 2022 and generated $423 million in 2025. The FDA had previously requested Amgen to withdraw Tavneos from the market due to concerns about data handling in the pivotal trial and the emerging liver toxicity profile, but Amgen rejected this, maintaining confidence in the drug’s benefit-risk balance. The recent safety communication from the FDA did not provide updates on the ongoing regulatory discussions regarding Tavneos’ potential withdrawal or labeling changes, which remain pending.
Pfizer, BioNTech Halt Large US COVID-19 Vaccine Trial Over Slow Enrollment
Pfizer and BioNTech have halted enrollment in a large U.S. trial of their updated COVID-19 vaccine for adults aged 50 to 64 due to slow enrollment, closing recruitment on March 6, 2024. The trial, targeting 25,000 to 30,000 healthy participants, struggled to meet its goals because most potential subjects failed to pass strict health criteria, with more than 80% being excluded at prescreening. Sources noted that excluding candidates with common chronic conditions such as hypertension and diabetes compounded the enrollment difficulties. Following this, Pfizer notified trial investigators on March 30 that surveillance for COVID-19 illness would also stop after April 3. The companies attributed the trial halt to an inability to generate meaningful post-marketing data in the face of sluggish enrollment trends.
The halted trial comes in the context of increased regulatory scrutiny, as the FDA now requires placebo-controlled trial data for COVID-19 vaccine use in adults aged 50 to 64, a standard not yet met by either Pfizer/BioNTech or Moderna for this group. Moderna is similarly conducting a U.S. trial in this age range and is reportedly experiencing similar enrollment challenges, though it has not made a formal statement on the matter. The broader U.S. COVID-19 vaccine market is experiencing commercial headwinds, with Moderna projecting a decline in 2026 U.S. sales and facing FDA resistance on its mRNA-based flu vaccine program, leading to delayed approvals and resubmissions. Analysts have observed increasing regulatory and political pressures on mRNA vaccine manufacturers in recent months.
Pfizer, BioNTech to pause COVID vaccine study due to low enrollment
Pfizer and BioNTech have announced the suspension of a post-marketing clinical trial for their COVID-19 vaccine, a study required by an FDA mandate implemented last year for all approved COVID-19 vaccines. The decision was attributed to slow enrollment rates driven by a decrease in COVID cases, which hindered the collection of sufficient data. The trial was designed to enroll 25,500 healthy adults between 50 and 64 years old to compare the vaccine to a placebo on measures including safety, immune response, and prevention of COVID-19 infection. Pfizer clarified that halting the study was unrelated to any safety or benefit-risk issues with the vaccine itself.
This regulatory hurdle comes amid increased scrutiny and stricter approval standards for COVID-19 vaccines under new leadership at the Department of Health and Human Services. The unusual requirement for a placebo-controlled trial when effective vaccines already exist, coupled with sharply reduced vaccine access as dictated by the CDC, have negatively impacted vaccine uptake and, consequently, trial enrollment. Policy changes have also limited recommendations for vaccination in healthy children and pregnant women. As a result, vaccine developers such as Pfizer and Moderna are facing declining revenues and have signaled strategic shifts, with Moderna publicly indicating a reduction in late-stage vaccine trials to refocus on oncology assets. Pfizer and BioNTech have not yet disclosed their next steps following the suspension.
A ‘hijacked plane’: CDC, under RFK Jr.’s influence, trades science for dogma
Over the past year, the CDC has experienced significant disruption and loss of scientific credibility following policy changes implemented under HHS Secretary Robert F. Kennedy Jr., who is known for his anti-vaccine stance. Major shifts include sweeping staff and leadership cuts, including the abrupt dismissal of agency director Susan Monarez, and the controversial reconstitution of the CDC’s Advisory Committee on Immunization Practices (ACIP) with members reportedly lacking relevant expertise or aligned with Kennedy’s views. This restructuring has resulted in changes to vaccine policy that depart from longstanding scientific evidence, such as reducing recommended childhood vaccines and diminishing support for established immunizations like the hepatitis B birth dose. The manner in which these changes occurred, including the secretive selection of new ACIP members and the exclusion of expert liaisons, has alarmed the medical community and led to high-profile resignations among senior staff.
The shift has been widely criticized by public health experts and leading medical organizations, who argue that CDC recommendations are now driven by dogma rather than data. Some states have rejected the new guidance while groups such as the American Academy of Pediatrics and others have issued independent recommendations. The lack of transparency and diminished scientific rigor have led to lawsuits and, most recently, a federal court decision blocking the new vaccine schedule and halting all ACIP actions, with the committee’s future now uncertain. The CDC is currently without permanent leadership, further compounding uncertainty. Critics warn that these developments are fragmenting national immunization practices, increasing public confusion, and threatening the integrity of evidence-based disease prevention in the U.S.
CONCLUSION
There you have it, another week of your Weekly Biotech News Fix. We hope you enjoyed it, please drop a comment with any feedback you may have.
We are now publishing 7x per week according to the following cadence:
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