Selected Developments in Biotechnology Law and the Biotechnology Industry

USFDA SECOND REJECTION FOR REPTMUNE’S NEW SKIN CANCER DRUG

Advanced melanoma is a serious form of skin cancer: it can metastasize and spread quickly, making aggressive treatment imperative. That need, however, was not enough to cause the U.S. Food and Drug Administration (FDA) to approve Reptimune’s new skin cancer drug, Tudriqev. Instead, the agency rejected the drug based on alleged concerns about reliance on a single-arm study, stating that the company must instead provide data demonstrating evidence of effectiveness collected from a well-controlled trial. This represents the drug’s second rejection in two years, both over alleged insufficient evidence of effectiveness and other issues in the clinical trials.

Tudriqev is the product of biotechnology. It uses a genetically modified herpes virus to detect and eliminate cancer cells.

The company will run a late-stage trial in an effort to satisfy the FDA, but even as it gears up to do so, it stated that the FDA’s current position contradicts the agency’s prior position(s) on the study(ies) supporting the cancer drug, including the agency’s position as recently as September 2025. This is not the first time the Trump Administration’s FDA has seemingly changed the goalposts for drug approval, especially biotechnology-derived drugs; other pharmaceutical companies have leveled the same charge. While disappointment and finger-pointing are to be expected whenever there is a drug disapproval, that this is Robert F. Kennedy Jr.’s FDA makes the accusations plausible.

CENTERS FOR DISEASE CONTROL AND PREVENTION WITHHOLDS POSITIVE REPORT ABOUT COVID-19 VACCINES

Research conducted by U.S. Centers for Disease Control and Prevention (CDC) scientists clearly found benefits to COVID-19 vaccines: it showed that between September and December 2025, healthy adults who had the vaccine reduced their likelihood of COVID-19-related hospitalizations by 55% compared to non-vaccinated individuals, and similarly reduced their likelihood of emergency and urgent care visits by 50%. The research was conducted using a “test-negative design,” which compares patients who are already sick and their vaccination rates. It is a well-known, frequently used methodology, which has been used by the CDC in numerous studies for more than 20 years.

However, well-known, well-accepted research design or not, the CDC’s acting director, Jay Bhattacharya, has delayed publication, citing unspecified concerns about the research’s methodology. Bhattacharya, who was appointed in January 2026 ¹ by noted vaccine skeptic and Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., had opposed COVID-19 lockdowns and mask mandates during the height of the pandemic. Kennedy has taken a hard line against COVID-19 vaccines, calling them the “deadliest vaccine[s] ever made” and ordering the CDC to cease recommending them. In addition to his public stances against vaccines, Kennedy and his subordinates have been engaged in significant behind-the-scenes efforts to undermine vaccine research and usage.

Former senior CDC advisor on vaccine policy Dr. Fiona Havers stated that withholding the report on the vaccine’s effectiveness “is definitely an escalation of this Administration’s undermining of CDC science,” saying that “[t]he fact that they are not blocking this [report] is extremely concerning.” Dr. Haves resigned from the CDC in 2025 over concerns about the Trump Administration’s vaccine policy, one of a number of CDC employees who resigned rather than support the Administration’s agenda.

RULES FOR CDC VACCINE COMMITTEE CHANGED TO INCORPORATE VACCINE SKEPTICISM

Another front in HHS Secretary Kennedy’s seeming war on vaccines is the revisions recently made to the rules governing the CDC’s Advisory Committee on Immunization Practices (ACIP). These rules include a number of practices, policies, and talking points long-sought by anti-vaccination or anti-science groups, including: •

Focusing on “identifying gaps in vaccine safety research, including adverse effects following vaccination”;

As former director of the CDC’s National Center for Immunization and Respiratory Diseases Dr. Demetre Daskalakis remarked, “[t]he new charter seems to try to codify the RFK vision of ACIP as a committee focused on risk only and not balance or risk and benefit.” Dr. Daskalakis resigned last year over the changes Kennedy was making to the agency’s vaccine policy. Other changes Kennedy made to ACIP include having dismissed all 17 previously appointed members and replacing them with seven new members, a number of whom had well-documented histories of exaggerating vaccine risks while ignoring or downplaying their benefits, and giving non-voting committee memberships to organizations publicly skeptical of or opposed to vaccines.

TRUMP ADMINISTRATION BOOSTS BIOFUEL BLENDING QUOTAS BY 8% TO RECORD HIGH

The Trump Administration in an obvious bid to succor farmers hit by a variety of forces ² and create a narrative that it is trying to mitigate consumers’ pain at the pump, is increasing the amount of biofuel to be blended into diesel and gasoline. The increase is significant: an increase of 8% over last June’s amount or a record-setting 25.82 billion gallons of biofuel. Increasing the amount of biofuel benefits farmers, a core Administration constituency, by increasing demand for the crops used as feedstock for biofuels. However, it is unlikely to have any effect on prices at the pump, which are trending steadily higher due to the blockade(s) of the Strait of Hormuz, global trade disruption, and the war in the Middle East.

The move also pits farmers against another Administration constituency: the fossil fuel industry. Blending biofuel into gasoline and diesel is more expensive than making them purely from petrochemicals, increasing refinery costs and eating into profit margins.