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After High-Profile FDA Exit, Peter Marks Lands at Eli Lilly
Peter Marks, M.D., Ph.D., the former head of the U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), has joined Eli Lilly as senior vice president of molecule discovery and head of infectious disease, a company spokesperson confirmed to Fierce Biotech. Marks served as CBER chief for nearly a decade until butting heads with U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. over vaccine policy. Under RFK Jr.’s HHS, Marks was forced out earlier this year, with his last day being April 5.
“Lilly continually evaluates breakthrough science which could benefit patients. Peter’s expertise strengthens our abilities across multiple areas, both in our existing portfolio and in our work in emerging areas,” the spokesperson said.
Early in the new Trump administration, Marks’ disagreements with RFK Jr. over vaccines led to his departure in what was possibly the most high-profile FDA exit of the year. In his resignation letter (PDF), Marks wrote that he hoped the “unprecedented assault on scientific truth” would end “so that the citizens of our country can fully benefit from the breadth of advances in medical science.”
People Are Finding Ways to Get Covid Shots Despite New Limits on Eligibility
A COVID-19 vaccine rollout unlike any other has given rise to confusion over who’s eligible and concerns that the shots might be harder to obtain this fall — especially for young children. Unlike in past years, when the vaccines were approved and recommended for everyone 6 months and older, the Food and Drug Administration this summer approved updated COVID-19 shots only for people 65 and older and those with medical conditions that put them at risk of severe illness.
On Monday, the Centers for Disease Control and Prevention (CDC) announced that it recommends COVID-19 shots for the same groups, based on people’s own decision-making or conversations with their doctors.
The change has created hurdles for people who want the shots but don’t obviously fit into either category — especially parents who want their infants or toddlers vaccinated. But for the most part, it hasn’t prevented adults from getting vaccinated. Younger adults must now attest either online or in person at pharmacies that they have health conditions that qualify them for the vaccine.
The CDC’s list of conditions is broad — it includes pregnancy, physical inactivity, being overweight, mental health conditions and a history of smoking. So many adults seeking shots say it’s easy to find something that describes them or to stretch the truth without pushback.
US Relies Heavily on China, Other Nations for Antibiotics
A new analysis by researchers at Johns Hopkins University shows the U.S. has become increasingly reliant on other countries for antibiotics over the past 30-plus years. The study, published late last week in JAMA Health Forum, found that annual importation of antibiotics increased approximately 26-fold from 1992 through 2024.
One of the countries that has emerged as a major supplier is India, which has accounted for nearly one third of finished antibiotics imported to the U.S. since 2020. But of even greater concern is that China provides U.S. domestic drug manufacturers with more than 60% of the active pharmaceutical ingredients (APIs) needed to make the finished product.
The authors of the study say the findings suggest the U.S., which already faces persistent drug shortages and is no longer able to domestically produce key antibiotics such as penicillin and doxycycline, is becoming overdependent on other countries for its antibiotic supply and highly vulnerable to supply chain disruptions that could affect public health.
Dangerous ‘Gray-Market’ Weight-Loss Drugs Flooding US as Experts Warn of Risks
As demand for GLP-1 medications continues to skyrocket for weight loss and diabetes, more Americans are skipping pharmacies and turning to unregulated sellers as a way to avoid high prices, insurance barriers and recurring shortages. The U.S. Food and Drug Administration (FDA) has warned that so-called “gray-market” GLP-1s (such as semaglutide or tirzepatide) are not evaluated for safety, quality or efficacy.
As they fall outside the legal drug supply chain, these unapproved drugs may be counterfeit, contaminated or improperly compounded, the agency states. Some are marketed online as “compounded semaglutide” or “research-use only,” shipped directly to consumers with little oversight.
Recent research published in JAMA Health Forum also warned that some compounded products use unverified chemical forms of semaglutide that differ from FDA-approved versions.
Pharma Companies Scramble to Make Deals With Trump After Pfizer Scored White House Praise
The agreement between Pfizer and the Trump administration to lower drug prices has sent other companies scrambling to make a deal.
Several major pharmaceutical firms that received letters from President Trump demanding lower prices have been hustling to show progress, with some hoping to announce a deal with the White House as soon as this week, according to five Washington representatives and lobbyists for the companies, granted anonymity to speak about private deliberations.
“They have to now,” said one lobbyist of their clients’ thinking, noting the “anger” with Pfizer for effectively adding to their pressure to come to an agreement with the administration.
Weight Loss Jabs Can Compromise Cancer Scans, Study Warns
The rise of GLP-1 receptor agonist drugs prescribed for weight loss and type 2 diabetes could be compromising the interpretation of some cancer scans and throwing doctors off course. This is the discovery of U.K.-based researchers who found the medications — known to alter glucose metabolism, stomach function and the body’s stress and energy system — may lead to “unique uptake” patterns of FDG PET-CT scans.
This is a combined imaging technique used to help identify areas of high metabolic activity like tumors or inflammation. The scan follows an injection of a radioactive form of glucose that provides a signal picked up by the scanner. In previous case reports, there has been increased FDG uptake in skeletal muscle, heart muscle and brown adipose tissue (fat that burns energy to produce heat), which could be mistaken for cancer or inflammatory disease.
In the new research by Alliance Medical Ltd — presented today at the 38th Annual Congress of the European Association of Nuclear Medicine — the team performed a retrospective case series review of these scans in patients taking GLP-1 agonists.
