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• Compare that to 2023, when eight of the top 20 drugmakers experienced revenue declines.

• Six of the top 20 drugmakers had double-digit increases in 2024, compared to just two in 2023.

• Five others saw a revenue bump of between 7% and 9%, compared to two reaching those figures in 2023.

• For the second year in a row, Eli Lilly (32%) and Novo Nordisk (26%) posted Big Pharma’s largest year-over-year sales bumps, though their positions were flipped from 2023 when Novo (31%) topped Lilly (20%).

• The Department of Health and Human Services (HHS) is cutting off funding to the long-running Women’s Health Initiative (WHI) in September, a move that leaves the fate of one of the world's largest women’s health studies hanging in the balance.

• One of WHI’s signature discoveries came from the estrogen plus progestin trial, which proved that a common hormone therapy used to treat menopause increased the risk of coronary heart disease and breast cancer. The evidence of the therapy’s dangers was so strong that the trial was halted three years early.

  • The WHI says the release of the findings prevented an estimated 126,000 breast cancer cases and 76,000 cardiovascular disease cases over the following decade, representing $35.2 billion saved in direct medical costs.

• Since then, WHI scientists have broadened their remit to a number of other age-related health issues, including frailty, vision loss, dementia, mental health and social isolation, according to the announcement.

• The Trump administration’s canceling of women’s health funding stands in stark contrast to his predecessor.

  • Former President Biden launched a women’s health effort in November 2023, helmed by former First Lady Jill Biden, and asked Congress for $12 billion to fund research on diseases that commonly affect women like rheumatoid arthritis, menopause, Alzheimer’s disease and endometriosis. (Fierce Biotech)

• The FDA asked Novavax to commit to producing post-marketing data of its Covid vaccine, the clearest example yet that the goalposts have changed for vaccine makers under HHS Secretary Robert F. Kennedy Jr.’s leadership.

• Novavax was supposed to receive a decision on its protein-based Covid-19 vaccine by April 1. A source familiar with the application previously said that the company was discussing labeling language with the agency, which is typically the final process in the approval timeline.

• But the PDUFA date came and went, and communication with the FDA largely went dark.

• Meanwhile, ousted CBER chief Peter Marks said in an interview earlier this month that the agency had no concerns with Novavax’s application and that “the review staff agreed it was an approval.” (Endpoints)

• For the first time since the Trump administration’s major staff cuts at the FDA this month, the agency publicly announced that the firings will lead to a long delay for what would otherwise be a relatively routine regulatory action.

• The delay relates to a hearing for Vanda Pharmaceuticals, which has been locked in a fight with the FDA over its stomach drug tradipitant, and over its sleep disorder drug in the past.

  • The rejection of tradipitant last year set off an appeals process, which few companies undertake as they typically don’t result in an FDA reversal. The FDA is deciding whether to grant an in-person hearing over the disagreement on tradipitant.

  • That hearing should occur by May 7, according to Vanda. But last week, the FDA said in a letter to Vanda that because of the staff reductions at the agency, it would no longer meet that deadline.

The firings affected the “offices assigned to lead the review and draft the written response to this Vanda matter,” the agency said in its letter to Vanda, including leadership at the FDA’s CDER, as well as “access to relevant subject matter experts, administrative support staff, library staff, and academic journal subscriptions.”

• The agency said it would push its deadline back by about four months to Sept. 12. (Endpoints)

• If his past views hold up, antidepressants, ADHD medication and drugs that use mRNA technology—both those on the market and those under development—could end up as his next targets.

• In fact, some of his words and actions since being nominated and confirmed as the nation’s top health official suggest they’re already on his list.

• He notably contradicted CDC researchers about why autism diagnoses are rising, pointing to what he called toxins in the environment, not better diagnostics (another familiar talking point).

• He’s also pledged to have results of a government-led effort to identify the cause of autism by September, a timeline that’s stoked deep suspicion in the public health community about his commitment to scientific rigor or accurate conclusions.

• And his recent remarks to FDA staff reinforcing his belief in the “deep state” caused enough alarm that Leerink Partners warned clients in an investor note that his agenda “is likely to negatively impact FDA’s commitment to proven science and its retention of talent.”

“He’s still pressing his pseudoscience agenda, he still shows no interest in understanding the complexity of autism and how it operates through autism genes with environmental factors, he still talks in childlike terms about how to deal with autism,” said professor and vaccine scientist Peter Hotez.

“cover timely topics in biomedicine and research as well as addressing enduring issues at the intersection of biomedicine and government, including some observations about how government functions.”