FDA recommends annual Covid booster

FDA scientists are recommending that Covid shots be updated and administered yearly, according to a proposal released ahead of an upcoming advisory panel meeting on vaccines. For people who are immunocompromised or older, the FDA scientists are recommending two doses of a revised shot.

The committee will vote Thursday on whether the existing vaccines, which are based on the original Covid strain, should be updated to match the current Omicron-fighting boosters. To underscore the need for a regularly updated booster, the FDA scientists pointed to a recent study that showed how older Israelis who'd received booster shots were 81% less likely to be hospitalized and 86% less likely to die. The study hasn't yet been peer-reviewed.

aging

Calico's on the lookout for an MVP (well, CSO)

Calico is on the lookout for a new CSO: The company's celebrated scientific officer, David Botstein, retired quietly last year after 10 years with the Alphabet portfolio company. Billions of dollars have already been invested into Calico, which is researching the intricacies of aging — and how it might be slowed.

The company has been head hunting for a new chief science lead since last year, according to two people who were approached about the job. This move is hardly a surprise: Botstein, a revered biologist at Princeton University, is now 80 years old, and was nearing retirement when Google approached him about Calico's mission. Before that, Botstein pioneered techniques that helped discover disease-causing genes in the 1980s, and helped devise the Human Genome Project.

stockS

Pliant pill's efficacy boosts stock 75%

Lung function in patients with idiopathic pulmonary fibrosis improved dramatically with an experimental pill made by Pliant Therapeutics, according to newly released data. Although the data come from just 29 patients, they suggest that a higher dose of Pliant's drug, bexotegrast, improved not only lung function but also scarring. Shares in the company shot up 75% on the news, from $22.51 to $39.44.

Some analysts peg this deadly lung disease as a $4 billion commercial opportunity — with bexotegrast functioning as "best in class." About 40,000 patients die each year from the disease — with about half living less than five years after their diagnosis.

PharmaLOT

Orphan drug exclusivity will remain unchanged

Surprisingly, the FDA will not be changing course on how long so-called orphan drugs will be able to retain exclusive marketing rights. It was seven years before, and seven years it'll stay — so long as the company is able to demonstrate the drug's orphan status.

The decision is unexpected, because it's based on the closely watched and contentious legal fight between Jacobus Pharmaceuticals and Catalyst Pharmaceuticals. Jacobus, a family-run drug company, had been distributing an unapproved medicine for free to a few hundred patients using the FDA's compassionate use program. A competitor, Catalyst Pharmaceuticals, quickly sent that same compound through the regulatory mill, where it was approved for adults. The company began charging $375,000 or more for the drug — leading to a national outcry about prescription drug costs.

A federal court in 2021 ruled that the FDA acted "arbitrarily and capriciously" when it approved Catalyst's LEMS drug as an orphan — a decision that was expected to impact how the agency would confer marketing exclusivity in the future. Turns out, regulators were unfazed.