Covid giveth, and Covid taketh away

For Pfizer, that means sliding sales of its Covid products Cominarty and Paxlovid as the U.S. government works through inventory and the market transitions to a commercial model. J.P. Morgan analyst Chris Schott is assuming Covid sales will decline from $56.6 billion in 2022 to $21.3 billion this year.

When Pfizer reports earnings on Tuesday, its 2023 financial outlook will reflect falling Covid product sales. The pharma giant is expected to report 2022 revenue of $100 billion and forecast $74 billion in revenue for 2023, according to analysts' consensus estimates. Likewise, Pfizer is expected to report 2022 adjusted earnings of $6.49 per share, falling to $4.44 per share this year.

Excluding Covid products, Pfizer has said previously that it is targeting revenue growth in the range of 7-9% in 2023.

More biopharma earnings this week: Novartis on Wednesday; Roche, Eli Lilly, Merck, Bristol Myers Squibb and Gilead Sciences on Thursday; Sanofi and Regeneron Pharmaceuticals on Friday.

Living forever

Longevity scientists hope to cast field in a new light

The science of longevity gets such a bad rap. Think of cultural touchstones like "Indiana Jones" — those seeking immortality wind up with sticky ends. And that's exactly the grouse of biotech executives who work in the business of extending life, who discussed the issue over dinner at the recent J.P. Morgan Healthcare Conference. "Why is it in popular culture, if you want to live forever, you are evil and you want to kill babies on the side?" one posited.

There are a number of biotechs that are studying the science of aging, and devising therapeutic interventions to suspend that process. Many were at that dinner — along with STAT's Jason Mast, who analyzes and ranks a dozen of the top players in the longevity field, including Altos Labs, Calico Labs, and Hevolution Foundation, to name a few.

The field is trying to reposition itself so that it's no longer viewed with such negativity. Longevity science is still real science, they say, and it's being studied in an ethical and rigorous manner. And it'll take time.

cell therapy

Legend's CAR-T worked better than conventional drugs

Carvykti, a CAR-T therapy made by Legend Biotech, kept multiple myeloma at bay longer than standard therapy in a Phase 3 trial.

The treatment was approved last year, on data that it substantially reduced the number of cancer cells in 97% of patients with multiple myeloma. But this new study compared the CAR-T treatment to existing treatments, and could make the case that the cell therapy could be used earlier in a patient's treatment course.

Even if the drug's approved as a primary or secondary treatment, cell therapies remain quite difficult to manufacture. Even now, access to Carvykti is limited because Legend and its U.S. partner, Johnson & Johnson, haven't been able to produce the drug at scale — though they're working on expanding capacity.

rare disease

Why orphan drug laws need a reboot

The Orphan Drug Act was signed into law in 1983, and this month marks its 40th anniversary. More than 1,100 rare disease treatments have been approved by the FDA over the last four decades. But so much has changed in biotech in these years — which means it's time that the legislation gets a refresh, opines Emil D. Kakkis, founder of the EveryLife Foundation for Rare Diseases.

Last year, many companies stopped developing their rare disease treatments thanks to regulatory, financial, and commercial hurdles. That means that the same problems that existed in the early 1980s are beginning to exist again today. "If legislators and the FDA don't adapt the clinical and regulatory framework to keep pace with scientific advancements, innovation will continue to be stymied," Kakkis says.

future pandemics

A proposal to monitor lab-made viruses

These days, research into manipulating pathogens to study their origin and transmission is ultra controversial — but important. A panel of federal advisers, which included biosecurity, ethics, and infectious disease experts, voted unanimously Friday to advance a set of proposals meant to oversee such work, to ensure it is conducted safely. The would-be proposals would only apply to U.S.-funded research, but it's expected that these policies, if enacted, would probably influence global research efforts.

"The idea was not to ban any kind of research, but to — if there are concerns identified — find ways to mitigate them," one panelist said.

More around STAT