generics

'Skinny labels' may face a Supreme Court reckoning

In a high stakes test for drug competition, the U.S. solicitor general is urging the Supreme Court to review a case that could determine whether “skinny labels” — a long-standing Hatch-Waxman carve-out allowing generics to sidestep patented indications — can survive. The dispute centers on a bid by Amarin, which markets the heart drug Vascepa, to block a generic made by Hikma Pharmaceuticals, STAT’s Ed Silverman writes. Hikma excluded Amarin’s patented cardiovascular-risk use from its skinny label.

This case “strikes me as existential for the generics market,” one intellectual property law expert at American University told STAT.

An appeals court revived Amarin’s suit, which is raising alarms because some believe it could prevent generics from entering the market at a lower cost. Skinny labels have already declined since a ruling two years ago between GSK and Teva Pharmaceuticals. If the court declines a review again, generics could abandon the tactic altogether — a potential “death knell” for market competition.

Read more.

cancer

A blossoming bank account

From my colleague Matt Herper: BlossomHill Therapeutics, a new company run by cancer drug developer Jean Cui, said Wednesday that it had raised $84 million from Janus Henderson Investors, Brahma Capital, BioTrack Capital, and some existing investors, bringing the total amount the private company has raised to $257 million.

Cui, a chemist, was key to the development of the targeted lung cancer pills Xalkori and Lorbrena at Pfizer, and then led the development of Augtoyro at Turning Point Therapeutics, which was bought by Bristol Myers Squibb for $4.1 billion in 2022.

BlossomHill is likewise focused on new targeted cancer medicines, this time using a type of molecule called a macrocycle that allows a small molecule medicine to, in some ways, mimic much larger protein drugs. (Macrocycles have a central ring with at least 12 atoms, much bigger than the central structures in most medicines.) BlossomHill's first experimental products are a molecule targeting EGFR, the same target hit by lung cancer drugs Iressa and Tarceva, that should remain effective against mutations that make cancer resistant to current treatments, and a treatment targeting a protein called CLK that would be used in relapsed or refractory acute myeloid leukemia.

Existing investors participating in the round included Cormorant Asset Management, OrbiMed, Plaisance Capital Management LLC, and Vivo Capital.

vaccines

FDA scrutiny of infant RSV shots escalates amid turmoil

The FDA has opened a safety review into infant RSV prophylaxis products from AstraZeneca/Sanofi and Merck, Reuters reports.

This is pulling the companies into the broader upheaval inside the agency as top officials question long-standing vaccine policies. Merck confirmed recent talks with regulators about Enflonsia — cleared in June — while Sanofi defended the real-world safety record of Beyfortus, which has been given to more than six million babies worldwide.

The probe comes as FDA leadership under HHS Secretary Robert F. Kennedy Jr. unsettles the public health community, with CBER chief Vinay Prasad telling staff the agency will acknowledge child deaths from Covid vaccines and pushing sweeping regulatory changes that triggered fierce backlash from former FDA commissioners. The resulting negative buzz has already hit U.S. vaccine sales, FiercePharma writes, raising the stakes of new scrutiny on RSV products heading into the winter season.