What keeps the FDA commissioner up at night?

How will Ozempic change the world? And what's behind WeightWaters' pivot? We cover all that and more this week on "The Readout LOUD," STAT's biotech podcast.

FDA Commissioner Robert Califf joins to discuss his first year on the job, the future of drug approvals, and how Duke basketball will do without Coach K. Then STAT's Elaine Chen explains how powerful new weight loss medicines are reshaping medicine, the drug industry, and the society at large. We also discuss the latest news in the life sciences, including the results of a new Alzheimer's disease study and a potential breakthrough in cardiovascular medicine.

Listen here.

monopolies

It's time to do away with the patent thicket

Lawmakers are finally enacting reforms that prevent drugmakers from extending patent exclusivity, but they aren't getting to the root of the problem, opines veteran IP lawyer Alfred Engelberg. Patent thickets run rampant, he says, and they need to be cleared. The approach allows branded drugmakers to stave off generic competition by engineering trivial changes into a previously patented drug — such as changing a drug from tablet to capsule form.

This alone doesn't prolong a branded drug's monopoly. It does, however, play into a provision of the 1984 Hatch-Waxman Act, which allows the owner of an approved new drug an automatic 30-month injunction for simply saying its patent was infringed upon — even if that is not true. AbbVie made more than $100 billion in extra profit for its top-selling drug, Humira, through these maneuvers.

Congress needs to create fixed time limits for drug patent monopolies, writes Engelberg, who originally helped draft Hatch-Waxman. "Otherwise, brand-name drug manufacturers will continue to find ways to game the system to accomplish the longest possible monopoly for any important drug," he says.

CANCER

New overall survival data on Tagrisso validate its potency in lung cancer

Early-stage lung cancer patients taking AstraZeneca's genetically targeted drug Tagrisso after their tumors were surgically removed showed statistically significant improvement in overall survival compared to those on placebo, the company says. The 682 patients in the trial had EGFR-mutated non-small cell lung cancer and were treated with the once-daily pill for three years, or until their disease recurred.

The results build on data from May 2020 that showed Tagrisso's "overwhelming benefit" for lung cancer patients with early-stage disease. At that point, 90% of the patients given Tagrisso after surgery were alive without recurrence of their tumors. Then, data this past September showed a median disease-free survival of five-and-a-half years in nearly three-quarters of the patients.

"Today, these exciting overall survival results validate adjuvant Tagrisso as the standard of care in this setting and reinforce the importance of early diagnosis and testing for EGFR mutation in lung cancer," an AstraZeneca oncology exec said in a statement.

biopharma

Bayer prioritizing the U.S.

Bayer is investing more in American biopharma: The drug giant plans to spend $1 billion in drug R&D this year alone, and intends to double its sales in the U.S. by the end of decade, Reuters reports. "It's time for us to double down on the U.S.," said Sebastian Guth, president of Bayer's pharmaceuticals business in the U.S.

This news comes on the heels of Bayer's appointment of a new CEO — longterm Roche executive Bill Anderson. Bayer's former chief executive, Werner Baumann, had a notably rocky tenure and exited earlier than expected. The company's stock has floundered in recent years, after a botched acquisition of agribusiness titan Monsanto. Bayer plans to build up its portfolio of new drugs, and sell the drugs it develops in the U.S. — as opposed to partnering with American companies as it has in the past.

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