HHS’ Office of the General Counsel late Friday withdrew an advisory opinion from December “in light of ongoing confusion” about its scope and impact, and which said drugmakers are obligated to deliver covered outpatient drugs to contract pharmacies under the drug discount program known as 340B.

The backpedal from HHS comes as drugmakers including AstraZeneca, Eli Lilly, Novo Nordisk and Sanofi sued HHS after the department threatened to fine them after they placed restrictions on which entities could receive deeply discounted prices for certain drugs, which originally had been for uninsured and vulnerable populations, but now included an increasing number of hospitals’ contract pharmacies. HHS said those restrictions placed by the drugmakers were in direct violation of the 340B statute, while the drugmakers said the number of new contract pharmacies has ballooned in recent years and driven up their costs.

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Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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