Pfizer, Novo Nordisk, Express Scripts updates

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Good morning. We’ve received a lot of information this morning, so let’s get straight into it.

Pfizer strikes ahead a each day GLP-1 weight problems tablet

Pfizer will advance a once-daily formulation of its oral GLP-1 weight problems candidate, danuglipron, after dealing with a number of setbacks within the house.

The corporate stated outcomes from an ongoing pharmacokinetic examine led it to decide on a formulation to maneuver ahead, however didn’t present particulars on the precise formulation. The corporate will nonetheless have to conduct dose optimization research within the second half of this yr.

Traders have been intently watching Pfizer’s work in weight problems as the corporate faces stress to seek out new development turbines amid declining gross sales of its Covid-19 merchandise.

Learn extra.

FTC to sue PBMs over excessive drug prices

The FTC plans to sue the three largest PBMs — Caremark Rx, Specific Scripts, and OptumRx — over their negotiating ways for numerous drugs together with insulin, my colleague Ed Silverman experiences.

This comes after the company launched a report earlier this week saying that the drug middlemen wield immense energy and may considerably have an effect on drug costs.

Ed experiences that the lawsuits are anticipated to deal with the position of rebates. Critics argue that deductions create incentives for PBMs to just accept increased costs relatively than negotiate decrease costs for well being insurers and employers.

Learn extra.

Novo’s weekly insulin rejected by FDA

The FDA rejected Novo Nordisk’s weekly insulin, because the company has requests associated to the manufacturing course of and using the insulin particularly in kind 1 diabetes sufferers.

Novo had submitted an software for the insulin, referred to as icodec, for each kind 1 and kind 2 diabetes sufferers, however a panel of FDA advisers not too long ago voted in opposition to approval of the drug in kind 1 sufferers, elevating considerations in regards to the threat of low blood sugar in that inhabitants.

Novo stated it doesn’t count on to meet the FDA’s requests this yr. Within the meantime, Eli Lilly can also be growing a weekly insulin.

Learn extra.

Turning on a ‘molecular change’ to deal with lupus

There’s primarily a double drawback with lupus: Sufferers have decrease ranges of useful immune cells and better ranges of damage-promoting ones. Cells are in a position to convert between these two useful and dangerous phenotypes, although, and in a brand new examine, scientists might have found a “molecular change” that may tip the plank within the course of useful cells.

The examine, revealed in Nature and led by researchers at Northwestern and Harvard, pinpoint the aryl hydrocarbon receptor, or AHR, as a controller of this seesaw. They discovered that suppressing AHR led the inhabitants of dangerous cells to proliferate, whereas boosting AHR elevated the presence of useful cells.

Current lupus medication broadly suppress the immune system, which may be efficient but in addition trigger undesirable negative effects. New analysis like this on what exactly causes the illness might information drug builders towards a extra slim strategy.

Learn extra from my colleague Isa Cueto.

Are you able to get satiety with GLP-1s with out the nausea?

Extremely standard GLP-1 medication like Ozempic and Wegovy can result in substantial weight reduction by suppressing urge for food, however in addition they usually trigger individuals to expertise the disagreeable and typically insufferable negative effects of nausea and vomiting. A brand new study in Nature suggests these the 2 results of satiety and aversion are caused via distinct mind circuits, indicating it could be potential sooner or later to realize urge for food suppression with out the nausea.

A gaggle of researchers led by scientists on the Monell Chemical Senses Heart ran mouse experiments to seek out that activation of NTS GLP-1 neurons triggered satiety with out aversive reactions, whereas activation of AP GLP-1 neurons triggered sturdy aversion together with a discount in meals consumption. The researchers say the findings level to NTS GLP-1 neurons as a potential goal to advertise weight reduction whereas avoiding the nausea and vomiting.

Scientists are nonetheless determining how and the place GLP-1s act within the mind to result in weight reduction, and the findings of this new examine nonetheless have to be confirmed in additional analysis. They seem to contradict earlier research that discovered that GLP-1 medication suppress urge for food by performing on distributed neural circuits involving the hypothalamus.

Extra reads

• In less-studied feminine mice, scientists discover hormone that would result in new bone illness therapies, Endpoints
• Medicaid is paying hundreds of thousands for salty, fat-laden ‘medically tailor-made’ cheeseburgers and sandwiches, STAT
• Opinion: Making ready faculties for the H5N1 fowl flu they’re prone to face, STAT