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Pfizer, Novo Nordisk, Express Scripts updates

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Pfizer, Novo Nordisk, Express Scripts updates

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Good morning. We have a lot of news this morning, so let’s jump straight into it.

Pfizer launches a daily GLP-1 obesity pill

Pfizer will bring forward a once-daily formulation of its oral GLP-1 obesity candidate, danugliprone, after facing multiple setbacks in the industry.

The company said the results of an ongoing pharmacokinetic study led it to select a formulation to move forward, but did not provide details on the specific formulation. The company will have to conduct dose optimization studies in the second half of this year.

Investors have been closely watching Pfizer’s work in obesity as the company faces pressure to find new growth generators amid slumping sales of its Covid-19 products.

Read more.

FTC to sue PBMs over high drug costs

The FTC plans to sue the three largest PBMs – Caremark Rx, Express Scripts and OptumRx – over their negotiating tactics for several drugs, including insulin, my colleague Ed Silverman reports.

This comes after the agency published a report earlier this week saying drug middlemen wield enormous power and can significantly influence drug prices.

Ed reports that the lawsuits are expected to focus on the role of rebates. Critics argue that rebates create incentives for PBMs to accept higher prices rather than negotiate lower prices for health insurers and employers.

Read more.

Novo’s weekly insulin rejected by the FDA

The FDA has rejected Novo Nordisk’s weekly insulin because the agency has requests regarding the insulin’s manufacturing process and use, specifically in type 1 diabetes patients.

Novo had applied for the insulin, called icodec, for both type 1 and type 2 diabetes patients, but a panel of FDA advisers recently voted against approving the drug in type 1 patients, raising concerns about the risk of low blood sugar in patients with type 1 diabetes. that population.

Novo said it does not expect to comply with the FDA’s requests this year. Meanwhile, Eli Lilly is also developing a weekly insulin.

Read more.

Turning on a ‘molecular switch’ to treat lupus

There’s essentially a double whammy with lupus: Patients have fewer helpful immune cells and more damage-promoting cells. However, cells are able to switch between these two helpful and harmful phenotypes, and in a new study, scientists may have discovered a ‘molecular switch’ that could tilt the plank toward beneficial cells.

The study, published in Nature and led by researchers at Northwestern and Harvard, pinpoints the aryl hydrocarbon receptor, or AHR, as the controller of this seesaw. They found that suppressing AHR caused the population of harmful cells to multiply, while boosting AHR increased the presence of helpful cells.

Existing lupus medications broadly suppress the immune system, which can be effective but can also cause unwanted side effects. New research like this into the precise cause of the disease could lead drug developers toward a more limited approach.

Read more from my colleague Isa Cueto.

Can You Get Satiety With GLP-1s Without Nausea?

Highly popular GLP-1 medications such as Ozempic and Wegovy can lead to significant weight loss by suppressing appetite, but they also often cause people to suffer the unpleasant and sometimes unbearable side effects of nausea and vomiting. A new studying in nature suggests that the two effects of satiety and aversion are mediated by different brain circuits, indicating that in the future it may be possible to achieve appetite suppression without the nausea.

A group of researchers led by scientists at the Monell Chemical Senses Center conducted mouse experiments to find that activation of NTS GLP-1 neurons caused satiety without aversive responses, while activation of AP GLP-1 neurons caused strong aversion, along with a reduction in food intake. . The researchers say the findings point to NTS GLP-1 neurons as a possible target to promote weight loss while avoiding nausea and vomiting.

Scientists are still figuring out how and where GLP-1s work in the brain to lead to weight loss, and the findings of this new study still need to be confirmed in further research. They appear to contradict previous studies showing that GLP-1 drugs suppress appetite by acting on distributed neural circuits involving the hypothalamus.

Read more

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