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Lynavoy (linerixibat) is now approved in the US as an oral treatment for cholestatic pruritus, or intense itch due to problems in how the digestive fluid bile flows in the body, in adults with primary biliary cholangitis (PBC).

The decision from the FDA makes Lynavoy the first therapy to be approved in the country for PBC-related itch, which can profoundly affect the quality of life of this patient population, according to a company press release from GSK.

GSK recently entered a licensing agreement with Alfasigma, which will acquire the exclusive rights to further develop, produce, and market Lynavoy worldwide. (Liver Disease News)

Johnson & Johnson won approval for a daily psoriasis pill that rivals the benefits of injectable medicines and could roil a multibillion-dollar market. The drug, Icotyde, is approved for patients over the age of 12 with moderate to severe plaque psoriasis.

Developed as icotrokinra, Icotyde is designed to mimic the effects of top-selling psoriasis treatments, including AbbVie’s Skyrizi and J&J’s own Tremfya, without the need for needles.

Analysts expect J&J’s drug to reshape one of the most competitive fields in the pharmaceutical industry. Patients with psoriasis typically cycle through topical drugs before getting prescribed an injectable therapy, and many opt out of treatment for reasons of convenience or cost. (STAT)

Novartis received FDA approval for Cosentyx (secukinumab) to treat pediatric patients aged 12 years and above with moderate to severe hidradenitis suppurativa (HS).

This marks Cosentyx as the first interleukin-17A (IL-17A) inhibitor approved for this population, offering a new biologic treatment option for pediatric patients with HS.

HS is a chronic, systemic inflammatory skin disease that presents with recurring boil-like lesions, which can rupture, become painful wounds, and lead to scarring. (Pharmaceutical Technology)

That is not true, according to a review by The New York Times and the German news organizations Süddeutsche Zeitung, NDR and WDR.

The German health system foots the bill, and records show that, more often than not, it pays less than what the Trump administration negotiated for Americans.

The list includes almost none of the most widely used drugs, like statins, or ultraexpensive drugs like cancer therapies.

The biggest names on TrumpRx are two blockbuster weight-loss drugs — Wegovy and Zepbound.

But the gap persists, and the reality does not match the hyperbole.

That is particularly true for patent-protected drugs, which consistently were cheaper in Germany.

The administration did not provide enough detail about how it ran those numbers for that claim to be checked. The New York Times examined raw numbers, comparing prices in US dollars.

Roche said it is expanding its partnership with NVIDIA to build what it calls the pharma industry’s “largest hybrid-cloud AI factory,” aimed at accelerating the development of new therapeutics and diagnostics.

The new pact boosts Roche’s AI capacity with 2,176 Nvidia Blackwell graphics processing units (GPUs), which will be deployed across the US and Europe.

For drugmakers, the number of GPUs a company has determines how fast AI models can be trained, scaled and improved. Adding more GPUs leads to faster data processing and the ability to run more complex models. (Tech Target)

Bicycle Therapeutics said that it will lay off 30% of its workers and deprioritize an experimental antibody-drug conjugate that has been seen as a possible threat to Pfizer’s bladder cancer drug Padcev.

The decision was driven by discussions with the FDA and other regulators about the approval path for the therapy, known as zelenectide pevedotin.

While regulators agreed with Bicycle on the optimal dosing strategy for the drug, they aren’t convinced that the results from an ongoing Phase 2 trial called Duravelo-2 will be sufficient to support an accelerated approval in metastatic bladder cancer. (BioPharma Dive)

The FDA once again rejected the Boston-area Aldeyra Therapeutics’s ophthalmology drug reproxalap following a three-month delay.

The agency’s complete response letter cited a “lack of substantial evidence consisting of adequate and well-controlled investigations” and neither recommended running more trials nor requested more confirmatory evidence, Aldeyra said.

The latest blow comes about four years after CEO Todd Brady had confidently told investors that reproxalap’s “approvability has been put to bed” following clinical data. (Endpoints)

A single bite from a tsetse fly carrying the parasite is all it takes to infect someone. Without treatment one form of the illness can progress from mild symptoms to death in a matter of weeks.

A committee of the European Medicines Agency has given an important green light to the first single-dose treatment—a medication called acoziborole, which could be in use by early next year.

Developed by Sanofi in partnership with the Drugs for Neglected Diseases initiative (DNDi), this new medicine is designed to be used as a "test-and-treat" tool, aimed at achieving the elimination of the disease.

Even the current first-line oral treatment, fexinidazole, must be taken for 10 days and comes with severe side effects such as nausea, vomiting and heart-rhythm disturbances.

By contrast, clinical trials of acoziborole found just one significant side effect: mild to moderate headache.