Pharminent

FDA approves Lilly’s breast cancer combination treatment

The FDA approved a new combination drug treatment from Eli Lilly for patients with an advanced form of breast cancer.

FDA issues direct final rule on non-animal safety testing methods

The FDA issued a direct final rule updating its regulations to clarify that non-animal methods can be used where appropriate to test the safety of drugs and biological products intended for human use before they are tried in humans.

Grail shares surge after FDA posts advisory committee documents

Shares in Grail rose Monday after the FDA posted documents ahead of an advisory committee meeting on the company’s Galleri blood test for cancer detection.

Roche’s GLP-1/GIP agonist meets phase 2 diabetes endpoints

A phase 2 trial of Roche’s dual GLP-1/GIP receptor agonist met its primary endpoints in people with type 2 diabetes and overweight or obesity.

Beacon’s gene therapy meets primary goal in phase 3 XLRP study

Beacon Therapeutics reported that its gene therapy met the main goal of a pivotal study in X-linked retinitis pigmentosa. The company said the findings represent the first time a treatment for the rare, potentially blinding condition has met its primary endpoint in a pivotal trial.

J&J’s Caplyta meets endpoint in phase 3 bipolar mania trial

Johnson & Johnson’s atypical antipsychotic Caplyta passed a phase 3 test in bipolar-associated manic episodes, its first phase 3 win in the setting. J&J acquired Intra-Cellular Therapies, Caplyta’s developer, for $14.6 billion.

Telix to acquire ITM in $1.65B all-stock radiopharmaceutical deal

Telix Pharmaceuticals is acquiring Isotope Technologies Munich (ITM) in a $1.65 billion stock deal creating a radiopharmaceuticals company with greater global scale. ITM’s lead pipeline asset is in late-stage development for a type of gastrointestinal cancer.

Iambic files for IPO and signs AbbVie discovery alliance

Iambic Therapeutics filed for an IPO, released the latest version of its AI platform and signed a multi-year drug discovery alliance with AbbVie, all within a day.

Boehringer and Envisagenics sign $1B oncology target collaboration

Boehringer Ingelheim and AI drug discovery company Envisagenics agreed to a multi-year collaboration worth up to $1 billion, under which Boehringer will validate tumor-specific targets.

Lilly’s CEO says 700,000 seniors started GLP-1s under Medicare coverage

Eli Lilly CEO David Ricks told CNBC that 700,000 new seniors have started GLP-1 medicines since Medicare coverage launched in July, with 70 percent taking Lilly drugs. Ricks also said one-third of new GLP-1 pill patients are taking Foundayo as the company ramps up production.

Lilly breaks ground on Houston API manufacturing site

Eli Lilly broke ground on a Houston facility that will manufacture active pharmaceutical ingredients for medicines including Foundayo (orforglipron) and employ more than 600 people. It is one of ten US manufacturing sites the company has announced since 2020, and Lilly is providing $12.5 million in support for a workforce training center with San Jacinto.

Novo outlines plans to expand pipeline beyond Wegovy by 2030

Novo, under CEO Maziar Mike Doustdar, outlined plans to expand its pipeline beyond the Wegovy franchise and find new products it could sell more like consumer goods than traditional medicines.

Public Citizen disputes savings claims from Trump’s MFN drug deals

Advocacy group Public Citizen said the drug price savings claimed for the Trump administration’s Most-Favored-Nation deals with pharmaceutical companies are “a mirage.”