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Lilly’s obesity pill was approved yesterday, setting it up for fierce competition against Novo Nordisk’s new Wegovy pill as more people seek alternatives to GLP-1 injections.

Lilly’s drug, which is called orforglipron and will be marketed as Foundayo, was approved under the FDA’s new commissioner’s voucher program, which grants speedy reviews to drugs that are aligned with national health priorities.

In phase 3 trials, Lilly tested Foundayo in capsules with doses ranging up to 36 mg. The FDA approved the drug as tablets, with doses ranging up to 17.2 mg, which Lilly said are equivalent to the capsule doses.

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Awiqli (insulin icodec-abae) injection 700 units/mL, is indicated as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults living with type 2 diabetes.

Approval grants people with type 2 diabetes a once-weekly basal insulin option for adults to fit into their routines and preferences.

Novo Nordisk plans to launch Awiqli in its FlexTouch device in the US in the second half of 2026.

FlexTouch is a disposable, pre-filled pen with a non-extending dose button and low injection force. (Drug Delivery Business News)

The new treatment option is for patients with a certain inherited immunodeficiency so severe that many babies do not live beyond infancy.

The ultra-rare disease is called leukocyte-adhesion deficiency type 1, or LAD-I. It’s caused by mutations in the ITGB2 gene that lead to low levels of CD18, a protein that leukocytes need to adhere to the blood vessel wall and migrate to tissues.

Rocket’s gene therapy Kresladi (marnetegragene autotemcel) is made by harvesting a patient’s blood stem cells and engineering them in a lab to introduce functional copies of the ITGB2 gene.

Kresladi is the first commercial product for Rocket. (MedCity News)

The company said the regimen, which includes 50mg and 28mg doses, was designed to deliver a higher concentration of the drug during both loading and maintenance phases.

The approval is based on data from the phase 2/3 Devote study, which evaluated the efficacy and safety of the high dose regimen in both treatment‑naïve patients and those previously treated with Spinraza.

The company said the new regimen will be available in the US in the coming weeks and is already approved in the EU, Switzerland and Japan. (PharmaTimes)

Alltrna, a startup developing a new class of RNA-based drugs where a single therapy could potentially be reused across many different diseases, has received clearance to begin its first clinical trial, the company said.

The Cambridge, MA-based company’s therapies are based on transfer RNA, a natural molecule that helps translate the genetic code into proteins.

Some genetic diseases are caused by mutations that interrupt that translation process, resulting in an incomplete protein. Alltrna has developed synthetic tRNA molecules that intercept those genetic typos and help the cell’s translation machinery finish making the protein.

The trial, which will begin soon in Australia, will be the first time a tRNA therapy has been tested in humans.

Although the initial test will be in healthy volunteers, Alltrna is already planning a bigger basket trial that could pit the therapy against a dozen or more rare metabolic diseases. (Endpoints)

With a second phase 3 win for Tyvaso in idiopathic pulmonary fibrosis (IPF), United Therapeutics is padding the case for an expansion and putting more color on its filing plans with the FDA.

In the wake of the “overwhelmingly positive” pair of late-stage readouts, multiple analysts are sharing in United’s optimism that Tyvaso (treprostinil) could change the treatment landscape in the lung scarring disease, which is estimated to affect more than 100,000 people in the US.

In the late-stage TETON-1 trial, nebulized Tyvaso bested placebo on changes in forced vital capacity (FVC)—measuring the amount of air a patient can forcefully exhale after a deep breath—from baseline to the study’s one-year mark.

This allowed the study to meet its primary efficacy endpoint and comes after another positive readout for Tyvaso in IPF in the TETON-2 study late last summer.

United’s drug won out on multiple fronts in the topline showing from TETON-1, demonstrating benefits across “all subgroups” of patients, regardless of smoking status and including those who used background therapy or supplemental oxygen, the company said in its release. (Fierce Pharma)

Eli Lilly and Insilico Medicine are expanding a three-year partnership with a discovery and development collaboration that could generate more than $2.75 billion for the AI-based drug developer, Insilico said.

Lilly has agreed to pay Insilico $115 million upfront, as well as development, regulatory, and commercial milestones, raising the value of the deal, plus tiered royalties on future sales.

In return, Insilico will grant Lilly an exclusive global license to develop, manufacture, and commercialize what an announcement described only as “potentially best-in-class, novel oral therapeutics in preclinical development for certain indications,” without detailing the therapeutic areas where the companies plan to partner. (Genetic Engineering & Biotechnology News)

Eli Lilly served up a triple-scoop of deals, while Gilead, GSK and Novartis went for more modest double-stacked cones in the first quarter.

The period ended with a flurry of activity, including deals from Biogen, Eli Lilly and Novartis. All told, companies dropped about $20 billion on deals in the final week of the first period alone.

The Indianapolis-based pharma also added to its inflammatory portfolio with Ventyx Biosciences for $1.2 billion in January, then entered the CAR T space at last with the $2.4 billion takeover of Orna Therapeutics in February.

Also executing multiple deals were GSK and Novartis.

Then they injected the tailored cells into the bloodstreams of chick embryos. They taped the eggshell windows shut and waited for the chicks to peck their way out.

The researchers have tailored the DNA of their chickens to produce abundant amounts of the proteins in each egg.