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• A drug included in one of the industry’s largest acquisitions this year is starting to paying dividends for GSK, winning a speedy regulatory nod that continues the pharma company’s growth strategy in oncology.

• The approval announcement Wednesday was earlier than expected. The drug, known in development as zidesamtinib, was set to receive a regulatory decision by Sept. 18.

• This drug, GSK’s first FDA-approved lung cancer medicine, will reach the market under the brand name Jideytro.

• Jideytro is an oral small molecule in the class of medicines called ROS1 inhibitors. ROS1 is a protein that plays a role in cellular growth and differentiation. (MedCity News)

• The FDA approved the expanded use of Ryaltris (olopatadine hydrochloride and mometasone furoate) nasal spray for the treatment of symptoms of Seasonal Allergic Rhinitis (SAR) in pediatric patients aged 6 to less than 12 years.

• With this approval, Ryaltris is now approved for adults and pediatric patients aged 6 years and older, extending this treatment option to a younger pediatric population. (press release)

• The FDA approved a new small molecule inhibitor with blockbuster potential that could become a new standard of care for patients with breast cancer.

• The regulator is allowing Celcuity to market Revtorpyk (gedatolisib) for previously treated patients with hormone receptor-positive, HER2-negative breast cancer without any mutations in the PIK3CA gene.

• Revtorpyk is used in combination with fulvestrant and with or without Pfizer’s Ibrance (palbociclib).

• The company is also developing the drug for patients with PIK3CA mutations and plans to file a supplemental application with the FDA in the third quarter of this year. (Fierce Pharma)

• One year on, Makary is no longer FDA commissioner and the legal basis for the initiative remains uncertain, with recent rapid-fire news of a pause, resumption and ongoing commitment to the policy pointing to an evolving situation.

It drives FDA workers “crazy” when companies post press releases that “bear a not-exact relationship with the actual CRL . . . that was issued,” Jungman said, fueling interest in a more transparent approach.

• The FDA’s regulations treat the existence of an application as confidential, suggesting that the release of a CRL for a publicly undisclosed submission could breach the agency’s own rules.

“I don’t see how you square that with the regulation,” Jungman said.

• Eli Lilly’s triple-G drug retatrutide has hit the primary endpoints of a pair of phase 3 obesity trials, although the peak weight loss fell short of previous trials in different patient populations while failing to prove the medication reduces cardiovascular risk.

• The pharma evaluated various doses of the GIP, GLP-1 and glucagon triple-hormone receptor agonist against placebo in both the TRIUMPH-2 study of 1,152 patients with type 2 diabetes and obesity or overweight, as well as the TRIUMPH-3 study of 1,949 patients with severe obesity and established cardiovascular disease. (Fierce Pharma)

• Novo Nordisk is suing its biggest obesity drug rival, alleging on Tuesday that Eli Lilly is engaging in deceptive advertising by intentionally using outdated studies to compare the higher doses of its medicines to lower doses of Novo’s products.

• Filed in a New Jersey District Court, the lawsuit follows a cease-and-desist order in which Novo asked Lilly to take down the advertisements.

• Lilly hasn’t, so the Danish drugmaker is seeking a permanent injunction to get the ads pulled and for Lilly to “conduct a corrective advertising campaign.” Lilly countered in a statement that the advertising is “truthful, it is transparent, and it is grounded in the most direct scientific evidence available.”

• The lawsuit comes as Lilly has gotten the upper hand in a high-stakes battle for market share. (BioPharma Dive)

• As use of GLP-1s surged across the US, average total payments per user also climbed sharply, according to a new Northwestern University study published in the Journal of the American Heart Association that analyzed national trends in GLP-1 use and spending between 2017 and 2022.

• These total payments included out-of-pocket costs paid by patients as well as payments from insurers, employers and government programs.

• The study authors say the findings raise questions about the long-term affordability of drugs that many patients may take for years or even decades.

• Those questions became even more relevant earlier this month when Medicare launched a temporary program that gives millions of eligible seniors potential access to GLP-1s for a flat $50 monthly copayment. (News-Medical Life Sciences)

• And the Boston drugmaker was bidding against itself.

• Vertex’s 102% premium for Crinetics came in well above the other $10 billion deals.

• AbbVie ponied up a 49% premium for Apogee in June, while GSK swung 40% above Nuvalent’s last trading price prior to deal disclosure that same month, according to a quarterly update from William Blair bankers.

• AbbVie and GSK were also the only bidders in the processes for Apogee and Nuvalent.

• Apogee is preparing for a phase 3 in eczema later this year, potentially broadening AbbVie’s moat beyond Skyrizi and Rinvoq in the bustling immunology and inflammation field.