Aug 31, 2022

Zachary Brennan Senior Editor The last members of its executive team have moved on, the phone number at its Boston-based HQ has been shut off, and as of earlier this month, the FDA has denied Intarcia Therapeutics’ final request for a hearing to re-review the company’s twice-rejected type 2 diabetes drug candidate and proprietary delivery system. The letter from the FDA earlier this month caps a nearly five-year saga from when the FDA first rejected Intarcia’s twice-yearly type 2 diabetes drug, known as ITCA 650, after calling on the company to address extensive clinical deficiencies, and device and product quality-related issues. Keep reading Endpoints with a free subscription Unlock this story instantly and join 149,100+ biopharma pros reading Endpoints daily — and it's free. SIGN UP John Carroll Editor & Founder Right on the heels of an EMA recommendation for EU approval, Sanofi has scooped up the FDA’s OK for the first approved therapy to treat symptoms that are not related to the central nervous system in patients with acid sphingomyelinase deficiency, which includes a range of ailments under the umbrella for Niemann-Pick disease. For Sanofi, the approval of the enzyme replacement therapy Xenpozyme (Olipudase alfa) marks a key win for Paul Hudson’s strategy to beef up their rare disease portfolio, but this one has been a long time coming. Sanofi picked up the drug after the 2011 acquisition of Genzyme and posted positive pivotal data two and a half years ago. Keep reading Endpoints with a free subscription Unlock this story instantly and join 149,100+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Beth Snyder Bulik Senior Editor It’s the most wonderful time of the year — for media planners that is. The annual ad strategy and brand planning for next year are in full swing, and Nancy Phelan, a former pharma commercial leader at Pfizer and Bristol Myers Squibb, has “radical” ideas about how it needs to evolve. Phelan, now an SVP at Indegene, is aiming to disrupt the status quo in timing, and update both the process and the thinking that goes into brand planning. Keep reading Endpoints with a free subscription Unlock this story instantly and join 149,100+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Beth Snyder Bulik Senior Editor Obesity is in the spotlight thanks to a raft of new and pending therapies in the pipeline. However, Currax Pharmaceuticals’ Contrave, the old guard of weight loss meds, isn’t ceding its veteran status. In fact, it’s doubling down on Contrave as an option with the launch of a new brand campaign “One Size Does Not Fit All.” The digital effort highlights the idea that different solutions fit different people, and includes the brand website along with digital and social media ads and posts, medical journal ads and education and in-office materials. Keep reading Endpoints with a free subscription Unlock this story instantly and join 149,100+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Paul Schloesser Associate Editor A California judge yesterday sided with a stem cell clinic chain against the FDA, setting shock waves through the agency as it potentially has to rework how it enforces these clinics moving forward. Judge Jesus Bernal ruled in federal court in California’s Central District against the FDA’s argument that a group of stem cell clinics called the Cell Surgical Network, led by Mark Berman and Elliot Lander, were selling unapproved drug products in the form of adipose, or fat, cell mixtures. Keep reading Endpoints with a free subscription Unlock this story instantly and join 149,100+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Max Gelman Senior Editor Looking to build out a case for its drugs that can better penetrate the blood-brain barrier, Denali Therapeutics touted new interim Hunter syndrome data Wednesday morning. And execs are sharpening their regulatory pitch. The South San Francisco biotech reported longer-term results from a Phase I/II study evaluating DNL310, saying the safety profile remained similar to the current standard of care — enzyme replacement therapy — after 85 weeks. Additionally, a larger group of patients gives the company more confidence that early biomarker results from July 2021 indicate the drug is positively affecting Hunter syndrome patients. Keep reading Endpoints with a free subscription Unlock this story instantly and join 149,100+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Amber Tong Senior Editor Lumakras, Amgen’s groundbreaking KRAS drug, was approved on data from an open-label, single-arm study suggesting, among other things, median progression-free survival of 6.8 months for patients with KRASG12C-mutated non-small cell lung cancer. Now, Amgen says it has the first proof that Lumakras beats chemotherapy — the current standard of care — on that metric. Further analyses are still ongoing and data will be reserved for future medical conferences, Amgen said, remaining tight-lipped. What it will say is that the drug, formerly known as sotorasib, met the primary endpoint of PFS in the CodeBreaK 200 trial, where it went head to head with intravenous docetaxel. Among 345 patients, Lumakras demonstrated “statistical significance and superiority” over the chemo. Keep reading Endpoints with a free subscription Unlock this story instantly and join 149,100+ biopharma pros reading Endpoints daily — and it's free. SIGN UP