China Test Concerns Keep Eli Lilly Cancer Drug Unapproved By FDA

CNBC: FDA Committee Votes Against Eli Lilly Cancer Treatment Over Concerns Trials Conducted Only In China
A Food and Drug Administration committee on Thursday recommended against full approval of a lung cancer treatment developed by Innovent Biologics and Eli Lilly over concerns the clinical trial was conducted solely in China in participants that weren’t as diverse as the U.S. population. The FDA’s Oncologic Drugs Advisory Committee, in a 14 to 1 vote, said the companies should conduct additional clinical trials that reflect U.S. patients before they receive final approval. The monoclonal antibody treatment, sintilimab, treats adults with non-small cell lung cancer in combination with chemotherapy. (Kimball, 2/10)

Stat: FDA Sends Message To Companies Partnered With Chinese Drugmakers
Message delivered — with a punch to the face. Earlier this week, Richard Pazdur, the Food and Drug Administration’s top cancer drug regulator, told STAT that he intended to use an upcoming advisory meeting to make clear to U.S. drug companies that data from cancer clinical trials conducted entirely in China would not be sufficient for approval here. On Thursday, Pazdur, director of the FDA’s Oncology Center of Excellence, made good on that pledge, as he and his lieutenants shredded the study results for sintilimab, an anti-PD-1 checkpoint inhibitor for the treatment of lung cancer that Lilly and its Chinese partner Innovent were trying to bring to the U.S. (Feuerstein, 2/10)

And in news about Alzheimer's treatments —

The Wall Street Journal: FDA Rejects Short Sellers’ Request To Halt Trials Of Alzheimer’s Drug
The Food and Drug Administration has denied a petition by short sellers to halt clinical trials of an experimental Alzheimer’s drug being developed by Cassava Sciences Inc. The two short sellers alleged in filings with the FDA and the Securities and Exchange Commission that Cassava’s published research contained images of experiments that appear to have been manipulated using software such as Photoshop. Cassava denied the allegations, and said it was cooperating with government investigations. (Walker and Michaels, 2/10)

Stat: Biogen Pushes Back On Medicare’s Limits On Alzheimer’s Drug Coverage
Biogen is calling Medicare’s bluff. The federal health insurance program for people 65 and older proposed to drastically limit how often it would pay for the embattled biotech’s controversial Alzheimer’s drug, Aduhelm, a blow to Biogen’s hopes for wide uptake among Medicare patients. Medicare said it needed more information about the drug’s efficacy and safety and said it would only pay for the drug for patients enrolled in clinical trials. Now, Biogen has a new proposal: The company will get Medicare the extra data it wants, but not through the slow, traditional trials Medicare is proposing. Instead, it will focus on speedier real-world evidence about the drug. Biogen can’t get that wider dataset, the company says, if the drug is only available for such a limited patient population. (Florko, 2/10)

In other pharmaceutical news —

CNN: Famotidine: Study Of Popular Heartburn Drug Shows Mixed Results Against Covid-19 
At one point at the beginning of the pandemic, there was hope that a popular and inexpensive over-the-counter heartburn drug might hold promise for treating Covid-19, but a newly published study shows mixed results. In the clinical trial, people with mild to moderate Covid-19 who took very high doses of famotidine, the active ingredient in Pepcid, had some improvement in their symptoms more quickly than those who took a placebo, a pill that does nothing. But the trial, believed to be the first of its kind, was small, and the effect was far from dramatic. Among the 55 study participants, those who were assigned to take famotidine had an estimated 50% reduction in symptoms at 8.2 days, and those who were assigned a placebo saw that reduction in 11.4 days. (Cohen, 2/10)

Modern Healthcare: Banner Aetna Partners With Type 2 Diabetes Reversal Company
Banner|Aetna, a joint health insurance venture owned by Banner Health and Aetna, is entering a partnership with Virta Health, a company that offers personalized treatment for those with type 2 diabetes. The treatment, which combines specialized nutrition plans and virtual care, will be available to Banner|Aetna's eligible members of fully insured and administrative services only groups, the company said Wednesday. As a physician, Dr. Robert Groves, chief medical officer at Banner|Aetna, said he was very skeptical at first that Virta could fix what is seen as a chronic and progressive disease. (Devereaux, 2/9)

Stat: Pharma's Global Productivity Rises, With China Accounting For Larger Share
Even as the pandemic continues to take a toll on the world economy, the pharmaceutical industry appears to have emerged well-positioned to churn out needed medicines, with China is capturing a larger share, according to a new report. The analysis also found a record number of clinical studies under way, burgeoning product pipelines, and increased R&D investments by the world’s largest drug makers. For instance, 84 novel new medicines were initially launched globally in 2021, a record amount and also double the number from five years ago. The total number of medicines actively being developed in human trials globally exceeds 6,000, up 67% from 2016. There are also more than 800 next-generation therapies in the R&D pipeline, up from 600 at the end of 2019. (Silverman, 2/10)

Axios: Partners Group Buys Skin Treatment Company Forefront Dermatology 
Partners Group is acquiring OMERS Private Equity's majority stake in Forefront Dermatology, one of the country’s largest players in the business of skin treatment. The seller, alongside physicians and executives, sits poised to put more skin in the game via a new minority investment, the firms tell Axios. After a year in which zero dermatology platform deals got done, the sector is seeing activity pick up, with Forefront marking the second such transaction this month alone in a specialty that remains highly fragmented. (Pringle, 2/10)