| | | |   | Good morning, all. Damian here with the latest confusion as to just what the FDA wants and yet another reason to question whether Aduhelm will ever find a commercial foothold. | | | Vertex runs into a ‘surprise’ FDA setback The FDA has suspended an early-stage trial of Vertex Pharmaceuticals’ stem-cell therapy for type 1 diabetes, the company said yesterday, with the agency citing “insufficient information” to continue the study.
As STAT’s Adam Feuerstein reports, Vertex management called the clinical hold a “surprise,” and Wall Street was similarly caught off guard. Last anyone heard about Vertex’s treatment, called VX-880, one patient had received a half dose and had started to produce his own insulin with only mild or moderate side effects. That convinced Vertex VX-880 was safe enough to test at a dosage, but the FDA apparently has outstanding questions.
The news left analysts with more questions than answers. It’s possible the clinical hold is just a bureaucratic speed bump on VX-880’s path to pivotal trials, but there’s also a risk that the FDA has seen something alarming in the early-stage data that might derail Vertex’s ambitious treatment.
Read more. | How much foreign data is too much foreign data? Biotech’s bright idea to bring Chinese-developed cancer treatments to the U.S. fell apart early this year when the FDA reversed its prior enthusiasm for medicines studied overseas. But the agency’s latest decisions leave unanswered questions about just what kind of evidence regulators will accept.
Yesterday, the Hong Kong-headquartered Hutchmed said the FDA rejected its application for a novel cancer treatment, telling the company that its supporting clinical trials — two conducted in China and one from the U.S. — were insufficient to win approval and asking for another study that would enroll “subjects more representative of the U.S. patient population,” the company said.
On the same day, the FDA rejected a drug invented by the Chinese firm Junshi Biosciences and licensed to the American company Coherus BioSciences. Like Hutchmed, Coherus submitted data from China and the U.S., but in this case, the FDA is not asking for another study but rather a change to the manufacturing process that the company called “readily addressable.” Coherus expects to resubmit by the summer.
The pair of rejections is likely to stoke confusion among drugmakers trying to parse the FDA’s evolving approach to Chinese-developed cancer drugs. In February, the FDA approved a Chinese-invented CAR-T treatment licensed to Johnson & Johnson, but in March, the agency rejected a treatment from Eli Lilly and Chinese partner Innovent Biologics. | Case study: Improving therapy initiation with an AI-guided patient support program It's no secret that patient support programs can positively impact speed to therapy and other outcomes. But what happens when you power up your program with artificial intelligence? In this case study, see how one manufacturer leveraged Lash Group's AI-driven adherence programs, in collaboration with AllazoHealth, to drive targeted interventions for high-risk patients and significantly improve speed to therapy. Download the case study. | For Biogen, the questions are only getting tougher This year has brought only disappointment for Biogen as it struggles to convince doctors, payers, and regulators that Aduhelm makes a difference for patients with Alzheimer’s disease. The latest: UnitedHealthcare is restricting coverage of the drug across all of its health plans, STAT’s Bob Herman reports, which means any physicians who want to prescribe it to covered patients will need prior approval from the insurance company.
The setback, which follows Medicare’s April decision to severely restrict coverage of Aduhelm, underlines a common question among analysts: At what point is Biogen simply throwing good money after bad? Management will get a chance to explain the path forward for Aduhelm today at 8 a.m. ET, when the company hosts its first quarterly earnings call since the Medicare ruling.
As Baird analyst Brian Skorney wrote in a note to clients, investors will be listening for any hints on the long-term plan for Aduhelm, including deeper cuts to Biogen’s spending, conversations with regulators, and whether the drug might ever turn a profit. | With key data months away, Guardant launches a cancer blood test Guardant Health, a contender in the crowded field of liquid biopsy, has started selling its blood test for colon cancer, hitting the market while a key clinical trial is still ongoing.
As STAT’s Jonathan Wosen reports, the company’s test, known as Shield, is now available to adults 45 and older who aren’t up to date with current screening guidelines, don’t have symptoms, and are at average risk of colon cancer. It’s a lab-developed test, meaning it has not yet won FDA approval, and each sample must be processed at a Guardant lab.
But that could change in the year to come. By the middle of 2022, Guardant expects data from a clinical trial measuring how accurately Shield detects colon cancer in those who have the disease but don’t yet have symptoms. The company plans to use those results to file for FDA approval and Medicare reimbursement. If everything goes well, the company believes Shield could become the leading colon cancer screening test by 2030, outpacing colonoscopies.
Read more. | More reads - Is the FDA taking advice from its expert panels? A new analysis points to inconsistencies in the process. STAT+
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- OrbiMed seeks $4.75 billion for fresh slate of healthcare-focused funds. Wall Street Journal
| Thanks for reading! Until tomorrow,  | | | |
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