| | | |   | Good morning! Damian here, bringing you the confusing saga of an inside-out FDA review, plus some numbers from the ever-darkening world of SPACs. | | | Lilly’s Chinese-developed cancer drug, destined for rejection, could have been a bargain The regulatory saga for Eli Lilly’s latest cancer medicine has been all out of order. First, the FDA’s top oncology regulator publicly criticized its supporting data, all sourced from China, more than a month before its scheduled decision date. Then, days before an independent review of the drug, he came out and said it wouldn’t be approved no matter what happens.
Now, in apparent keeping with this unorthodox process, Lilly did something drug companies almost never do: discussed pricing before approval.
In a statement yesterday, Lilly said that if the drug were approved, the company would sell it at “a significant and transparent [wholesale] price discount that will be in line with some of the deeper discounts we’ve seen for biosimilars relative to their branded comparators, an approximate 40% discount.” Rival medicines carry list prices of around $160,000 a year, which would put Lilly’s at around $100,000.
None of this matters if the FDA rejects Lilly’s drug, which Richard Pazdur, head of the agency’s oncology division, has said it will do. Later today, a panel of FDA advisers will convene to discuss Lilly’s supporting data, which will give Pazdur a forum to weigh in on the more than two dozen Chinese-developed cancer medicines licensed by U.S. companies. | Using NK’s to give cancer the KO Cell therapy keeps reaching new heights, with researchers recently declaring one of the first CAR-T patients cured after a decade cancer-free. But a new Bay Area biotech is betting on a different cancer-quashing approach: unleashing the immune system’s natural killers.
Indapta Therapeutics sprung out of stealth mode this week with more than $50 million, an experienced team, and plans to use so-called natural killer cells, or NK cells, to battle cancer. These cells routinely clear tumors and virus-infected cells, and the company is focused on a subset of NK cells that pack a particularly powerful punch, according to Mark Frohlich, a medical oncologist and cell therapy veteran with 20-plus years in this field, including stints at Juno Therapeutics, Dendreon, and Xcyte.
Unlike T-cells, NK cells from one person can be safely given to another without attacking the recipient’s cells. That makes NK cells a promising off-the-shelf cell therapy, though time (and trials) will tell how well this strategy works. Indapta expects to begin its first clinical trial in 2023, said Frohlich, possibly in non-Hodgkin lymphoma or multiple myeloma. | Rapidly evolving technology demands leadership that keeps pace Driven by scientific discovery, competition, and ever-increasing demand, the life sciences industry produces pioneering therapies and meets novel challenges. Success in the life sciences requires a firm grasp of intellectual property protection, regulatory compliance, and continually advancing fundamental science, as well as their complex intersections. Discover how a Master of Science in Law: Life Sciences bridges boundaries separating science, law, and business and prepares leaders for success in the dynamic biotech and pharma sectors. | Looking to the future of CRISPR on its 10th anniversary Later this year, that Nobel Prize-winning paper that first described how CRISPR could be used to edit genomes, setting in motion thousands of experiments, will mark its 10th anniversary. Scientists have used the technology to cure disease in mice and made promising strides in human trials, while entrepreneurs have raised billions of dollars to turn those advances into practical medicines.
With an eye on the next 10 years of genome editing, today STAT is re-launching an updated tool to keep tabs on milestone studies in the world of CRISPR. It’s called the CRISPR Trackr, and it’s a curated selection of studies from research journals, preprints, and company announcements. It has a search function with which you can filter studies by particular conditions, specific types of CRISPR editing, and other useful characteristics.
Give it a spin. | All is not well in SPAC world The SPAC boom, a pandemic financial trend that raised about $250 billion in blank-check IPOs in 2020 and 2021, is entering a game of musical chairs that is certain to leave some investors under water.
As Bloomberg reports, there are about 600 SPACs now searching for private companies to acquire and take public, with roughly $160 billion in cash between them. The vast majority of SPACs have 24-month shelf lives, meaning they must settle on a target within two years or give all the IPO money back. Next year, more than 300 SPACs will be up against their deadlines, which could create a nightmare scenario for investors in which blank-check firms outbid one another for so-so startups just to stay alive. Some SPAC IPO buyers are already backing out. The biotech company Gelesis saw more than 99% of shareholders ask for their money back.
Meanwhile, the returns on SPAC mergers are plunging. The DSPC, an index that tracks companies that have gone public through SPAC transactions, is down 25% since the start of the year and more than 40% since 2021. | More reads - Cost of a Vertex drug could worsen the global disparities in cystic fibrosis treatment, study finds. STAT+
- Noisy activists aside, GSK investors backed Walmsley and her strategy. The Guardian
- EU ramps up efforts to gather public-health data to improve drug reviews. Reuters
- Thirty Madison and Nurx to merge, as digital pharmacy companies outgrow their origins. STAT+
| Thanks for reading! Until tomorrow,  | | | |
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