| | | |   | Hello, all. Damian here with the latest from an all-important Alzheimer's disease conference, an update on an erstwhile unicorn, and a potential multibillion-dollar merger. | | | Lecanemab clears a major hurdle Eisai and Biogen’s latest treatment for Alzheimer’s disease held up to scrutiny in a detailed scientific presentation last night, setting the stage for the lengthy process of turning this medicine into the commercial success Aduhelm was meant to be.
Experts said Eisai’s presentation, delivered over the course of 75 minutes at the Clinical Trials in Alzheimer’s Disease conference in San Francisco, helped dispel concerns that lecanemab’s success, first disclosed in a September press release, was a mirage. And the presentation marked Eisai’s first detailed comments on the deaths of two patients who received lecanemab alongside blood-thinners.
The task ahead for Eisai is to convince the FDA to grant full approval to lecanemab, and then to persuade Medicare to roll back an Aduhelm-inspired policy that all but prohibits reimbursing for amyloid-targeting drugs, a vital step if the new drug is going to avoid the commercial disappointment of its predecessor.
Read more. | Even unicorns stumble sometimes Back in 2019, Sana Biotechnology raised $700 million with an idea board member Noubar Afeyan warned “will seem grandiose” and “unconnected to the current reality”: creating a technology to reprogram and replace any cell in the body. Two years later came an IPO that valued Sana at more than $6 billion, all without getting a single drug into human trials.
Now Sana is pulling back. The company said yesterday it would lay off 15% of its staff, refocus its pipeline, and end research on a medicine meant to restore heart tissue. The goal is to extend the company’s cash runway into 2025, Sana said, by which point it hopes to have clinical data on at least one of its projects.
Sana, which has lost more than 85% its value since that 2021 IPO, is the product of a frothier era in biotech, when the rainmakers of venture capital — like Afeyan and fellow investor Robert Nelsen — had little trouble raising massive sums for ambitious startups that always found buyers on the public markets. Biotech’s recent retrenchment has made that era feel like the distant past, and Sana’s sudden focus on practicality speaks volumes. | Prognostic digital twins overcome the limitations of external control arms Methods using patient data from previously completed trials are desirable not only for reducing trial sizes but also for honoring the valuable contributions of past participants. Both prognostic digital twins and external control arms (ECAs) utilize external data to reduce trial sizes, but only digital twins overcome the issues of confounding variables and bias. Learn how RCTs with digital twins leverage AI and historical data to produce the regulatory-acceptable evidence needed to move research forward. | A 2022 megadeal could yet come through Despite drug company stocks seeming to get cheaper by the day in 2022, Wall Street’s oft-predicted spike in high-dollar buyout deals never quite materialized, with a few rumored acquisitions reportedly falling apart of price negotiations.
But that could change before the year is out. Horizon Therapeutics, maker of treatments for rare diseases, said yesterday that Amgen, Johnson & Johnson, and Sanofi were in talks to acquire the company, adding that the conversations were “highly preliminary.” The company’s takeover interest was first reported by the Wall Street Journal.
While those conversations could well amount to nothing, Horizon, carrying a market value of nearly $20 billion, would be the year’s biggest pharmaceutical deal if it were to change hands.
Read more. | Three decades after a breakthrough, where are the medicines for Huntington’s? It took more than a decade of work by disease detectives around the world to isolate the gene responsible for Huntington’s disease, leading to a landmark 1993 discovery that promised to unlock the molecular underpinnings of the disease and provide a road map for developing a potential cure.
Almost 30 years later, effective treatments — let alone curative ones — have yet to materialize. In the last two years, four drugs have failed in clinical trials, and at least as many prospective therapies have been abandoned before reaching human testing.
As STAT’s Megan Molteni reports, scientists are divided on just why Huntington’s has resisted the field’s best efforts. Some argue it’s just a matter of dosing in clinical trials. Others increasingly believe the drug industry, in an echo of its disappointing record with Alzheimer’s, has been pursuing a solution based on an incomplete understanding of the disease.
Read more. | More reads - After three years in prison, ‘CRISPR babies’ scientist is attempting a comeback, STAT
- Indictment of monkey importers could disrupt U.S. drug and vaccine research, Science
- Nestlé reconsiders peanut allergy program two years after $2.6B buyout, Endpoints
| Thanks for reading! Until tomorrow,  | | | |
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