| | | |   | Good morning! Damian here with an update on biotech's loudest Twitter shouting match, a case that the sector has reached its bottom, and an invitation to ruminate on the miracle of Covid-19 vaccines. | | | The Cassava saga is just getting started The often bitter debate over Cassava Sciences’ treatment for Alzheimer’s disease is likely to drag out for years to come thanks to an FDA decision last week.
As STAT’s Adam Feuerstein reports, the agency denied — on a technicality — several citizen petitions that questioned the integrity of Cassava's data on its drug and sought to halt ongoing clinical trials.
Any resolution to the Cassava debate will now likely have to wait for the results of two Phase 3 trials now enrolling patients. Each is recruiting about 1,000 patients and would follow them for between one year and 18 months, meaning data are unlikely to be ready until well into 2024 at the earliest.
Read more. | Lilly’s new antibody is cleared against Omicron and its worrisome relative The FDA has authorized a new Covid-19 antibody treatment from Eli Lilly, one that appears to work against not only Omicron but an emerging variant of concern.
As STAT’s Andrew Joseph reports, the therapy is called bebtelovimab, and Lilly developed it to be a broadly neutralizing antibody that works against multiple strains of SARS-CoV-2. Lilly said lab testing indicated that bebtelovimab worked against the Omicron variant — technically known as BA.1 — and also maintained its effectiveness against a sister lineage called BA.2, which is more transmissible and has become dominant in countries including India, Denmark, and South Africa.
The U.S. has signed a deal with Lilly to buy 600,000 courses of the treatment for at least $720 million. Shipments were expected to start imminently, with 300,000 courses arriving this month and another 300,000 next month. That should ease the strain on sotrovimab, from GlaxoSmithKline and Vir Biotechnology, which has demonstrated efficacy against Omicron but has been in short supply.
Read more. | 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. | One sign biotech has reached its bottom After 12 months of steady declines, biotech investors are left to wonder each week whether the sector has finally bottomed out — or if it has further to fall. The latest investor survey from the analysts at Cowen offers some evidence that sentiment is finally starting to turn around.
For the first time in the survey’s history, the majority of respondents said mid-size biotech companies were under-valued. Said another way, biotech stocks have fallen so far that a critical mass of investors now thinks they’re cheap.
That doesn’t mean an immediate rebound is afoot. Just 41% of respondents in Cowen’s survey said they expected mid-size biotech to outperform the broader market in 2022. But it does suggest the sector’s recent nadir won’t last forever. | Consider the Covid vaccine Between variants, boosters, regulatory arguments, and the endless debate about children, it’s easy to lose sight of a simple fact: It’s borderline miraculous that we have vaccines against SARS-CoV-2.
STAT’s Helen Branswell zoomed out on the past two years of human endeavor, specifically the development, testing, manufacturing, and global distribution of Covid-19 vaccines. It hasn’t been an unqualified success — many lower-income countries are still waiting on doses — but what has been accomplished in the 25 months since Chinese scientists first shared the genetic sequence of the newly discovered SARS-CoV-2 virus has defied the predictions of the most optimistic prognosticators.
“I would have to say at the outset I would not have thought we’d be here by now, given the technology,” said Rick Bright, who was the head of BARDA at the outset of the pandemic.
Read more. | More reads - Pfizer and FDA pull back from plan to expedite review of Covid-19 vaccine in young children. STAT
- Germans pin hopes on Novavax moving the needle among anti-vaxxers. Reuters
- ProQR shares plummet as eye disease treatment flops in pediatric trial. FierceBiotech
- What we know — and still don’t know — about whether telehealth can cut costs. STAT+
| Thanks for reading! Until tomorrow,  | | | |
No comments