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Hey there. Right now, we check out a biotech acquisition, ASCO’s new AI instrument to assist streamline most cancers remedy pointers, unpack the brand new restrictions on Covid-19 vaccines, and extra.
Sanofi acquisition provides Alzheimer’s drug to pipeline
From my colleague Adam Feuerstein: French drug maker Sanofi is buying the small biotech Vigil Neuroscience for $470 million, including an experimental remedy for Alzheimer’s illness to its neuroscience pipeline, the businesses introduced Wednesday night.
The buyout values Vigil at $8 per share, or a 246% premium over the inventory’s Wednesday closing value. Sanofi has additionally supplied a further fee to Vigil shareholders equal to $2 per share, contingent on its lead drug securing approval and producing gross sales.
“This acquisition is absolutely supporting Sanofi’s strategic give attention to neurology and on advancing science and leveraging our experience in immunology to resolve areas of essential unmet want,” mentioned Houman Ashrafian, Sanofi’s R&D chief, in an announcement.
The centerpiece of the Vigil acquisition is an experimental small-molecule drug known as VG-3927 that’s designed to focus on TREM2, a protein thought to spice up the neuroprotective capacity of microglial cells within the mind. Sanofi plans to conduct a Section 2 examine of VG-3927 in sufferers with Alzheimer’s, the corporate mentioned.
Final 12 months, an antibody remedy that additionally focused TREM2, developed by Alector and licensed to Abbvie, didn’t gradual the development of Alzheimer’s in a Section 2 examine.
ASCO has partnered with Google Cloud to launch the ASCO Pointers Assistant, an AI-powered instrument designed to make the group’s trusted however unwieldy most cancers remedy pointers extra accessible to clinicians. The assistant, which is free to ASCO members, limits itself to the society’s official consensus-based paperwork — a “walled backyard” method that distinguishes it from broader instruments like ChatGPT or Gemini.
“We’ve had this paradox the place our content material is basically high-quality and trusted, however exhausting to method and to make use of,” ASCO CEO Clifford Hudis advised STAT. “And that was the issue we wished to resolve.”
The instrument is supposed for time-strapped oncologists managing a variety of cancers. In an illustration for 2 STAT reporters, the ASCO instrument’s efficiency was blended — precisely prescribing therapies for one prostate most cancers affected person whereas providing none for one more with lung most cancers. (It did higher in a do-over.) None of what the instrument learns is supposed to be fed again into Google’s Gemini instrument or its Vertex AI platform.
What to know concerning the FDA’s Covid-19 vaccine pivot
The FDA’s abrupt pivot on Covid-19 vaccine approvals — introduced by way of a commentary by Commissioner Marty Makary and prime regulator Vinay Prasad — has created a whirl of questions. Whereas the brand new framework restricts vaccine use to older adults and high-risk teams except additional trials are achieved, it bypassed the standard regulatory course of and blindsided stakeholders.
STAT digs into 5 burning questions concerning the implications of this modification — corresponding to what it means for the prevailing market, whether or not firms will hold making the photographs in the event that they don’t need to conduct extra trials, and extra. The sudden change, in spite of everything, lacks public enter and a consensus from profession employees — injecting great uncertainty into the equation. The murky particulars on trial requirement worries some consultants:
“I’d be involved that such a requirement might decelerate vaccine entry after a pressure change, if wanted … by 2-3 months,” Jesse Goodman, who headed FDA’s Heart for Biologics Analysis and Analysis from 2003 to 2009, and was the company’s chief scientist until 2014, advised STAT in an electronic mail.
Nonprofit drugmaker reveals clear pricing works
5 years after its launch, nonprofit CivicaScript has unveiled information exhibiting that its low-cost, clear method to distributing generic medicine — beginning with a model of prostate most cancers drug Zytiga — led to dramatic financial savings: sufferers lower prices by as much as 98%, and payers by a median of 92%.
Backed by Blue Cross Blue Defend plans, STAT’s Ed Silverman writes, CivicaScript goals to reshape the generics market by prioritizing affordability over revenue. The corporate is now increasing its choices and gearing as much as manufacture its personal medicine, staking its declare as a sustainable antidote to price-gouging within the U.S. pharmaceutical system.
Why the protection and efficacy mRNA vaccine information holds
As soon as thought of a pandemic hero, mRNA vaccines are actually below fireplace. As a Senate subcommittee launches a listening to that probes alleged cover-ups of vaccine unwanted side effects like myocarditis, state legislatures weigh bans and the Trump administration questions NIH-funded analysis. However mRNA vaccines stay among the many most rigorously studied medical merchandise in historical past. Giant-scale trials involving greater than 70,000 individuals confirmed preliminary efficacy above 90%, and subsequent real-world research verify sturdy safety towards extreme Covid-19.
With billions of doses administered globally, security has been carefully monitored by way of giant databases. These instruments flagged uncommon circumstances of gentle myocarditis in younger males, however information present the danger is way increased after Covid an infection itself. Notably, mRNA can’t alter DNA, making the vaccines biologically secure.
Extra reads
- Roche’s Genentech sticks with Orionis in second molecular glue deal price $2 billion, FierceBiotech
- Teva, Novartis get recent warnings from FTC over Orange E-book patent listings, Endpoints
