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Boston’s biotech identification is beneath stress as founders decamp for California, Alzheimer’s researchers uncover extra secrets and techniques of tau operate, and Replimune lastly secures a hard-fought FDA approval.
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Replimune lastly wins battle for FDA approval
After two rejections and a unprecedented third evaluate, the FDA has granted accelerated approval to Replimune’s melanoma remedy RP1 — a call that means regulators are making use of a extra versatile strategy to most cancers drug critiques, regardless of lingering issues from FDA employees concerning the underlying knowledge. The record worth of the drug, Tudriqev, shall be $450,000 per course of remedy earlier than rebates and reductions.
“We anticipate sturdy demand for the routine given its relative ease of entry and benign security profile,” stated Leerink biotech analyst Daina Graybosch in a analysis word final week.
Regardless of issues from former FDA oncology chief Richard Pazdur through the approval bid final yr, the company’s advisers in the end concluded that the remedy’s obvious advantages for sufferers who’ve exhausted PD-1 inhibitors outweighed any flaws within the single-arm trial.
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Boston is giving up floor to SF
Boston retains insisting it’s the biotech capital of the world, and it nonetheless has an excellent case to make. But it surely’s additionally onerous to disregard founders who had been generated there however determined it’s time to go away.
Felix Wong grew up in Massachusetts, earned levels from Harvard, educated at MIT, and nonetheless concluded Silicon Valley supplied one thing Boston couldn’t: traders keen to wager on formidable younger individuals earlier than they’d grey hair.
“There’s some loopy experiments that we’re at the moment working … that I most likely wouldn’t have thought of once I was in Boston,” Wong stated.
His firm, Built-in Biosciences, is only one startup, but it surely embodies a broader nervousness hanging over Massachusetts as AI reshapes biotech.
Learn extra from The Boston Globe’s Emma Platoff.
Tau’s darkish facet factors towards new therapies
Tau has lengthy been thought of one in all Alzheimer’s most necessary culprits, however Stanford researchers have now uncovered what could also be one of many protein’s most damaging tips, a brand new Neuron paper reveals. The protein appears to power electrons to run backward via mitochondria, triggering oxidative stress, irritation, and neuronal damage, STAT’s Jonathan Wosen writes.
In mice, flies, and human neurons, blocking this reverse electron transport diminished neurodegeneration and improved reminiscence — elevating the potential of a completely new therapeutic technique. The work’s impressed a startup, Cerepeut, to develop small molecule medicine geared toward stopping the method earlier than neurons succumb.
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Delicate Medicare coverage shift might delay drug worth negotiations
A delicate Trump administration coverage change could have handed AbbVie years of further pricing energy, STAT’s Ed Silverman writes. A brand new evaluation from Public Citizen argues CMS reset the clock for a slender class of biologic medicine that had been initially accredited as conventional medicine earlier than being reclassified.
This delayed the date by which AbbVie’s blockbuster pancreatic enzyme drug Creon would possibly grow to be eligible for Medicare worth negotiations — pushing Creon’s eligibility again seven years regardless of costing the federal program $1.5 billion yearly. The group contends the reinterpretation runs counter to Congress’s intent, prices taxpayers cash, and will in the end profit different corporations — together with Novo Nordisk and doubtlessly Eli Lilly — if extra medicine are later reclassified as biologics.
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Extra reads
Braveheart fees previous expectations with $382.5 million IPO to fund cardio drug from Hengrui, FierceBiotech
FDA outlines expedited IND pilot plans, searching for to choose as much as 10 applications by year-end, Endpoints
