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STAT+: Color me skeptical: Drinking gold is not an ALS cure
This is the online version of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.
It’s been a while since I wrote a “Mean Adam” newsletter.
The biotech company Clene is developing a treatment for ALS called CNM-Au8 that it describes as a “highly concentrated aqueous suspension of catalytically-active, clean-surfaced, faceted gold nanocrystals.”
Allow me to translate: The Clene “drug” is gold microdust suspended in water.
This is the online version of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.
It’s been a while since I wrote a “Mean Adam” newsletter.
The biotech company Clene is developing a treatment for ALS called CNM-Au8 that it describes as a “highly concentrated aqueous suspension of catalytically-active, clean-surfaced, faceted gold nanocrystals.”
Allow me to translate: The Clene “drug” is gold microdust suspended in water.
Uncategorized
Pennsylvania sues AI chatbot company for posing as a licensed doctor
Pennsylvania sues AI chatbot company for posing as a licensed doctor
The state of Pennsylvania has sued Character.AI, a startup that lets users chat with different AI-generated personas, for illegally presenting a chatbot as a licensed doctor in the state.
This is the first lawsuit brought … Read More
Sarepta Therapeutics has put in place several initiatives to help its gene therapy Elevidys return to growth, but recovery will take a long time, according to company executives.
Uncategorized
STAT+: FDA to reconsider treatment for rare cancer after its surprise rejection
Two companies developing a therapy for a rare blood cancer have reached an agreement with the Food and Drug Administration that walked back the agency’s main reason for rejecting the drug in January.
Pierre Fabre Pharmaceuticals and Atara Biotherapeutics, makers of the drug called Ebvallo, said Thursday that a meeting held in late April with FDA officials ended with the agency agreeing that their already completed, single-arm clinical trial was sufficient to support a review and potential approval.
When the FDA rejected Ebvallo, the agency said the same study was flawed and the data produced from it was “insufficient” to support the drug’s approval. The drug’s review was conducted by the FDA’s Center for Biologics Evaluation and Research, led at the time by Vinay Prasad. He departed the agency at the end of April.
Two companies developing a therapy for a rare blood cancer have reached an agreement with the Food and Drug Administration that walked back the agency’s main reason for rejecting the drug in January.
Pierre Fabre Pharmaceuticals and Atara Biotherapeutics, makers of the drug called Ebvallo, said Thursday that a meeting held in late April with FDA officials ended with the agency agreeing that their already completed, single-arm clinical trial was sufficient to support a review and potential approval.
When the FDA rejected Ebvallo, the agency said the same study was flawed and the data produced from it was “insufficient” to support the drug’s approval. The drug’s review was conducted by the FDA’s Center for Biologics Evaluation and Research, led at the time by Vinay Prasad. He departed the agency at the end of April.
Illinois’ financial crisis could bring the state to a halt
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Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
Pennsylvania sues AI chatbot company for posing as a licensed doctor
Sarepta says to ‘exercise prudence’ in setting expectations for Elevidys’ recovery
STAT+: FDA to reconsider treatment for rare cancer after its surprise rejection
GSK goes beyond weight-loss with $1B buyout of Chinese siRNA specialist
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Angelini fortifies neurology portfolio with $4.1B buyout of Catalyst Pharma
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
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