Category: Adam’s Take
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STAT+: The FDA, urged to avoid controversy, creates a new headache with attack against UniQure
STAT+: The FDA, urged to avoid controversy, creates a new headache with attack against UniQure There was a telling exchange during a Thursday media call set up by the Food and Drug Administration to enable a “senior FDA official” — he could only be quoted anonymously — to attack UniQure and its experimental treatment for…
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STAT+: A rival goes after Ocular Therapeutix on eve of pivotal readout on eye treatment
STAT+: A rival goes after Ocular Therapeutix on eve of pivotal readout on eye treatment Ocular Therapeutix and Eyepoint Pharmaceuticals are developing competing treatments for wet age-related macular degeneration, a common cause of vision loss in older people. Their CEOs don’t particularly like each other. So, with Ocular in a self-imposed quiet period ahead of…
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STAT+: Why the JP Morgan conference is important — but not make-or-break
STAT+: Why the JP Morgan conference is important — but not make-or-break 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. My advice for JPM week: chill SAN FRANCISCO — The super-sized gathering of the biopharma universe is important, but it’s…
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STAT+: Top FDA drug regulator’s unusual criticism of a therapy gets Wall Street wagging
STAT+: Top FDA drug regulator’s unusual criticism of a therapy gets Wall Street wagging Is George Tidmarsh, the Food and Drug Administration’s top regulator, trying to exact revenge on a prominent Wall Street investor after a run-in with him six years ago? It’s the question biotech investors were wagging about all Monday after Tidmarsh used…
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STAT+: Cogent Biosciences-Blueprint Medicines tiff turns spicy on eve of immune drug study readout
STAT+: Cogent Biosciences-Blueprint Medicines tiff turns spicy on eve of immune drug study readout This story is an excerpt from Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. Cogent Biosciences and Blueprint Medicines are direct competitors who hate each other. During a talk at the recent…
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STAT+: What’s next for Sarepta Therapeutics with gene therapy under fire?
STAT+: What’s next for Sarepta Therapeutics with gene therapy under fire? This story is an excerpt from Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. The Duchenne muscular dystrophy community is reeling following the second death of a patient from liver failure caused by Sarepta Therapeutics’…
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STAT+: FDA’s ‘key man’ Peter Marks is out. Biotech investors will now deal with the consequences
STAT+: FDA’s ‘key man’ Peter Marks is out. Biotech investors will now deal with the consequences Robert F. Kennedy Jr. forcing Peter Marks out of the Food and Drug Administration has blown a hole in the agency’s leadership ranks and threatens to unmoor the oversight of drugs and vaccines from bedrock scientific principles. For biotech…