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@bio_clouseau
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Healthcare and Tech investor.bioclouseau at the other site
Joined May 2009
$SRPT gets a platform tech designation on 6/4 for its AAVrh74 viral vector for LGMD 2E/R4 which seems to indicate the viral vector is "well understood" and "utilized by more than one drug without an adverse effect on quality, manufacturing, or safety". A little more than a month
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ODAC votes against $GSK blenrep. Not suprising given the benefit/risk conclusions from the review docs
www.onclive.com
The FDA’s ODAC voted against the risk/benefit profiles of belantamab mafodotin–based combinations in relapsed/refractory multiple myeloma.
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$SRPT "has agreed to include a black box". Like it had a choice. Also worth noting that the go forward R&D+SG&A guidance excludes the $ARWR milestone payments with at least 350M of the 10.3B due near term. Also when are the confirmatory trials due?
$SRPT Sarepta Therapeutics Announces Strategic Restructuring and Pipeline Prioritization Plan to Maintain Long-term, Sustainable Growth and Provides Update on ELEVIDYS Label.
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RT @PearlF: A Beijing court sentenced a Japanese pharma exec on Wed to 3½ yrs in prison on charges of espionage, Japan said, in a case tha….
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Consistently hypocritical.
Incredible, @VPrasadMDMPH and @Sensible__Med have repeatedly argued that public health decisions MUST be backed by rigorous clinical trial data with practical endpoints, and Makary is just going with family narratives.
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RT @Sanctuary_Bio: $srpt layoffs
www.reddit.com
Explore this post and more from the biotech community
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The benefit risk conclusions for $GSK belantamab mafodotin arent that flattering. Focus seems to be on the dosage
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RT @matthewherper: @bradloncar @ADeAngelis_bio That seems like a very strange straw man, Brad. The US could lose a lot of ground, and Germa….
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This seems like a steal considering $MRK paid lanova close to 600M in in November 24 for the pd-1/vegf and ~2.7B bio bucks remaining. Though thats only if one thinks there's a very good chance of achieving even 1/3 of the biobucks.
Hong Kong-listed Sino Biopharmaceutical said on Tuesday it will buy the remaining 95.09% stake it does not hold in Shanghai-based LaNova Medicines for no more than $950.92 million.
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Not sure of the details of the $RARE CRL but the post by the CEO refutes some of the rhetoric coming from the fda with respect to flexibility for rare diseases. Though the company PR mentions "months" to respond so in fairness to the FA its unclear that with a little more than a.
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Quite remarkable that most are equating some misleading mixed with bombastic statements to be good communication from the FDA. A sign of the times where simply "flooding the zone" works.
FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the sake of an uncertain payoff.
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Most of the CRL stuff should already be in the review docs for those diligent enough to go through them.
Wait. BIG caveat. These CRL letters are for drugs that were later approved. The really good stuff -- CRLs for drugs not/never approved are not being disclosed.
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RT @capitalweather: The news surrounding the Texas floods is heart-breaking -- as at least 59 people have died and 11 girls attending a su….
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RT @manorlaboratory: My lab’s 5-year NIH R01 grant, awarded to study gene therapy for hearing loss, was abruptly terminated. I want to shar….
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RT @AppleHelix: 1/. $NKTR has become a cult stock. But people should temper their enthusiasms for a quick buyout. - The efficacy data is e….
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RT @AndrewE_Dunn: NEW: An inside look at the growing divide among US biotech investors over China's ascent. Some VCs are capitalizing on Ch….
endpoints.news
US investors debate response to China's rise in drug development, with some seeing a national security threat while others embrace collaboration. FDA and policymakers consider reforms to maintain...
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RT @BioStocks: $VYNE Provides Program Update on Oral BET inhibitor VYN202.
www.globenewswire.com
BRIDGEWATER, N.J., July 02, 2025 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical...
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A choice other than authoritarianism or socialism sounds great -A Saber-Rattling Musk Promises a New Political Party if the G.O.P. Bill Passes
www.nytimes.com
The billionaire and former Trump adviser suggested that if the domestic policy bill passed, he would swiftly form a new “America Party” and back primary challenges to Republicans.
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Shades of michael gove in "we need to stop trusting the experts" by RFK. But apparantly we can trust ELSA
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