BridgeBio CEO Neil Kumar had all but reserved the champagne to celebrate the success of its big Phase III study for acoramidis, designed to stabilize transthyretin and slow or halt the progression of TTR amyloidosis. They had bought out full rights to the drug in late 2020 and borrowed the first $450 million of a $750 million loan, adding to a hefty debt load while confidently predicting a straight march to the FDA in 2022.
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The FDA on Thursday authorized another new pill to treat the Omicron variant, this time from Merck.
While Pfizer’s antiviral may prove to be more effective, and Merck’s pill has left some scientists questioning the dangers behind its mechanism of action, molnupiravir will be another weapon in the armamentarium of Covid-19 treatments for the US in a time of need, as two mAb treatments from Regeneron and Eli Lilly are no longer effective against Omicron, and as supplies of a third mAb from Vir/GlaxoSmithKline are very limited.
It’s time for our holiday break here at Endpoints News, and like a lot of you, we’ve been prepping for 2022.
Anyone who’s spent some time in industry can tell you the past decade has shoved the drug-hunting field into the forefront of the world’s view of things, garnering tens of billions in investment as new technologies look to change the landscape of R&D. And anyone who qualifies for first-in-class and best-in-class can clean up.
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Khurem Farooq, Gyroscope CEO
Christmas is coming early for Gyroscope.
In its latest gene therapy gambit, Novartis is paying $800 million upfront to acquire the Syncona-backed biotech, with another $700 million reserved for milestones.
Novartis has been diving deep into retinal disorders, and Gyroscope’s lead candidate adds a potential one-time treatment for geographic atrophy — a leading cause of blindness — to the pipeline.
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Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from the market.
‘An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval,’ they wrote to FDA, explaining how Aduhelm ‘did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression.’
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Angie You and Volker Schellenberger, Amunix
Sanofi is crashing the year-end M&A party with a deal of its own.
Immuno-oncology is the name of the game as it swallows Mountain View, CA-based Amunix for $1 billion upfront and up to $225 million in biobucks, tagging a suite of T cell engagers and cytokine therapies as well as a tech platform for making ‘conditionally activated biologics.’
‘The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues,’ said Sanofi R&D chief John Reed, ‘thus bringing the promise of more effective and safer treatment options for cancer patients.’
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Graphic: Alexander Lefterov for Endpoints News
Drug pricing reform has been a political football for years, with both Donald Trump and Joe Biden championing changes during their presidencies. Little has moved the needle on Capitol Hill, however, thanks in part to the drug industry’s powerful lobbyists.
In the most recent example, Democrats tried to allow Medicare to negotiate drug prices — an immediate non-starter for biopharma proponents. After months of negotiation, the measure fell apart in favor of provisions on a small subset of drugs that passed the House but marked a far cry from Biden’s promises and what many activists had hoped for. The bill, included as part of Biden’s broad social policy agenda, now appears dead after Democrats failed to secure 50 votes in the Senate.
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Michael Yang, ViaCyte CEO
Over the last 20 years, ViaCyte — under one name or another — has pursued one of the most audacious goals in biotech: a cure for type 1 diabetes.
The company’s plan was to take lab-grown stem cells and turn them into the insulin-producing cells that are destroyed in T1D patients. The first attempt to implant these cells into patients in 2014 failed entirely. But the San Diego biotech regrouped and launched trials for a new candidate in 2017, raising $80 million in the process.
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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)
Just 6 days after Eli Lilly execs ID’d its $1.1 billion atopic dermatitis drug lebrikizumab as one of its top late-stage drug candidates, the pharma giant has followed up with another round of positive late-stage data as it paves the way to planned regulatory filings in 2022.
The Christmas week statement from Lilly included little by way of hard data — the big outfit typically reserves that for its science conferences — but researchers touted a clean sweep of the primary and all secondaries in its 3rd round of late-stage results.
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https://endpts.com/bridgebio-shares-go-into-meltdown-mode-as-their-lead-phiii-drug-implodes-at-the-finish-line/
