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Home » Authors » Randy Osborne

Articles by Randy Osborne

Oh boy-a, sequoia: BMS up tree? Redwood phase II takes bough for Cytokinetics in HCM

July 19, 2021
By Randy Osborne
Cytokinetics Inc. CEO Robert Blum declined to remark upon what one analyst called “the elephant in the room” as the company popped the lid off positive top-line data from the first and second cohorts of the phase II study with CK-3773274 (known by the shorthand CK-274) in hypertrophic cardiomyopathy (HCM).
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ICER panel: Aduhelm cost not glossed as Biogen balks about talks

July 16, 2021
By Randy Osborne
A sometimes contentious policy roundtable on how to handle Alzheimer’s disease therapies followed the July 15 meeting of the California Technology Assessment Forum, an independent evidence appraisal committee of the Institute for Clinical and Economic Review (ICER). CTAF’s 15 panelists voted unanimously that the evidence was not adequate to prove Biogen Inc.’s recently approved Aduhelm (aducanumab) superior to supportive care alone.
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Dueling CMOs, Aduhelm takes it on the nose in CTAF session

July 15, 2021
By Randy Osborne
Members of the California Technology Assessment Forum (CTAF), an independent appraisal committee of the Institute for Clinical and Economic Review (ICER), discussed – and voted on – the safety vs. efficacy and other aspects of Biogen Inc.’s embattled Aduhelm (aducanumab), the amyloid beta-targeting therapy recently approved for Alzheimer’s disease. It didn’t go well for Biogen.
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Furoscix

Ace heart-wear store Scpharma wields proven tool for cardiac cost saving

July 14, 2021
By Randy Osborne
Approval could come next year for Furoscix from Scpharmaceuticals Inc. (Scpharma), a solution of the standard-of-care heart failure diuretic furosemide formulated to a neutral pH and designed for outpatient use.
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Gene editing illustration

It’s Prime’s time; editing firm highly rated with $315M in bank

July 13, 2021
By Randy Osborne
Prime Medicine Inc. (PM) likely has “a lock on prime editing technology for therapeutic uses,” CEO Keith Gottesdiener told BioWorld, though research labs are continuing to refine the approach. Cambridge, Mass.-based PM has $315 million in the bank that will help advance the platform, which behaves like a DNA word processor to search and replace disease-causing genetic sequences at their exact location in the genome.
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Starter KIT: Celldex wows in urticaria phase Ib

July 12, 2021
By Randy Osborne
Riding high on dramatic phase Ib results with KIT receptor-binding monoclonal antibody CDX-0159 in urticaria (hives), Celldex Therapeutics Inc. plans to begin phase II work in the first half of next year. Shares of Hampton, N.J.-based Celldex (NASDAQ:CLDX) closed July 12 at $40.67, up $8.26, or 25%, as Wall Street reacted to favorable data from the trial in antihistamine-refractory cold urticaria and symptomatic dermographism, the two most common forms of chronic inducible urticaria (CindU).
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Red blood cells, DNA

Time-out capsule: Sigilon’s novel hemophilia bid sidelined in phase I/II

July 9, 2021
By Randy Osborne
Officials at Sigilon Therapeutics Inc. declined to comment beyond a press release on the FDA’s clinical hold for the phase I/II study with encapsulated cell therapy SIG-001 for severe or moderately severe hemophilia A. Shares of Cambridge, Mass.-based Sigilon (NASDAQ:SGTX) closed at $6.90 on July 9, down $2.34, or 25% after Wall Street learned of the regulatory move, which came because one of three patients treated has developed inhibitors to factor VIII (FVIII).
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FDA website and logo

Situation more Grimm for Biogen as Woodcock seeks Aduhelm probe

July 9, 2021
By Randy Osborne
As rumblings continued about possible skulduggery between Biogen Inc. and the FDA related to Aduhelm (aducanumab), an already precedent-setting case took yet another turn: Acting FDA Commissioner Janet Woodcock asked acting U.S. Inspector General Christi Grimm’s office to conduct an independent review of goings-on that led to approval of the amyloid-beta-targeting drug in Alzheimer’s disease.
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Bayer wins FDA clearance for Kerendia in CKD with T2D

July 9, 2021
By Randy Osborne

Following a priority review, the FDA approved Bayer AG’s Kerendia (finerenone) for chronic kidney disease (CKD) associated with type 2 diabetes (T2D). A non-steroidal mineralocorticoid receptor antagonist, Kerendia targets a key driver in CKD and has proven positive as well with regard to cardiovascular outcomes – risked especially by patients with loss of kidney function.


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Blue heart and data grid

Cardio’s working out as players flex in heart failure

July 8, 2021
By Randy Osborne
Recent findings with the sodium glucose transporter-2 inhibitor Jardiance (empagliflozin) from Boehringer Ingelheim International GmbH and Eli Lilly and Co. drew more attention to the cardiovascular space.
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