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BioWorld - Tuesday, December 23, 2025
Home » Authors » Randy Osborne

Articles by Randy Osborne

Neurocrine Biosciences raises $142M to push VMAT2 inhibitor; phase III design ahead

Feb. 28, 2014
By Randy Osborne
Pulling down about $142 million from a public offering of 8 million shares priced at $17.75 each, Neurocrine Biosciences Inc. is moving ahead with phase III plans for the vesicular monoamine transporter 2 (VMAT2) inhibitor for tardive dyskinesia candidate NBI-98854.
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‘Capacity’ to ASCEND: Intermune’s win in IPF paving way for new Esbriet NDA

Feb. 26, 2014
By Randy Osborne
Intermune Inc. plans to resubmit its new drug application (NDA) for Esbriet (pirfenidone) for idiopathic pulmonary fibrosis (IPF) in the third quarter of this year, based on home run phase III data from a trial called ASCEND that sent the company’s shares into the upper altitudes. Given a six-month review, Esbriet could hit the U.S. market as early as the second quarter of 2015.
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Thesan series B garners $49M for skin therapies; keeps mum on pipeline

Feb. 25, 2014
By Randy Osborne
Thesan Pharmaceuticals Inc. followed up last fall’s $16 million series A financing with $49 million in series B money to support research in acne and atopic dermatitis.
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Spinal zap: Isis’ atrophy drug shines in top-line results for kids and babies

Feb. 24, 2014
By Randy Osborne
Calling the top-line phase Ia/IIb data with the company’s antisense drug for spinal muscular atrophy (SMA) in children “achingly important” and the benefit in a subset “shocking,” Isis Pharmaceuticals Inc. CEO Stanley Crooke said intrathecal ISIS-SMNRx has proven safe so far, too.
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Strike two for rigosertib: Onconova phase III miss in MDS wallops shares

Feb. 21, 2014
By Randy Osborne
Not surprising but hardly well taken by investors was the second setback with Onconova Therapeutics Inc.’s intravenous (I.V.) rigosertib for higher-risk myelodysplastic syndromes (MDS), which failed to meet its primary endpoint of overall survival (OS) in the phase III trial known as ONTIME.
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Chelsea: ‘ballpark’ price, second-quarter launch of Northera in NOH

Feb. 20, 2014
By Randy Osborne
With a launch expected in the second half of this year, Chelsea Therapeutics International Ltd. is firming up other plans for Northera (droxidopa), just approved by the FDA for neurogenic orthostatic hypotension (NOH), or a sudden drop in blood pressure when the patient stands up.
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Akebia takes its place in the IPO lineup, seeks $75M for anemia drug

Feb. 19, 2014
By Randy Osborne
With phase IIb experiments under way in nondialysis chronic kidney disease patients with anemia, Akebia Therapeutics Inc. filed for an initial public offering (IPO) that would raise as much as $75 million, as plans also firm up for a phase II study in dialysis patients, slated to begin in the first half of this year.
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Chelsea Therapeutics’ Northera wins FDA nod in NOH; black-box warning in label

Feb. 19, 2014
By Randy Osborne
The long, hazard-fraught road for Chelsea Therapeutics International Ltd. with Northera (droxidopa) – including unfavorable briefing documents, followed by a positive advisory committee (adcom) vote – came to a happy end with approval of the drug by the FDA for neurogenic orthostatic hypotension (NOH), or a sudden drop in blood pressure when the patient stands up.
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‘Tivo’ off screen: Astellas ending Aveo VEGF deal after failure reruns

Feb. 18, 2014
By Randy Osborne
Steadily declining hopes for tivozanib, the tyrosine kinase inhibitor of vascular endothelial growth factor (VEGF) receptors, hit bottom with Astellas Pharma Inc.’s decision to quit its deal with Aveo Oncology Inc., which brought $125 million up front in 2011 and the promise of more than $1 billion in potential milestone payments.
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PTC ‘Pax’ cash coffers, Macrogenics, too: $109M each in priced offerings

Feb. 14, 2014
By Randy Osborne
Though winter storm Pax put the freeze on air and ground traffic in the Northeast U.S. after ravaging the South, biotech funders seemed to feel little of the chill, with PTC Therapeutics Inc. and Macrogenics Inc. pricing public offerings for $109.7 million and $109.5 million, respectively.
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