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BioWorld - Saturday, May 2, 2026
Home » Authors » Randy Osborne

Articles by Randy Osborne

Alexion's Soliris label chalks another indication with FDA nod for anti-AQP4+ NMOSD

June 28, 2019
By Randy Osborne
Alexion Pharmaceuticals Inc. gained expansion from the FDA of the label for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive.
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The skinny in vasculitis: Fail in HS not AAV doom, players hold onto hope

June 27, 2019
By Randy Osborne
Recent bad phase IIb news from Inflarx NV with IFX-1, a first-in-class anti-human complement factor C5a monoclonal antibody in the moderate to severe skin disease hidradenitis suppurativa (HS), also dinged shares of Chemocentryx Inc., which has small-molecule avacopan targeting the C5a receptor in a registration-grade phase II study targeting the same indication – but the story's hardly over in HS or vasculitis.
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Lights, camera ... auction? Query $63B show-stopper in Abbvie's Allergan grab

June 26, 2019
By Randy Osborne
Abbvie Inc.'s agreement to take over Allergan plc in a cash and stock deal worth about $63 billion jarred Wall Street and set pundits mulling the price tag – seen by some as too low – along with the prospects for a satisfying marriage as pipelines are sorted out.
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Lights, camera ... auction? Query $63B showstopper in Abbvie's Allergan grab

June 26, 2019
By Randy Osborne
Abbvie Inc.'s agreement to take over Allergan plc in a cash and stock deal worth about $63 billion jarred Wall Street and set pundits mulling the price tag – seen by some as too low – along with the prospects for a satisfying marriage as pipelines are sorted out.
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Vyleesi does it: Sales risk tempers HSDD drug hoopla, Amag launch due this fall

June 25, 2019
By Randy Osborne
With the FDA go-ahead for Vyleesi (bremelanotide) in generalized hypoactive sexual desire disorder (HSDD), Amag Pharmaceuticals Inc.'s comparison of prospects for the compound to those of depression drugs in an earlier time gained more scrutiny, as Wall Street continued trying to guess revenues due from the auto-injectable melanocortin receptor agonist.
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Razza-ma-taz(emetostat): Epizyme's FL phase II databode brisk approval path?

June 24, 2019
By Randy Osborne
Attendees of the International Conference on Malignant Lymphoma in Lugano, Switzerland, got even more interim data than expected from Epizyme Inc.'s phase II trial with lead candidate tazemetostat for relapsed or refractory follicular lymphoma (FL) in patients who have undergone at least two prior lines of systemic therapy.
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Amag: All hands Andexxa to prep for Vyleesi launch as reverser nears key test

June 21, 2019
By Randy Osborne

Diamedica kidney phase I results bolster case; target next stages in second half

June 21, 2019
By Randy Osborne
Minneapolis-based Diamedica Therapeutics Inc. shares (NASDAQ:DMAC) closed Thursday at $4.94, up $1.12, or 29%, after trading as high as $5.93 as Wall Street made known its appreciation of positive interim data from the phase Ib study from 28 evaluable participants with moderate and severe chronic kidney disease (CKD).
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Amag: All hands Andexxa to prep for Vyleesi launch as reverser nears key test

June 20, 2019
By Randy Osborne
As the weekend PDUFA date for bremelanotide approaches, investors in Waltham, Mass.-based Amag Pharmaceuticals Inc. hope an approval will revive the stock, on the slide since last summer. Generating interest at the same time, though, is ciraparantag, brought in-house via the buyout in December of Perosphere Pharmaceuticals Inc., of Danbury, Conn. 
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Mass spec(ulation) blots DMD gene therapy space as PPMD data come soon

June 19, 2019
By Randy Osborne
Last week at the Goldman Sachs Healthcare Conference in Rancho Palos Verdes, Calif., Sarepta Therapeutics Inc. CEO Douglas Ingram noted that "more than a kid a day dies" from Duchenne muscular dystrophy (DMD) in the U.S., adding that officials at his Cambridge, Mass.-based firm "feel an enormous obligation to move heaven and earth to get this [gene] therapy to the community if it's possible" and quickly.
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