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BioWorld - Saturday, December 27, 2025
Home » Authors » Randy Osborne

Articles by Randy Osborne

'NAPOLI-1' dynamite: Merrimack wins in pancreatic phase III with MM-398

May 2, 2014
By Randy Osborne

As soon as Merrimack Pharmaceuticals Inc. unveiled strongly positive data from the NAPOLI-1 phase III trial with MM-398 in metastatic pancreatic cancer patients previously treated with gemcitabine, investors began to mull the chances for the drug – a nanoliposomal encapsulation of the chemotherapy agent irinotecan – in first-line disease.

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More autonomy for Otonomy: $49M series D drums up new investors for ear-therapy push

May 1, 2014
By Randy Osborne
After drawing $45.9 million in a series C financing round last September, Otonomy Inc. put another $49 million into the coffers by way of an oversubscribed series D round, which will let the San Diego-based firm advance its products for ear conditions "well into the second half of 2015," said CEO David Weber.
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Chaperone goes it alone: Amicus' migalastat wins in phase III Fabry study

April 30, 2014
By Randy Osborne
A rejiggered phase III Fabry disease trial with migalastat, the oral small-molecule chaperone for alpha-galactosidase A, did the trick for Amicus Therapeutics Inc., which reported favorable data in patients with the amenable mutations using the drug as a monotherapy.
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GI mojo: Forest paying $1.1B for Furiex for IBS therapy, ready for NDA

April 29, 2014
By Randy Osborne
The timing of Forest Laboratories Inc.'s takeover of Furiex Pharmaceuticals Inc. for $95 per share, or about $1.1 billion in cash, and up to $30 per share – about $360 million – in a contingent value right (CVR) should not affect Forest's pending merger with Actavis plc, CEO Brent Saunders said.
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Secondary BENEFIT in ALS trial? Cytokinetics’ Tirasemtiv might be saved post-blowup

April 28, 2014
By Randy Osborne
The phase IIb failure of tirasemtiv in amyotrophic lateral sclerosis (ALS) jolted Wall Street, though some analysts had been wary from the start about the chances for the fast skeletal muscle troponin activator.
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'Data' lot of money: Celgene's pays Nogra $710M up front for phase II Crohn's drug

April 24, 2014
By Randy Osborne
Analysts had plenty of questions but few data-driven answers about Celgene Corp.'s decision to pay $710 million up front to privately held Nogra Pharma Ltd. to develop and commercialize GED-0301, a phase III-ready, oral antisense DNA oligonucleotide targeting Smad7 mRNA for the treatment of moderate to severe Crohn's disease (CD) and other indications.
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'Adderall' up: Neos gets $18M series C plus $20M loan deal for ADHD push

April 24, 2014
By Randy Osborne
Neos Therapeutics Inc.'s upsized series C financing – from $15.5 million to $18 million – along with a $20 million loan facility with Hercules Technology Growth Capital Inc. means the firm will "not only have enough money to hit the key regulatory milestones over the next 12-15 months, but to give us financial flexibility into 2016," said Victor Miller, vice president of finance.
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Deals Roundup: Allergan the target of hostile $46B takeover bid, but will board be on board?

April 23, 2014
By Randy Osborne

Valeant $45B Allergan bid clever, but will board go along?

April 23, 2014
By Randy Osborne
As Tuesday wore on, skepticism gave way regarding success for the hostile try by Valeant Pharmaceuticals International Inc., with help from the hedge fund Pershing Square Capital Management L.P., to take over Allergan Inc. in a deal valued at about $45 billion. But the merger is by no means a deal.
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'Exon' spill: Sarepta says FDA greased path for eteplirsen NDA, available data set OK

April 22, 2014
By Randy Osborne
Breaking the silence that has prevailed since last November on the upshot of ongoing talks with the FDA regarding eteplirsen, Sarepta Therapeutics Inc. said the FDA's once-dim view of data with the exon-skipping candidate for Duchenne muscular dystrophy (DMD) has changed.
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