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BioWorld - Sunday, January 18, 2026
Home » Authors » Randy Osborne

Articles by Randy Osborne

Repros' Androxal moving toward NDA by year-end; FDA needs no more trials

Nov. 10, 2014
By Randy Osborne
Repros Therapeutics Inc.'s CEO Joseph Podolski acknowledged the "nauseating" Wall Street ride for the company of late, but told investors during a conference call that "with time and continued progress, our share prices are going to move in the right direction."
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Macrelin CRL darkens Aeterna sunshine; phase III found far from spotles

Nov. 7, 2014
By Randy Osborne
Investors this morning will find out more about the fate of Aeterna Zentaris Inc.'s new drug application (NDA) for Macrilen (macimorelin), an oral ghrelin agonist for use as a diagnostic in evaluating adult growth hormone deficiency (AGHD) in the wake of a complete response letter (CRL) from U.S. regulators.
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'Fold'-ed wings: Astellas lifts work by Proteostasis, deal valued up to $1.2B

Nov. 5, 2014
By Randy Osborne
Following up a whopper deal with Biogen Idec Inc. about a year ago, Proteostasis Therapeutics Inc. (PTI) nailed down a pact with Astellas Pharma Inc. that brings up-front cash, a securities investment and potentially $400 million in milestone payments, ultimately gaining as much as $1.2 billion if Astellas exercises options for two more projects under the same terms and they succeed fully.
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Undeliverable male: Will Nymox phase III blowup in BPH give Sophiris 'gland' slam?

Nov. 4, 2014
By Randy Osborne
Despite encouraging data shared earlier by Nymox Pharmaceutical Corp., a pair of phase III studies with NX-1207 for benign prostatic hyperplasia (BPH), known as NX02-0017 and NX02-0018, failed to meet their primary endpoints in top-line results, and the company blamed a strong placebo response – stronger than was seen in previous experiments.
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Juxtapid juxta-'pose'? Consensus mismatch: 3Q sales disappointing, Aegerion tumbles

Nov. 3, 2014
By Randy Osborne
When Isis Pharmaceuticals Inc.'s Kynamro (mipomersen) was approved in January 2013 by the FDA for homozygous familial hypercholesterolemia (HoFH), the big question was whether the weekly injectable apolipoprotein B synthesis inhibitor could stand up against the daily pill from Aegerion Pharmaceuticals Inc.'s Juxtapid (lomitapide), a microsomal triglyceride transfer protein blocker for the same indication.
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$4M from Gates MAPS Affinivax's road ahead; more dough for 'Velcro'?

Oct. 31, 2014
By Randy Osborne
The $4 million investment by the Bill & Melinda Gates Foundation in Affinivax Inc.'s vaccine technology "provides us the opportunity and the runway to build out this platform and get additional points of validation, which will allow us to bring on potentially new funders, but also pharma partners," said CEO Steven Brugger.
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Hot dog: Aileron banks upsized $48M series E, p53 effort to take wing

Oct. 30, 2014
By Randy Osborne
Aileron Therapeutics Inc.'s wider series E round of $48 million came as a result of upped attention from investors, thanks to "work that's gone on during the last 10 months," said Joseph Yanchik, CEO of the Cambridge, Mass.-based firm, which is developing stapled-peptide technology.
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What's not too 'alike'? Analysts cheer Amgen earnings, biosimilars

Oct. 29, 2014
By Randy Osborne
Amgen Inc.'s moves into the biosimilar space drew attention during the company's business review meeting, which followed the release of investor-pleasing third quarter financial results that showed the company beating estimates and included higher guidance for the full year's earnings.
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Re-moxie for Remoxy: Wiser Pfizer backs off; new trial results could draw new Pain swain

Oct. 28, 2014
By Randy Osborne
A candid conference call with investors by Pain Therapeutics Inc. CEO Remi Barbier didn't stop Wall Street from pummeling the company's shares after partner Pfizer Inc. made known that it's returning all rights to Remoxy, the long-acting, tamper-resistant form of oxycodone stalled at the FDA.
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Neighborhood watch: Gene maps get 'Syros,' draw $53M series B

Oct. 27, 2014
By Randy Osborne
Mapper of gene-control pathways directly in human disease tissue, Syros Pharmaceuticals Inc. plans to use $53 million in series B cash to advance cancer programs toward the clinic and widen the gene-control product engine into new therapeutic areas.
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