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BioWorld - Thursday, April 9, 2026
Home » Authors » Randy Osborne

Articles by Randy Osborne

‘Gate’ foundation? Enter here for early de-risking and add-on indications

April 3, 2014
By Randy Osborne
The once-popular image of disease foundations as “old ladies in tennis shoes” busy mainly with direct patient care is going away, said Annette Bakker, president and chief scientific officer of the Children’s Tumor Foundation (CTF). And that’s good news.
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Diabetes ‘Foresite’ pumps Intarcia $200M for exenatide delivery already in phase III

April 2, 2014
By Randy Osborne
With its once-yearly implanted-pump exenatide in phase III FREEDOM trials for type 2 diabetes, Intarcia Therapeutics Inc. became the highest-valued privately held biotech in the history of the industry by way of a $200 million financing that includes $57 million from the Foresite Capital Fund II, a growth equity stash designed to back firms “when we know things are working,” said managing director Christine Aylward.
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PCSK9 dogfight: Amgen wins in phase III results, Regeneron snarls back

April 1, 2014
By Randy Osborne
With its protein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab showing strong anti-cholesterol results across patient populations and dosing schedules (monthly as well as every two weeks) in phase III trials, Amgen Inc. held fast against data provided thus far by Regeneron Pharmaceuticals Inc. with alirocumab, also targeting PCSK9.
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Kindex brewing diabetes drug with hops-derived humulone; $5M series A

March 26, 2014
By Randy Osborne
It’s only $5 million in series A funding, but enough to move start-up Kindex Pharmaceuticals Inc. into a phase II trial with lead compound KDT 501, a hops-derived candidate for type 2 diabetes that regulates the cross-talk between macrophages and adipocytes to influence the complex of proteins that regulate inflammation, also known as the inflammasome.
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FDA says yes to Celgene’s Otezla in PsA: instead of ‘me-too’ drug, maybe ‘me-first’?

March 25, 2014
By Randy Osborne
With a label warning about weight loss that might actually help sales, Celgene Corp.’s oral phosphodieasterase-4 (PDE4) inhibitor Otezla (apremilast) was approved by the FDA on its Friday PDUFA date for adults with active psoriatic arthritis (PsA).
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No ‘weight’-ing: Celgene’s Otezla wins FDA nod on PDUFA date

March 24, 2014
By Randy Osborne
Right on time, the FDA approved Celgene Corp.’s phosphodieasterase-4 inhibitor Otezla (apremilast) for adults with active psoriatic arthritis (PsA), a drug that could sell in the range of $1.5 billion to $2 billion by 2017, the company said.
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Endocyte soars on news from Europe, phase IIb vintafolide data in NSCLC

March 24, 2014
By Randy Osborne
Wall Street hailed Endocyte Inc.’s double play – a positive opinion from European regulators on vintafolide in platinum-resistant ovarian cancer (PROC) and good news from a phase IIb trial in non-small-cell lung cancer (NSCLC) with the same compound – by sending its stock through the roof.
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Akebia blossoms: IPO upsized, raises $100M for CKD anemia effort

March 21, 2014
By Randy Osborne
Akebia Therapeutics Inc. beat the target amount raised in its initial public offering to raise about $100 million, and started off trading with a bang, closing Thursday (NASDAQ:AKBA) at $26.70, up 57 percent.
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Through thick and thin: Portola starts phase III with Factor Xa reverser

March 20, 2014
By Randy Osborne
Still enrolling a pivotal trial of its own Factor Xa inhibitor betrixaban, Portola Pharmaceuticals Inc. launched a new phase III study, this one testing andexanet alfa, designed to reverse the action of the anticoagulant class.
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Medivation, Astellas Pharma submit Xtandi sNDA for chemo-naïve PC

March 19, 2014
By Randy Osborne
Medivation Inc. and partner Astellas Pharma Inc. made the latest move in the battle for prostate cancer marketing share by submitting a supplemental new drug application (sNDA) seeking a label for Xtandi (enzalutamide) in chemotherapy-naïve men.
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