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Home » Authors » Randy Osborne

Articles by Randy Osborne

No CKD coup d'etat as Fibrogen-erates phase III tangle

May 13, 2019
By Randy Osborne
Although some on Wall Street kept faith that the hobbled shares of Fibrogen Inc. will make up their losses as investors pick through the data, pundits meanwhile sought to unriddle the pooled phase III findings offered from the global program with roxadustat, an inhibitor of hypoxia-inducible-factor (HIF) prolyl hydroxylase activity.
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Debt-laden Takeda sells Xiidra to Novartis in potential $5.3B deal; Tachosil goes to J&J

May 10, 2019
By Randy Osborne

Debt-laden Takeda sells Xiidra to Novartis in potential $5.3B deal; Tachosil goes to J&J

May 10, 2019
By Randy Osborne
Novartis AG is buying from Takeda Pharmaceutical Co. Ltd. the dry eye therapy Xiidra (lifitegrast ophthalmic solution) for a $3.4 billion up-front payment, with up to $1.9 billion more if milestones are met, and the Basel, Switzerland-based firm is bringing aboard about 400 employees – mostly based in the U.S. and Canada – associated with the drug, which was approved by the FDA in the summer of 2016.
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Investors keeping 'tab' on Atara progress; phase III's enrollment less than brisk

May 10, 2019
By Randy Osborne
Atara Biotherapeutics Inc.'s backers proved less than happy with the phase III delay for the T-cell immunotherapy tab-cel (tabelecleucel), but the company remained upbeat about prospects with the compound in patients with Epstein-Barr virus (EBV)-associated post-transplant lymphoproliferative disease (PTLD, or lymphomas that develop after a transplant).
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Tweet this: Goldfinch deal could net $1.95B back end, kidney registry Gilead lure

May 9, 2019
By Randy Osborne
Goldfinch Bio Inc. CEO Anthony Johnson told BioWorld that his company's deal with Gilead Sciences Inc. represents "a phenomenal opportunity, because this [kidney disease patient registry] will be the biggest of its type, definitely for the kidney but arguably across other disease areas as well."
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Putting a lid on ptosis, try by Osmotica turns up data for NDA due later this year

May 8, 2019
By Randy Osborne

Putting a lid on ptosis, try by Osmotica turns up data for NDA due later this year

May 8, 2019
By Randy Osborne
What could become the first nonsurgical therapy for ptosis, or droopy eyelid, inched closer to an NDA submission with upbeat top-line phase III efficacy results from Study 202, Osmotica Pharmaceuticals plc's test of RVL (oxymetazoline hydrochloride ophthalmic solution 0.1%), supplemented by new long-term phase III safety data, known as Study 203.
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Vyndaqel vindicated, mull ATTR bids post Pfizer win; foresee 'no' Onpattro risk

May 7, 2019
By Randy Osborne
Almost nine years after its complete response letter (CRL) from the FDA for tafamidis, Pfizer Inc.'s approval of two forms of the drug well ahead of their PDUFA dates to treat wild-type or hereditary transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM) left investors in Pfizer and other firms speculating about what the win might mean.
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THOR: IL-2 bids' Marvel? Dark world of combos lit by nascent not-alpha try

May 6, 2019
By Randy Osborne
Synthorx Inc. has rolled out intriguing data over the past couple of months and more is due ahead at the American Society of Clinical Oncology (ASCO) meeting in early June, when the San Diego-based firm unveils how synthetic biology can be used to reprogram the therapeutic activity of interleukin-2 (IL-2).
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Pig PERT quirt can hurt: Azurrx whips new effort against CF EPI into play

May 3, 2019
By Randy Osborne
Exocrine pancreatic insufficiency (EPI) is one of the potential dreaded accompaniments of cystic fibrosis (CF) that patients must deal with, a condition that means downing as many as 40 pills per day if they take porcine-derived pancreatic enzymes (PPEs), the standard of care.
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