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Home » Newsletters » BioWorld

BioWorld

Feb. 18, 2016

View Archived Issues

In the clinic

Repros Therapeutics Inc., of The Woodlands, Texas, said it fully randomized a phase II double-blind, placebo-controlled proof-of-concept study of enclomiphene, an estrogen receptor antagonist, in conjunction with rigorous diet and exercise in the treatment of obese secondary hypogonadal men. The study enrolled its target of 45 subjects, and top-line interim results for three months and six months are expected this summer. Read More

Other news to note

Asterias Biotherapeutics Inc., of Fremont, Calif., and Biotime Inc., of Alameda, Calif., along with Biotime's wholly owned subsidiary ES Cell International Pte Ltd., have entered into a share transfer agreement through which Biotime will re-acquire from Asterias shares of capital stock of Biotime subsidiaries Cell Cure Neurosciences Ltd. and Orthocyte Corp. Read More

Earnings

The Medicines Co., of Parsippany, N.J., reported fourth-quarter and full-year earnings that included worldwide net revenue of $67.2 million for the fourth quarter of 2015 compared to $173.1 million in the fourth quarter of 2014, with thrombin inhibitor Angiomax/Angiox (bivalirudin) net product sales at $23.2 million in the fourth quarter of 2015 compared to $165.9 million in the fourth quarter of 2014. Read More

Financings

Mast Therapeutics Inc., of San Diego, said it closed its underwritten public offering of 29.09 million units at $0.275 per unit. Each unit consisted of one share of the company's common stock and one warrant to purchase one share of the company's common stock at an exercise price of $0.42 per share. Read More

JHL gets U.K. green light to start rituximab biosimilars trials

HONG KONG – Taiwan's JHL Biotech Inc. has received approval to start clinical trials of a biosimilar to Roche AG's Rituxan (rituximab), marking the first European clinical trial approval for a monoclonal antibody biosimilar developed in the Greater China region. Read More

Muting myostatin makes for mightier mice

An antibody directed at myostatin improved both muscle strength and metabolism in aged mice. The findings provide support for the idea that targeting myostatin could be a therapeutic option for improving muscle strength as well as metabolic function in the elderly. Read More

Third Rock serves up 'Pliant' prospect in fibrosis with $45M series A

Third Rock Ventures LLC planted yet another seed in its garden of flourishing start-ups by forming Pliant Therapeutics Inc. with a $45 million series A designed to advance multiple small molecules and propel its lead candidate through investigational new drug (IND)-enabling studies in idiopathic pulmonary fibrosis (IPF). Read More

Hepatitis C combo data buoys Regulus Therapeutics' shares

Interim data suggesting that the length of direct-acting antiviral (DAA) treatment regimens for many hepatitis C (HCV) cases could be halved by adding Regulus Therapeutics Inc.'s microRNA antagonist, RG-101, pushed company shares (NASDAQ:RGLS) 19.3 percent higher to $7.49 by Wednesday's market close. Read More

Zilretta hits in phase III knee pain study; Flexion looks to 2H NDA filing

Flexion Therapeutics Inc. looked to move Zilretta (FX006) over the goal line after a damaging pivotal phase IIb miss in late 2015 by reporting findings from an initial phase III showing that the injected intra-articular (IA) sustained-release, non-opioid, non-steroid treatment achieved clinically meaningful and highly statistically significant separation from placebo in treating moderate to severe osteoarthritis (OA) knee pain at each measured time point in weeks one through 16, meeting the primary endpoint at week 12 with a "p" value of Read More

No timolol 8-ball: FDA likes Ocular phase III plan for glaucoma punctal plug

Echoing last year's hoopla surrounding Inotek Pharmaceuticals Corp.'s progress with trabodenoson, Wall Street cheered the FDA blessing on Ocular Therapeutix Inc.'s phase III plan with OTX-TP (travoprost), a sustained-release punctal plug for glaucoma and ocular hypertension – a program minus any timolol comparator arm. Read More

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