BioCentury | Sep 5, 2016
Clinical News

Prolia denosumab: Phase III data

Top-line data from the double-blind, double-dummy, international Phase III GIOP trial in 795 patients receiving glucocorticoid treatment showed that 60 mg subcutaneous Prolia every 6 months met the primary endpoint of non-inferiority to risedronate in...
BioCentury | Apr 2, 2015
Targets & Mechanisms

Breathing through bone drugs

Reversing or halting progressive airway damage is still the biggest challenge in COPD, but a study from Japan suggests a subclass of osteoporosis drugs could offer a new way to tackle the disease that takes...
BioCentury | Sep 2, 2013

Back to School: Facing Reality

BC Staff For the first time since the 2008 meltdown, nearly everything appears to be coming up roses for biopharma. Money is again flowing into the sector, FDA , EMA and Japan's Pharmaceuticals and Medical Devices...
BioCentury | Mar 11, 2013
Company News

Ajinomoto Pharmaceuticals Co. Ltd., Eisai, Takeda sales and marketing update

Ajinomoto and Eisai announced the launch of once-monthly 75 mg Actonel / Benet risedronate in Japan to treat osteoporosis. Japan's National Health Insurance (NHI) listed the antiresorptive pyridinyl bisphosphonate at ¥2,945.50 ($31.52) per tablet. Ajinomoto...
BioCentury | Jan 7, 2013
Clinical News

once-monthly Actonel/Benet risedronate regulatory update

On Dec. 25, 2012, Ajinomoto Pharmaceuticals Co. Ltd. (Tokyo, Japan) and Takeda said Japan's Ministry of Health, Labor and Welfare (MHLW) approved once-monthly Actonel/Benet risedronate to treat osteoporosis. Ajinomoto will be responsible for manufacturing Actonel,...
BioCentury | Nov 12, 2012

BVF's private return

Biotechnology Value Fund invested in a private company for the first time in more than five years, putting money into a spinout of potentially first-in-class assets from Pfizer Inc. (NYSE:PFE). Newco Ziarco Pharma Ltd. announced...
BioCentury | Aug 13, 2012
Clinical News

Forteo: Phase III data

A double-blind, international Phase III trial in 710 postmenopausal women with >=1 moderate or severe vertebral fracture thought to be the cause of back pain showed once-daily 20 µg subcutaneous Forteo missed the primary endpoint...
BioCentury | May 14, 2012

Outcomes trumping volume

In their quest to establish value for money, payers in the U.S. are asking drug manufacturers to experiment with new contracting models that tie rebates and discounts to health outcomes instead of drug volumes. At...
BioCentury | May 11, 2012
Clinical News

Bisphosphonate uncertainties linger at FDA

Eight months after an FDA panel recommended clarifying the duration of use in labels of bisphosphonates for osteoporosis, the agency said further investigation on the benefit-risk profile is still needed to determine the best long-term...
BioCentury | May 7, 2012

BG-12 deal keeps on giving

The former shareholders of Fumapharm AG could be looking forward to more than $2.5 billion in milestones if sales for multiple sclerosis treatment BG-12 from Biogen Idec Inc. live up to Wall Street expectations. Last...
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