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Home » Newsletters » BioWorld

BioWorld

Sep. 17, 2014

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FDA clears Nektar/Astrazeneca's Movantik in OIC; new players welcome, Sucampo says

Right on time, the FDA gave its marketing nod to Nektar Therapeutics Inc.'s Movantik (naloxegol) as an oral treatment for opioid-induced constipation (OIC) in adults with chronic noncancer pain, and the peripherally active mu-opioid receptor antagonist (PAMORA) will be available to patients in the first half of next year. Read More

Window is closing on opportunity to control Ebola epidemic

A joint Senate committee hearing on fighting the Ebola epidemic in West Africa opened on a grim note Tuesday as Sen. Tom Harkin (D-Iowa) shared the World Health Organization's (WHO) prediction that the epidemic could spread to 20,000 people by the first of December. Read More

Orion, Bayer target prostate cancer with new phase III

Orion Corp. and Bayer Healthcare AG, part of Bayer AG, have begun to enroll patients in a phase III trial of ODM-201, an oral androgen receptor (AR) inhibitor the companies are co-developing to treat castration-resistant prostate cancer (CPRC). Supported by a €50 million (US$68 million) up-front Bayer paid Orion at the collaboration's June start, the study will test ODM-201 in men with non-metastatic CPRC who have rising prostate-specific antigen levels. Read More

Plethora raises $30M, in potential $60M product deal with Recordati

Plethora Solutions Holdings PLC completed a tightly choreographed, three-way transaction Tuesday, involving a share issue that grossed £18.2 million (US$29.5 million), the buyback of all outstanding rights to its premature ejaculation drug PSD502, and the licensing of rights to the same drug in Europe and neighboring territories to Recordati SpA in a deal worth up to €46 million (US$59.5 million) in up-front and milestone payments, plus royalties. Read More

Astrazeneca woos Lilly to $500M alliance to develop AD BACE inhibitor

Eli Lilly and Co. stepped into the leading role in another effort to develop an oral beta secretase cleaving enzyme (BACE) inhibitor in Alzheimer's disease (AD), this time with fellow pharma Astrazeneca plc. Read More

Study identifies multiple novel fusion kinases

Scientists from Cambridge, Mass.-based biotech company Blueprint Medicines Corp. have identified multiple new fusion kinases that play roles in different cancers. They published their findings in the Sept. 10, 2014, issue of Nature Communications. Read More

Biocon restructures: Some R&D will move out of India

NEW DELHI – The Indian biotech firm Biocon Ltd. plans to buy back a stake in its research unit, Syngene, now held by GE Capital. The rapidly growing subsidiary represents more than a quarter of Biocon's revenues. Read More

Dengue arrives in Japan, prompts funding for neglected diseases

TOKYO – For three decades now, a dengue pandemic has moved around the world, making its way to Europe, the U.S., China and, since last month, Japan. For the first time in 70 years, a local case of dengue was identified in Tokyo. Neglected diseases like malaria, Chagas and dengue are coming back into the spotlight in Japan thanks to the dengue outbreak and now an infusion of research capital. Read More

'Romo' to grow? Phase II analyses showing osteo upside, Amgen reports

Exploratory analyses of phase II results with the sclerostin inhibitor romosozumab (romo) in postmenopausal women with low bone mineral density (BMD) turned up more good news for Amgen Inc. and partner UCB SA, which have the compound in phase III already. Read More

Stock movers

Read More

Financings

Synereca Pharmaceutics Inc., of Oklahoma City, said it raised $1.4 million from a convertible debt financing led by Accele Venture Partners, the investing arm of life sciences accelerator Accele Biopharma Inc., with participation from i2E, Inc., a nationally recognized private not-for-profit corporation focused on growing innovative small businesses in Oklahoma and private investors. Read More

In the clinic

Amarin Corp. plc, of Dublin, said it plans to complete the ongoing REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial) cardiovascular outcomes study of Vascepa (icosapent ethyl), which was approved by the FDA as an adjunct to diet to reduce triglyceride levels in adult patients with severely high (> 500 mg/dL) triglyceride levels. Read More

Other news to note

Boston Therapeutics Inc., of Manchester, N.H., will present data on BTI-320, its lead drug candidate, as a poster presentation at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD 2014), this week in Vienna. Read More

Pharma: In the clinic

Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, presented results from a 52-week phase III study that demonstrated sustained efficacy of the investigational empagliflozin/linagliptin combination tablet in adults with type 2 diabetes already taking metformin and in those who were previously untreated. Read More

Pharma: Other news to note

Pershing Square Capital Management LP, of New York, and Valeant Pharmaceuticals International Inc., of Laval, Quebec, formed an agreement with Allergan Inc., of Irvine, Calif., to settle pending litigation before the Delaware Court of Chancery. Read More

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