Pfizer's Bosutinib Wins Positive Opinion for CMA from CHMP; Lilly's Solanezumab Chosen for Alzheimer's Study Print E-mail
By Staff and Wire Reports   
Friday, 18 January 2013 19:44
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 18, 2013.

Pfizer Inc. (NYSE: PFE)
announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the conditional marketing authorization of bosutinib in the European Union (EU) for the treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

The positive opinion for bosutinib was based on data from Study 200, a global, single-arm, open-label, multi-cohort, Phase 1/2 study of bosutinib in more than 500 patients with Ph+ CML with separate cohorts for chronic, accelerated and blast phase disease previously treated with one or more prior TKIs.

Conditional approvals in the EU are granted to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit.


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Researchers have chosen an experimental drug by Eli Lilly & Co. (NYSE:LLY) for a large federally funded study testing whether it's possible to prevent Alzheimer's disease in older people at high risk of developing it.

The drug, called solanezumab, is designed to bind to and help clear the sticky deposits that clog patients' brains. Earlier studies found it did not help people with moderate to severe Alzheimer's but it showed some promise against milder disease. Researchers think it might work better if given before symptoms start. "The hope is we can catch people before they decline," which can come 10 years or more after plaques first show up in the brain, said Dr. Reisa Sperling, director of the Alzheimer's center at Brigham and Women's Hospital in Boston. She will help lead the new study, which will involve 1,000 people ages 70 to 85 whose brain scans show plaque buildup but who do not yet have any symptoms of dementia. They will get monthly infusions of solanezumab or a dummy drug for three years.

The main goal will be slowing the rate of cognitive decline. The study will be done at 50 sites in the U.S. and possibly more in Canada, Australia and Europe, Sperling said. In October, researchers said combined results from two studies of solanezumab suggested it might modestly slow mental decline, especially in patients with mild disease. Taken separately, the studies missed their main goals of significantly slowing the mind-robbing disease or improving activities of daily living. Those results were not considered good enough to win the drug approval.

So in December, Lilly said it would start another large study of it this year to try to confirm the hopeful results seen patients with mild disease. That is separate from the federal study Sperling will head. About 35 million people worldwide have dementia, and Alzheimer's is the most common type. In the U.S., about 5 million have Alzheimer's. Current medicines such as Aricept and Namenda just temporarily ease symptoms. There is no known cure.


Also Friday:


Align Technology, Inc. (NASDAQ: ALGN)
announced today that SmartTrack™, the next generation of Invisalign clear aligner material, will be available commercially on January 21, 2013.

Amgen (NASDAQ: AMGN)
today announced that it will report its fourth quarter and full year 2012 financial results on Wednesday, Jan. 23, 2013, after the close of the financial markets.

BioTime, Inc. (NYSE MKT: BTX)
, a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Executive Officer Michael D. West, PhD will present at the Scale-Up and Manufacturing of Cell-Based Therapies II conference in San Diego, California on Monday, January 21, 2013.

Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP)
, developer of a rapid and painless testing platform that uses biophotonics for the early detection of disease, today announced plans to showcase the LuViva® Advanced Cervical Scan at the 38th Annual Arab Health 2013 Healthcare Exhibition and Congress taking place January 28 – 31, 2013 in Dubai, United Arab Emirates.

ImmunoGen, Inc. (Nasdaq: IMGN)
, a biotechnology company that develops anticancer products using its Targeted Antibody Payload (TAP) technology and antibody expertise, today announced that the Company will host a conference call at 8:00 a.m. ET on Friday, January 25, 2013, to discuss ImmunoGen's financial results for the three-month period ended December 31, 2012 – the second quarter of the Company’s 2013 fiscal year.

MetaStat, Inc. (OTCBB: MTST)
, ("MetaStat" or the "Company"), a life science company focused on understanding and treating systemic metastasis, today announced that the Company will be presenting at the NINE 2013 - Noble Financial Capital Markets' Ninth Annual Equity Conference held at the Hard Rock Hotel & Casino, Hollywood, Florida, on Tuesday, January 22, 2013 at 4:30 p.m. Eastern Time.  

MediSwipe Inc. (OTCQB: MWIP)
, a patient security solutions and financial products company for the health care industry, today announced an exclusive agreement with Payteller LLC (www.mypayteller.com), a leading provider of bill payment and customized kiosks based in South Florida.

Perrigo Company (Nasdaq: PRGO;TASE:)
today announced that it will release financial results for its second quarter fiscal year 2013 on Friday, February 1, 2013  at approximately 8:00 a.m. (ET).

St. Jude Medical, Inc. (NYSE:STJ)
, a global medical device company, today announced European CE Mark approval of its AMPLATZER™ Amulet™ Left Atrial Appendage Occluder.

Tonix Pharmaceuticals Holding Corp. (OTCQB: TNXP)
develops prescription medications for challenging disorders of the central nervous system ("CNS").

Viratech Corp. (PINKSHEETS: VIRA)
, the first open source biotech research social network platform, announced today that it has entered into a letter of intent to provide a turnkey Social Network for Wellness Builder, Inc., a company engaged in the development of a series of nutraceutical products designed to combat the effects of stress, inadequate nutrition and exposure to environmental toxins.

YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM)
, today reported that leading proxy advisory firms Institutional Investor Services ("ISS") and Glass, Lewis & Co. ("Glass Lewis") have recommended that shareholders of YM BioSciences Inc. ("YM" or the "Company") vote in favor of the previously announced plan of arrangement under which a wholly owned subsidiary of Gilead Sciences, Inc. will acquire YM for U.S.$2.95 per share in cash.



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