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Mylan's subsidiary receives FDA approval for GoLytely laxative

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP, the generic version of Braintree Laboratories' GoLytely® laxative.

30 Jan 2010

$Perifosine holds promise as a single agent for relapsed/refractory Waldenstrom's Macroglobulinemia$

Perifosine holds promise as a single agent for relapsed/refractory Waldenstrom's Macroglobulinemia

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrinology, today announced that an article entitled "Clinical and Translational Studies of a Phase II Trial of the Novel Oral Akt Inhibitor Perifosine in Relapsed or Relapsed/Refractory Waldenstrom's Macroglobulinemia," reporting Phase 2 data demonstrating the single agent activity of perifosine (KRX-0401) for the treatment of advanced Waldenstrom's Macroglobulinemia ("Waldenstrom's"), will appear in the February 1, 2010 issue of the Journal of Clinical Cancer Research.

30 Jan 2010

Positive Phase 2 trial results of Keryx Biopharmaceuticals' KRX-0401 announced

Keryx Biopharmaceuticals, Inc. (the "Company") today announced that an article entitled "Clinical and Translational Studies of a Phase II Trial of the Novel Oral Akt Inhibitor Perifosine in Relapsed or Relapsed/Refractory Waldenstrom's Macroglobulinemia," reporting Phase 2 data demonstrating the single agent activity of KRX-0401 (Perifosine) for the treatment of advanced Waldenstrom's Macroglobulinemia ("Waldenstrom's"), will appear in the February 1, 2010 issue of Clinical Cancer Research.

29 Jan 2010

FDA grants accelerated approval for GlaxoSmithKline's TYKERB

GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using TYKERB® (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer.

29 Jan 2010

Abstract submission deadline is one week away

The abstract submission deadline of February 4th is only one week away! Ensure that your research appears at the most important international osteoporosis meeting of the year, the IOF WCO-ECCEO10. Click here to submit your abstract online: http://www.iofwco-ecceo10.org/abstracts/

29 Jan 2010

Regis Technologies' 4-Aminopyridine manufacturing facility receives FDA's EIR and PAI approval

Regis Technologies, Inc., a leading provider of cGMP and non-GMP synthesis and separations services for active pharmaceutical ingredients (APIs) and intermediates, announced it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) stating that Regis passed the FDA’s pre-approval inspection (PAI) for its manufacture of 4-Aminopyridine the active ingredient in Ampyra™.

29 Jan 2010

Conatus Pharmaceuticals initiates combination trial of CTS-1027 with pegylated interferon and ribavirin for HCV

Conatus Pharmaceuticals Inc. announced today the initiation of a Phase II clinical trial evaluating CTS-1027 in combination with pegylated interferon (Pegasys®) and ribavirin (Copegus®) in refractory HCV patients. Antiviral activity, safety and tolerability of the triple combination will be assessed after up to 48 weeks of therapy.

28 Jan 2010

Rotavirus vaccine could save millions of children in developing countries, studies find

Efforts to vaccinate "infants against rotavirus could save the lives of millions of children in developing nations who would otherwise die from the diarrhea-causing disease, two new studies show," HealthDay/BusinsessWeek reports.

28 Jan 2010

ChemoCentryx announces the initiation of Phase I clinical trial of CCX168

ChemoCentryx, Inc., today announced the initiation of a Phase I clinical trial of CCX168, an orally-administered small molecule designed to treat autoimmune diseases.

28 Jan 2010

Celgene reports total revenue of $758M for fourth-quarter of 2009

Celgene Corporation announced non-GAAP (Generally Accepted Accounting Principles) net income of $290.3 million, or non-GAAP diluted earnings per share of $0.62 for the quarter ended December 31, 2009. Non-GAAP net income for the fourth quarter of 2008 was $200.9 million or non-GAAP diluted earnings per share of $0.43. Based on U.S. GAAP, Celgene reported net income of $254.2 million, or diluted earnings per share of $0.54 for the quarter ended December 31, 2009. GAAP net loss for the fourth quarter of 2008 was $149.3 million, or diluted loss per share of $0.33.

28 Jan 2010

Procter & Gamble reports increased net sales for October - December quarter

The Procter & Gamble Company delivered net sales growth of six percent for the October - December quarter to $21.0 billion. Organic sales grew five percent which was at the top of the Company's guidance range.

28 Jan 2010

Anacor Pharmaceuticals to present data on its PDE4 inhibitor at the Cytokines and Inflammation Conference

Anacor Pharmaceuticals announced today that it will present a poster and oral presentation on a novel systemic anti-inflammatory candidate, AN6415, at the upcoming 8th Cytokines and Inflammation Conference, taking place January 28-29, 2010 in La Jolla, California.

28 Jan 2010

AHF to conduct HIV testing events in Texas

AHF’s Magic Johnson ‘Testing America’ Tour, a six-month, 48-state national cross-country HIV testing tour, will ride into San Antonio, Texas, for two days of testing events at two Walgreens location.

28 Jan 2010

Studies in Mexico and Africa demonstrate the effectiveness of rotavirus vaccine

For the first time ever, studies in Mexico and Africa, published today in the New England Journal of Medicine, demonstrate a reduction in diarrheal disease deaths following rotavirus vaccine introduction in Mexico and vaccine efficacy among impoverished populations in Malawi and South Africa.

28 Jan 2010

MedPage Today publishes most read medical stories

Which medical news stories are physicians reading to stay informed about key developments? MedPage Today publishes the Most Read Stories for the Past Week.

28 Jan 2010

Pfizer's new pipeline shows growth and diversity in research and development

Pfizer Inc. today provided an update to its pipeline for the first time since the close of the acquisition of Wyeth in October, 2009. The new development pipeline, composed of assets from both legacy companies, includes 133 programs from phase 1 through registration, and shows growth and increased diversity in each of the areas where the company invests in research and development.

28 Jan 2010

Transdermal estrogen therapies: Effective alternatives to oral estrogen and compounded bioidentical hormones

Clinical and experimental evidence suggests that non-patch, transdermal estrogen therapies, such as Divigel® (estradiol gel 0.1%), prescribed for the management of moderate-to-severe hot flashes, including night sweats, associated with menopause are effective alternatives to oral estrogen and compounded bioidentical hormones.

28 Jan 2010

MedCI forms new strategic alliance with Genta

MedCI LLC, a life-science business consulting services company, announced the formation of a new strategic alliance with Genta Incorporated to secure licensing partners for Genta’s small molecule oncology compound, tesetaxel.

28 Jan 2010

Warner Chilcott receives complete response letter from FDA for low dose oral contraceptive

Warner Chilcott plc announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) to its New Drug Application submitted in March 2009 for its "low dose" oral contraceptive (also referred to as WC 3016).

27 Jan 2010

Treating septic shock patients with intensive insulin therapy does not reduce risk of in-hospital death

Treating adults with septic shock with intensive insulin therapy to counter elevated blood glucose levels associated with corticosteroid therapy did not result in a reduced risk of in-hospital death, compared to patients who received conventional insulin therapy, according to a study in the January 27 issue of JAMA.

27 Jan 2010

Oral News and Research

Mylan's subsidiary receives FDA approval for GoLytely laxative

Perifosine holds promise as a single agent for relapsed/refractory Waldenstrom's Macroglobulinemia

Positive Phase 2 trial results of Keryx Biopharmaceuticals' KRX-0401 announced

FDA grants accelerated approval for GlaxoSmithKline's TYKERB

Abstract submission deadline is one week away

Regis Technologies' 4-Aminopyridine manufacturing facility receives FDA's EIR and PAI approval

Conatus Pharmaceuticals initiates combination trial of CTS-1027 with pegylated interferon and ribavirin for HCV

Rotavirus vaccine could save millions of children in developing countries, studies find

ChemoCentryx announces the initiation of Phase I clinical trial of CCX168

Celgene reports total revenue of $758M for fourth-quarter of 2009

Procter & Gamble reports increased net sales for October - December quarter

Anacor Pharmaceuticals to present data on its PDE4 inhibitor at the Cytokines and Inflammation Conference

AHF to conduct HIV testing events in Texas

Studies in Mexico and Africa demonstrate the effectiveness of rotavirus vaccine

MedPage Today publishes most read medical stories

Pfizer's new pipeline shows growth and diversity in research and development

Transdermal estrogen therapies: Effective alternatives to oral estrogen and compounded bioidentical hormones

MedCI forms new strategic alliance with Genta

Warner Chilcott receives complete response letter from FDA for low dose oral contraceptive

Treating septic shock patients with intensive insulin therapy does not reduce risk of in-hospital death

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

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