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Mylan receives FDA approval for generic Sporanox ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Itraconazole Capsules, 100 mg.

27 Jul 2012

New platform for detecting substandard and counterfeit medicines using microfluidics

A new platform for detecting substandard and counterfeit medicines using microfluidics has been recognized with a grant from Saving Lives at Birth's "Grand Challenge through Development." Dubbed PharmaCheck, the technology is a portable, field-based tool for assessing the quality of medicines in developing countries with increased accuracy, sensitivity and reliability.

27 Jul 2012

TB combination drug: an interview with Mel Spigelman, MD, CEO and President of TB Alliance

TB is a leading global killer. It is the second leading infectious disease in the world, behind HIV. TB is spread through the air, so it can affect anyone, but has its worst impact on impoverished communities and those people with HIV.

27 Jul 2012

First Edition: July 27, 2012

Today's headlines include reports about a new effort launched by the Obama administration and insurers to fight health care fraud.

27 Jul 2012

Viewpoints: AIDS spread in U.S. South; Abortion opponents battle in Ariz.; GOP's costly effort to kill health law

More than 30 years into the AIDS epidemic, a combination of safe-sex education and a new generation of pharmaceuticals has left many Americans convinced that HIV/AIDS is a problem that has been, if not solved, at least addressed. But that's certainly not true in the American South, which accounts for nearly 50% of all new HIV infections in the United States.

27 Jul 2012

FDA DODAC recommends approval of ThromboGenics’ ocriplasmin for VMA

ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the US Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has recommended that the FDA grant ocriplasmin approval for the treatment of symptomatic Vitreomacular Adhesion.

27 Jul 2012

Navidea announces results from Lymphoseek Phase 3 trial on head and neck squamous cell carcinoma

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, noted today that individual site, investigator-initiated results of an ongoing Phase 3 clinical trial of 99m-Tc-Tilmanocept (Lymphoseek) were presented at the American Head and Neck Society's 8th International Conference on Head and Neck Cancer (ICHNC), held in Toronto, July 21-25, 2012.

27 Jul 2012

Preliminary findings from Protalex's PRTX-100 Phase 1b study on active rheumatoid arthritis

Protalex, Inc., a clinical stage biopharmaceutical company that is developing a class of drugs designed to treat a wide array of autoimmune and inflammatory diseases today announced preliminary findings from its recently completed Phase 1b randomized, multiple-dose, dose-escalation study.

26 Jul 2012

Takeda, Sucampo file AMITIZA sNDA with FDA for treatment of opioid-induced constipation

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A. Inc. today announced the filing of a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking approval for a new indication for AMITIZA (lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.

26 Jul 2012

Insomnia: an interview with Dr Darryle Schoepp

Insomnia is a very common disorder. In medical terms it can affect a third of people. It affects elderly as well as non-elderly people, and is more common in women.

26 Jul 2012

AIDS 2012 plenary speakers call for innovative financing, continued research for HIV cure

Speakers at Tuesday's plenary session at the XIX International AIDS Conference in Washington, D.C. highlighted the challenges that lie ahead in the response to HIV/AIDS and discussed potential solutions, ABC News reports.

26 Jul 2012

BD Hyflow needle essential for patient comfort and device integration

BD Medical, a segment of BD, today announced the launch of the BD Hyflow™ needle, a unique 27-gauge thin-wall needle designed for use with BD's prefillable syringe systems.

From BD (Becton, Dickinson and Company) 26 Jul 2012

FDA grants priority review to GSK’s Promacta sNDA for treatment of thrombocytopenia

Ligand Pharmaceuticals Incorporated today announced that its partner GlaxoSmithKline has been granted priority review from the US Food and Drug Administration for the supplemental new drug application for Promacta to treat thrombocytopenia in adult patients with chronic hepatitis C virus (HCV) infection.

26 Jul 2012

Study identifies 329 instances of potentially inappropriate prescribing in Irish older patients

Research published in the journal Age and Ageing, which studied nursing homes in the Munster region of Ireland, has found that a significant proportion of older patients have either been prescribed a potentially inappropriate medicine or they are not prescribed a medicine that would normally be beneficial.

26 Jul 2012

CytRx commences aldoxorubicin plus doxorubicin Phase 1b trial in advanced solid tumors

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced the initiation of a Phase 1b clinical trial to determine the maximum tolerated dose and to evaluate preliminary efficacy of aldoxorubicin (formerly INNO-206) administered in combination with the commonly used chemotherapeutic agent doxorubicin in patients with advanced solid tumors who have failed other therapies.

26 Jul 2012

Reduced white matter integrity in schizophrenia patients

Patients with schizophrenia show widespread reductions in white matter integrity, particularly in fronto-temporal regions, researchers report.

25 Jul 2012

Alexion second quarter net product sales increase to $274.7 million

Alexion Pharmaceuticals, Inc. today announced financial results for the three and six months ended June 30, 2012.

25 Jul 2012

Regeneron reports total revenues of $304 million for second quarter 2012

Regeneron Pharmaceuticals, Inc. announced financial and operating results for the second quarter of 2012 and provided an update on development programs.

25 Jul 2012

EntreMed commences ENMD-2076 Phase 2 study in triple-negative breast cancer

EntreMed, Inc., a clinical-stage pharmaceutical company, announced today the initiation of a dual-institutional Phase 2 study of ENMD-2076 in triple-negative breast cancer. Jennifer R. Diamond, MD at the University of Colorado serves as the principal investigator for the study.

25 Jul 2012

Roundup: Minn. seeks its own independent Medicaid audit; Feds renew Wis. Family Care program

The Minnesota Department of Human Services is commissioning an independent audit to respond to lingering questions about the state Medicaid program's past practices in paying private HMOs. The Medicaid rate-setting process also is the subject of several federal investigations. Questions have swirled at the state Capitol this year about whether Minnesota officials have been manipulating the rate certification process in Medicaid to wrongly gain excess federal funds.

25 Jul 2012

Pharmaceuticals News and Research

Mylan receives FDA approval for generic Sporanox ANDA

New platform for detecting substandard and counterfeit medicines using microfluidics

TB combination drug: an interview with Mel Spigelman, MD, CEO and President of TB Alliance

First Edition: July 27, 2012

Viewpoints: AIDS spread in U.S. South; Abortion opponents battle in Ariz.; GOP's costly effort to kill health law

FDA DODAC recommends approval of ThromboGenics’ ocriplasmin for VMA

Navidea announces results from Lymphoseek Phase 3 trial on head and neck squamous cell carcinoma

Preliminary findings from Protalex's PRTX-100 Phase 1b study on active rheumatoid arthritis

Takeda, Sucampo file AMITIZA sNDA with FDA for treatment of opioid-induced constipation

Insomnia: an interview with Dr Darryle Schoepp

AIDS 2012 plenary speakers call for innovative financing, continued research for HIV cure

BD Hyflow needle essential for patient comfort and device integration

FDA grants priority review to GSK’s Promacta sNDA for treatment of thrombocytopenia

Study identifies 329 instances of potentially inappropriate prescribing in Irish older patients

CytRx commences aldoxorubicin plus doxorubicin Phase 1b trial in advanced solid tumors

Reduced white matter integrity in schizophrenia patients

Alexion second quarter net product sales increase to $274.7 million

Regeneron reports total revenues of $304 million for second quarter 2012

EntreMed commences ENMD-2076 Phase 2 study in triple-negative breast cancer

Roundup: Minn. seeks its own independent Medicaid audit; Feds renew Wis. Family Care program

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