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Lantheus Medical Imaging, JBCPL partner to launch DEFINITY ultrasound contrast imaging agent in India

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced the launch of its ultrasound contrast imaging agent, DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension, in India. The company has signed a multi-year agreement with Mumbai-based J.B. Chemicals & Pharmaceuticals, Ltd. for the distribution and marketing of DEFINITY® in the Indian marketplace.

15 Jul 2010

Kidney Cancer Canada applauds Ontario for granting coverage for RCC therapy TORISEL

Ontario has taken a major step forward in access to treatment for patients in the province with advanced kidney cancer by granting coverage for TORISELTM (temsirolimus), for advanced renal cell carcinoma (RCC) with poor prognostic features.

15 Jul 2010

MD Buyline identifies top emerging technologies with highest impact

This release will explain how these important technologies encourage high utilization rates across multiple service lines, bringing value to hospitals. Reimbursement changes and hospital structure enable technology purchases to generate a sequence of changes throughout service lines and dramatically impact the bottom line.

15 Jul 2010

New Cystex Liquid Cranberry Complex with Proantinox reduces incidence of UTIs in women: Study

A new study being published in the journal Urology shows that Proantinox, a proprietary cranberry-based blend used successfully in hospitals and long-term care facilities as UTI-Stat, and now available directly to consumers as new Cystex Liquid Cranberry Complex with Proantinox, is safe and effective in significantly reducing the incidence of UTIs in women at risk for recurring infections.

15 Jul 2010

GSK confirms FDA advisory committees' vote to allow Avandia to remain on the market

GlaxoSmithKline confirmed today that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions to withdrawal from the U.S. market.

15 Jul 2010

Mylan subsidiary receives FDA final approval for Nabumetone Tablets ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nabumetone Tablets USP, 500 mg and 750 mg.

15 Jul 2010

KRX-0401 receives Orphan Drug designation from FDA for treatment of neuroblastoma

Keryx Biopharmaceuticals, Inc. today announced that KRX-0401 (perifosine) has received Orphan Drug designation from the U.S. Food and Drug Administration for the treatment of neuroblastoma, a cancer of the nervous system affecting mostly children and infants for which there are no FDA approved therapies.

15 Jul 2010

Gilead sues Lupin over Ranexa patent infringement

Gilead Sciences, Inc. today announced that it has filed a lawsuit in U.S. District Court in New Jersey against Lupin Limited for infringement against Gilead's patents for Ranexa® (ranolazine extended-release tablets). The lawsuit is based on an Abbreviated New Drug Application filed by Lupin, which seeks approval to manufacture and market a generic version of Ranexa before the expiration of Gilead's Ranexa patents.

15 Jul 2010

Aeterna Zentaris' partner Keryx receives FDA orphan-drug designation for perifosine in neuroblastoma

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that its partner, Keryx Biopharmaceuticals, Inc., has been granted orphan-drug designation by the U.S. Food and Drug Administration for perifosine, Aeterna Zentaris' novel, potentially first-in-class, oral Akt inhibitor, for the treatment of neuroblastoma.

15 Jul 2010

Amorfix grants Biogen Idec exclusive worldwide rights to lead ALS monoclonal antibodies

Amorfix Life Sciences Ltd. today announced that it has entered into a licensing agreement granting Biogen Idec exclusive worldwide rights to Amorfix's lead amyotrophic lateral sclerosis (ALS) monoclonal antibodies. The antibodies have shown efficacy in animal models of ALS and Biogen Idec will now, at its expense, complete the development and prepare for clinical trials.

15 Jul 2010

Starpharma gets FDA nod to start phase 2 bacterial vaginosis study for VivaGel

Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced it had received clearance from the US Food and Drug Administration (FDA) to commence a phase 2 study to investigate VivaGel® for the treatment of bacterial vaginosis (BV).

15 Jul 2010

OraVerse MAA accepted for review in five key European countries

Sanofi-Aventis Deutschland GmbH and Novalar Pharmaceuticals, Inc. today announced that the Marketing Authorization Application (MAA) for OraVerse has been accepted for review by the regulatory agencies of the United Kingdom (UK), Germany, Italy, France and Spain. OraVerse is the first and only local anesthesia reversal agent that accelerates the return of normal sensation and function following routine dental procedures. OraVerse is approved for use in the U.S. by the Food and Drug Administration and sold by Novalar direct to U.S. dentists.

14 Jul 2010

Health Canada approves FluMist for preventing seasonal influenza

AstraZeneca Canada Inc. announced today that Health Canada has approved FluMist (Influenza Vaccine, Live, Attenuated) for the prevention of seasonal influenza. FluMist is the first vaccine in Canada that is administered as a gentle mist sprayed into the nose.

14 Jul 2010

Scientists discover three human antibodies that neutralize HIV

Scientists have discovered three previously unknown human antibodies that neutralize HIV, two of which target a broad range of HIV strains. The findings, reported online July 8 in two Science papers, add a level of encouragement to the AIDS vaccine research field.

14 Jul 2010

Invida Group, Amdipharm partner to promote proprietary products in key Asian markets

Invida Group Pte Ltd, the leading specialty biopharmaceutical company focused on the commercialization of healthcare products throughout Asia Pacific, today announced that it has entered into an agreement with Amdipharm for the licensing and commercialization of its proprietary products throughout Asia. Under this agreement, Invida will leverage its full suite of capabilities to bring Amdipharm's products to market, from regulatory approval and licensing, through packaging and supply chain optimization, to commercialization, sales, and marketing.

14 Jul 2010

CTI signs agreement with NerPharMa for long-term manufacture of pixantrone

Cell Therapeutics today announced that it has signed a manufacturing agreement with NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences S.r.l. for CTI's drug candidate pixantrone.

14 Jul 2010

Drugs taken for common medical conditions cause long term cognitive impairment in older adults: Study

Drugs commonly taken for a variety of common medical conditions including insomnia, allergies, or incontinence negatively affect the brain causing long term cognitive impairment in older African-Americans, according to a study appearing in the July 13, 2010 print issue of Neurology, the medical journal of the American Academy of Neurology.

14 Jul 2010

In N.J., patients who receive free AIDS meds to face stricter income limits; some W. Va. state employees will no longer receive monthly insurance subsidies

The (Bergen County, N.J.) Record: "New Jersey will no longer provide free AIDS medications for 950 people who are HIV-positive, under a little-noticed provision of the state budget enacted this month.

14 Jul 2010

FDA opens two-day hearing to examine safety of diabetes drug Avandia

The Fiscal Times: "There will be more at stake than just one drug's future when the Food and Drug Administration opens a two-day hearing Tuesday on the safety of the diabetes drug Avandia. The 30-member panel of outside experts will also be rendering judgment on research methods that are frequently used to compare effectiveness and are slated to become a pillar of the nation's drug safety monitoring system.

14 Jul 2010

Emergent awarded $107M HHS BARDA contract to develop large-scale manufacturing of BioThrax

Emergent BioSolutions Inc. announced today that it has signed a contract valued at up to $107 million with the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), to develop and obtain regulatory approval for large-scale manufacturing of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55. Building 55 is the company's large-scale state-of-the-art vaccine manufacturing facility in Lansing, Michigan.

14 Jul 2010

Pharmaceutical News

Lantheus Medical Imaging, JBCPL partner to launch DEFINITY ultrasound contrast imaging agent in India

Kidney Cancer Canada applauds Ontario for granting coverage for RCC therapy TORISEL

MD Buyline identifies top emerging technologies with highest impact

New Cystex Liquid Cranberry Complex with Proantinox reduces incidence of UTIs in women: Study

GSK confirms FDA advisory committees' vote to allow Avandia to remain on the market

Mylan subsidiary receives FDA final approval for Nabumetone Tablets ANDA

KRX-0401 receives Orphan Drug designation from FDA for treatment of neuroblastoma

Gilead sues Lupin over Ranexa patent infringement

Aeterna Zentaris' partner Keryx receives FDA orphan-drug designation for perifosine in neuroblastoma

Amorfix grants Biogen Idec exclusive worldwide rights to lead ALS monoclonal antibodies

Starpharma gets FDA nod to start phase 2 bacterial vaginosis study for VivaGel

OraVerse MAA accepted for review in five key European countries

Health Canada approves FluMist for preventing seasonal influenza

Scientists discover three human antibodies that neutralize HIV

Invida Group, Amdipharm partner to promote proprietary products in key Asian markets

CTI signs agreement with NerPharMa for long-term manufacture of pixantrone

Drugs taken for common medical conditions cause long term cognitive impairment in older adults: Study

In N.J., patients who receive free AIDS meds to face stricter income limits; some W. Va. state employees will no longer receive monthly insurance subsidies

FDA opens two-day hearing to examine safety of diabetes drug Avandia

Emergent awarded $107M HHS BARDA contract to develop large-scale manufacturing of BioThrax

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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