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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

Amira granted UK patents for AM103, AM803 FLAP inhibitors for respiratory disorders

Amira Pharmaceuticals, Inc. today announced that the U.K. Intellectual Property Office has granted patent number GB2431927, titled, "5-Lipoxygenase Activating Protein (FLAP) Inhibitors," which includes coverage of Amira's AM103 and AM803 FLAP inhibitors for the treatment of respiratory disorders.

14 Jul 2010

CMAJ publishes new, updated guidelines on vitamin D

New and updated guidelines on recommended vitamin D intake have been published this week in the online issue of the Canadian Medical Association Journal.

14 Jul 2010

K-V announces resubmission to FDA's Complete Response action letter for Gestiva

K-V Pharmaceutical Company, a specialty pharmaceutical company, announced today that it has been informed by Hologic, Inc. that a resubmission to the FDA's Complete Response action letter received in January 2009 has been submitted for Gestiva™ (hydroxyprogesterone caproate injection), 250 mg/mL.

14 Jul 2010

FDA to decide on Avandia’s fate Wednesday

Avandia, a drug used as a treatment for type 2 diabetes was approved for use in 1999. However controversies have surrounded it since 2007 when a Cleveland Clinic cardiologist Steven E. Nissen published a study in the acclaimed New England Journal of Medicine that concluded that the drug significantly increased the risk for heart problems like heart attacks, heart failure and deaths.

13 Jul 2010

Cognis exclusively licensed two new active ingredients from IMD

Specialty chemicals supplier Cognis and InterMed Discovery, a world class natural product lead-discovery company, are continuing their strategic cooperation: Cognis has now exclusively licensed two new active ingredients for weight management and cognitive performance from IMD, further expanding the company's innovation pipeline.

13 Jul 2010

Protalix BioTherapeutics' taliglucerase alfa for Gaucher disease granted French ATU

Protalix BioTherapeutics, Inc. announced today that the French regulatory authority has granted an Autorisation Temporaire d'Utilisation (ATU), or Temporary Authorization for Use, for taliglucerase alfa for the treatment of Gaucher disease. An ATU is the regulatory mechanism used by the French Health Products and Safety Agency to make non-approved drugs available to patients in France when a genuine public health need exists.

13 Jul 2010

Pharmaceutical News

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

Amira granted UK patents for AM103, AM803 FLAP inhibitors for respiratory disorders

CMAJ publishes new, updated guidelines on vitamin D

K-V announces resubmission to FDA's Complete Response action letter for Gestiva

FDA to decide on Avandia’s fate Wednesday

Cognis exclusively licensed two new active ingredients from IMD

Protalix BioTherapeutics' taliglucerase alfa for Gaucher disease granted French ATU

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