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Sun Pharma settles litigation with Orion over generic Stalevo, Comtan ANDAs

Sun Pharmaceutical Industries Ltd. announced that together with its affiliates ("Sun Pharma") it has executed a settlement agreement with Orion stipulating a dismissal of the lawsuits filed in the United States against Sun Pharma regarding submission of Abbreviated New Drug Applications (ANDAs) for generic versions of Stalevo® and Comtan® tablets.

22 Jun 2010

Dietary antioxidants improve insulin resistance in obese adults, study finds

A diet rich in natural antioxidants improves insulin sensitivity in insulin-resistant obese adults and enhances the effect of the insulin-sensitizing drug metformin, a preliminary study from Italy finds. The results will be presented Monday at The Endocrine Society's 92nd Annual Meeting in San Diego.

22 Jun 2010

TransGenRx to produce protein-based therapeutics to support Esperion's research on HDL therapies

Esperion Therapeutics, a privately held biopharmaceutical company working to discover, develop and commercialize treatments for cardiovascular and metabolic diseases, today announced that TransGenRx, a global leader in transgenic technology, will produce protein-based therapeutics to be used in the company's research efforts targeting HDL therapies for the treatment of cardio-metabolic disease.

22 Jun 2010

Omega-3 effective for treating depression in patients without anxiety disorders

The use of Omega-3 supplements is effective among patients with major depression who do not have anxiety disorders, according to a study directed by Dr. Fran-ois Lesp-rance of the Centre de recherche du Centre hospitalier at the Universit- de Montr-al (CRCHUM), head of CHUM's Department of Psychiatry and a professor at the Universit- de Montr-al. The study was published June 15 in the online Journal of Clinical Psychiatry.

22 Jun 2010

OMJPI, Diamyd Medical sign agreement to develop and commercialize GAD65 antigen-based therapy

Ortho-McNeil-Janssen Pharmaceuticals, Inc. announced today it has signed an exclusive agreement with Diamyd Medical AB, a Swedish publicly traded company focusing on the development of pharmaceuticals for the treatment of autoimmune diabetes and its complications, to develop and commercialize their GAD65 antigen-based therapy for the treatment and prevention of type 1 diabetes and associated conditions.

22 Jun 2010

Gastric cancer drug market to grow from $700M in 2009 to $1.5B in 2019

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the rapid uptake and market penetration of key targeted agents, beginning with Roche/Genentech/Chugai's Herceptin, will drive the gastric cancer drug market to more than double, from $700 million in 2009 to nearly $1.5 billion in 2019.

22 Jun 2010

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

Pfizer Inc. announced today that based on discussions with the U.S. Food and Drug Administration (FDA), it will be discontinuing commercial availability of Mylotarg® (gemtuzumab ozogamicin for Injection) (used for the treatment of relapsed acute myeloid leukemia (AML)) in the United States and that it will be voluntarily withdrawing the new drug application (NDA) for Mylotarg effective October 15, 2010.

22 Jun 2010

FDA Advisory Committee recommendation against flibanserin will not affect LibiGel program: BioSante

BioSante Pharmaceuticals, Inc. commented today that the recommendation on June 18, 2010 by the FDA Advisory Committee regarding the safety and efficacy of flibanserin (Boehringer-Ingelheim) will have no impact on its own ongoing development program or approval pathway for LibiGel (testosterone gel), for the treatment of hypoactive sexual desire disorder (HSDD).

22 Jun 2010

Diamyd Medical, Ortho-McNeil-Janssen Pharmaceuticals sign agreement for diabetes therapy

Diamyd Medical AB has signed an agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company, to develop and commercialize the Diamyd® diabetes therapy.

22 Jun 2010

OXiGENE reports encouraging data from ZYBRESTAT program at Glaucoma and Retinopathies 2010 conference

OXiGENE, Inc., a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that the company presented an update on its ZYBRESTAT ophthalmology program, including encouraging preclinical data showing that the company's topical formulation achieved target retina/choroid concentrations with minimal systemic exposure.

22 Jun 2010

APP Pharmaceuticals receives FDA approval to market Ganciclovir for Injection, USP

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration to market Ganciclovir for Injection, USP. Ganciclovir for Injection, USP is therapeutically equivalent to the reference-listed drug Cytovene-IV, which is marketed by Roche Laboratories, Inc.

22 Jun 2010

Star Scientific seeks FDA approval of Stonewall-BDL as "modified risk tobacco product"

Star Scientific, Inc. announced that on Friday, June 18 the company filed an application with the Food & Drug Administration for approval to market Stonewall-BDL™ as a "modified risk tobacco product" under the Family Smoking Prevention and Tobacco Control Act of 2009. This is Star's second such application to the Tobacco Products Center of the FDA, which has been established to oversee all aspects of tobacco regulation outlined in the 2009 Act.

22 Jun 2010

Pfizer announces voluntary withdrawal of Mylotarg from U.S. market following FDA request

Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product's safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

22 Jun 2010

WHO issues comprehensive recommendations on children's medicines

The WHO on Friday issued "its first-ever guidance on how to use more than 240 essential medicines for children under 13," the Associated Press reports. "The data provide information on use, dosage and side effects of medicines as well as warnings about which children should not take them" and possible complications from interactions from drugs taken together, according to the WHO, the news service reports (6/19).

22 Jun 2010

Walgreens will stay in Caremark's prescription network

Los Angeles Times: Walgreens and Caremark announced Friday "they had settled a dispute that threatened to prevent thousands of people from filling their prescriptions at Walgreens stores." Caremark runs CVS stores and pharmacies. "At issue: the way Caremark, one of the nation's biggest prescription-plan operators, prices discounts for prescriptions filled at Walgreens pharmacies, which often compete fiercely with nearby CVS stores nationwide.

22 Jun 2010

FDA approves NAMENDA XR for treatment of Alzheimer's type dementia

Forest Laboratories, Inc. and Merz Pharmaceuticals GmbH announced today that NAMENDA XR(TM) (memantine hydrochloride) was approved by the U.S. Food and Drug Administration for the treatment of moderate to severe dementia of the Alzheimer's type. NAMENDA XR is a 28 mg once-daily extended-release formulation of NAMENDA.

22 Jun 2010

Martek extends sole-source supply agreement with Mead Johnson for DHA and ARA for infant formula products

Martek Biosciences Corporation announced today that it has extended its sole-source supply agreement with Mead Johnson & Company, LLC, for DHA (docosahexaenoic acid) and ARA (arachidonic acid) for infant formula products. Under the terms of the amendment, Martek will remain Mead Johnson's global sole-source supplier of DHA and ARA for all of its infant formula products through December 31, 2015, an extension of four years beyond the earliest possible termination date of the current agreement.

21 Jun 2010

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

Ferring Pharmaceuticals Inc. announced today the U.S. commercial availability of LYSTEDA™ (tranexamic acid) tablets, the only non-hormonal and non-surgical therapy indicated specifically for the treatment of women with cyclic heavy menstrual bleeding (HMB). In clinical studies, LYSTEDA significantly reduced menstrual blood loss (MBL) over three and six cycles of use with the reduction seen as early as the first cycle of use.

21 Jun 2010

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Kowa Pharmaceuticals America, Inc., and Eli Lilly and Company today announced that LIVALO® (pitavastatin) tablets is now available in retail pharmacies throughout the United States. LIVALO, a statin medication approved by the U.S. Food and Drug Administration (FDA) in August 2009 is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia. LIVALO is available in doses of 1 mg, 2 mg and 4 mg.

21 Jun 2010

ViroPharma provides update on recent progress in Cinryze manufacturing expansion activities

ViroPharma is increasing its Cinryze manufacturing capacity through two concurrent efforts. The first project, the parallel chromatography process, was implemented earlier this year and allows production to run across multiple shifts, effectively doubling the capacity of the current manufacturing line and increasing the amount of drug supply available to patients suffering from hereditary angioedema, or HAE.

21 Jun 2010

Pharmaceutical News

Sun Pharma settles litigation with Orion over generic Stalevo, Comtan ANDAs

Dietary antioxidants improve insulin resistance in obese adults, study finds

TransGenRx to produce protein-based therapeutics to support Esperion's research on HDL therapies

Omega-3 effective for treating depression in patients without anxiety disorders

OMJPI, Diamyd Medical sign agreement to develop and commercialize GAD65 antigen-based therapy

Gastric cancer drug market to grow from $700M in 2009 to $1.5B in 2019

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

FDA Advisory Committee recommendation against flibanserin will not affect LibiGel program: BioSante

Diamyd Medical, Ortho-McNeil-Janssen Pharmaceuticals sign agreement for diabetes therapy

OXiGENE reports encouraging data from ZYBRESTAT program at Glaucoma and Retinopathies 2010 conference

APP Pharmaceuticals receives FDA approval to market Ganciclovir for Injection, USP

Star Scientific seeks FDA approval of Stonewall-BDL as "modified risk tobacco product"

Pfizer announces voluntary withdrawal of Mylotarg from U.S. market following FDA request

WHO issues comprehensive recommendations on children's medicines

Walgreens will stay in Caremark's prescription network

FDA approves NAMENDA XR for treatment of Alzheimer's type dementia

Martek extends sole-source supply agreement with Mead Johnson for DHA and ARA for infant formula products

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

ViroPharma provides update on recent progress in Cinryze manufacturing expansion activities

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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