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Upsher-Smith Laboratories introduces new formulation of PreNexa Rx prenatal vitamins

Upsher-Smith Laboratories, Inc. is pleased to announce the introduction of a new formulation of PreNexa® Rx prenatal vitamins. The new formulation contains an increased amount of algal-oil, plant-based docosahexaenoic acid (DHA), from 265 mg to 300 mg and increased vitamin D3, from 170 IU to 400 IU.

3 Feb 2010

Artefill could be viable for lipoatrophy and non-surgical anti-aging enhancement

Suneva Medical, a privately-held aesthetic medical device company, today announced that two clinical studies suggest Artefill may be a safe, effective, long-term treatment option for age-related and HIV lipoatrophy patients.

3 Feb 2010

VIDAZA prolongs survival in AML patients

The Myelodysplastic Syndromes (MDS) Foundation says a study published this week in the Journal of Clinical Oncology concludes VIDAZA (azacitidine) “prolongs survival and is well tolerated” in patients with acute myeloid leukemia (AML) - an aggressive form of leukemia that in many cases progresses from MDS.

3 Feb 2010

Sales of Nutra Pharma's Cobroxin totaled $583,955 for fourth-quarter ending December 31, 2009

Nutra Pharma Corp., a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that sales of its recently launched over-the-counter pain reliever, Cobroxin, totaled $583,955 for the fourth quarter ending December 31, 2009.

3 Feb 2010

Lannett Company plans to submit NDA for Morphine Sulfate products to FDA

Lannett Company, Inc. today announced plans to submit its New Drug Application (NDA) for its Morphine Sulfate products to the U.S. Food and Drug Administration (FDA) at the end of the month.

2 Feb 2010

Hovione announces filing of new drug application in Japan for the influenza drug CS-8958

Hovione is announcing the filing of a new drug application in Japan by its licensee Daiichi Sankyo Company Ltd. for the influenza drug CS-8958, which is delivered using Hovione's TwinCaps(R) inhaler.

2 Feb 2010

FDA accepts Teva Pharmaceutical Industries' BLA for XM02 G-CSF

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Teva’s Biologics License Application (BLA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.

2 Feb 2010

Javelin Pharmaceuticals' NDA for Dyloject Injection accepted for formal review

Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, has been accepted for formal review.

2 Feb 2010

FDA approves INNOPHARMA's ibutilide fumarate injection ANDA

INNOPHARMA LLC announced today FDA approval of the Abbreviated New Drug Application (ANDA) for ibutilide fumarate injection (the generic equivalent of Corvert® from Pfizer Inc).

2 Feb 2010

Xiaflex receives FDA approval for treatment of Dupuytren's contracture

The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person's ability to straighten and properly use their fingers.

2 Feb 2010

FDA approves Taro Pharmaceutical Industries' levetiracetam tablets ANDA

Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application (“ANDA”) for Levetiracetam Tablets, 250 mg, 500 mg, 750 mg and 1000 mg (“levetiracetam tablets”).

2 Feb 2010

Cytheris broadens patent protection for recombinant human interleukin-7

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its patent application "Glycosylated IL-7, Preparation and Uses", US Patent Application Number 11/996,176. The Notice of Allowance is the USPTO’s official communication that the Company’s application has successfully completed examination and that a patent will be issued.

2 Feb 2010

Spectrum Pharmaceuticals signs co-development and commercialization agreement with TopoTarget A/S

Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has entered into a co-development and commercialization agreement with TopoTarget A/S for Belinostat, a novel histone deacetylase (HDAC) inhibitor.

2 Feb 2010

FDA requests additional data on CMC section of NDA for taliglucerase alfa from Protalix BioTherapeutics

Protalix BioTherapeutics, Inc. announced today that, in connection with the New Drug Application (NDA) filed by the Company in December 2009 for taliglucerase alfa for the treatment of Gaucher disease, the U.S. Food and Drug Administration (FDA) has requested additional data regarding the Chemistry, Manufacturing and Controls (CMC) section of the NDA.

2 Feb 2010

Extended nicotine patch therapy benefits relapsing smokers trying to quit

New research from the University of Pennsylvania School of Medicine may help more smokers keep their New Year's resolution by helping them quit smoking. Extended use of a nicotine patch - 24 weeks versus the standard eight weeks recommended by manufacturers - boosts the number of smokers who maintain their cigarette abstinence and helps more of those who backslide into the habit while wearing the patch, according to a study which will be published in the February 2 issue of Annals of Internal Medicine.

2 Feb 2010

First annual Translational Regenerative Medicine Forum to be held in Winston-Salem

The Regenerative Medicine Foundation today announced the first annual Translational Regenerative Medicine Forum to be held April 6-8, 2010 at the Benton Convention Center in Winston-Salem.

2 Feb 2010

Suzhou Erye Pharmaceutical receives Chinese SFDA approval for manufacturing penicillin at new facility

NeoStem, Inc., an international biopharmaceutical company with operations in the U.S. and China, announced that it recently was advised that its Suzhou Erye Pharmaceutical subsidiary ("Erye") received approval from the State Food and Drug Administration (SFDA) in China to manufacture solvent crystallization sterile penicillin and freeze dried raw sterile penicillin at their new facility which provides 50% and 100% greater manufacturing capacity, respectively, than its existing facility. Historically, these two lines have accounted for approximately 20% of Erye's sales.

2 Feb 2010

New therapeutic made from tobacco plants shown to arrest West Nile virus infection

A new therapeutic made from tobacco plants has been shown to arrest West Nile virus infection, according to a new study by Arizona State University scientist Qiang Chen and his colleagues.

2 Feb 2010

ADT can worsen heart risk factors and may increase the risk of heart attack

Androgen-deprivation therapy (ADT), commonly used to treat prostate cancer, can worsen heart risk factors and may increase the risk of heart attack and/or cardiac death, although the relationship between ADT and heart attack or cardiac death has not been definitively established, according to a science advisory published in Circulation: Journal of the American Heart Association and CA: A Cancer Journal for Clinicians.

2 Feb 2010

SDI selected for third consecutive time as key monoclonal antibody provider

SDI (Strategic Diagnostics Inc.), a leading provider of biotechnology-based products and services for a broad range of life science, food safety, and industrial applications, today announced it has been selected again by Science Applications International Corporation - Frederick (SAIC-F) to develop monoclonal antibodies for the National Cancer Institute’s “Clinical Proteomic Technologies for Cancer” initiative (CPTC: http://proteomics.cancer.gov).

2 Feb 2010

Pharmaceutical News

Upsher-Smith Laboratories introduces new formulation of PreNexa Rx prenatal vitamins

Artefill could be viable for lipoatrophy and non-surgical anti-aging enhancement

VIDAZA prolongs survival in AML patients

Sales of Nutra Pharma's Cobroxin totaled $583,955 for fourth-quarter ending December 31, 2009

Lannett Company plans to submit NDA for Morphine Sulfate products to FDA

Hovione announces filing of new drug application in Japan for the influenza drug CS-8958

FDA accepts Teva Pharmaceutical Industries' BLA for XM02 G-CSF

Javelin Pharmaceuticals' NDA for Dyloject Injection accepted for formal review

FDA approves INNOPHARMA's ibutilide fumarate injection ANDA

Xiaflex receives FDA approval for treatment of Dupuytren's contracture

FDA approves Taro Pharmaceutical Industries' levetiracetam tablets ANDA

Cytheris broadens patent protection for recombinant human interleukin-7

Spectrum Pharmaceuticals signs co-development and commercialization agreement with TopoTarget A/S

FDA requests additional data on CMC section of NDA for taliglucerase alfa from Protalix BioTherapeutics

Extended nicotine patch therapy benefits relapsing smokers trying to quit

First annual Translational Regenerative Medicine Forum to be held in Winston-Salem

Suzhou Erye Pharmaceutical receives Chinese SFDA approval for manufacturing penicillin at new facility

New therapeutic made from tobacco plants shown to arrest West Nile virus infection

ADT can worsen heart risk factors and may increase the risk of heart attack

SDI selected for third consecutive time as key monoclonal antibody provider

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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