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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

Kyowa Hakko Kirin enters into distribution agreement with Hisamitsu Pharmaceutical

Orexo AB announces today that its partner Kyowa Hakko Kirin Co., Ltd. has entered a joint distribution agreement for the cancer pain drug KW-2246 (Orexo’s sublingual fentanyl product) with the pharmaceutical company Hisamitsu Pharmaceutical Co., Inc.

2 Feb 2010

Decision Resources: Benlysta to garner more than $500M in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, following its expected regulatory approval in 2011 in the United States and Europe, Human Genome Sciences/GlaxoSmithKline's Benlysta will garner sales of more than $500 million in 2018 in the systemic lupus erythematosus drug market.

2 Feb 2010

Some states mull requiring prescription for meth ingredients

"State and local efforts to thwart methamphetamine production by further limiting consumer access to a popular decongestant are pitting law enforcement against pharmacists and patients," USA Today reports.

2 Feb 2010

BRI partners with French Government to create therapeutic antibodies for treatment of major diseases

"We are delighted to be working with such esteemed institutions in order to generate cutting-edge therapeutic antibodies," said Matthew Baker, chief scientific officer and co-founder of Antitope. "This agreement combines our partners' expertise in novel therapeutic strategies with Antitope's expertise in engineering humanized antibodies to create therapeutic antibodies that may have a significant impact on the treatment of these major diseases."

2 Feb 2010

FDA and PATH collaborate to advance pneumococcal vaccine development for children

The U.S. Food and Drug Administration (FDA) today announced a collaboration with PATH to advance development of a vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia.

2 Feb 2010

Long-chain omega-3 polyunsaturated fatty acids may reduce risk of psychotic disorders

Individuals at extremely high risk of developing psychosis appear less likely to develop psychotic disorders following a 12-week course of fish oil capsules containing long-chain omega-3 polyunsaturated fatty acids, according to a report in the February issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

2 Feb 2010

Pharmaceutical News

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

Kyowa Hakko Kirin enters into distribution agreement with Hisamitsu Pharmaceutical

Decision Resources: Benlysta to garner more than $500M in 2018

Some states mull requiring prescription for meth ingredients

BRI partners with French Government to create therapeutic antibodies for treatment of major diseases

FDA and PATH collaborate to advance pneumococcal vaccine development for children

Long-chain omega-3 polyunsaturated fatty acids may reduce risk of psychotic disorders

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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