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Isis Pharmaceuticals announces addition of two new drugs to development pipeline

Isis Pharmaceuticals, announced today that it has added two new drugs to its development pipeline, ISIS-FGFR4Rx and ISIS-STAT3Rx.

7 Jan 2011

FDA introduces new Web resource that helps companies to save time, resources

The U.S. Food and Drug Administration today introduced a new Web resource called FDA Basics for Industry to help companies and others save time and resources in their interactions with the agency.

7 Jan 2011

Choosing between EGFR therapeutic options in metastatic colorectal cancer

Colorectal cancer (CRC) is the third most common cancer in men and women in the USA, with a new diagnosis made every 3.5 minutes and an associated death every 9 minutes.

6 Jan 2011

Lab21 acquires Microgen Bioproducts

Lab21 Limited, the Cambridge, UK-based specialist in personalised medicine and clinical diagnostics, has announced that it has acquired Microgen Bioproducts Ltd a UK company specialising in the development, manufacture and sale of diagnostic tests to identify diseases and organisms which pose a threat to health.

6 Jan 2011

Problems reported with Implanon contraceptive implant

Quite a few women have reported accidental and unwanted pregnancies while using Implanon, a hormone implant injected into the arm which is designed to last three years. Although the hormonal implant is described to be 99% effective, is thought to be due to problems with the initial implantation, rather than its efficacy once correctly inserted beneath the skin.

6 Jan 2011

Study shows clinical benefits of iniparib in combination with standard chemotherapy for triple-negative breast cancer

A current New England Journal of Medicine study indicates that the use of the PARP inhibitor iniparib in combination with standard chemotherapy to treat metastatic triple-negative breast cancer offers a significant increase in clinical benefit, a measure of durable response or disease stabilization, as well as an increase in progression-free survival.

6 Jan 2011

Medical experts issue warning about common practice of tablet splitting

Medical experts have issued a warning about the common practice of tablet splitting, after a study found that nearly a third of the split fragments deviated from recommended dosages by 15 per cent or more.

6 Jan 2011

VEREGEN Ointment added as new therapeutic option in 2010 CDC STD Treatment Guidelines

PharmaDerm, a division of Nycomed US Inc., announced today that VEREGEN (sinecatechins) Ointment, 15%, a topical medication for the treatment of external genital and perianal warts, has been added as a new therapeutic option in the 2010 Centers for Disease Control and Prevention Sexually Transmitted Diseases Treatment Guidelines.

6 Jan 2011

Findings of AM095 in various in vitro, in vivo models of fibrotic disease published in JPET

Amira Pharmaceuticals, Inc. announced today the publication of its findings in the Journal of Pharmacology and Experimental Therapeutics which describes the biologic effects and the characterization of AM095, a lysophosphatidic acid receptor 1 antagonist, in various in vitro and in vivo models of fibrotic disease.

6 Jan 2011

Opexa completes meetings with FDA regarding planned development program for Tovaxin

Opexa Therapeutics, Inc., a leading cell therapy company developing Tovaxin for multiple sclerosis, today announced the successful completion of two separate meetings with the U.S. Food and Drug Administration regarding the Company's planned development program for Tovaxin.

6 Jan 2011

J&JPRD submits New Drug Application to FDA for rivaroxaban

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration for rivaroxaban, an investigational, oral, once-daily anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

6 Jan 2011

Indian drugmaker seeks to make, sell generic version of Pfizer's HIV drug

The Indian drugmaker Natco Pharma "said Wednesday it has informed Pfizer Inc. that it wants to make and sell a low-cost generic version of the U.S. company's [drug] maraviroc for treating the HIV infection under a so-called 'compulsory license'," Dow Jones Newswires/Smart Money reports.

6 Jan 2011

FDA awards supplemental approval to support efficacy of ACTEMRA in treating RA

Genentech, Inc., a member of the Roche Group, today announced that the United States Food and Drug Administration has extended the ACTEMRA (tocilizumab, RoACTEMRA in the European Union) label to include inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adult patients with moderately to severely active rheumatoid arthritis, when given in combination with methotrexate.

6 Jan 2011

Avaxia Biologics generates compelling pre-clinical data in animal models of IBD

Avaxia Biologics, Inc., a privately-held biotech company developing an innovative platform technology to deliver orally-active antibodies to the gastrointestinal tract, announced today that it has generated compelling pre-clinical data in animal models of inflammatory bowel disease.

6 Jan 2011

Water Street Healthcare announces acquisition of OraPharma from Johnson & Johnson

Water Street Healthcare Partners announced today that it has acquired OraPharma, Inc. from Johnson & Johnson. Water Street, a strategic private equity firm focused exclusively on health care, plans to build OraPharma into a leading specialty pharmaceutical company focused on dental and oral health care.

6 Jan 2011

Study: Antibiotics can provide long-lasting relief to patients with irritable bowel syndrome

A ground-breaking antibiotic therapy developed at Cedars-Sinai Medical Center is the first potential drug treatment to provide irritable bowel syndrome patients with long-lasting relief of their symptoms even after they stop taking the medication, according to a study published in the Jan. 6 issue of the New England Journal of Medicine.

6 Jan 2011

FDA grants additional marketing exclusivity to INOMAX for pediatric BPD treatment

Ikaria, Inc. today announced that the U.S. Food and Drug Administration has granted INOMAX for inhalation an additional six months of marketing exclusivity, known as "pediatric exclusivity."

6 Jan 2011

Spectrum Pharmaceuticals enters agreement with Viropro to develop biosimilar rituximab

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that it has signed a letter of agreement with Viropro, Inc., for the development of a biosimilar version of the monoclonal antibody drug rituximab (marketed by Genentech/Roche). Worldwide sales of rituximab in 2009 in all indications, including non-Hodgkin's lymphoma and chronic lymphocytic lymphoma, were approximately $5.6 billion.

5 Jan 2011

Tablet splitting leads to inaccurate dosages

5 Jan 2011

EUSA receives FDA Priority Review status for ERWINAZE BLA

EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that its Biologics License Application for ERWINAZE(R) has been accepted for filing and awarded Priority Review status by the U.S. Food and Drug Administration.

5 Jan 2011

Pharmaceutical News

Isis Pharmaceuticals announces addition of two new drugs to development pipeline

FDA introduces new Web resource that helps companies to save time, resources

Choosing between EGFR therapeutic options in metastatic colorectal cancer

Lab21 acquires Microgen Bioproducts

Problems reported with Implanon contraceptive implant

Study shows clinical benefits of iniparib in combination with standard chemotherapy for triple-negative breast cancer

Medical experts issue warning about common practice of tablet splitting

VEREGEN Ointment added as new therapeutic option in 2010 CDC STD Treatment Guidelines

Findings of AM095 in various in vitro, in vivo models of fibrotic disease published in JPET

Opexa completes meetings with FDA regarding planned development program for Tovaxin

J&JPRD submits New Drug Application to FDA for rivaroxaban

Indian drugmaker seeks to make, sell generic version of Pfizer's HIV drug

FDA awards supplemental approval to support efficacy of ACTEMRA in treating RA

Avaxia Biologics generates compelling pre-clinical data in animal models of IBD

Water Street Healthcare announces acquisition of OraPharma from Johnson & Johnson

Study: Antibiotics can provide long-lasting relief to patients with irritable bowel syndrome

FDA grants additional marketing exclusivity to INOMAX for pediatric BPD treatment

Spectrum Pharmaceuticals enters agreement with Viropro to develop biosimilar rituximab

Tablet splitting leads to inaccurate dosages

EUSA receives FDA Priority Review status for ERWINAZE BLA

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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