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IGI submits first ANDA to FDA

IGI Laboratories, Inc., a New Jersey based formulation and manufacturing company, today announced that it has submitted its first abbreviated new drug application (ANDA) to the US FDA. IGI President and CEO Charlie Moore commented "This is a significant step forward in validating IGI's commitment to pharmaceutical product development.

14 Sep 2010

AskBio enters patent license agreement with Pfizer for HCV therapy

Asklepios BioPharmaceutical, Inc., a privately-owned clinical-stage biotechnology company, announced today it has entered into a patent license agreement with Pfizer, Inc. granting Pfizer access to certain proprietary gene-delivery platform technologies developed by AskBio, for use in developing novel therapies for patients with Hepatitis C virus (HCV).

14 Sep 2010

Arno Therapeutics closes private placement to advance cancer treatment

Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing oncology therapeutics, today announced that it has closed a private placement of its securities resulting in gross proceeds to the company of over $15 million.

14 Sep 2010

Ironwood, Forest Laboratories announce positive results for linaclotide Phase 3 clinical trials in IBS-C patients

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from the first of two Phase 3 clinical trials assessing the efficacy and safety of the investigational drug, linaclotide, in patients with irritable bowel syndrome with constipation (IBS-C).

14 Sep 2010

Arthritis Foundation, Takeda launch Gout Living educational campaign

The Arthritis Foundation and Takeda Pharmaceuticals North America, Inc., announced the launch of a new educational campaign, Gout Living, to help increase understanding and encourage better management of gout.

14 Sep 2010

Complementary medicine to save millions: Report

According to a new report substituting pharmaceutical antidepressants with St John’s Wort could save the health system $50 million a year. This research was conducted by Access Economics for the National Institute of Complementary Medicine (NICM) at the University of Western Sydney. It showed that cost effectiveness of complementary and alternative therapies have the potential to cut costs without compromising patient outcomes.

13 Sep 2010

Acsis recognized as 2010 'Top Preferred Solution Provider' by LogiPharma

Acsis, Inc., a leader in supply chain visibility and traceability for manufacturing and distribution, today announced that it has been recognized as a 2010 "Top Preferred Solution Provider" by LogiPharma. The company was selected based on a survey by World Business Research (WBR) to more than 2,000 pharmaceutical executives who identified Acsis, Inc. as one of the top solution providers focused on advancing supply chain efficiencies.

13 Sep 2010

DSP Clinical Research ranked #1674 on Inc. 5000 list

DSP Clinical Research achieved a ranking of No. 1674 on the prestigious Inc. 5000 list. DSP provides customized contract research services for small to mid-size pharmaceutical and biotechnology companies conducting Phase I to IV clinical studies.

13 Sep 2010

Provectus's PV-10 Phase 2 data to be presented at 7th International Melanoma Research Congress

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announces that data from its Phase 2 PV-10 metastatic melanoma study will be presented at the 7th International Melanoma Research Congress in Sydney, Australia, on November 4, 2010 at 4:30 p.m., as part of the 4th Interdisciplinary Melanoma & Skin Cancer Centres Meeting,

13 Sep 2010

Counterfeit drugs become growing problem

"Last year, nearly 1,700 incidents of counterfeit drugs were reported worldwide, triple the number in 2004, says the Pharmaceutical Security Institute (PSI), a group funded by drugmakers," USA Today reports. "Estimates for the size of the counterfeit drug market range from $75 billion to $200 billion a year. The market is likely much bigger because many cases are hard to detect.

13 Sep 2010

Orion extends use of Medidata Rave enterprise-wide EDC and clinical data management system

Medidata Solutions, a leading global provider of SaaS-based clinical development solutions, today announced that European pharmaceutical company Orion has extended its use of Medidata Rave® as its enterprise-wide electronic data capture (EDC) and clinical data management (CDM) system, which Orion successfully brought in-house and deployed for all clinical trials for the past three and a half years.

13 Sep 2010

Synta expands STA-9090 Phase 2 clinical trial in NSCLC

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it was expanding its Phase 2 clinical trial of STA-9090 in patients with Stage IIIB and Stage IV non-small cell lung cancer (NSCLC) from up to 69 patients to up to 146 patients based on encouraging activity observed in the first stage of the two stage clinical trial.

13 Sep 2010

Relypsa completes $70M Series B financing

Relypsa, Inc., a biopharmaceutical company developing non-absorbed polymeric drugs, today announced the completion of a Series B financing totaling $70 million. OrbiMed Advisors, LLC, led the financing with participation from existing Relypsa investors New Leaf Venture Partners, 5AM Ventures, Delphi Ventures, Sprout Group and Mediphase Venture Partners.

13 Sep 2010

FDA updates Shire's ProAmatine medicine for symptomatic orthostatic hypotension treatment

Shire, the global specialty biopharmaceutical company, announces that the United States Food and Drug Administration today posted an update on its website related to ProAmatine (known generically as midodrine), a medicine approved for the treatment of symptomatic orthostatic hypotension.

13 Sep 2010

AB SCIEX, University of Melbourne join to develop drug metabolism studies of biopharmaceuticals

AB SCIEX, a global leader in life science analytical technologies, and the University of Melbourne today announced a joint technology development project to improve drug metabolism studies of biopharmaceuticals.

13 Sep 2010

Tetraphase Pharmaceuticals presents TP-434 drug candidate clinical data

Tetraphase Pharmaceuticals, Inc., yesterday presented new clinical and preclinical data for its lead drug candidate, TP-434, which demonstrated the novel antibiotic as a once daily intravenous (I.V.) monotherapy capable of treating multidrug-resistant gram-negative pathogens while also having potency and broad spectrum coverage of other serious and multidrug resistant gram-positive pathogens.

13 Sep 2010

Pro-Pharmaceuticals engages Numoda Corporation to optimize DAVANAT Phase III clinical trial

Pro-Pharmaceuticals, Inc., the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced that it has engaged the Numoda Corporation, a leading information, process and logistics management company, to oversee the Phase III clinical trial of DAVANAT and 5-FU compared with the standard of care in the treatment of patients with advanced, metastatic colorectal cancer.

13 Sep 2010

ARIAD commences ponatinib Phase 2 clinical trial in Ph+ ALL and chronic myeloid leukemia

ARIAD Pharmaceuticals, Inc. today announced the initiation of the pivotal Phase 2 clinical trial of its investigational pan-BCR-ABL inhibitor, ponatinib (previously known as AP24534), in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL).

13 Sep 2010

Genzyme Corporation enters into asset purchase agreement with LabCorp

Genzyme Corporation today announced that it has entered into an asset purchase agreement under which Laboratory Corporation of America Holdings (LabCorp) will acquire Genzyme Genetics for $925 million in cash.

13 Sep 2010

Cyclacel reaches SPA agreement with FDA for sapacitabine Phase 3 trial in AML

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase 3 trial for the Company's sapacitabine oral capsules as a front-line treatment in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy.

13 Sep 2010