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Amira submits IND application for AM152 antagonist

Amira Pharmaceuticals, Inc. announced today that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for AM152, a novel LPA1 antagonist. If accepted, the IND will enable Amira to begin Phase 1 safety studies with the compound in healthy subjects.

28 Sep 2010

UGA researcher receives NIH award for high-risk, high-reward carbohydrate research

The National Institutes of Health has awarded a prestigious EUREKA award to Robert Woods, a professor at the University of Georgia Complex Carbohydrate Research Center, to develop a new method for understanding how antibodies interact with large molecules known as glycans that are a major component of all cell surfaces.

27 Sep 2010

KAI Pharmaceuticals enrolls patients in Phase 1b study of KAI-4169 for treatment of SHPT

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced enrollment of the first patients in a Phase 1b study of KAI-4169, a novel pharmaceutical agent being tested for the treatment of secondary hyperparathyroidism, which is a frequent and serious complication of end-stage renal disease.

27 Sep 2010

REMURA Phase 2 clinical study results highlighted at Tear Film & Ocular Surface conference

ISTA Pharmaceuticals, Inc. today highlighted results from the Company's REMURA (bromfenac ophthalmic solution for dry eye) Phase 2 clinical study.

27 Sep 2010

Chem Rx reaches asset purchase agreement with PharMerica

Chem Rx Corporation, the third largest long-term care pharmacy in the United States, today announced that it has reached a "stalking horse" asset purchase agreement to sell substantially all of the assets of the company to PharMerica Corporation, an industry-leading pharmaceutical services company serving residents in long-term facilities and settings.

27 Sep 2010

MediciNova receives FDA approval to proceed with initial trial of ibudilast

MediciNova Inc, a biopharmaceutical company publicly traded on the NASDAQ Global Market and the Hercules Market of the Osaka Securities Exchange (Code Number:4875), today reported FDA's approval to proceed with an initial trial of the company's neurological drug candidate, ibudilast (MN-166/AV411), as a potential new pharmacotherapy for methamphetamine addiction.

27 Sep 2010

GBS pathogen suppresses immune cell function in newborn infants: Research

Group B Streptococcus (GBS), a bacterial pathogen that causes sepsis and meningitis in newborn infants, is able to shut down immune cell function in order to promote its own survival, according to researchers at the University of California, San Diego School of Medicine and the Skaggs School of Pharmacy and Pharmaceutical Sciences.

27 Sep 2010

Takeda announces SGN-35 ADC trial results in Hodgkin lymphoma patients

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced positive top line results from the pivotal trial of single agent brentuximab vedotin (SGN-35), an antibody drug conjugate (ADC) targeted to CD30. The trial was conducted in 102 relapsed or refractory Hodgkin lymphoma (HL) patients.

27 Sep 2010

OncoGenex initiates OGX-427 Phase 2 trial for metastatic prostate cancer

OncoGenex Pharmaceuticals, Inc. announced today the initiation of a randomized, controlled, investigator sponsored Phase 2 trial of OGX-427 in men with metastatic prostate cancer.

27 Sep 2010

Hospira's Nivestim receives Australian TGA approval

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced that it has received Australian Therapeutic Goods Administration approval for its biosimilar filgrastim product, Nivestim.

27 Sep 2010

Ore Pharmaceutical files Form 15 with Securities and Exchange Commission

Ore Pharmaceutical Holdings Inc., announced today the filing of a Form 15 with the Securities and Exchange Commission (the "SEC"). Ore filed the Form 15 with the SEC in order to effect a termination of the registration of its common stock under the Securities Exchange Act of 1934.

27 Sep 2010

Boston releases HORIZONS-AMI trial data

Angiotech Pharmaceuticals, Inc. announced that its corporate partner, Boston Scientific Corporation, has released three-year follow-up data from the HORIZONS-AMI trial.

27 Sep 2010

FDA, European regulators restrict Avandia use

The Food and Drug Administration and European regulators said they were taking action on Avandia, made by GlaxoSmithKline PLC, because of data tying it to increased risk of heart attacks.

27 Sep 2010

OCHCP launches VBB program to improve employees’ health

This week the non-profit Oregon Coalition of Health Care Purchasers (OCHCP) launched a new program to assist employers in coordinating and aligning their health benefits to improve health.

27 Sep 2010

TU Delft's nuclear research to be used for producing medical isotopes

TU Delft's nuclear research reactor will be used as a back-up facility for the production of the radioactive isotope molybdenum-99, when supplies run out. Molybdenum-99 is widely used in hospitals in order to locate cancer.

27 Sep 2010

Vertex exercises option to purchase additional $25 million notes

Vertex Pharmaceuticals Incorporated today announced that the underwriter for its offering of 3.35% convertible senior subordinated notes due 2015 has exercised in full its option to purchase an additional $25 million aggregate principal amount of notes. The exercise of the option brings the total aggregate principal amount of notes sold in the offering to $400 million

27 Sep 2010

Research Roundup: Medical homes; Drug samples and prescribing; The health law and disparities; Women's health; CBO projections

Institute of Medicine: Women's Health Research: Progress, Pitfalls, and Promise -"Substantial progress has been made since the expansion of investment in women's health research. Research findings have changed the practice of medicine and public-health recommendations in several prominent contexts, including changes in standards of care for women. There have also been decreases in mortality in women from breast cancer, heart disease, and cervical cancer. In other contexts, however, there has been less progress..."

24 Sep 2010

Yaupon reports positive results from mechlorethamine gel study for early-stage cutaneous T-cell lymphoma

Yaupon Therapeutics, a privately held specialty pharmaceutical company, today announced positive top-line results from the pivotal multi-center study of its lead product candidate, a proprietary topical mechlorethamine gel for the treatment of early-stage cutaneous T-cell lymphoma (CTCL - stages I-IIa). The top-line data show that the study, which was conducted under a Special Protocol Assessment (SPA), achieved its primary and secondary endpoints.

24 Sep 2010

Cylene commences CX-4945 Phase I trial in multiple myeloma

Cylene Pharmaceuticals, Inc. announced today the initiation of a Phase I clinical trial of their first-in-class, oral CK2 inhibitor CX-4945 in patients with multiple myeloma. Cylene also announced the simultaneous closing of a $12 million financing with participation from existing investors including Sanderling Ventures, HBM BioVentures (Cayman) Ltd., Novartis BioVenture Fund, BioVentures Investors, Lilly Ventures, Mitsui & Co. and Morningside Venture Investments Ltd.

24 Sep 2010

Warner Chilcott to acquire U.S. rights to Enablex from Novartis for $400 million

Warner Chilcott plc today announced that it has agreed to terminate its existing co-promotion agreement with Novartis and signed a definitive agreement to purchase the U.S. rights to Enablex® from Novartis for $400 million in cash. Enablex (darifenacin) is a product indicated to treat adults with symptoms of overactive bladder, which had U.S. sales of approximately $190 million for the year ended December 31, 2009.

24 Sep 2010