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Erye's new facility passes SFDA inspection for manufacture of penicillin, cephalosporin powder

NeoStem, Inc., an international biopharmaceutical company with operations in the U.S. and China, announced on June 15, 2010 that its 51% owned Suzhou Erye pharmaceutical subsidiary passed the government inspection by the State Food and Drug Administration ("SFDA") in China to manufacture penicillin and cephalosporin powder for injection at its new manufacturing facility.

30 Jun 2010

Recent, upcoming FDA efforts address rare, 'neglected' diseases

The FDA's new rare disease review group will hold its first public hearing on Tuesday and Wednesday to discuss how to expand efforts to develop treatments for rare diseases that affect fewer than 200,000 people, Reuters

30 Jun 2010

ACRO calls for sufficient resources for FDA to monitor foreign clinical trials

The Association of Clinical Research Organizations, which represents the global CRO industry, today released the following statement regarding a report from the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) titled Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials.

30 Jun 2010

Greenwire/New York Times examine dengue vaccine development

Greenwire/New York Times reports on the growing number of cases of dengue worldwide, including the CDC's report last month that the virus has now been locally acquired in the continental U.S. for the first time in 65 years. "While a few cases were reported earlier, they were primarily in Americans who had caught the virus abroad or at the Texas-Mexico border," the news service writes.

30 Jun 2010

AqueSys secures $35 million in Series C financing round

AqueSys, Inc., a medical device company that develops, manufactures and distributes proprietary implants for glaucoma, today announced that it has secured $35 million in Series C financing. The round was led by Longitude Capital and Rho Ventures, with participation from existing investors Accuitive Medical Ventures, The Carlyle Group and SV Life Sciences.

30 Jun 2010

Novel method of encapsulating gases, liquids and solids using miniature bubbles

Researchers from University College London have won a £25,000 prize for developing technology that could be used to improve medical imaging, the targeted delivery of drugs and much more.

29 Jun 2010

Threshold Pharmaceuticals commences TH-302 Phase 1 clinical trial in patients with advanced leukemias

Threshold Pharmaceuticals, Inc., today announced that it has initiated a Phase 1 clinical trial of TH-302 in patients with advanced leukemias. TH-302 is a proprietary Hypoxia-Activated Prodrug (HAP) that specifically targets tumor hypoxia.

29 Jun 2010

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that its applications for ALN-TTR01 have been given clearance by Portuguese, Swedish, and British regulatory authorities to begin clinical testing. The trial will begin enrolling patients shortly in a blinded, randomized, placebo-controlled, multicenter Phase I study.

29 Jun 2010

Zymeworks closes $3.2 million financing round

Zymeworks Inc., a privately held biotechnology company focused on the development of next generation antibody-based therapeutics, today announced the close of a financing totaling $3.2 million. The financing consists of a follow-on round of institutional investment by CTI Life Sciences Fund, L.P. ("CTI") which led the Company's previous financing in 2009.

29 Jun 2010

Alimera submits Iluvien NDA for DME to FDA

Alimera Sciences, Inc.,, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Iluvien®, (flucocinolone acetonide intravitreal insert), its investigational, sustained drug delivery system releasing sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema (DME).

29 Jun 2010

BBD reports analyze effectiveness and safety of statin use

A series of new reports from Consumer Reports Best Buy Drugs (BBD) caution that the benefits of statin use by children and some women may not outweigh the risks. Drugs to lower cholesterol - including statins - are the most commonly prescribed drugs in the U.S. and garnered more than $14 billion in sales last year.

29 Jun 2010

Mylan Pharmaceuticals receives FDA final approval for Anastrozole Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Anastrozole Tablets, 1 mg, the generic version of AstraZeneca's Arimidex® Tablets, a treatment for early breast cancer.

29 Jun 2010

AlphaRx regains all rights to Indaflex from Cypress Bioscience

AlphaRx, Inc. today announced that it has entered into an agreement with Cypress Bioscience, under which AlphaRx is regaining all rights to Indaflex(TM) from Cypress Bioscience, which AlphaRx had previously licensed to Proprius Pharmaceuticals, which was subsequently acquired by Cypress Bioscience.

29 Jun 2010

CorMedix joins broad-market Russell Microcap Index

CorMedix Inc., a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of Cardiorenal disease, today announced that CorMedix has been added to the broad-market Russell Microcap® Index when Russell Investments reconstituted its comprehensive set of U.S. and global equity indexes on June 25, 2010.

29 Jun 2010

Vitae earns $14M milestone payment from Boehringer Ingelheim

Vitae Pharmaceuticals, Inc., an integrated discovery and development company, today announced that it has earned a $14 million clinical milestone payment from Boehringer Ingelheim, one of the world's 20 leading pharmaceutical companies. Vitae's 11beta-hydroxysteroid dehydrogenase (HSD)-1 is targeted for the treatment of diabetes and metabolic syndrome-related diseases in a strategic alliance with Boehringer Ingelheim. The payment recognizes Boehringer Ingelheim's recent advancement of a small molecule inhibitor of 11beta-HSD-1 into Phase I clinical trials.

29 Jun 2010

BIND Biosciences announces $12.4 million Series C-1 financing

BIND Biosciences, Inc. (BIND), a privately held biopharmaceutical company developing best in class therapeutics based on its proprietary targeted nanotechnology platform, announced today that it has secured a $12.4 Million Series C-1 financing. This financing included all of BIND's current investors (including Polaris Venture Partners, Flagship Ventures, ARCH Venture Partners, NanoDimension and DHK Investments) as well as a new venture investor, Endeavour Vision, and private investors.

29 Jun 2010

AMAG, Takeda provide regulatory and clinical update for Feraheme Injection

AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited today provided a regulatory and clinical update for Feraheme® (ferumoxytol) Injection for intravenous (IV) use.

29 Jun 2010

AVEO Pharmaceuticals joins Russell 2000 Index and S&P MidCap 400

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that the company has been added to the Russell 2000® Index, as part of the annual reconstitution of the entire Russell family of indexes that took place on June 25, 2010 following the close of the market.

29 Jun 2010

New ISR's report highlights current and future adoption of biomarker technologies

Industry Standard Research (ISR) today announced the release of The State of Biomarkers in Drug Development report. 44 pharmaceutical and biotechnology professionals provided their strategies, insights, and predictions in this snapshot of a rapidly evolving market. In total, 37 significant pharma and biotech companies contributed to this endeavor.

29 Jun 2010

Quark reports results from QPI-1007 siRNA drug study in rat ocular hypertension model of glaucoma

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced results from a second study of QPI-1007, a neuroprotective siRNA drug, in rat ocular hypertension model of glaucoma, conducted by Prof. Adriana Di Polo of the Department of Pathology and Cell Biology, Universite de Montreal.

29 Jun 2010