Biopharmaceutical News and Research

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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

Amorcyte receives patent for chemotactic hematopoietic stem cell product

Amorcyte, Inc., a biopharmaceutical company developing cell therapy products to treat cardiovascular disease, today announced that it has been granted United States Patent number 7,794,705 titled "Compositions and Methods of Vascular Injury Repair." The patent contains both composition of matter and method claims surrounding therapeutic chemotactic hematopoietic stem cell products used in treating or repairing a vascular injury following an acute myocardial infarction (AMI), and delivery of the cell therapy.

13 Sep 2010

Santarus expands development pipeline, adds two novel biologic drug candidates

Santarus, Inc., a specialty biopharmaceutical company, has expanded its development pipeline with the addition of two novel biologic drug candidates focused on specialty markets.

13 Sep 2010

Debiopharm, Aurigene commence IND enabling studies for Debio 0617 inhibitor

Debiopharm Group, a Swiss-based global biopharmaceutical group of companies with a focus on the development of innovative prescription drugs that target unmet medical needs, and Aurigene Discovery Technologies Ltd., a Bangalore based fully integrated, global biotech focused on small molecule and peptide drug discovery and development from target identification and validation to pre IND drug candidates, today announced the successful nomination of a development candidate, Debio 0617, a novel inhibitor of an undisclosed oncology pathway.

13 Sep 2010

Harris Teeter to distribute Oragenics' EvoraPlus and EvoraKids oral care probiotics

Florida-based biopharmaceutical company Oragenics, Inc. has announced the continued retail expansion of its oral care probiotics EvoraPlus and EvoraKids™ with an initial order from Harris Teeter. It is anticipated that the products will be available at Harris Teeter stores in September 2010.

10 Sep 2010

Bioniche reduces net loss per share from $0.15 in fiscal 2009 to $0.02 in fiscal 2010

Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, today announced financial results for its 2010 fiscal year ended June 30, 2010.

10 Sep 2010

395 new vaccines being developed for infectious diseases: PhRMA

Critical challenges remain in the centuries-old battles against infectious diseases, particularly as bacteria and viruses mutate and as the threat of bioterrorism grows. Responding to this need, America's biopharmaceutical research companies this year have 395 new medicines and vaccines in the pipeline to fight infectious diseases. All 395 are in later stages of development, meaning in clinical trials or under Food and Drug Administration (FDA) review.

10 Sep 2010

USIBC to embark Life Sciences Executive Mission for India

The U.S.India Business Council will embark on a Life Sciences Executive Mission to coincide with the Biotechnology Industry Organization's First Annual International Partnering Conference in Hyderabad, India from September 21-22. The mission will be led by Amgen's Dr. Romi Singh, Executive Director of Global Regulatory Affairs and Safety.

10 Sep 2010

Shire announces expansion of Human Genetic Therapies pipeline

Shire plc, the global specialty biopharmaceutical company, today announced the expansion of its Human Genetic Therapies pipeline through the exclusive license, in markets outside of North America, for the activin receptor type IIB class of molecules being developed by Acceleron Pharma Inc., a private biotechnology company based in Cambridge, Massachusetts.

10 Sep 2010

Acceleron Pharma and Shire announce joint development of ACE-031 for DMD

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including muscle, bone, fat, red blood cells and the vasculature, and Shire plc, the global specialty biopharmaceutical company, today announced a joint development and commercialization agreement for ACE-031 and other novel molecules targeting the activin receptor type IIB (ActRIIB) pathway. This pathway plays critical roles in regulating the growth of skeletal muscle.

9 Sep 2010

CombinatoRx is now Zalicus

CombinatoRx, Incorporated today announced that it has changed its name to Zalicus Inc. The company will begin trading under the new ticker symbol ZLCS on the NASDAQ Global Market at market open on September 9, 2010.

9 Sep 2010

Exostar's FIS on-demand digital credential service achieves SBCA cross-certification

Exostar, whose cloud-based solutions enable secure, cost-effective business-to-business collaboration, today announced that its Federated Identity Service (FIS) on-demand digital credential service is now fully-compliant with the SAFE-BioPharma® digital identity and signature standard.

9 Sep 2010

Tetraphase announces 13 data presentations on TP-434 broad spectrum antibiotic at ICAAC 2010

Tetraphase Pharmaceuticals, Inc., today announced that 12 poster presentations and an oral summary presentation on preclinical and clinical data for its lead drug candidate, TP-434, will be presented at the 2010 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston, MA, being held September 12 -15 at the Boston Convention and Exhibition Center.

9 Sep 2010

iPierian raises $28 million from Series B equity financing closure

iPierian, Inc., the leading biopharmaceutical company using patient-derived induced pluripotent stem cells (iPSCs) for drug discovery, today announced the second closing of its Series B equity financing, bringing the total amount raised in this round to $28 million.

9 Sep 2010

NEXUS Biosystems acquires REMP from Tecan Group

NEXUS Biosystems, Inc., a leading innovator and worldwide provider of automated sample management systems, today announced the completion of the acquisition of REMP AG of Switzerland, a wholly-owned subsidiary of the Tecan Group.

From Tecan 8 Sep 2010

Vela Laboratories renews GMP certificate for analytical and Quality Control laboratories

Vela Laboratories, a provider of analytical services to the global biopharmaceutical industry, today announced the renewal of the GMP certificate for its analytical and Quality Control laboratories until 2013.

8 Sep 2010

Champions Biotechnology signs agreement to test Cephalon's CEP-32496 in Biomerk Tumorgraft platform

Champions Biotechnology, Inc., an oncology drug development company with a predictive preclinical platform aimed at accelerating the development and enhancing the value of oncology drugs, announced the establishment of an agreement with Cephalon, Inc., a global biopharmaceutical company, for the testing of the Cephalon novel B-Raf inhibitor CEP-32496 in Champions' Biomerk Tumorgraft™ platform.

8 Sep 2010

Quintiles new lab in Japan achieves CAP accreditation

Quintiles today announced that its new lab in Tokyo, Japan has received accreditation from the College of American Pathologists (CAP), joining the largest network of fully harmonized, CAP-accredited central labs in the world.

7 Sep 2010

Oragenics launches oral care probiotic products through GNC Stores

Florida-based biopharmaceutical company Oragenics, Inc. announced today that its oral care probiotic EvoraPlus® is now expected to be available at corporate-owned GNC stores nationwide. In addition, GNC has included Oragenics' oral care probiotic for children, EvoraKids™, in its concept stores and on GNC.com.

7 Sep 2010