Biopharmaceutical News and Research

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Ambit initiates Phase 2 study of quizartinib in acute myeloid leukemia patients

Ambit Biosciences, a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced the initiation of the Phase 2 cohort of the MD Anderson Cancer Center-sponsored Phase 1/2 study of quizartinib in combination with either 5-azacitidine or low dose cytarabine for previously untreated FLT3-ITD positive acute myeloid leukemia (AML) patients age 60 or older, or FLT3-ITD positive AML patients 18 years of age or older in first relapse.

7 Apr 2014

Merck KGaA initiates Phase 3 START2 study of MUC1 antigen-specific cancer immunotherapy tecemotide

Oncothyreon Inc. today announced that Merck KGaA, Darmstadt, Germany, has initiated the international Phase 3 START2 study, which is designed to assess the efficacy and safety of the investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC).

7 Apr 2014

Accele Venture Partners co-led $4.1M Series A private equity financing of Otologic Pharmaceutics

Accele Venture Partners, the investing arm of life sciences accelerator Accele Biopharma, Inc., announced today that it has co-led a $4.1 million Series A private equity financing of Otologic Pharmaceutics, Inc. (OPI), a development-stage biopharmaceutical company committed to developing and commercializing novel pharmacological solutions and approaches to treat hearing disorders.

3 Apr 2014

Corium International prices initial public offering of common stock

Corium International, Inc., a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, announced today the pricing of its initial public offering of 6,500,000 shares of common stock at a price to the public of $8.00 per share.

3 Apr 2014

Auxogyn signs exclusive license agreement with Merck Serono for Eeva Test

Auxogyn, Inc., a company dedicated to advancing women's reproductive health, today announced an exclusive license agreement with Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany which operates as EMD Serono in the United States and Canada, for Auxogyn's proprietary Early Embryo Viability Assessment (Eeva) Test.

3 Apr 2014

CMC Biologics wins Life Science Leader CMO Leadership award for highest standards of quality, reliability

CMC Biologics, a leading global contract manufacturing organization known for technical excellence and customer satisfaction in biopharmaceutical development and commercial manufacture of protein based therapeutics, was recognized again in 2014 for innovation, quality and reliability by Life Science Leader at an awards ceremony at DCAT Week14 in New York last month.

3 Apr 2014

FDA grants orphan drug designation to ERYTECH’s lead product for AML treatment

ERYTECH Pharma, a French biopharmaceutical company that develops innovative treatments for acute leukemia and other oncology indications with unmet medical needs, announces that its lead product GRASPA®/ERY-ASP has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Acute Myeloid Leukemia (AML), an aggressive form of blood cancer.

2 Apr 2014

CytRx’s aldoxorubicin receives European orphan medicinal product designation for treatment of advanced soft tissue sarcomas

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced that aldoxorubicin has received orphan medicinal product designation from the European Commission for the treatment of advanced soft tissue sarcomas. The designation is to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases.

31 Mar 2014

ADMA Biologics reports consolidated net loss of $15.5M in 2013

ADMA Biologics, Inc., a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, today announced its financial results for the year ended December 31, 2013 and provided recent company developments as well as anticipated milestones for 2014.

28 Mar 2014

Cytrx releases statement in response to two recent lawsuits

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today issued the following statement in response to two recent lawsuits filed in the name of CytRx shareholders:

27 Mar 2014

SAGE Therapeutics doses first patient in SAGE-547 Phase 1/2 trial for treatment of SRSE

SAGE Therapeutics, a biopharmaceutical company developing novel medicines to treat life-threatening and rare central nervous system (CNS) disorders, today announced dose initiation of the first patient in a Phase 1/2 clinical trial of SAGE-547, a neuroactive steroid, in super-refractory status epilepticus (SRSE), a critical condition in which the brain is in a state of persistent seizure.

27 Mar 2014

Alimera Sciences resubmits New Drug Application for ILUVIEN

Alimera Sciences, Inc. (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has resubmitted its New Drug Application for ILUVIEN® to the U.S. Food and Drug Administration (FDA).

27 Mar 2014

Surveys show drug safety budgets grew between 2012 and 2013, estimated to increase in 2014

Recent surveys by Cutting Edge Information found that the majority of drug safety budgets grew between 2012 and 2013, and are projected to continue growth for 2014.

26 Mar 2014

FMCNA introduces newly branded Frenova Renal Research business

Fresenius Medical Care North America, the world's largest provider of dialysis services, today introduced its newly branded Frenova Renal Research business, the only Phase I-IV drug and device clinical development partner dedicated exclusively to renal research.

26 Mar 2014

FDA grants PMA for Pinnacle's Optiguide DCYL700 Fiber Optic Diffuser Series flexible fiber

Concordia Healthcare Corp. announced today that its subsidiary Pinnacle Biologics, Inc., a biopharmaceutical research and development company specializing in rare diseases, was granted U.S. Food and Drug Administration premarket supplemental approval (PMA) for its Optiguide DCYL700 Fiber Optic Diffuser Series flexible fiber.

26 Mar 2014

AM-Pharma reports positive results from recAP Phase I trial for Acute Kidney Injury

AM-Pharma B.V., a biopharmaceutical company focused on the development of recAP (recombinant human Alkaline Phosphatase) for inflammatory indications, announces the results of its Phase I trial with both single and multiple ascending doses, which demonstrate that recAP is safe and well tolerated at all doses.

26 Mar 2014

Precision for Medicine announces acquisition of Hobart Group Holdings

Precision for Medicine, Inc., formed in 2012 to support next generation approaches to drug development and commercialization, announces the acquisition of Hobart Group Holdings, LLC, a leading market access firm. With this addition, Precision for Medicine has established the foundation for its next phase of growth in providing integrated solutions focused on demonstrating value in the era of precision medicine.

25 Mar 2014

Transgene raises €65.5M via two-step capital increase

Transgene SA, a French biopharmaceutical company focused on discovering, developing and manufacturing targeted immunotherapies for the treatment of cancer and infectious diseases, announces that it has raised a total of €65.5 million via a two-step capital increase.

25 Mar 2014

CytRx initiates Phase 3 clinical trial to evaluate efficacy of aldoxorubicin in STS patients

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has initiated a pivotal global Phase 3 clinical trial to evaluate the efficacy and safety of aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma (STS) under a Special Protocol Assessment with the FDA.

25 Mar 2014

Rexahn provides updates on clinical development programs, reports full-year 2013 financial results

Rexahn Pharmaceuticals, Inc. a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, is providing an overview of its three clinical development programs and Year for the year ended December 31, 2013.

24 Mar 2014

Biopharmaceutical News and Research

Ambit initiates Phase 2 study of quizartinib in acute myeloid leukemia patients

Merck KGaA initiates Phase 3 START2 study of MUC1 antigen-specific cancer immunotherapy tecemotide

Accele Venture Partners co-led $4.1M Series A private equity financing of Otologic Pharmaceutics

Corium International prices initial public offering of common stock

Auxogyn signs exclusive license agreement with Merck Serono for Eeva Test

CMC Biologics wins Life Science Leader CMO Leadership award for highest standards of quality, reliability

FDA grants orphan drug designation to ERYTECH’s lead product for AML treatment

CytRx’s aldoxorubicin receives European orphan medicinal product designation for treatment of advanced soft tissue sarcomas

ADMA Biologics reports consolidated net loss of $15.5M in 2013

Cytrx releases statement in response to two recent lawsuits

SAGE Therapeutics doses first patient in SAGE-547 Phase 1/2 trial for treatment of SRSE

Alimera Sciences resubmits New Drug Application for ILUVIEN

Surveys show drug safety budgets grew between 2012 and 2013, estimated to increase in 2014

FMCNA introduces newly branded Frenova Renal Research business

FDA grants PMA for Pinnacle's Optiguide DCYL700 Fiber Optic Diffuser Series flexible fiber

AM-Pharma reports positive results from recAP Phase I trial for Acute Kidney Injury

Precision for Medicine announces acquisition of Hobart Group Holdings

Transgene raises €65.5M via two-step capital increase

CytRx initiates Phase 3 clinical trial to evaluate efficacy of aldoxorubicin in STS patients

Rexahn provides updates on clinical development programs, reports full-year 2013 financial results

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