Biopharmaceutical News and Research

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Irvine Scientific announces launch of BalanCD MDCK cell culture medium

Irvine Scientific is pleased to announce the launch of its BalanCD MDCK cell culture medium, a next generation cell culture product responding to today's requirements for media used in cell-based vaccine manufacturing. This new flagship product expands Irvine Scientific's current BalanCD product portfolio of animal component-free and chemically-defined media with the addition of a new purpose-built product.

15 Apr 2014

Domain Therapeutics receives grant to support development of mGluR3 PAM for Parkinson’s disease

Domain Therapeutics, a biopharmaceutical company specializing in the research and development of new drug candidates targeting G protein-coupled receptors (GPCRs), today announces the receipt of a second grant of 230 000 dollars (USD) from The Michael J. Fox Foundation for Parkinson’s Research to support its metabotropic glutamate receptor type III (mGluR3) positive allosteric modulators (PAM) program.

15 Apr 2014

Oral therapy cures hepatitis C infection in more than 90% of patients with liver cirrhosis

Twelve weeks of an investigational oral therapy cured hepatitis C infection in more than 90 percent of patients with liver cirrhosis and was well tolerated by these patients, according to an international study that included researchers from UT Medicine San Antonio and the Texas Liver Institute.

15 Apr 2014

Study: CD206-targeting Manocept platform may provide potential avenues to enhance diagnosis in Kaposi Sarcoma

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that collaborators from the University of California, San Francisco (UCSF) presented results at the 2014 American Association for Cancer Research (AACR) conference, April 5-9, 2014 in San Diego, CA, highlighting the potential utility of imaging agents derived from Navidea's Manocept™ platform in identifying affected tissues and lymph nodes in patients with Kaposi Sarcoma (KS).

10 Apr 2014

BioLineRx to initiate Phase 1/2 clinical trial on new drug candidate for CML treatment

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that Prof. Arnon Nagler, Director of the Hematology Division and Bone Marrow Transplantation Center at Sheba Medical Center, Israel, has received final regulatory approval to evaluate BioLineRx's BL-8040 as a treatment for chronic myeloid leukemia (CML) in a Phase 1/2 clinical study.

10 Apr 2014

Spero Therapeutics enters into antibiotics partnership with Roche

Spero Therapeutics, LLC, a biopharmaceutical company founded to develop novel therapies for treatment of bacterial infections, has entered into an antibiotics partnership with Roche.

9 Apr 2014

Production of Immutep’s ImmuFact IMP321 starts at WuXi AppTec facilities in China

Immutep S.A., the biopharmaceutical company specializing in immuno-oncology, and Eddingpharm have started production of Immutep’s ImmuFact IMP321 (a LAG-3Ig fusion protein) at WuXi AppTec facilities in China. The product is being produced to European, U.S. and Chinese GMP standards.

8 Apr 2014

Ambit initiates QUANTUM-R Phase 3 clinical trial of quizartinib in FLT3-ITD positive AML 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 QUANTUM-R Phase 3 clinical trial comparing quizartinib as monotherapy to chemotherapy regimens in relapsed/refractory acute myeloid leukemia (AML) patients with the FMS-like tyrosine kinase-3 (FLT3)-ITD mutation.

8 Apr 2014

PeptiDream develops novel macrocyclic peptide inhibitor for treatment of multiple influenza strains

PeptiDream Inc., a public Tokyo-based biopharmaceutical company ("PeptiDream")( TOKYO:4587) announced today, in collaboration with The Tokyo Metropolitan Institute of Medical Science ("Tokyo Metropolitan Institute") the discovery and development of a novel macrocyclic peptide inhibitor for the treatment of multiple influenza strains.

8 Apr 2014

Curis and Debiopharm present data for Debio 0932 at Annual Meeting of AACR

Curis, Inc., an oncology focused company developing novel, targeted drug candidates for the treatment of human cancers, and Debiopharm Group™ (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, including oncology as well as companion diagnostics, today announced presentation of data for Debio 0932 at the Annual Meeting of the American Association for Cancer Research (AACR) that demonstrated synergy between Debio 0932 and various standard of care (SOC) agents in multiple in vitro and xenograft models of non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC).

8 Apr 2014

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

Biopharmaceutical News and Research

Irvine Scientific announces launch of BalanCD MDCK cell culture medium

Domain Therapeutics receives grant to support development of mGluR3 PAM for Parkinson’s disease

Oral therapy cures hepatitis C infection in more than 90% of patients with liver cirrhosis

Study: CD206-targeting Manocept platform may provide potential avenues to enhance diagnosis in Kaposi Sarcoma

BioLineRx to initiate Phase 1/2 clinical trial on new drug candidate for CML treatment

Spero Therapeutics enters into antibiotics partnership with Roche

Production of Immutep’s ImmuFact IMP321 starts at WuXi AppTec facilities in China

Ambit initiates QUANTUM-R Phase 3 clinical trial of quizartinib in FLT3-ITD positive AML patients

PeptiDream develops novel macrocyclic peptide inhibitor for treatment of multiple influenza strains

Curis and Debiopharm present data for Debio 0932 at Annual Meeting of AACR

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

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