Biopharmaceutical News and Research

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Ardelyx announces positive Phase 2b results for tenapanor in IBS-C patients

Ardelyx, Inc., a clinical-stage biopharmaceutical company focused on cardio-renal, gastrointestinal and metabolic diseases, today announced positive results from its 371 patient Phase 2b clinical trial evaluating tenapanor in patients with constipation-predominant irritable bowel syndrome (IBS-C).

1 Oct 2014

Johnson & Johnson inks definitive deal to acquire Alios BioPharma

Johnson & Johnson today announced a definitive agreement to acquire Alios BioPharma, Inc., a privately held clinical stage biopharmaceutical company focused on developing therapies for viral diseases, for approximately $1.75 billion in cash.

30 Sep 2014

CytRx begins aldoxorubicin Phase 2b clinical trial in patients with extensive-stage SCLC

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced the initiation of a global Phase 2b clinical trial evaluating aldoxorubicin compared to topotecan in subjects with extensive-stage small cell lung cancer (SCLC) who have relapsed or were refractory to prior chemotherapy.

30 Sep 2014

Arisaph Pharmaceuticals receives STTR grants to develop cancer drug candidates

Arisaph Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on discovery and development of novel therapies for cardiometabolic diseases and cancer, announced today that it has been awarded a phase II Small Business Technology Transfer (STTR) grant and a supplemental phase I grant, both from the National Cancer Institute of the National Institutes of Health.

29 Sep 2014

Galmed Pharmaceuticals purchases EndoPAT devices, accessories from Itamar Medical

Galmed Pharmaceuticals Ltd. ("Galmed"), a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral medication for the treatment of liver diseases and cholesterol gallstones, announced today that it purchased 60 EndoPAT™ devices and accessories from Itamar Medical Ltd.

29 Sep 2014

Tianyin Pharmaceutical's Qionglai Facility completes official GMP site visit by CFDA

Tianyin Pharmaceutical Co., Inc., a pharmaceutical company that specializes in patented biopharmaceutical, modernized traditional Chinese medicine (mTCM), branded generics and active pharmaceutical ingredients (API), today announced that its Qionglai Facility (QLF) has successfully completed the official site visit by the China Food & Drug Administration's (CFDA) for its Good Manufacturing Practice (GMP) certification.

29 Sep 2014

FDA grants multiple Orphan Drug Designations for CytRx's aldoxorubicin

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced that the U.S. Food and Drug Administration has granted multiple Orphan Drug Designations for the Company's lead drug candidate, aldoxorubicin, in three indications: glioblastoma multiforme (GBM), small cell lung cancer and ovarian cancer.

29 Sep 2014

Daiichi Sankyo, Ambit Biosciences enter into definitive merger agreement

Daiichi Sankyo Company, Ltd. (hereinafter Daiichi Sankyo) and Ambit Biosciences, jointly announced today that they have entered into a definitive merger agreement under which Daiichi Sankyo will acquire all of the outstanding common stock of Ambit Biosciences for $15 per share in cash through a tender offer followed by a merger with a subsidiary of Daiichi Sankyo, or approximately $315 million on a fully diluted basis.

29 Sep 2014

EMD Serono declares winners of first Grant for Oncology Innovation

EMD Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, today announced the winners of the first Grant for Oncology Innovation (GOI), who will receive grants totaling $1.3 million.

27 Sep 2014

Research report on biopharmaceutical and vaccine manufacturing markets

The total biopharmaceutical manufacturing market is growing, according to Kalorama Information's report, Biopharmaceutical and Vaccine Production Markets.

24 Sep 2014

Axio Research announces launch of Statistical Genetics and Genomics services

Axio Research announced today the launch of Statistical Genetics and Genomics services in response to the biopharmaceutical industry's need for advanced statistical support in the analysis and interpretation of complex genomic data for drug discovery and development, drug repositioning, and companion diagnostics development.

24 Sep 2014

C Diff Foundation to present 2014 "Raising C.difficile Awareness" conference in November

C Diff Foundation is proud to present the 2014 "Raising C.difficile Awareness" conference. Join us November 4th at 8 a.m. – 5 p.m. at the University of Illinois at Chicago, Student Center, West 828 S. Wolcott Avenue, Thompson Room, Chicago, IL.

23 Sep 2014

Elusys completes phase 3 clinical program of obiltoxaximab in healthy adult volunteers

Elusys Therapeutics, Inc., a biopharmaceutical company developing antibody therapies to treat infectious disease, today announced it has completed three phase 3 healthy adult volunteer safety studies of obiltoxaximab (ETI-204).

23 Sep 2014

Soligenix awarded $24.7 million contract to advance development of Rivax vaccine

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that it has been awarded a contract valued at up to $24.7 million inclusive of options by the US Department of Health and Human Service's National Institutes of Health (specifically funded by the National Institute of Allergy and Infectious Diseases or NIAID).

19 Sep 2014

Regulus begins ATHENA study to monitor changes in renal function in Alport syndrome patients

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today it has initiated its ATHENA natural history of disease study in patients with Alport syndrome, a life-threatening genetic kidney disease with no approved therapy.

19 Sep 2014

EnGeneIC receives award from Cancer Institute NSW for groundbreaking cancer research

EnGeneIC, Ltd., an emerging biopharmaceutical company focused on revolutionizing the treatment of cancer through the targeted delivery of therapeutic agents directly to cancer cells, announced that, together with the Asbestos Disease Research Institute, it has received the 2014 Cancer Institute New South Wales Premier’s Award for Excellence in Translational Cancer Research.

17 Sep 2014

3SBio signs exclusive license agreement with JenKem for PEG-irinotecan

3SBio Inc., a leading biotechnology company based in China focusing on researching, developing, manufacturing and marketing biopharmaceutical products, announced today that it has entered into an exclusive license agreement with JenKem Technology Co., Ltd for the development, manufacturing and marketing in Mainland China of PEG-irinotecan, a long-acting polymer-drug conjugate which inhibits topoisomerase I (Topo-I).

17 Sep 2014

Sanofi contributes $2.5 million to CCNA for dementia research

Sanofi announced today its $2.5 million contribution to co-fund the Canadian Consortium on Neurodegeneration in Aging, a partnership officially launched in Montreal today in the presence of The Honourable Rona Ambrose, Minister of Health.

10 Sep 2014

Soligenix acquires novel orphan drug candidate for treatment of CTCL

8 Sep 2014

FDA provides QIDP designation to Debiopharm’s Debio 1450 for treatment of ABSSSI

Debiopharm Group™(Debiopharm), a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs including anti-infective and oncology therapeutics as well as companion diagnostics, today announced that the US Food and Drug Administration (FDA) has designated its anti-infectious agent Debio 1450 as a Qualified Infectious Disease Product (QIDP) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

4 Sep 2014

Biopharmaceutical News and Research

Ardelyx announces positive Phase 2b results for tenapanor in IBS-C patients

Johnson & Johnson inks definitive deal to acquire Alios BioPharma

CytRx begins aldoxorubicin Phase 2b clinical trial in patients with extensive-stage SCLC

Arisaph Pharmaceuticals receives STTR grants to develop cancer drug candidates

Galmed Pharmaceuticals purchases EndoPAT devices, accessories from Itamar Medical

Tianyin Pharmaceutical's Qionglai Facility completes official GMP site visit by CFDA

FDA grants multiple Orphan Drug Designations for CytRx's aldoxorubicin

Daiichi Sankyo, Ambit Biosciences enter into definitive merger agreement

EMD Serono declares winners of first Grant for Oncology Innovation

Research report on biopharmaceutical and vaccine manufacturing markets

Axio Research announces launch of Statistical Genetics and Genomics services

C Diff Foundation to present 2014 "Raising C.difficile Awareness" conference in November

Elusys completes phase 3 clinical program of obiltoxaximab in healthy adult volunteers

Soligenix awarded $24.7 million contract to advance development of Rivax vaccine

Regulus begins ATHENA study to monitor changes in renal function in Alport syndrome patients

EnGeneIC receives award from Cancer Institute NSW for groundbreaking cancer research

3SBio signs exclusive license agreement with JenKem for PEG-irinotecan

Sanofi contributes $2.5 million to CCNA for dementia research

Soligenix acquires novel orphan drug candidate for treatment of CTCL

FDA provides QIDP designation to Debiopharm’s Debio 1450 for treatment of ABSSSI

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