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ReproCELL to enter collaborative iPS cell-derived hepatocytes R&D agreement with NIBIO

ReproCELL, Inc. (CEO: Chikafumi Yokoyama PhD) announces today that the company will enter a collaborative R&D agreement with the National Institute of Biomedical Innovation (NIBIO; Director General: Koichi Yamanishi; Osaka, Japan), which could offer new hepatocyte derived from human iPS (induced pluripotent stem) cells used for an effective in-vitro drug screening for hepatic toxicity and liver metabolism.

5 Jan 2011

Pico-Tesla announces expansion of Magneceutical Phase III trail for Parkinson's disease

Pico-Tesla, The Magneceutical Company, announced that it has expanded its ongoing Phase III pivotal clinical trial by adding three Principal Investigators, including two university-affiliated clinicians: one in Denver; and one in Tampa.

5 Jan 2011

Anadys begins ANA598 Phase IIb study for hepatitis C

Anadys Pharmaceuticals, Inc. announced today that it has initiated the planned Phase IIb study of ANA598 in combination with pegylated interferon and ribavirin. The protocol for the study has been cleared by the United States Food and Drug Administration and Health Canada.

4 Jan 2011

FDA approves ImmunoCellular Therapeutics IND amendment for ICT-107 Phase II clinical trial

ImmunoCellular Therapeutics, Ltd., a biotechnology company that is developing immune-based therapies for the treatment of various forms of cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) amendment to conduct a Phase II clinical trial in the U.S. of ICT-107, the company's dendritic cell based cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM).

4 Jan 2011

Isis commences ISIS-EIF4ERx Phase 2 studies in non-small cell lung cancer and prostate cancer

Isis Pharmaceuticals, Inc. announced the initiation of two Phase 2 studies of ISIS-EIF4ERx in patients with non-small cell lung cancer and prostate cancer. These studies are part of Isis' broad Phase 2 development program designed to evaluate ISIS-EIF4ERx in multiple types of cancer. ISIS-EIF4ERx targets eukaryotic initiation factor-4E (eIF-4E), a traditionally "undruggable" target that is thought to promote tumor growth and metastasis in many cancers.

4 Jan 2011

Bupropion and varenicline help curb cigarette craving

The smoking cessation medications bupropion and varenicline may both be associated with changes in the way the brain reacts to smoking cues, making it easier for patients to resist cravings, according to two reports posted online today that will appear in the May print issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

4 Jan 2011

Embryome Sciences announces $4M equity financing, changes name to ReCyte Therapeutics

BioTime, Inc. today announced a $4 million equity financing by its subsidiary, Embryome Sciences, Inc. Concurrent with the financing, Embryome Sciences will be renamed ReCyte Therapeutics, Inc. and will develop therapeutic products for cardiovascular and blood diseases. The new equity financing is being led by a $2.5 million investment by private investors and a $1.5 million investment from BioTime that valued ReCyte Therapeutics at a post money valuation of $60 million on a fully diluted basis.

4 Jan 2011

Repros receives IRB approval for Androxal Phase IIb study in secondary hypogonadism

Repros Therapeutics Inc. today reported it has received Institutional Review Board (IRB) approval to commence the Phase IIb study of Androxal® in men with secondary hypogonadism. The Company has submitted the protocol for FDA comment and plans to begin enrolling subjects in January. Depending on the rate of subject enrollment, Repros hopes to have the study completed before the end of 2011.

3 Jan 2011

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

Juventas Therapeutics, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular disease, announces that the U.S. Food and Drug Administration (FDA) authorized commencement of a Phase II clinical trial evaluating the efficacy and safety of its lead product, JVS-100, for the treatment of critical limb ischemia (CLI).

3 Jan 2011

Top-line results of TIGER-2 Phase 3 clinical trial for CF treatment

Inspire Pharmaceuticals, Inc. announced today the top-line results from its second Phase 3 clinical trial, TIGER-2, with denufosol tetrasodium for the treatment of cystic fibrosis.

3 Jan 2011

Immunitor reports positive safety imm01 clinical trial against tuberculosis

Immune Network Ltd., advises that Immunitor has published data from the first half of the 120-patient imm01 clinical trial of its V5 immunomodulator product against tuberculosis, including difficult-to-treat forms of the disease.

30 Dec 2010

Enrollment commences in belinostat-Tarceva combination trial for NSCLC

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, and Topotarget A/S announced today that the first patient has been dosed in an Investigator Initiated Trial of belinostat in combination with Tarceva® for patients with Non-Small Cell Lung Cancer (NSCLC).

30 Dec 2010

Dosing initiated in combination Phase I study of palifosfamide with etoposide and cisplatin/carboplatin in SCLC

ZIOPHARM Oncology, Inc., announced today that the first patient has been dosed in a Phase I, single arm, dose escalation study at the Indiana University Cancer Center of intravenous (IV) palifosfamide (ZIO-201) in combination with etoposide (VP-16) and cisplatin/carboplatin (platinum) in the treatment of small cell lung cancer (SCLC) and other cancers.

29 Dec 2010

Positive results from OMS201 Phase 1/2 trial in patients undergoing urologic procedures

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced results from the Phase 1/2 clinical trial of OMS201, the Company's urological PharmacoSurgery™ product candidate.

29 Dec 2010

Centocor Ortho Biotech files REMICADE sBLA for ulcerative colitis in pediatric patients

Centocor Ortho Biotech Inc. announced today that it has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) requesting the approval of REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.

29 Dec 2010

FDA approves Endo's FORTESTA Gel for low testosterone

Endo Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved FORTESTA Gel for the treatment of low testosterone, or 'Low T,' also known as hypogonadism. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.

29 Dec 2010

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).

29 Dec 2010

Sinovac's inactivated EV71 vaccine clinical trial against HFMD receives Chinese SFDA approval

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it received approval from the China State Food and Drug Administration (SFDA) to commence clinical trials for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD).

28 Dec 2010

International reference standards for use of bone turnover markers in clinical studies recommended

An expert working group of the International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has released a new position paper which reviews the evidence of bone turnover markers (BTMs) in fracture risk prediction and monitoring of osteoporosis therapy. More importantly, it identifies research priorities and recommends that specific markers be used as reference analytes for BTMs in clinical and observational studies.

28 Dec 2010

Proellex vaginal delivery exhibits four times activity of oral dose in animal study

Repros Therapeutics Inc. today announced it has completed two animal model studies of the use of Proellex® in a vaginally administered formulation that demonstrated effects on progesterone sensitive tissues equivalent to the highest oral dose formerly in development by the Company.

28 Dec 2010

Efficacy News and Research

ReproCELL to enter collaborative iPS cell-derived hepatocytes R&D agreement with NIBIO

Pico-Tesla announces expansion of Magneceutical Phase III trail for Parkinson's disease

Anadys begins ANA598 Phase IIb study for hepatitis C

FDA approves ImmunoCellular Therapeutics IND amendment for ICT-107 Phase II clinical trial

Isis commences ISIS-EIF4ERx Phase 2 studies in non-small cell lung cancer and prostate cancer

Bupropion and varenicline help curb cigarette craving

Embryome Sciences announces $4M equity financing, changes name to ReCyte Therapeutics

Repros receives IRB approval for Androxal Phase IIb study in secondary hypogonadism

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

Top-line results of TIGER-2 Phase 3 clinical trial for CF treatment

Immunitor reports positive safety imm01 clinical trial against tuberculosis

Enrollment commences in belinostat-Tarceva combination trial for NSCLC

Dosing initiated in combination Phase I study of palifosfamide with etoposide and cisplatin/carboplatin in SCLC

Positive results from OMS201 Phase 1/2 trial in patients undergoing urologic procedures

Centocor Ortho Biotech files REMICADE sBLA for ulcerative colitis in pediatric patients

FDA approves Endo's FORTESTA Gel for low testosterone

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Sinovac's inactivated EV71 vaccine clinical trial against HFMD receives Chinese SFDA approval

International reference standards for use of bone turnover markers in clinical studies recommended

Proellex vaginal delivery exhibits four times activity of oral dose in animal study

How can microdialysis benefit drug development

Global and Local Efforts to Take Action Against Hepatitis

Addressing Important Cardiac Biology Questions with Shotgun Top-Down Proteomics

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