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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

ImmuVen to develop T cell receptor proteins for treating MRSA, cancer

Start-up company ImmuVen and the University of Illinois Urbana-Champaign have entered into a license agreement under which ImmuVen will develop modified T cell receptor proteins for the purpose of treating cancer and methicillin-resistant Staphylococcus aureus.

4 Jan 2011

MGH, Veridex establish research center of excellence on circulating tumor cell technologies

Massachusetts General Hospital (MGH) has entered into a collaborative agreement with Veridex LLC to establish a center of excellence in research on circulating tumor cell (CTC) technologies. The overall goal of the agreement is to develop and commercialize novel technologies for capturing and characterizing CTCs, solid tumor cells found at extremely low levels in the bloodstream, which may offer a key to noninvasive characterization of cancer and potentially to early detection.

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

Mercator, Pepscan enter multi-program cancer research collaboration

Mercator Therapeutics, the first biopharmaceutical company to systematically use in vivo phage display technology to develop novel cancer drugs and Pepscan Therapeutics, a world leader in protein mimicry technologies for improved therapeutic peptides and anti-GPCR antibodies, today announced a multi-program research collaboration. The companies will collaborate to optimize Mercator's 'Homing Peptides' using Pepscan's proprietary CLIPS technology.

4 Jan 2011

Fondation Leducq awards Penn Medicine researcher $6M grant for cardiovascular disease study

An international team of researchers led by Daniel J. Rader, MD, associate director of Penn Medicine's Institute for Translational Medicine and Therapeutics, has received a $6 million grant from the Paris-based Fondation Leducq to study the molecular genetics of atherosclerotic cardiovascular disease. The team's proposal, "Molecular Mechanisms of Novel Genes Associated with Plasma Lipids and Cardiovascular Disease," was selected to receive the award through the Fondation's Transatlantic Networks of Excellence Program.

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

FDA approves 200 mg formulation of INTELENCE for HIV-1

The U.S. Food and Drug Administration (FDA) approved a label update to include a 200 mg formulation of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.

3 Jan 2011

Florida Hospital, Sanford-Burnham and Takeda enter obesity research collaboration

Florida Hospital, Sanford-Burnham Medical Research Institute (Sanford-Burnham), and Takeda Pharmaceutical Company Limited (Takeda)(TSE: 4502), announced today that they have signed a research agreement to form a collaboration to discover and evaluate new therapeutic approaches to obesity, a growing worldwide health problem. The partnership aligns complementary strengths in biomedical research, clinical research and drug development to identify and validate obesity- related biomarkers and new peripheral molecular targets of mutual interest.

29 Dec 2010

NEI awards Case Western Reserve $10M for study of retinal diseases

The Departments of Pharmacology and Ophthalmology and Visual Sciences at Case Western Reserve University School of Medicine have been awarded a $10.1 million grant from the National Eye Institute (NEI) to research and develop new treatments for diseases of the retina, a leading cause of blindness.

29 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

King Pharmaceuticals resubmits NDA for REMOXY

King Pharmaceuticals®, Inc. and Pain Therapeutics®, Inc. today announced that King has resubmitted a New Drug Application for REMOXY® to the U.S. Food and Drug Administration in response to a Complete Response letter received by Pain Therapeutics in December 2008.

28 Dec 2010

Vicus initiates VT-122 Phase 2 trial in advanced liver cancer, systemic inflammation and cachexia

Vicus Therapeutics, LLC, today announced the initiation of a Phase 2 trial evaluating VT-122, a novel investigational combination of etodolac and propranolol, and Nexavar® (sorafenib) tablets, as a potential new treatment option for patients with advanced liver cancer (hepatocellular carcinoma), systemic inflammation and cachexia.

28 Dec 2010

NDA resubmitted for DURECT's ORADUR technology based REMOXY

DURECT Corporation today reported that King Pharmaceuticals, Inc. and Pain Therapeutics, Inc. have announced that King has resubmitted a New Drug Application (NDA) for REMOXY® to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter received by Pain Therapeutics in December 2008. This is a Class 2 resubmission with a six month review cycle.

28 Dec 2010

Transition, Elan to modify collaboration agreement for development, commercialization of ELND005

Transition Therapeutics Inc. today announced that the Company and Elan Corporation, plc have mutually agreed to modify their collaboration agreement for the development and commercialization of ELND005.

27 Dec 2010

Stem cell therapy helps patient with diabetes gangrene recover from foot ulcer: ICMS conference

During ICMS Annual International Congress on Regenerative and Cell Based Medicine Conference held on November 12, 2010 in Las Vegas, Nevada, it was announced that a patient with complications of diabetes gangrene recovered from foot ulcer through stem cell therapy.

27 Dec 2010

ARYx provides additional clarification about operations

ARYx Therapeutics, Inc. today provided further clarification of its status as an operating company, including the on-going appointment of its officers on behalf of the Company. The NASDAQ Staff has requested additional clarification about the Company's operations in conjunction with their on-going consideration of the Company's eligibility for continued listing on The NASDAQ Capital Market.

24 Dec 2010

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference therapeutics, announced today it has initiated patient dosing in a Phase 1 human clinical trial for its lead oncology product, TKM-PLK1. TKM-PLK1 targets polo-like kinase 1, or PLK1, a cell cycle protein involved in tumor cell proliferation and a validated oncology target.

22 Dec 2010

Seaside purchases additional $2.5M of NanoViricides' Series B Convertible Preferred Stock

NanoViricides, Inc., announced today that it had consummated a closing with Seaside 88, LP ("Seaside"), a Florida limited partnership, on Seaside's purchase of an additional $2.5M of the Company's Series B Convertible Preferred Stock. Seaside has financed several leading-edge bio-pharma companies, including Cytori Therapeutics, Inc., Generex Biotechnology Corporation, and NovaDel Pharma, Inc. among others.

22 Dec 2010

Therapeutics News and Research

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

ImmuVen to develop T cell receptor proteins for treating MRSA, cancer

MGH, Veridex establish research center of excellence on circulating tumor cell technologies

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

Mercator, Pepscan enter multi-program cancer research collaboration

Fondation Leducq awards Penn Medicine researcher $6M grant for cardiovascular disease study

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

FDA approves 200 mg formulation of INTELENCE for HIV-1

Florida Hospital, Sanford-Burnham and Takeda enter obesity research collaboration

NEI awards Case Western Reserve $10M for study of retinal diseases

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

King Pharmaceuticals resubmits NDA for REMOXY

Vicus initiates VT-122 Phase 2 trial in advanced liver cancer, systemic inflammation and cachexia

NDA resubmitted for DURECT's ORADUR technology based REMOXY

Transition, Elan to modify collaboration agreement for development, commercialization of ELND005

Stem cell therapy helps patient with diabetes gangrene recover from foot ulcer: ICMS conference

ARYx provides additional clarification about operations

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Seaside purchases additional $2.5M of NanoViricides' Series B Convertible Preferred Stock

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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