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Novelos Therapeutics to conclude pivotal Phase 3 trial in advanced non-small cell lung cancer

Novelos Therapeutics, Inc., a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the 725th event (patient death) has been reached in its pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) studying its lead product, NOV-002, in combination with first-line chemotherapy.

8 Jan 2010

Access Pharmaceuticals completes enrollment for Prolindac monotherapy trail, begins combination study

ACCESS PHARMACEUTICALS, INC., today announced that it has completed enrollment and evaluation of the last additional cohort of patients in the ongoing clinical study of ProLindac as a monotherapy in ovarian cancer patients who have received at least two prior platinum based treatment regimens.

8 Jan 2010

Additional education to liver transplant candidates increases live donation and donor evaluation

A recent study found that living donation increased 42% and the number of individuals who presented for donation evaluation increased 74% at centers in New York. The surge in live donation and donor evaluation occurred after additional education was provided to liver transplant candidates.

8 Jan 2010

Chinese researchers become the world's fifth most prolific contributors to regenerative medicine

Chinese researchers have become the world's fifth most prolific contributors to peer-reviewed scientific literature on clock-reversing regenerative medicine even as a skeptical international research community condemns the practice of Chinese clinics administering unproven stem cell therapies to domestic and foreign patients.

8 Jan 2010

3Sbio submits registrational clinical trial application for Feraheme injection

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a registrational clinical trial to the Chinese State Food and Drug Administration ("SFDA") for Feraheme (ferumoxytol) Injection for intravenous use.

8 Jan 2010

Cell Medica signs R&D agreement with the Center for Cell and Gene Therapy

Cell Medica, a clinical cellular therapeutics company developing proven cell therapies which address important unmet clinical needs in oncology and infectious diseases, announced today the signing of an R&D agreement with the Center for Cell and Gene Therapy, a joint program of Baylor College of Medicine, Texas Children’s Hospital and The Methodist Hospital, Houston, Texas.

8 Jan 2010

Patient enrollment in Tolerx's Phase 3 clinical study DEFEND-1 completed

Tolerx, Inc., today announced the completion of patient enrollment in its Phase 3 clinical study DEFEND-1, which is evaluating the safety and efficacy of otelixizumab, a targeted T cell immunomodulator, in patients with new-onset autoimmune type 1 diabetes.

8 Jan 2010

FDA issues Fast Track Designation to Sopherion Therapeutics' Myocet

Sopherion Therapeutics, LLC, a biopharmaceutical company focused on the development and commercialization of anti-cancer therapies, announced today that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for nonpegylated liposomal doxorubicin (Myocet(TM)) for first-line therapy of HER2 positive metastatic breast cancer.

7 Jan 2010

Positive results from phase 2 study evaluating the safety and efficacy of Qnexa announced

VIVUS, Inc. today announced positive results from a phase 2 study evaluating the safety and efficacy of Qnexa®, an investigational drug, for the treatment of obstructive sleep apnea (OSA). VIVUS recently completed phase 3 development of Qnexa for the treatment of obesity and submitted a New Drug Application (NDA) to the FDA for that indication.

7 Jan 2010

Heart Force Medical closes its private, non-brokered financing after raising $4.8 million net

Heart Force Medical Inc., a Vancouver-based company that is developing a non-invasive cardiac assessment, monitoring and screening device, announces today that it has closed its private, non-brokered financing after raising $4.8 million net.

7 Jan 2010

Positive top-line results from Phase III study of aclidinium bromide announced

orest Laboratories, Inc. and Almirall, S.A. (ALM.MC) today announced positive top-line results from ACCORD COPD I, a three-month Phase III study comparing aclidinium 200µg and 400µg BID versus placebo.

7 Jan 2010

UMBI announces exclusive licensing of fully human antibody technology platform to Prolias

The University of Maryland Biotechnology Institute (UMBI) today announced the exclusive licensing of a fully human antibody technology platform to Prolias, a biotechnology company working to discover and develop novel therapeutic proteins and antibodies for treatment of disease.

7 Jan 2010

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

Gilead Sciences, Inc. today announced that a Phase II clinical trial of its investigational integrase inhibitor-based, once-daily, fixed-dose “Quad” regimen of elvitegravir, GS 9350 and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV-1 infection met its primary objective.

7 Jan 2010

New tools show potential for treating brain disorders

Neuroscientists at MIT have developed a powerful new class of tools to reversibly shut down brain activity using different colors of light.

7 Jan 2010

Enzon Pharmaceuticals treats first patient in Phase 2 studies of PEG-SN38

Enzon Pharmaceuticals, Inc. today announced that the first patient has been treated in the Phase 2 studies of PEG-SN38 for metastatic breast cancer. PEG-SN38 or EZN-2208 is Enzon’s PEGylated form of SN38, the active metabolite of the cancer drug Camptosar® (irinotecan HCl injection).

6 Jan 2010

Ensemble Discovery initiates strategic alliance with Pfizer

Ensemble Discovery today announced the initiation of a strategic alliance with Pfizer Inc. to discover and develop drug candidates of a novel class against a number of high-value pharmaceutical targets.

6 Jan 2010

Oral cladribine to be the first oral disease-modifying multiple sclerosis therapy despite receiving RTF letter

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a recent "refuse to file" (RTF) letter issued by the Food and Drug Administration (FDA) regarding Merck Serono's oral cladribine has heightened the competition between oral cladribine and its primary competitor, Novartis/Mitsubishi Tanabe's FTY-720 (fingolimod), to be the first oral disease-modifying multiple sclerosis therapy to reach the market in the United States.

6 Jan 2010

More research needed to assess psychological debriefing in schools

There is no evidence to support psychological debriefing in schools after traumatic events such as violence, suicides and accidental death, which runs counter to current practice in some Canadian school jurisdictions, according to a commentary http://www.cmaj.ca/embargo/cmaj091621.pdf in CMAJ (Canadian Medical Association Journal) www.cmaj.ca .

6 Jan 2010

Innexus Biotechnology designs new psoriasis product

InNexus Biotechnology Inc. (TSX.V: IXS) (www.ixsbio.com), a drug development company commercializing the next generation of antibodies based on its groundbreaking Dynamic Cross Linking (DXL™) technology, today announced the development of a new psoriasis product based on its proprietary dermal permeating Transmab™ technology.

6 Jan 2010

Keryx Biopharmaceuticals reaches SPA agreement for Phase 3 clinical program for Zerenex

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical program for Zerenex(TM) (ferric citrate), its iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD).

6 Jan 2010

Efficacy News and Research

Novelos Therapeutics to conclude pivotal Phase 3 trial in advanced non-small cell lung cancer

Access Pharmaceuticals completes enrollment for Prolindac monotherapy trail, begins combination study

Additional education to liver transplant candidates increases live donation and donor evaluation

Chinese researchers become the world's fifth most prolific contributors to regenerative medicine

3Sbio submits registrational clinical trial application for Feraheme injection

Cell Medica signs R&D agreement with the Center for Cell and Gene Therapy

Patient enrollment in Tolerx's Phase 3 clinical study DEFEND-1 completed

FDA issues Fast Track Designation to Sopherion Therapeutics' Myocet

Positive results from phase 2 study evaluating the safety and efficacy of Qnexa announced

Heart Force Medical closes its private, non-brokered financing after raising $4.8 million net

Positive top-line results from Phase III study of aclidinium bromide announced

UMBI announces exclusive licensing of fully human antibody technology platform to Prolias

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

New tools show potential for treating brain disorders

Enzon Pharmaceuticals treats first patient in Phase 2 studies of PEG-SN38

Ensemble Discovery initiates strategic alliance with Pfizer

Oral cladribine to be the first oral disease-modifying multiple sclerosis therapy despite receiving RTF letter

More research needed to assess psychological debriefing in schools

Innexus Biotechnology designs new psoriasis product

Keryx Biopharmaceuticals reaches SPA agreement for Phase 3 clinical program for Zerenex

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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