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Teva Pharmaceuticals, OncoGenex initiate SYNERGY Phase 3 trial to evaluate custirsen

Teva Pharmaceuticals Industries Ltd. and OncoGenex Pharmaceuticals, Inc. announced today the initiation of SYNERGY, a global Phase 3 trial evaluating custirsen (also known as OGX-011/TV-1011) as first line therapy for the treatment of castrate-resistant prostate cancer (CRPC).

30 Sep 2010

AVEO regains global rights for development, commercialization of AV-299 anti-HGF antibody candidate

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that AVEO has regained worldwide rights from Merck (through its subsidiary, Schering Corporation) to develop and commercialize AV-299 (also known as SCH 900105), its anti-hepatocyte growth factor (HGF) antibody candidate.

30 Sep 2010

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

Repros Therapeutics Inc. today announced that the Company has been granted a Type B meeting to be held on November 8, 2010 with the Division of Reproductive and Urologic Products to review the Company's Phase III pivotal efficacy protocols for Androxal in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.

30 Sep 2010

NIH awards $3.1 million to further fund Inovio's universal SynCon flu vaccine development

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that Inovio Pharmaceuticals and the University of Pennsylvania have received a grant of $3.1 million from the National Institutes of Health (NIH) Director's Office to further fund Inovio's universal SynCon™ flu vaccine development.

30 Sep 2010

Circassia announces advancement in T-cell allergy vaccines development

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that it has further advanced the clinical development of three of its leading T-cell allergy vaccines.

30 Sep 2010

ThromboGenics enters 10-year supply agreement with MSD Biologics for microplasmin

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, cardiovascular disease and cancer, announces that it has signed a 10-year supply agreement with MSD Biologics (UK) Ltd, part of the Merck BioManufacturing Network, for the production of microplasmin. ThromboGenics anticipates that this deal will meet its long-term commercial needs for bulk drug substance of this novel therapeutic agent.

30 Sep 2010

Zyclara 3.75% more effective than cryotherapy alone in treatment of Actinic Keratoses: Study

Results from a randomized, double-blinded, placebo-controlled, multicentred study just published in the Journal of Drugs in Dermatology shows that treating Actinic Keratoses (AK) with imiquimod 3.75% (Zyclara®) following cryotherapy was more effective than cryotherapy alone in reducing total AK lesion count and achieving complete clearance of AK.

30 Sep 2010

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

Santarus, Inc. and Cosmo Pharmaceuticals S.p.A. today announced positive top-line results from the Phase III clinical study conducted in the U.S. and India to evaluate the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo.

30 Sep 2010

ACT updates myoblast program for heart failure treatment

Advanced Cell Technology, a leader in the field of regenerative medicine, provided an update today on the status of its myoblast program. The program has successfully and safely completed Phase I human clinical trials in more than forty patients in over four independent studies.

30 Sep 2010

Duke receives approval to initiate NPC-1C Phase I trial for advanced pancreatic and colorectal cancer

Neogenix Oncology, Inc. announced today that researchers at Duke University Medical Center have received approval to move forward with a Phase I trial of the company's lead therapeutic antibody, NPC-1C, in patients with advanced stage pancreatic or colorectal cancer. Duke joins Johns Hopkins Hospital which is already conducting the Phase I trial of NPC-1C. In addition to Johns Hopkins, North Shore - LIJ has also enrolled patients on this multi-center study.

30 Sep 2010

Alnylam Pharmaceuticals publishes ALN-RSV01 Phase IIa study results

Alnylam Pharmaceuticals, Inc. a leading RNAi therapeutics company announced today that it has published results in the American Journal of Respiratory and Critical Care Medicine from its double-blind, placebo-controlled, randomized Phase IIa study of ALN-RSV01 in lung transplant patients naturally infected with respiratory syncytial virus (RSV).

30 Sep 2010

Memantine enhances language and communication skills in patients with Alzheimer's disease

Memantine enhances language and communication skills in patients with moderate to severe Alzheimer’s disease (AD), a valuable contribution for patient independence and quality of life for both the patient and the family/caregivers. These are the findings discussed at the 14th Congress of the European Federation of Neurological Societies (EFNS).

30 Sep 2010

NEUROKIN accentuates its leadership in the treatment of acute neurological diseases

Bbiotechnology company NEUROKIN, dedicated to the development of neuroprotective drugs to treat acute neurological diseases, announces today that the European Patent Office (EPO) has granted patent EP 1998778 protecting the use of NK-102, its most advanced drug candidate. This first European award constitutes an important milestone for NEUROKIN. An application for registration is under way in Brazil, Canada, China, USA and Japan.

29 Sep 2010

Unique genetic markers point to patient response to SCV-07 treatment

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that researchers have identified two unique gene clusters that differentiated subjects who responded to treatment in the Company’s phase 2a proof of concept study of SCV-07 for the prevention of severe oral mucositis (OM; WHO grades 3-4) in patients with advanced head and neck cancer.

29 Sep 2010

Medivation and Astellas commence MDV3100 second Phase 3 clinical trial in advanced prostate cancer

Medivation, Inc. and Astellas Pharma Inc. today announced treatment of the first patient in a second Phase 3 clinical trial of the investigational drug MDV3100, which expands the Phase 3 development of the novel, triple-acting oral androgen receptor antagonist into an earlier-stage patient population. Known as PREVAIL, the trial will evaluate MDV3100 in men with advanced prostate cancer who have not yet received chemotherapy. Initiation of the PREVAIL trial triggers a milestone payment to Medivation under its collaboration agreement with Astellas.

29 Sep 2010

Keryx commences Zerenex Phase 3 study for hyperphosphatemia in patients with ESRD on dialysis

Keryx Biopharmaceuticals, Inc. announced today the initiation of the long-term Phase 3 study of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.

29 Sep 2010

Rigel earns $25M milestone payment from Astrazeneca for clinical development of fostamatinib

Rigel Pharmaceuticals, Inc. today announced that it has earned $25 million from AstraZeneca for the fulfillment of two major milestones in the agreement the two companies have regarding the clinical development of fostamatinib (R788), a novel oral syk inhibitor. The first milestone is for initiation of the phase 3 clinical program with fostamatinib in patients with rheumatoid arthritis (RA) that was announced by AstraZeneca earlier today.

29 Sep 2010

Pulmokine receives NIH SBIR grants to develop novel treatments for PAH

YM BioSciences Inc., today reported that Pulmokine Inc. (Slingerlands, New York), a licensee of several small molecule compounds from YM, has been awarded two National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grants. The grants, totaling more than US$650,000, are Phase I awards to develop novel treatments for Pulmonary Arterial Hypertension (PAH).

29 Sep 2010

XOMA completes patient enrollment in XOMA 052 Phase 2a trial

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced that patient enrollment was recently completed for the company's Phase 2a trial of XOMA 052 in patients with Type 2 diabetes.

29 Sep 2010

NIH trial selects Inovio's PENNVAX-G DNA vaccine candidate to evaluate HIV-1 prevalent

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that a Phase I study, called RV262, recently began to evaluate a combination DNA prime/MVA vector boost regimen that was developed to protect against diverse subtypes of HIV-1 prevalent in North America, Europe, Africa, and South America.

29 Sep 2010

Drug Trial News

Teva Pharmaceuticals, OncoGenex initiate SYNERGY Phase 3 trial to evaluate custirsen

AVEO regains global rights for development, commercialization of AV-299 anti-HGF antibody candidate

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

NIH awards $3.1 million to further fund Inovio's universal SynCon flu vaccine development

Circassia announces advancement in T-cell allergy vaccines development

ThromboGenics enters 10-year supply agreement with MSD Biologics for microplasmin

Zyclara 3.75% more effective than cryotherapy alone in treatment of Actinic Keratoses: Study

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

ACT updates myoblast program for heart failure treatment

Duke receives approval to initiate NPC-1C Phase I trial for advanced pancreatic and colorectal cancer

Alnylam Pharmaceuticals publishes ALN-RSV01 Phase IIa study results

Memantine enhances language and communication skills in patients with Alzheimer's disease

NEUROKIN accentuates its leadership in the treatment of acute neurological diseases

Unique genetic markers point to patient response to SCV-07 treatment

Medivation and Astellas commence MDV3100 second Phase 3 clinical trial in advanced prostate cancer

Keryx commences Zerenex Phase 3 study for hyperphosphatemia in patients with ESRD on dialysis

Rigel earns $25M milestone payment from Astrazeneca for clinical development of fostamatinib

Pulmokine receives NIH SBIR grants to develop novel treatments for PAH

XOMA completes patient enrollment in XOMA 052 Phase 2a trial

NIH trial selects Inovio's PENNVAX-G DNA vaccine candidate to evaluate HIV-1 prevalent

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