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Pfizer and Debiopharm Group enter into co-development agreement to conduct Phase 3 trial of tremelimumab

Pfizer Inc. (Pfizer) and Debiopharm Group™ (Debiopharm) announced today that they have entered into a co-development agreement to conduct a Phase 3 trial of tremelimumab (CP675,206), a fully human anti-CTLA4 monoclonal antibody for the treatment of patients with unresectable, Stage IV melanoma.

8 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

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

BioVex's Phase 3 melanoma study amended to include first line patients

BioVex Inc, a company developing new generation biologics for the treatment of cancer and prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has agreed that BioVex's ongoing OPTiM clinical study in unresectable Stage IIIb-IV melanoma be amended to include untreated (i.e., first line) patients as well as previously treated patients as defined in the original protocol.

7 Jan 2010

Phase II clinical trial results of Liposome-Entrapped Paclitaxel announced

NeoPharm, Inc. today announced the results of a Phase II clinical trial of Liposome-Entrapped Paclitaxel (LEP) an active component of Taxol®. This multicenter, open-label trial of LEP was conducted at 5 centers in India.

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

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

Tumor Biology Center to initiate Phase 2 clinical trial with CytRx’s INNO-206

CytRx Corporation, a biopharmaceutical company, today announced that the Tumor Biology Center, Freiburg, Germany, plans to initiate a Phase 2 clinical trial with CytRx’s doxorubicin prodrug INNO-206 as a treatment for patients with advanced pancreatic cancer.

6 Jan 2010

OncoGenex Pharmaceuticals receives grant funding for Phase 2 clinical trial of OGX-427

OncoGenex Pharmaceuticals, Inc., today announced that a randomized, controlled, investigator-sponsored Phase 2 clinical trial evaluating OGX-427 when administered as a monotherapy to patients with castrate resistant prostate cancer (CRPC) has received grant funding.

6 Jan 2010

Treatment with Effient more cost effective, show TRITON-TIMI 38 clinical trial results

Results from a health economic substudy of the TRITON-TIMI 38 clinical trial showed that among patients with acute coronary syndromes (ACS) managed with percutaneous coronary intervention (PCI), including stenting, treatment with Effient(®) (prasugrel) compared with branded clopidogrel (Plavix(®)) was more cost effective, and in most cases cost saving.

6 Jan 2010

Patient enrolled in Phase I clinical study of two investigational compounds: MK-2206 and AZD6244

Dr. Anthony Tolcher, clinical director for South Texas Accelerated Research Therapeutics (START) at the START Center for Cancer Care in San Antonio, announced today that the first patient has been enrolled in a groundbreaking Phase I clinical trial of a novel combination anticancer regimen composed of two investigational compounds: MK-2206 from Merck & Co., Inc. and AZD6244 (ARRY-886*) from AstraZeneca.

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

Phase I clinical trial for Intellikine's INK128 inhibitor initiated

Intellikine, Inc. has initiated a Phase I clinical trial for its targeted anticancer drug INK128, a novel orally-available small molecule inhibitor of both the TORC1 and TORC2 complexes, key components of the PI3K/mTOR signaling pathway.

6 Jan 2010

Scott & White's CRI launches two clinical trials targeting cancers

Scott & White's Cancer Research Institute (CRI) has launched two clinical trials targeting cancers that affect both adults and children.

6 Jan 2010

Excaliard Pharmaceuticals initiates Phase 2 trials of EXC 001

Excaliard Pharmaceuticals, Inc. announced today the initiation of three proof of concept Phase 2 trials of EXC 001, an antisense medicine that reduces fibrosis, for the amelioration of skin scarring and other fibrotic disorders.

6 Jan 2010

EnVivo Pharmaceuticals announces initiation and dosing of patients in Phase 2b study of EVP-6124

EnVivo Pharmaceuticals today announced the initiation and dosing of patients in a Phase 2b study of its EVP-6124 compound, a selective alpha-7 nicotinic agonist in patients with schizophrenia. EnVivo is conducting the multi-center, dose ranging, placebo controlled, three-month study in the U.S. and Europe.

6 Jan 2010

IBI initiates Phase 2/3 pivotal clinical trial to assess the safety and efficacy of IBI-10090

Icon Bioscience, Inc., (IBI), a privately held biopharmaceutical company that specializes in the development and commercialization of novel ophthalmic pharmaceuticals announced today that it has initiated its Phase 2/3 pivotal clinical trial to assess the safety and efficacy of IBI-10090 in patients undergoing cataract surgery.

6 Jan 2010

Cancer Research UK and CRT to undertake phase I clinical trial of DI-B4

CANCER RESEARCH UK and Cancer Research Technology (CRT), the charity's development and commercialisation arm, are to undertake a phase I clinical trial of an investigational monoclonal antibody1 drug from Merck KGaA, Darmstadt, Germany, called DI-B4 - it is announced today (Monday).

6 Jan 2010

Enrollment for sham-controlled study of radiation therapy for treatment of wet AMD announced

Oraya Therapeutics, Inc., announced today that enrollment is now underway for the first ever masked and sham-controlled study to demonstrate the efficacy and safety of radiation therapy for the treatment of wet age-related macular degeneration (AMD).

6 Jan 2010

DSMB recommends Quark Pharmaceuticals to continue clinical study of QPI-1002

Quark Pharmaceuticals, Inc., the world leader in clinical development of RNAi-based therapeutics, announced today that the independent Data Safety Monitoring Board ("DSMB") recommended that QPI-1002 (I5NP) continue on to the next phase of clinical testing.

5 Jan 2010

Drug Trial News

Pfizer and Debiopharm Group enter into co-development agreement to conduct Phase 3 trial of tremelimumab

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

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

BioVex's Phase 3 melanoma study amended to include first line patients

Phase II clinical trial results of Liposome-Entrapped Paclitaxel announced

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

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

Tumor Biology Center to initiate Phase 2 clinical trial with CytRx’s INNO-206

OncoGenex Pharmaceuticals receives grant funding for Phase 2 clinical trial of OGX-427

Treatment with Effient more cost effective, show TRITON-TIMI 38 clinical trial results

Patient enrolled in Phase I clinical study of two investigational compounds: MK-2206 and AZD6244

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

Phase I clinical trial for Intellikine's INK128 inhibitor initiated

Scott & White's CRI launches two clinical trials targeting cancers

Excaliard Pharmaceuticals initiates Phase 2 trials of EXC 001

EnVivo Pharmaceuticals announces initiation and dosing of patients in Phase 2b study of EVP-6124

IBI initiates Phase 2/3 pivotal clinical trial to assess the safety and efficacy of IBI-10090

Cancer Research UK and CRT to undertake phase I clinical trial of DI-B4

Enrollment for sham-controlled study of radiation therapy for treatment of wet AMD announced

DSMB recommends Quark Pharmaceuticals to continue clinical study of QPI-1002

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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