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Investigational compound dapagliflozin receives negative recommendation from FDA Advisory Committee

Bristol-Myers Squibb Company and AstraZeneca today reported the outcome of the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting on the New Drug Application for the investigational compound dapagliflozin.

20 Jul 2011

Janssen presents EDURANT 96-week Phase 3 trial data at International AIDS Society Conference

Janssen Therapeutics, Division of Janssen Products, LP, presented today 96-week findings from two pivotal Phase 3 clinical trials, known as ECHO and THRIVE, comparing the efficacy, safety and virology profile of its non-nucleoside reverse transcriptase inhibitor EDURANT tablets versus efavirenz (EFV) in antiretroviral treatment-naive, HIV-1-infected adults.

20 Jul 2011

Millennium submits VELCADE sNDA to FDA to add OS data for previously untreated multiple myeloma

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced the submission of a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration for VELCADE® (bortezomib) for injection to add overall survival data after a five-year follow up to the product label.

20 Jul 2011

CEL-SCI expands licensing agreement with Teva for Multikine cancer drug

CEL-SCI Corporation announced today that it has expanded the licensing agreement with Teva Pharmaceutical Industries Ltd. for its cancer drug Multikine.

20 Jul 2011

Aeterna's AEZS-108 final Phase 2 results in endometrial cancer to be presented at ESGO 2011

Aeterna Zentaris Inc. today announced that final Phase 2 results in endometrial cancer on its anticancer compound, AEZS-108, will be presented during a poster session at the upcoming 17th International Meeting of the European Society of Gynaecological Oncology, to be held September 11-14, 2011, at the Milan Convention Center in Milan, Italy.

19 Jul 2011

Convergence initiates CNV1014802 Phase II study in lumbosacral radiculopathy

Convergence Pharmaceuticals Limited, the company focused on the development of novel and high value analgesic medicines, today announces that the Phase II proof of concept study with CNV1014802 for treating pain associated with lumbosacral radiculopathy (LSR) has started.

19 Jul 2011

Upsher-Smith initiates USL261 ARTEMIS1 Phase III study for seizure clusters in epilepsy patients

Upsher-Smith Laboratories, Inc. announced today the initiation of a Phase III clinical trial to evaluate the safety and efficacy of USL261, an investigational intranasal midazolam, for the rescue treatment of seizures in patients on stable anti-epileptic drug (AED) regimens who require control of intermittent bouts of increased seizure activity, frequently referred to as seizure clusters. USL261 has been granted orphan drug designation for this use by the Food and Drug Administration (FDA).

18 Jul 2011

ISENTRESS demonstrates comparable efficacy to efavirenz in treatment-naïve adult HIV-1 patients

Merck, known as MSD outside the United States and Canada, today announced final results from a Phase II clinical study, extending out to 240 weeks, of its integrase inhibitor ISENTRESS® (raltegravir) Tablets in combination therapy in previously untreated (treatment-naïve) adult HIV-1-infected patients.

18 Jul 2011

Study: IL-2 monotherapy not effective as maintenance therapy for acute myeloid leukemia

EpiCept Corporation announced today the publication of a new meta-analysis which concluded that interleukin-2 (IL-2) monotherapy is not effective as a maintenance therapy for acute myeloid leukemia (AML) patients in first complete remission. These results were published in the July 7, 2011 edition of Blood, a leading scientific journal in hematology.

18 Jul 2011

Positive results from levomilnacipran Phase III study for major depressive disorder

Forest Laboratories, Inc. and Pierre Fabre Medicament today announced preliminary top-line results from a Phase III study of levomilnacipran for the treatment of adults with major depressive disorder (MDD).

18 Jul 2011

SEEK HIV-v vaccine demonstrates 90% reduction in HIV viral load

SEEK, a privately owned biopharmaceutical company specializing in immunology, announces today that it has completed a Phase Ib/II clinical trial of its HIV-v vaccine which demonstrates a one log (approx 90 percent) difference in viral count in HIV-infected people compared with the placebo group, after just a single vaccine injection.

18 Jul 2011

Inovio reports strong immune responses with VGX-3100 vaccine for cervical dysplasia and cancer

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, has reported data demonstrating long-term durability of T cell immune responses of up to over two years (at the latest time measured) in 7 of 8 evaluated patients following a fourth vaccination of VGX-3100, its investigational SynCon® DNA vaccine for treating cervical dysplasia and cancer caused by human papillomavirus (HPV) that is delivered using intramuscular electroporation.

15 Jul 2011

CLEOPATRA Phase III study on HER2-positive mBC meets primary endpoint

Genentech, a member of the Roche Group, today announced that CLEOPATRA, a pivotal Phase III study, met its primary endpoint.

15 Jul 2011

BioMarin commences BMN 673 Phase 1 trial in hematological malignancies

BioMarin Pharmaceutical Inc. today announced the initiation of a Phase 1 trial for BMN 673, a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with advanced hematological malignancies.

15 Jul 2011

Michael J. Fox Foundation awards Impax $400,000 grant for research of IPX066 for Parkinson’s disease

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc., has been awarded funding of up to $400,000 by The Michael J. Fox Foundation for ongoing clinical research of the Company's investigational carbidopa-levodopa extended release (CD-LD ER) product IPX066, which is intended to treat the motor symptoms of Parkinson's disease (PD).

14 Jul 2011

Positive data from Inovio's VGX-3400X Phase I study against H5N1 influenza

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that significant T cell and antibody responses were generated in its Phase I clinical study of VGX-3400X, a SynCon DNA vaccine for the prevention of avian H5N1 influenza delivered using intramuscular (IM) electroporation.

14 Jul 2011

Eisai's DACOGEN sNDA for acute myeloid leukemia accepted by FDA for review

SuperGen, Inc., a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that Eisai Inc. today released information that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) seeking approval of DACOGEN (decitabine) for injection in the treatment of acute myeloid leukemia.

14 Jul 2011

PharmAthene demonstrates 36 month stability of rPA anthrax vaccine program candidate

PharmAthene, Inc. announced today that it has achieved an important program milestone in its recombinant protective antigen (rPA) anthrax vaccine program and demonstrated 36 month stability of its rPA drug product candidate previously produced at Avecia Biologics Laboratories in the United Kingdom. The stability data were prepared utilizing a variety of analytical methods and a well characterized mouse challenge potency assay.

14 Jul 2011

DARA's DB959 shows promise against type 2 diabetes

A new peroxisome proliferator activated receptor agonist currently in development, DB959, will most likely be administered orally once a day, according to a presentation made by researchers recently at the American Diabetes Association's 71st Scientific Sessions.

14 Jul 2011

Chimerix initiates CMX001 Phase 2 study for prevention of adenovirus disease following HSCT

Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, today announced that patient dosing has begun in the AdV HALT Trial (A Randomized, Placebo-Controlled, Multi-site Phase 2 Study Evaluating the Safety and Efficacy of Preemptive Treatment with CMX001 for the Prevention of Adenovirus Disease Following Hematopoietic Stem Cell Transplantation [HSCT]).

14 Jul 2011

Drug Trial News

Investigational compound dapagliflozin receives negative recommendation from FDA Advisory Committee

Janssen presents EDURANT 96-week Phase 3 trial data at International AIDS Society Conference

Millennium submits VELCADE sNDA to FDA to add OS data for previously untreated multiple myeloma

CEL-SCI expands licensing agreement with Teva for Multikine cancer drug

Aeterna's AEZS-108 final Phase 2 results in endometrial cancer to be presented at ESGO 2011

Convergence initiates CNV1014802 Phase II study in lumbosacral radiculopathy

Upsher-Smith initiates USL261 ARTEMIS1 Phase III study for seizure clusters in epilepsy patients

ISENTRESS demonstrates comparable efficacy to efavirenz in treatment-naïve adult HIV-1 patients

Study: IL-2 monotherapy not effective as maintenance therapy for acute myeloid leukemia

Positive results from levomilnacipran Phase III study for major depressive disorder

SEEK HIV-v vaccine demonstrates 90% reduction in HIV viral load

Inovio reports strong immune responses with VGX-3100 vaccine for cervical dysplasia and cancer

CLEOPATRA Phase III study on HER2-positive mBC meets primary endpoint

BioMarin commences BMN 673 Phase 1 trial in hematological malignancies

Michael J. Fox Foundation awards Impax $400,000 grant for research of IPX066 for Parkinson’s disease

Positive data from Inovio's VGX-3400X Phase I study against H5N1 influenza

Eisai's DACOGEN sNDA for acute myeloid leukemia accepted by FDA for review

PharmAthene demonstrates 36 month stability of rPA anthrax vaccine program candidate

DARA's DB959 shows promise against type 2 diabetes

Chimerix initiates CMX001 Phase 2 study for prevention of adenovirus disease following HSCT

Flow chemistry, AI, and NMR: A next-gen approach to scalable API production

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Bioprocess Efficiency with Cell Density Monitoring

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