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Positive results from Celldex’s CDX-1401 Phase 1 study on solid tumors

Celldex Therapeutics, Inc. today announced positive results demonstrating promising clinical effects in a Phase 1 study of CDX-1401 in solid tumors in combination with the toll-like receptor (TLR) agonists resiquimod and/or Poly ICLC.

30 Oct 2012

Positive interim data from XBiotech monoclonal antibody Phase II study for type 2 diabetes

XBiotech, a privately held biotechnology company, announced positive interim analysis results today from a Phase II study using a True Human monoclonal antibody (MABp1) in patients with type 2 diabetes. Results from this study continue to reinforce the role of IL-1α as a master regulator of chronic inflammation in multiple disease states, and the therapeutic benefits of neutralizing antibodies produced from the XBiotech platform.

29 Oct 2012

Antidepressant doxepin eases pain associated with oral mucositis

An oral rinse of the antidepressant doxepin significantly eased pain associated with oral mucositis in patients receiving radiation therapy for cancers of the head and neck, a study led by Mayo Clinic found. The findings were presented at the American Society for Radiation Oncology annual meeting in Boston.

29 Oct 2012

Par to acquire Handa's ANDA for generic Seroquel XR

Par Pharmaceutical Companies, Inc. today announced that its Par Pharmaceutical, Inc. operating subsidiary has entered into an exclusive acquisition and license agreement with Handa Pharmaceuticals, LLC to acquire Handa's Abbreviated New Drug Application (ANDA) for quetiapine fumarate extended-release tablets, the generic version of AstraZeneca's Seroquel XR.

29 Oct 2012

Isis commences ISIS-FXIRx Phase 2 study in knee replacement surgery patients

Isis Pharmaceuticals, Inc. announced the initiation of a Phase 2 comparator-controlled study evaluating ISIS-FXIRx in patients undergoing knee replacement surgery, also referred to as total knee arthroplasty (TKA).

29 Oct 2012

AstraZeneca commences FASLODEX Phase III study for hormone receptor-positive metastatic breast cancer

AstraZeneca today announced the start of a Phase III study (FALCON), a global clinical trial which will involve 450 postmenopausal patients with hormone receptor-positive locally advanced or metastatic breast cancer who have not previously been treated with any hormonal therapy. The Phase III study is designed to evaluate the efficacy and tolerability of fulvestrant 500 mg compared to anastrozole 1 mg in this patient population.

29 Oct 2012

Nonclinical data on Provectus PV-10 oncology drug presented at 27th SITC

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, presented nonclinical data on PV-10 at the Society for Immunotherapy of Cancer (SITC) 27th Annual Meeting on October 26 and 27, 2012 in North Bethesda, MD.

29 Oct 2012

GTx to continue enobosarm Phase III trials for muscle wasting in patients with NSCLC

GTx, Inc. today announced that a per protocol interim safety review on Friday, October 26, 2012, by an independent Data Safety Monitoring Board (DSMB) recommended that GTx continue clinical development as planned with its two pivotal Phase III trials of enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer.

29 Oct 2012

Intracoronary and IV abciximab during angioplasty do not result in differences in myocardial damage

A study confirmed no differences in various measures of heart damage, according to cardiac magnetic resonance (MRI) imaging, in patients receiving the anti-clotting medication abxicimab directly into the heart (intracoronary) compared to those receiving it intravenously (IV).

26 Oct 2012

Journal of Pediatrics assesses issues surrounding lack of clinical drug trials for neonates

Clinical drug trials are a vital part of pharmaceutical manufacturers gaining approval for use by the U.S. Food and Drug Administration. A Commentary scheduled for publication in The Journal of Pediatrics assesses the issues surrounding the lack of clinical trials on medications used by children, most notably neonates, and how drug manufacturers and academic researchers could work together to create clinical trials that would benefit this underrepresented population.

26 Oct 2012

Resveratrol does not appear to offer metabolic benefits in healthy women

Resveratrol, an ingredient in red wine thought to improve insulin sensitivity, reduce risk of heart disease and increase longevity, does not appear to offer these benefits in healthy women, new research at Washington University School of Medicine in St. Louis indicates.

26 Oct 2012

Durata completes target enrollment in dalbavancin Phase 3 trial for ABSSSI

Durata Therapeutics today announced that it has completed its target enrollment for DISCOVER 2 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response"), the second global, Phase 3 clinical trial of Durata's lead product candidate, dalbavancin, under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria.

26 Oct 2012

Prasugrel reduces cardiovascular events among patients managed medically for ACS

A study has found that the anti-clotting medication prasugrel reduced cardiovascular events among patients who present with an acute coronary syndrome and are managed medically after an angiogram is performed to determine coronary anatomy.

25 Oct 2012

Thrasos completes $35 Million financing for development of THR-184 against AKI

Thrasos Therapeutics announced that it has completed a $35 Million (U.S.) financing for the development of THR-184, its lead product candidate for the treatment of acute kidney injury (AKI).

25 Oct 2012

BioLineRx intends to conduct interim analysis of BL-1020 Phase II/III trial for schizophrenia

BioLineRx, a biopharmaceutical development company, announced today that it intends to conduct an interim analysis of the Phase II/III CLARITY trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia.

25 Oct 2012

Ophthotech announces data from Fovista Phase 2b trial on wet AMD

Ophthotech Corporation today announced that data from a large, prospective, randomized, controlled Phase 2b clinical trial of Ophthotech's Fovista anti-PDGF therapy (1.5 mg) in patients with neovascular age-related macular degeneration (wet AMD) will be presented during Retina Subspecialty Day at the American Academy of Ophthalmology Annual Meeting (AAO) on Sat., Nov. 10, 2012 at 9:15 a.m.

25 Oct 2012

Azaya Therapeutics commences ATI-0918 bioequivalence study in ovarian cancer

Azaya Therapeutics, Inc. today announced the initiation of a bioequivalence study of ATI-0918 in patients with ovarian cancer.

25 Oct 2012

Bayer announces data from riociguat Phase III trial on CTEPH

Bayer HealthCare today announced data from the Phase III CHEST-1 trial evaluating its investigational drug riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery.

24 Oct 2012

Probiotic supplementation improves health-related quality of life during common cold

College students are notoriously sleep-deprived, live in close quarters and lead stress-filled lives, making them especially susceptible for contracting colds and upper-respiratory infections. For these reasons, a team lead by researchers at the University of Medicine and Dentistry of New Jersey-School of Health Related Professions (UMDNJ-SHRP) selected this population to study the effects of probiotic supplementation on health-related quality of life (HRQL) during the common cold.

24 Oct 2012

Genzyme, Alnylam partner to develop and commercialize RNAi therapeutics against ATTR

Alnylam Pharmaceuticals, Inc. and Genzyme, a Sanofi company, announced today that they have formed an exclusive alliance to develop and commercialize RNAi therapeutics targeting transthyretin (TTR) for the treatment of transthyretin-mediated amyloidosis (ATTR) in Japan and other Asia-Pacific countries.

23 Oct 2012

Drug Trial News

Positive results from Celldex’s CDX-1401 Phase 1 study on solid tumors

Positive interim data from XBiotech monoclonal antibody Phase II study for type 2 diabetes

Antidepressant doxepin eases pain associated with oral mucositis

Par to acquire Handa's ANDA for generic Seroquel XR

Isis commences ISIS-FXIRx Phase 2 study in knee replacement surgery patients

AstraZeneca commences FASLODEX Phase III study for hormone receptor-positive metastatic breast cancer

Nonclinical data on Provectus PV-10 oncology drug presented at 27th SITC

GTx to continue enobosarm Phase III trials for muscle wasting in patients with NSCLC

Intracoronary and IV abciximab during angioplasty do not result in differences in myocardial damage

Journal of Pediatrics assesses issues surrounding lack of clinical drug trials for neonates

Resveratrol does not appear to offer metabolic benefits in healthy women

Durata completes target enrollment in dalbavancin Phase 3 trial for ABSSSI

Prasugrel reduces cardiovascular events among patients managed medically for ACS

Thrasos completes $35 Million financing for development of THR-184 against AKI

BioLineRx intends to conduct interim analysis of BL-1020 Phase II/III trial for schizophrenia

Ophthotech announces data from Fovista Phase 2b trial on wet AMD

Azaya Therapeutics commences ATI-0918 bioequivalence study in ovarian cancer

Bayer announces data from riociguat Phase III trial on CTEPH

Probiotic supplementation improves health-related quality of life during common cold

Genzyme, Alnylam partner to develop and commercialize RNAi therapeutics against ATTR

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

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

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