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Advanced Radioactive Iodine Refractory Differentiated Thyroid Cancer

R&D VBL2015-10-23 10:07 Read   269

VBL Therapeutics Presents Positive Data on VB-111 in Advanced Radioactive Iodine Refractory Differentiated Thyroid Cancer at the ITC 2015 Conference

Oncodesign Presents Novel LRRK2 Inhibitor Jointly Discovered with Ipsen at the 2015 Neurosciences Meeting in Chicago

R&DOncodesign2015-10-23 09:51 Read   335

ONCODESIGN presented with Ipsen (Euronext: IPN, ADR: IPSEY), a global specialty-driven pharmaceutical company, the discovery and characterization of ODS2005294, a novel LRRK2 inhibitor they jointly discovered in a research collaboration started in January 2012.

Gilead Announces Phase 3 Results for Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), an Investigational Once-Daily Single Tablet Regimen for HIV

R&DGilead2015-10-23 09:39 Read   1123

Gilead Sciences announced 96-week results from two Phase 3 studies (Studies 104 and 111) evaluating its investigational once-daily single tablet regimen (STR), Genvoya (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg or E/C/F/TAF), for the treatment of HIV-1 infection in treatment-naïve adults.

Ember Therapeutics Announce Initial Positive Results From a Phase 2 Trial of BMP-7 in Patients with Moderate Osteoarthritis of the Knee

R&DEmber2015-10-21 18:03 Read   392

Ember said that an initial analysis of 78 of the 320 total patients enrolled in the Phase 2 trial provided evidence that even a single local dose of BMP-7 could prevent cartilage loss and had potential anabolic effects.

Neurocrine Announces Initiation of Phase II Clinical Study of VMAT2 Inhibitor NBI-98854 in Adults with Tourette Syndrome

R&DNeurocrine2015-10-21 17:44 Read   276

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that it has expanded the clinical efforts for NBI-98854 (Valbenazine), a highly selective small molecule Vesicular Monoamine Transporter 2 (VMAT2) inhibitor, by initiating a Phase II clinical trial in adults with Tourette syndrome.  

Cancer Patients Treated with Lexicon’s Telotristat Etiprate Report Improved Function and Well-Being

R&DLexicon2015-10-20 17:42 Read   171

The first oral therapy in development for the treatment of carcinoid syndrome (CS), was associated with patient-reported improvements in social and physical function and emotional well-being according to new exit interview data from the Phase 3 TELESTAR study presented at the 2015 Neuroendocrine Tumor Society Annual Symposium in Austin, Texas.

Tarsa Therapeutics’ NDA for TBRIA(TM), the First Oral Calcitonin for the Treatment of Postmenopausal Osteoporosis, Accepted for Filing

R&DTarsa Therapeutics2015-10-20 17:13 Read   300

October 19, 2015 — TARSA Therapeutics, Inc. today announced that its New Drug Application (NDA) for TBRIATM(calcitonin-salmon [rDNA origin] delayed release tablets) submitted to the U.S. Food and Drug Administration (FDA) in July 2015, has been accepted for review, with a PDUFA date of May 30, 2016.

Phase 3 Data Show STELARA® Induced Clinical Response And Remission In The Treatment Of Patients With Moderate To Severe Crohn's Disease

R&DJanssen2015-10-20 16:53 Read   296

Phase 3 data presented for the first time showed treatment with STELARA® (ustekinumab) induced clinical response and clinical remission in patients with moderate to severe Crohn's disease who had previously failed conventional therapy, the majority of whom were naive to treatment with anti-tumor necrosis factor (TNF)-alpha therapy.

Pfizer’s Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia (ALL)

R&DPfizer2015-10-20 15:45 Read   1493

 October 19, 2015 I Pfizer Inc. today announced that investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for acute lymphoblastic leukemia (ALL).

Cempra Antibiotic Hits Phase 3 Target, FDA Filing Planned

Commentswww.xconomy.com2015-10-19 19:28 Read   228

Cempra’s next-generation antibiotic, which has been touted as a potential blockbuster, is moving toward an FDA filing on news that the drug achieved positive results in a Phase 3 clinical trial.

FDA rejects AstraZeneca's diabetes combo and demands more data

CommentsPharmacodia.com2015-10-19 00:00 Read   227

 The FDA wants to see more clinical trial data on AstraZeneca's ($AZN) new combination diabetes treatment, the company said, likely delaying a potential launch by more than a year.

In pharma M&A, 2015 trumps red-hot 2014 so far, report says

CommentsPharmacodia.com2015-10-18 00:00 Read   382

Think last year was a hot one for pharma M&A? Just take a look at 2015, a new report says.