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Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib - a CDK 4 and 6 Inhibitor - in Advanced Breast Cancer

R&DPharmacodia.com2015-10-09 00:00 Read   585

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer.

BioCryst Announces Completion of Patient Enrollment in OPuS-2: a Clinical Trial of Avoralstat in Patients With HAE

R&DPharmacodia.com2015-10-09 00:00 Read   215

October 8, 2015, BioCryst Pharmaceuticals, Inc., announced that it has completed enrollment in OPuS-2 (Oral ProphylaxiS-2), a blinded, randomized, placebo-controlled clinical trial of orally-administered avoralstat in patients with hereditary angioedema (HAE).

Pulmatrix's PUR1900 Inhaled Cystic Fibrosis Drug Demonstrates High Lung Retention and Potency Against Fungal Infection

R&DPharmacodia.com2015-10-09 00:00 Read   170

October 8, 2015, Pulmatrix, Inc. announced preclinical data showing that PUR1900 (iSPERSE™-formulated itraconazole), which is being developed as the first inhaled antifungal medication for cystic fibrosis, was active and potent in vitro against Aspergillus fumigatus, a pathogen causing pulmonary infection in cystic fibrosis, while achieving high lung concentrations and low systemic exposure in rats.

Treatment Effects Maintained Over Five Years in Majority of Patients with Relapsing Remitting Multiple Sclerosis who Received Genzyme's Lemtrada® (alemtuzumab) in Clinical Trials

R&DPharmacodia.com2015-10-09 00:00 Read   339

October 8, 2015, Sanofi and its subsidiary Genzyme today announced positive new five-year investigational data from the extension study of Lemtrada(alemtuzumab) for patients with relapsing remitting multiple sclerosis (RRMS).

Genentech’s Ocrelizumab First Investigational Medicine to Show Positive Pivotal Study Results in Both Relapsing and Primary Progressive Forms of Multiple Sclerosis

R&DPharmacodia.com2015-10-09 00:00 Read   391

October 8, 2015, Genentech, a member of the Roche group (SIX: RO, ROG; OTCQX: RHHBY) today announced data from three positive, pivotal Phase III studies of ocrelizumab in people with relapsing multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS).

Nektar Submits Investigational New Drug Application (IND) for NKTR-214 To Treat Solid Tumor Malignancies

R&DPharmacodia.com2015-10-08 00:00 Read   707

Nektar Therapeutics today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NKTR-214, its lead immuno-oncology candidate. NKTR-214 is a CD122-biased immune-stimulatory cytokine that is designed to stimulate the patient's own immune system to destroy cancer cells. The company plans to initiate a Phase 1/2 clinical study by the end of 2015. The study will evaluate the safety, tolerability and efficacy of NKTR-214 in patients with solid tumor malignancies and will include expansion cohorts that will evaluate NKTR-214 both as a single-agent and in combination with a checkpoint inhibitor.

Immune Pharmaceuticals Submits Investigational New Drug Application (IND) in the U.S. for its Lead Product Candidate Bertilimumab for the Treatment of Bullous Pemphigoid

R&DPharmacodia.com2015-10-08 00:00 Read   204

Immune Pharmaceuticals, Inc. announced today that it has submitted an Investigational New Drug Application in the U.S. to expand recruiting for its first in class lead product candidate, Bertilimumab, for the treatment of Bullous Pemphigoid (BP).

Ascend Announces Patients with Nodular Basal Cell Carcinoma Receives First Dose of ASN-002 in Phase 1/2a Study

R&DPharmacodia.com2015-10-08 00:00 Read   201

Ascend Biopharmaceuticals, a Melbourne-based immunotherapy company focused on developing innovative cancer therapeutics, today announced the first nodular Basal Cell Carcinoma patient (nBCC) dosed with ASN-002 (an injectable immunotherapy) in a Phase 1/2a clinical study. BCC is a type of non-melanoma skin cancer diagnosed in an estimated two million people worldwide every year. It is the most prevalent form of cancer in Australia, the United States and Europe. Surgery is currently the primary treatment for BCC, however for many patients it can be a poor treatment option for both clinical and cosmetic reasons.

New Data Show Strong, Sustained Effects of TECFIDERA® (Dimethyl Fumarate) in Newly-Diagnosed and Early Disease Course Multiple Sclerosis Patients

R&DPharmacodia.com2015-10-08 00:00 Read   502

Biogen's new data show that TECFIDERA significantly reduced multiple sclerosis (MS) relapses and delayed disability progression in patients who are newly diagnosed and those early in their disease course; these effects were sustained over six years of follow-up.

Advaxis Reports Clinical Hold of Investigational Agent Axalimogene Filolisbac

R&DPharmacodia.com2015-10-08 00:00 Read   283

Advaxis, Inc., a clinical-stage biotechnology company developing cancer immunotherapies, today announced that last Thursday the company received verbal notice from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for axalimogene filolisbac (formerly ADXS-HPV) has been placed on clinical hold, affecting four clinical trials.

New Analysis Suggests Aubagio® (teriflunomide) Slows Brain Atrophy in People with Relapsing Multiple Sclerosis

R&DPharmacodia.com2015-10-08 00:00 Read   322

Sanofi and its subsidiary Genzyme announced today that magnetic resonance imaging (MRI) data from the Phase III TEMSO study demonstrate that Aubagio® (teriflunomide) significantly slowed brain volume loss (or atrophy) vs. placebo over two years in people with relapsing multiple sclerosis (RMS). In this analysis, MRI data from TEMSO were analyzed utilizing SIENA (structural image evaluation using normalization of atrophy), an alternative methodology than originally used.

Roche's investigational combination of Cotellic and Zelboraf helped people with advanced melanoma live significantly longer than Zelboraf alone

R&DPharmacodia.com2015-10-08 00:00 Read   178

Roche today announced final survival data from the Phase III coBRIM study showing that Cotellic (cobimetinib), when used with Zelboraf (vemurafenib), helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer (overall survival, OS) compared to Zelboraf alone. Ongoing study monitoring did not identify any new safety signals. Long-term safety data are expected later this year.