Publication: Drug Discovery and Development

First reported 21 hours ago - Updated 2 hours ago - 1 reports

Blood Pressure Drug Prevents Epilepsy After Brain Injury

Between 10 and 20% of all cases of epilepsy result from severe head injury, but a new drug promises to prevent post-traumatic seizures and may forestall further brain damage caused by seizures in those who already have epilepsy.A team of researchers from ... [Published Drug Discovery and Development - 21 hours ago]
First reported 21 hours ago - Updated 4 hours ago - 1 reports

Glioblastoma Vaccine Hits Primary Endpoints in Phase 1

Immatics biotechnologies GmbH, together with its collaborators Cancer Research UK and Cancer Research Technology, announced that they have entered a license agreement in which Immatics will continue to develop its cancer vaccine IMA950 for glioblastoma, ... [Published Drug Discovery and Development - 21 hours ago]
First reported 21 hours ago - Updated 9 hours ago - 1 reports

Alexion's Soliris Gets EC Orphan Status for New Treatment

Alexion Pharmaceuticals Inc. announced that the European Commission has granted an orphan drug designation (ODD) to Soliris (eculizumab), a first-in-class terminal complement inhibitor, for the prevention of graft rejection following solid organ transplantation. ... [Published Drug Discovery and Development - 21 hours ago]
First reported 17 hours ago - Updated 17 hours ago - 1 reports

FDA Clears IND Amendment for Hematologic Cancer Drug

Fate Therapeutics Inc., a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application ... [Published Drug Discovery and Development - 17 hours ago]
First reported 21 hours ago - Updated 19 hours ago - 1 reports

FDA Fast Tracks OncoGenex Drug for Prostate Cancer

OncoGenex Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of custirsen when administered in combination with cabazitaxel/prednisone for the treatment of men with metastatic ... [Published Drug Discovery and Development - 21 hours ago]
First reported 21 hours ago - Updated 20 hours ago - 1 reports

Bayer Submits Riociguat for PAH in Japan

Bayer HealthCare has filed riociguat for the treatment of pulmonary arterial hypertension (PAH) for regulatory approval in Japan. PAH is a progressive and life-threatening form of pulmonary hypertension in which the blood pressure in the pulmonary arteries ... [Published Drug Discovery and Development - 21 hours ago]
First reported Apr 22 2014 - Updated Apr 23 2014 - 1 reports

Pfizer Reports Positive Phase 3 Results for Psoriasis Drug

Pfizer Inc. announced top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials (OPT) Program, OPT Pivotal #1 (A3921078) and OPT Pivotal #2 (A3921079), evaluating the efficacy and safety of tofacitinib, an oral Janus kinase ... [Published Drug Discovery and Development - Apr 22 2014]
First reported Apr 22 2014 - Updated Apr 23 2014 - 1 reports

GSK, Theravance Launch Phase 3 COPD Trial

GlaxoSmithKline and Theravance Inc. announced the start of a Phase 3 efficacy and safety study of a combination treatment of the inhaled corticosteroid (ICS), fluticasone furoate and long-acting beta-2 agonist (LABA), vilanterol (FF/VI). The study will ... [Published Drug Discovery and Development - Apr 22 2014]
First reported Apr 22 2014 - Updated Apr 22 2014 - 1 reports

Breaking News: Gastric Cancer Drug Approved

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Cyramza (ramucirumab) as a single-agent treatment for patients with advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma with ... [Published Drug Discovery and Development - Apr 22 2014]
First reported Apr 22 2014 - Updated Apr 22 2014 - 1 reports

AbbVie Submits NDA for Hep C Regimen

AbbVie submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis ... [Published Drug Discovery and Development - Apr 22 2014]
First reported Apr 22 2014 - Updated Apr 22 2014 - 1 reports

Zonegran Shows Promise in Children with Partial Epilepsy

Zonegran (zonisamide) is well tolerated and efficacious when used as an adjunctive (add-on) treatment for partial epilepsy, with or without secondary generalization, in children aged between six and 17 years for at least one year, according to the results ... [Published Drug Discovery and Development - Apr 22 2014]
First reported Apr 21 2014 - Updated Apr 21 2014 - 1 reports

Emergent’s BioThrax Granted Orphan Drug Status

Emergent BioSolutions Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BioThrax (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed ... [Published Drug Discovery and Development - Apr 21 2014]

Quotes

...with leukemia, many of whom may ultimately require HSC transplantation," commented Pratik Multani, chief medical officer of Fate Therapeutics. "Building upon our encouraging clinical experience with Prohema in adult patients, we look forward to expanding our clinical program to pediatric patients with life-threatening forms of leukemia and other hematologic malignancies. Our goal is to deliver a pharmacologically-optimized HSC therapeutic that can support rapid and durable hematologic and immunologic reconstitution, and enable the curative potential of HSC transplantation in patients across a wide range of ages and a broad spectrum of life-threatening malignant and rare genetic disorders."
...submission is a significant advancement for AbbVie's HCV development program," said Scott Brun, vice president, Pharmaceutical Development, AbbVie. "Based on the robust data that have been generated in our international Phase 3 HCV program, we believe our all-oral, interferon-free regimen holds the potential to be a promising new therapy for patients living with this chronic infection."
...extend the lives of people with cancer," said Richard Gaynor, senior vice president, product development and medical affairs for Lilly Oncology. "Until now, there were no FDA-approved options for patients in this indication. We are pleased that the FDA has approved Cyramza for these patients. This is an aggressive disease that is difficult to treat, and the prognosis has typically been very poor."
...remain refractory to treatment," pointed out Professor Renzo Guerrini from the Children's Hospital Anna Meyer-University of Florence, Italy. "There is still a need for additional treatment options. The results of this 1-year open-label extension of a randomized-controlled study of zonisamide are therefore particularly welcomed and zonisamide could be a valuable treatment option for children with partial epilepsy."

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FDA Clears IND Amendment for Hematologic Cancer... [Published Drug Discovery and Development - 17 hours ago]
Alexion's Soliris Gets EC Orphan Status for New... [Published Drug Discovery and Development - 21 hours ago]
FDA Fast Tracks OncoGenex Drug for Prostate Cancer [Published Drug Discovery and Development - 21 hours ago]
Bayer Submits Riociguat for PAH in Japan [Published Drug Discovery and Development - 21 hours ago]
Blood Pressure Drug Prevents Epilepsy After Bra... [Published Drug Discovery and Development - 21 hours ago]
Glioblastoma Vaccine Hits Primary Endpoints in ... [Published Drug Discovery and Development - 21 hours ago]
Pfizer Reports Positive Phase 3 Results for Pso... [Published Drug Discovery and Development - Apr 22 2014]
AbbVie Submits NDA for Hep C Regimen [Published Drug Discovery and Development - Apr 22 2014]
Breaking News: Gastric Cancer Drug Approved [Published Drug Discovery and Development - Apr 22 2014]
Zonegran Shows Promise in Children with Partial... [Published Drug Discovery and Development - Apr 22 2014]
GSK, Theravance Launch Phase 3 COPD Trial [Published Drug Discovery and Development - Apr 22 2014]
Emergent’s BioThrax Granted Orphan Drug Status [Published Drug Discovery and Development - Apr 21 2014]
FDA Guides Sarepta on Muscular Dystrophy Drug NDA [Published Drug Discovery and Development - Apr 21 2014]
Cubist Submits Ceftolozane/Tazobactam NDA [Published Drug Discovery and Development - Apr 21 2014]
Daiichi Sankyo Names New Executive Appointment [Published Drug Discovery and Development - Apr 21 2014]
Ivabradine Fast Tracked for Chronic HF [Published Drug Discovery and Development - Apr 18 2014]
Canada is First to Approve GSK's New COPD Drug [Published Drug Discovery and Development - Apr 18 2014]
Productive Hands-Free Evaporation [Published Drug Discovery and Development - Apr 17 2014]
VentiRx Completes Enrollment in Study of Orphan... [Published Drug Discovery and Development - Apr 17 2014]
A Cinderella Story: Stem Cells in Personalized ... [Published Drug Discovery and Development - Apr 17 2014]
EC, FDA Give Orphan Status to Boehringer’s New ... [Published Drug Discovery and Development - Apr 17 2014]
Phase 1 Results Positive for Tumor Vaccine [Published Drug Discovery and Development - Apr 16 2014]
Small Molecule Shows Potential in Advanced Cancers [Published Drug Discovery and Development - Apr 16 2014]
Drug Developers Using New Models, Methods to Bo... [Published Drug Discovery and Development - Apr 16 2014]
AbbVie’s Lung Cancer Drug Advances to Phase 3 [Published Drug Discovery and Development - Apr 15 2014]
2014 R&D 100 Awards Entry Deadline Extended [Published Drug Discovery and Development - Apr 15 2014]
FDA OKs Trials for Vivolux First-in-Class Cance... [Published Drug Discovery and Development - Apr 15 2014]
Ex Vivo Data Supports Mast's Sickle Cell Treatment [Published Drug Discovery and Development - Apr 14 2014]
FDA Accepts BI, Lilly NDA for Type 2 Diabetes C... [Published Drug Discovery and Development - Apr 14 2014]
Janssen Posts Final Data from Phase 2 COSMOS Study [Published Drug Discovery and Development - Apr 14 2014]
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