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Roche CEO: Big Data needs Big Pharma, and vice versa

CommentsPharmacodia.com2015-10-10 00:00 Read   290

Count Roche CEO Severin Schwan among those who see digital partnerships as the way Big Pharma can finally take advantage of Big Data. And to his mind, tech companies really need to take advantage of pharma's expertise if they want to get ahead in healthcare.

TauRx Completes US$135m Financing Round to Support Phase 3 Clinical Trials Program in Alzheimer's and Frontotemporal Dementia

TrendPharmacodia.com2015-10-09 00:00 Read   369

TauRx Pharmaceuticals Ltd, a clinical-stage biopharmaceutical company developing a novel treatment for Alzheimer's disease, announced the completion of the final tranche of a US$135m equity financing that it launched in March.

Results from ZINBRYTA™ (Daclizumab High-Yield Process) Phase 3 DECIDE Study Highlighting Efficacy Compared to Interferon Beta-1a Published in the New England Journal of Medicine and Presented at ECTRIMS

R&DPharmacodia.com2015-10-09 00:00 Read   477

Full results from the Phase 3 DECIDE study published this week in the New England Journal of Medicine (NEJM), as well as new post-hoc analyses of Phase 3 clinical data presented at an international congress, show once-monthly, investigational ZINBRYTA™ (daclizumab high-yield process [HYP]) improved results on key measures of multiple sclerosis (MS) disease activity in patients with relapsing-remitting MS (RRMS) compared to interferon beta-1a 30 mcg intramuscular (IM) injection.

OPKO Presents Clinical Data on its Long-acting Human Growth Hormone (hGH-CTP) in Two Oral Presentations at the 54th Annual Meeting of the European Society for Pediatric Endocrinology (ESPE)

R&DPharmacodia.com2015-10-09 00:00 Read   365

OPKO Health, Inc. presented clinical data from its completed 12-month hGH-CTP Phase 2 pediatric growth hormone deficiency clinical study in two oral presentations at the 54th Annual Meeting of the European Society for Paediatric Endocrinology on October 3, 2015, in Barcelona, Spain. The presentations included pharmacokinetic, pharmacodynamic, safety and efficacy data of OPKO's hGH-CTP in comparison to a daily Genotropin arm.

UCB with positive results for Vimpat® (lacosamide) in EU Phase 3 monotherapy study

R&DPharmacodia.com2015-10-09 00:00 Read   665

UCB announced positive results of a Phase 3 non-inferiority study designed to compare efficacy and safety of lacosamide to carbamazepine-CR (controlled release; retard tablets) as monotherapy in newly or recently diagnosed adult patients with partial-onset seizures. The study met its primary endpoint for the proportion of patients remaining seizure free for six consecutive months of treatment. UCB plans to submit to the European Medicines Agency (EMA) these data as part of its variation file to extend the marketing authorization of lacosamide as monotherapy , which is planned in the first half of 2016.

MD Anderson, Theraclone Sciences form OncoResponse

TrendPharmacodia.com2015-10-09 00:00 Read   177

OncoResponse, an immuno-oncology antibody discovery company, has been launched jointly by The University of Texas MD Anderson Cancer Center and Theraclone Sciences, of Seattle, Washington.

Glycotope and Octapharma enter exclusive worldwide license agreement on human blood coagulation factors

TrendPharmacodia.com2015-10-09 00:00 Read   195

October 8, 2015, Glycotope GmbH, a global leader in glyco-optimization of biopharmaceuticals, and Octapharma AG, one of the worldwide largest human protein product manufacturers, announced today that they have entered into an exclusive worldwide licensing agreement for Glycotope's portfolio of preclinical human blood coagulation factors based on its unique and proprietary GlycoExpress(TM) (GEX(TM)) technology platform.

Long-term efficacy of Gilenya® reinforced by new 'no evidence of disease activity' (NEDA-4) analysis in MS patients over seven years

R&DPharmacodia.com2015-10-09 00:00 Read   533

Novartis announced today a new analysis from the phase III FREEDOMS and FREEDOMS II trials reinforcing the long-term efficacy profile of Gilenya® (fingolimod). The analysis evaluated the proportion of Gilenya patients with relapsing multiple sclerosis (RMS) achieving 'no evidence of disease activity' (NEDA-4) every year over seven years.

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.

Roche looks to shake up the MS market with some promising Phase III data

CommentsPharmacodia.com2015-10-09 00:00 Read   258

Roche's much-hyped multiple sclerosis treatment ocrelizumab kept up its momentum with the release of detailed late-stage data, burnishing hopes the injected drug is a blockbuster in the making.