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GSK’s Advair® Diskus® achieves primary endpoint in LABA safety study of patients with asthma

R&DGSK2015-10-28 17:29 Read   394

GlaxoSmithKline plc (GSK) today announced results from the ‘LABA’ (long acting beta2-agonist) safety study, AUSTRI (SAS115359).

Ophthotech Completes Patient Recruitment of the Second Phase 3 Pivotal Trial of Fovista® Anti-PDGF Therapy in Combination with Lucentis® in Wet Age-Related Macular Degeneration

R&DOphthotech2015-10-28 17:22 Read   411

October 26, 2015 I Ophthotech Corporation (Nasdaq:OPHT) today announced the completion of patient recruitment for its second Phase 3 trial of Fovista (pegpleranib) in combination with Lucentis (ranibizumab) for the treatment of wet age-related macular degeneration (AMD).

Novavax Initiates Phase 2 Safety and Immunogenicity Trial to Evaluate Annual Re-Dosing of the RSV F Vaccine in Older Adults

R&DNovavax2015-10-26 18:03 Read   283

Novavax announced that enrollment has begun in a Phase 2 rollover clinical trial of its respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine) in older adults enrolled in the prior Phase 2 trial.

Novartis receives positive CHMP opinion for the first IL-17A inhibitor Cosentyx(TM) to treat ankylosing spondylitis and psoriatic arthritis

R&DPipelinereview2015-10-26 17:59 Read   1054

Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Cosentyx(TM) (secukinumab) in Europe to treat ankylosing spondylitis (AS) and psoriatic arthritis (PsA) patients.

Amgen Receives CHMP Positive Opinion For IMLYGIC™ (Talimogene Laherparepvec)

R&DAmgen2015-10-26 17:40 Read   631

 THOUSAND OAKS, CA, USA I October 23, 2015 I Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending that IMLYGIC™ (talimogene laherparepvec) be granted approval for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.

Reviva Pharmaceuticals Reports RP5063 Positive Efficacy Results for Memory Deficits

R&DReviva2015-10-26 17:18 Read   812

 Reviva Pharmaceuticals, Inc., a privately held drug discovery and development company, today presented new positive preclinical efficacy data for memory deficits at the Society for Neuroscience annual meeting in Chicago. RP5063 reverses and prevents subchronic phencyclidine-induced declarative memory deficits and increases cortical dopamine efflux in C57BL/6J mice.

FDA Advisory Committee recommends the approval of lesinurad for gout patients

RegulatorPipelinereview2015-10-26 14:37 Read   363

October 23, 2015 I AstraZeneca today announced that the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 4 to recommend the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout.

Roche's Kadcyla fails in gastric cancer trial

R&DPmlive2015-10-25 19:59 Read   317

Kadcyla (trastuzumab emtansine) - an antibody-drug conjugate (ADC) that links the antibody in Roche's Herceptin to a cytotoxic molecule - was unable to show a benefit as a second-line treatment for HER2-positive advanced gastric cancer in the study.

Strategic planning in pharma and avoiding frog soup

CommentsPmlive2015-10-25 19:46 Read   297

The secret of strategic planning in the pharmaceutical industry may come from asking the most unlikely of questions: has my brand team succumbed to the Parable of the Boiled Frog?

MacroGenics and Merck to Collaborate on Immuno-Oncology Study Evaluating Margetuximab in Combination with KEYTRUDA(R) (pembrolizumab) for Advanced Gastric Cancer

TrendMacroGenics2015-10-23 11:07 Read   372

Clinical trial to evaluate MacroGenics' Fc-optimized anti-HER2 antibody with Merck's anti-PD-1 therapy in patients with advanced HER2-positive gastric cancer

Xenon Announces Its Partner Genentech Has Advanced GDC-0310, a Second Nav1.7 Inhibitor for Pain, Into Clinical Development

R&Dpeplinereview2015-10-23 10:46 Read   393

Xenon Pharmaceuticals Inc. announced that the Company's partner Genentech, a member of the Roche Group, has advanced a second Nav1.7 inhibitor into clinical development.

OXiGENE Announces Initiation of Phase 1b/2 Clinical Trial of OXi4503 in Acute Myeloid Leukemia

R&DOXiGENE 2015-10-23 10:33 Read   241

October 21, 2015, OXiGENE, Inc. (OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, today announced that it has initiated a phase 1b/2 clinical trial (Study OX1222) of its investigational drug OXi4503 for treatment of acute myeloid leukemia (AML).