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No list of clinical disasters is ever complete without GlaxoSmithKline

R&Dfiercebiotech2015-10-30 10:21 Read   258

No list of clinical disasters is ever complete without GlaxoSmithKline.

Lilly's the Phase III for CETP inhibition evacetrapib failed

R&Dfiercebiotech2015-10-30 09:56 Read   191

The third straight Phase III failure for CETP inhibition points to trouble ahead for Merck.

Astellas Inititaties Phase 3 Registration Trial of gilteritinib (ASP2215) in Relapsed or Refractory Acute Myeloid Leukemia Patients

R&DPipelinereview2015-10-29 18:26 Read   523

Astellas announced dosing of the first patient in a randomized Phase 3 registration trial of gilteritinib (ASP2215) versus salvage chemotherapy in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML).

Macrocure Ltd. Announces Results for Phase III Clinical Trial of CureXcell(R) in Diabetic Foot Ulcers and Provides Corporate Update

R&DPipelinereview2015-10-29 18:26 Read   207

Macrocure announced that results from a pivotal Phase 3 of CureXcell(R) in the treatment of diabetic foot ulcers (DFUs) did not meet its primary endpoint.

Celltrion Healthcare: No difference in efficacy or immunogenicity following switch to Remsima® (infliximab) from originator

R&DPipelinereview2015-10-29 18:26 Read   428

Celltrion Healthcare: No difference in efficacy or immunogenicity following switch to Remsima (infliximab) from originator

Boehringer Ingelheim’s Biosimilar Candidate Demonstrated Pharmacokinetic Bioequivalence to Adalimumab

R&DPipelinereview2015-10-29 18:26 Read   547

Boehringer Ingelheim today announced results from a Phase I study (NCT02045979) of its biosimilar candidate (BI695501) for adalimumab (AbbVie’s Humira).

Shire's OPUS-3 Phase 3 Trial with Lifitegrast Meets Primary and Key Secondary Endpoints, Significantly Reducing Patient-Reported Symptoms for Dry Eye Disease

R&DPipelinereview2015-10-28 17:54 Read   491

Shire plc (LSE: SHP, NASDAQ: SHPG) today announced positive topline results from OPUS-3, a phase 3 efficacy and safety study of lifitegrast versus placebo.

Amgen and Cytokinetics Announce Positive Top-Line Results From COSMIC-HF, A Phase 2 Trial of Omecamtiv Mecarbil in Patients With Chronic Heart Failure

R&DAmgen2015-10-28 17:47 Read   298

Amgen (NASDAQ:AMGN) and Cytokinetics Incorporated (NASDAQ:CYTK) today announced that data from the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure).

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.