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AZ gets $100m from Lilly as Alzheimer's drug moves into phase III

TrendPmlive2016-04-12 10:26 Read   189

AstraZeneca and Eli Lilly's candidate therapy for Alzheimer's disease (AD) has cleared a phase II/III trial and will now move on to pivotal phase III testing.

FDA Grants Priority Review for Genentech’s Cancer Immunotherapy Atezolizumab in Specific Type of Lung Cancer

Trenddrugs2016-04-12 10:17 Read   193

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy.

Pfizer's PCSK9 inhibitor clears another phase III trial

Trendpmlive2016-04-06 11:17 Read   106

Pfizer has reported positive phase III trial results with its cholesterol-lowering candidate bococizumab, setting up a possible regulatory filing in the coming months.

Merck And Pfizer Announce First Patient Treated In Phase III Combination Study With Avelumab And INLYTA® In Renal Cell Carcinom

Trendpfizer2016-04-06 11:04 Read   711

Merck and Pfizer (NYSE:PFE) today announced the treatment of the first patient in a Phase III study of avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in an advanced renal cell carcinoma (RCC) setting.

Motus Presents Clinical Proof-of-Concept Results for Relamorelin in the Treatment of Anorexia

TrendMotus2016-04-06 10:23 Read   125

Motus announced today the presentation of clinical proof-of-concept data for relamorelin (RM-131), Motus’ ghrelin agonist, in anorexia nervosa.

GSK gene therapy tops CHMP recommendations

TrendPMLIVE2016-04-05 11:18 Read   152

The EU's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of what could become the first corrective ex vivo gene therapy for children anywhere in the world.

GENFIT TO BEGIN ELAFIBRANOR CLINICAL PROGRAM IN PBC

TrendGENFIT2016-04-01 09:52 Read   108

GENFIT today announced at the GENFIT R&D Event in New York City, that the Company plans to begin a second Elafibranor clinical program in 2016, targeting unmet need in the liver disease Primary Biliary Cholangitis (PBC)

Lilly's new arthritis drug beats placebo in latest successful trial

TrendFierce biotech2016-04-01 09:38 Read   125

Eli Lilly ($LLY) and research partner Incyte ($INCY) released positive new data from the RA-BEACON Phase III trial showing its investigational rheumatoid arthritis pill baricitinib met its primary endpoint of improved ACR 20 response when compared with placebo at week 12.

Genital Herpes Immunotherapy GEN-003 Shows Sustained Reduction of Viral Shedding Rate, Durable Impact on Clinical Disease 12 Months Post-Dosing

TrendGenocea Biosciences2016-04-01 09:29 Read   285

Genocea Biosciences, Inc. (GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced positive 12 month efficacy data from its Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes.

Newron Receives Complete Response Letter from US FDA for Xadago® (safinamide)

TrendBUSINESS WIRE2016-03-31 12:37 Read   134

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a research and development company focused on novel CNS and pain therapies, and its partners Zambon S.p.A. and US WorldMeds announced today that a complete response letter from the FDA has been received for safinamide.

Keryx Biopharmaceuticals Announces Positive Top-line Results from Pivotal Phase 3 Study of Ferric Citrate for the Treatment of Iron Deficiency Anemia in Adults with Non-Dialysis Dependent Chronic Kidney Disease

TrendYAHOO2016-03-31 10:54 Read   78

Keryx Biopharmaceuticals, Inc. (KERX), a biopharmaceutical company focused on bringing innovative medicines to market for people with renal disease, today announced positive top-line results for its pivotal 24-week Phase 3 study of ferric citrate, an oral, iron-based medicine in development for the treatment of iron deficiency anemia (IDA) in adults with stage 3-5 non-dialysis dependent chronic kidney disease (NDD CKD).

Alder Reports Phase 2b Trial of ALD403 Meets Primary and Secondary Endpoints Demonstrating Migraine Prevention in Patients with Chronic Migraine

Trendyahoo2016-03-29 09:34 Read   175

Alder BioPharmaceuticals, Inc. (ALDR), today announced positive top-line data from two clinical trials evaluating ALD403, Alder’s proprietary monoclonal antibody product candidate for migraine prevention that targets calcitonin gene-related peptide (CGRP).