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Phase 3 Data Show STELARA® Induced Clinical Response And Remission In The Treatment Of Patients With Moderate To Severe Crohn's Disease

R&DJanssen2015-10-20 16:53 Read   296

Phase 3 data presented for the first time showed treatment with STELARA® (ustekinumab) induced clinical response and clinical remission in patients with moderate to severe Crohn's disease who had previously failed conventional therapy, the majority of whom were naive to treatment with anti-tumor necrosis factor (TNF)-alpha therapy.

Pfizer’s Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia (ALL)

R&DPfizer2015-10-20 15:45 Read   1493

 October 19, 2015 I Pfizer Inc. today announced that investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for acute lymphoblastic leukemia (ALL).

OncoQR’s Breast Cancer Vaccine Successfully Completes Pre-Clinical Proof-of-Concept Study

R&DPharmacodia.com2015-10-17 00:00 Read   256

OncoQR ML, a company developing Adjustable Cancer Immunotherapies, today announced that its breast cancer vaccine candidate OQR200 has successfully completed a proof-of-concept study in non-human primates (NHPs).

PTC Announces Results from Phase 3 ACT DMD Clinical Trial of Translarna™ (ataluren) in Patients with Duchenne Muscular Dystrophy

R&DPharmacodia.com2015-10-17 00:00 Read   580

October 15, 2015, PTC Therapeutics, Inc. (PTCT) today announced results from the Phase 3, double-blind, placebo-controlled, 48-week ACT DMD trial of Translarna™ (ataluren), an oral, first-in-class, protein restoration therapy for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

Pfizer Receives Complete Response Letter from FDA for Oral XELJANZ® (tofacitinib citrate) Supplemental New Drug Application for Moderate to Severe Chronic Plaque Psoriasis

R&DPharmacodia.com2015-10-16 00:00 Read   1161

October 14, 2015, Pfizer Inc. (NYSE: PFE) announced today it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis.

Galapagos advances triple combination therapy in cystic fibrosis

R&DPharmacodia.com2015-10-16 00:00 Read   308

Galapagos NV announced today that GLPG2665 has been selected as the first next generation corrector compound candidate.

Loxo Oncology Announces First Patient Enrolled in LOXO-101 Phase 2 Basket Trial in Patients With Solid Tumors Harboring TRK Fusions

R&DPharmacodia.com2015-10-16 00:00 Read   442

Loxo Oncology, Inc. (LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced the enrollment of the first patient in its Phase 2 basket trial of LOXO-101 in adult cancer patients whose tumors harbor tropomyosin receptor kinase (TRK) fusions.

Transition Therapeutics Announces Results of Data Analysis from ELND005 Phase 2/3 Clinical Study in Agitation and Aggression in Alzheimer's Disease Patients

R&DPharmacodia.com2015-10-16 00:00 Read   288

Transition Therapeutics Inc. ("Transition" or the "Company") (NASDAQ: TTHI, TSX: TTH) announced that its subsidiary, Transition Therapeutics Ireland Limited ("TTIL"), has completed a thorough review of the data related to the Phase 2/3 study of ELND005 in Alzheimer's disease ("AD") patients with moderate or severe agitation and aggression.

Eleven Biotherapeutics Completes Enrollment in Pivotal Phase 3 Study of Isunakinra (EBI-005) in Patients with Allergic Conjunctivitis

R&DPharmacodia.com2015-10-16 00:00 Read   252

Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced the completion of patient enrollment in its first pivotal, Phase 3 clinical study of isunakinra (EBI-005) in patients with moderate to severe allergic conjunctivitis.

Cerulean Announces Completion of Enrollment of Randomized Phase 2 Trial of CRLX101 in Combination with Avastin® in Relapsed Renal Cell Carcinoma

R&DPharmacodia.com2015-10-16 00:00 Read   271

Cerulean Pharma Inc. (NASDAQ:CERU), a clinical stage company developing nanoparticle-drug conjugates (NDCs), today announced completion of enrollment of a randomized Phase 2 trial of its lead NDC, CRLX101, in combination with Avastin®, in third- and fourth-line relapsed renal cell carcinoma (RCC).

Alnylam Demonstrates Continued Commitment to Transthyretin-Mediated Amyloidosis Patients with Advancement of ALN-TTRsc02, an Investigational RNAi Therapeutic with Potential for Low Volume, Once Quarterly, Subcutaneous Dose Regimen

R&DPharmacodia.com2015-10-15 00:00 Read   363

Alnylam Pharmaceuticals, Inc. announced today that it presented key pre-clinical data and provided program guidance for ALN-TTRsc02, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR amyloidosis).

Baricitinib Demonstrates Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis in Pivotal Phase 3 Study

R&DPharmacodia.com2015-10-15 00:00 Read   731

Oct. 14, 2015, Eli Lilly and Company and Incyte Corporation announced positive topline results of RA-BEAM, the fourth successful Phase 3 study of baricitinib, an investigational medicine for patients with moderately-to-severely active rheumatoid arthritis.