Specialty Pharma Journal Specialty, Precision & Technology
BOTHELL, Wash.–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq: SGEN), a global biotechnology company, today announced that it is discontinuing the phase 3 CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in frontline older acute myeloid leukemia (AML) patients. Seattle Genetics took this action following consultation with the Independent Data Monitoring Committee (IDMC) and …
Tag Archives: clinical trials
June, 2017
October, 2016
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19 October
FDA Awards 21 Grants to Stimulate Product Development for Rare Diseases
The U.S. Food and Drug Administration today announced that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and …
August, 2016
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17 August
OncoGenex’s Prostate Cancer Candidate Fails in Late-Stage Trial
BOTHELL, Wash. and VANCOUVER, British Columbia, Aug. 16, 2016 /PRNewswire/ — OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today results from the final analysis of AFFINITY, the Phase 3 trial of custirsen in men with metastatic castrate-resistant prostate cancer (CRPC) whose disease has progressed after treatment with docetaxel. The trial did …
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5 August
FDA Puts a Partial Clinical Hold on Adaptimmune’s Cancer Therapy Trial
PHILADELPHIA and OXFORD, United Kingdom, Aug. 03, 2016 (GLOBE NEWSWIRE) — Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy for treatment of cancer, today announced that it has received notice from the U.S. Food and Drug administration that a partial clinical hold has been placed on its planned pivotal …
July, 2016
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18 July
Ziopharm Reports Patient’s Death in Gene Therapy Trial for Patients with Brain Cancer
BOSTON, July 15, 2016 (GLOBE NEWSWIRE) — ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) today issued the following statement regarding the Company’s ongoing multicenter Phase 1 study of Ad-RTS-hIL-12 + orally administered veledimex in recurrent or progressive glioblastoma (GBM) or grade III malignant glioma: “This Phase I study is being conducted in late-stage, …
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15 July
FDA Rejects Accelerated Review of Santhera’s Duchenne Muscular Dystrophy Drug
Liestal, Switzerland, July 14, 2016 – Santhera Pharmaceuticals (SIX:SANN) announces that it has received written correspondence from the U.S. Food and Drug Administration (FDA) on its proposed subpart H approval pathway for Raxone in DMD patients not taking concomitant glucocorticoids. Santhera had proposed that the planned SIDEROS trial would provide confirmatory …
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13 July
FDA Removes Clinical Hold on Juno’s CAR-T Trial
SEATTLE–(BUSINESS WIRE)–Juno Therapeutics, Inc. (Nasdaq: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced that the U.S. Food and Drug Administration has removed the clinical hold on the Phase II clinical trial of JCAR015 (known as the “ROCKET” trial) in …
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8 July
Pfizer’s Sutent Meets Primary Endpoint in its Late-Stage Kidney Cancer Trial
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the S-TRAC clinical trial (Sunitinib Trial in Adjuvant Renal Cancer), a Phase 3 study of SUTENT versus placebo in the adjuvant setting, met its primary endpoint of improving disease-free survival (DFS) as determined by blinded independent central review in patients with renal cell …
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7 July
FDA Places Clinical Hold on Juno Therapeutics’ Lead Drug After 3 Patient Deaths
SEATTLE–(BUSINESS WIRE)–Jul. 7, 2016– Juno Therapeutics, Inc. (NASDAQ:JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on the Phase II …
June, 2016
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8 June
Biogen’s Multiple Sclerosis Drug Misses Main Goal in its Phase 2 Study
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Today Biogen (NASDAQ: BIIB) reported top-line results from the Phase 2 SYNERGY study evaluating opicinumab (anti-LINGO-1), an investigational, fully human monoclonal antibody being developed as a potential neuroreparative therapy in people with relapsing forms of multiple sclerosis (RMS). In the study, opicinumab missed the primary endpoint, a multicomponent …