Clinical Trials (Phase III)
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Roche’s Tecentriq, in combination with chemotherapy, hit its co-primary endpoint of progression-free survival in a Phase III trial for non-small cell lung cancer patients. But, the Swiss pharma giant said the combination has so far failed to achieve statistical significance in overall survival, a...
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Allergan and Molecular Partners Announce Two Positive Phase 3 Clinical Trials for Abicipar pegol ...
7/19/2018
Allergan plc, a leading global pharmaceutical company and Molecular Partners, a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin® therapies, today announced the release of two positive clinical trials. -
AVEO Oncology Issues Statement Regarding Revised TIVO-3 Trial Guidance
7/19/2018
AVEO Oncology today issued the following statement regarding its recently revised guidance on the timing of topline data from the TIVO-3 study, its Phase 3 trial of tivozanib as a third-line treatment for advanced renal cell carcinoma.
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Journal of Clinical Oncology publishes pivotal Phase 3 data for Jazz Pharmaceuticals' Vyxeos® (daunorubicin and cytarabine) Liposome for Injection
7/19/2018
Jazz Pharmaceuticals plc announced that data from the pivotal Phase 3 study of Vyxeos® (daunorubicin and cytarabine) liposome for injection compared to standard of care cytarabine and daunorubicin (7+3) were published online in the Journal of Clinical Oncology.
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Innovative Alzheimer's Treatment from China Concludes Phase 3 Clinical Trials
7/19/2018
Green Valley plans to submit the application for treatment to the China National Drug Administration this Year
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New Phase 3 Data Show Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in Achieving Clinical Remission at Week 52 in Patients with Moderately to Severely Active Ulcerative Colitis
7/19/2018
Data to be discussed with global health authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)
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Genentech’s TECENTRIQ in Combination With Pemetrexed and Platinum-Based Chemotherapy Reduced the Risk of Disease Worsening or Death in the Initial Treatment of People With Advanced Lung Cancer
7/19/2018
Genentech announced that the Phase III IMpower132 study met its co-primary endpoint of progression-free survival (PFS)
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Pfizer and Eli Lilly released results from its 16-week Phase III clinical trial in patients with osteoarthritis (OA) pain receiving a subcutaneous dose of tanezumab. The drug hit all three co-primary endpoints.
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Pfizer And Lilly Announce Positive Top-Line Results From Phase 3 Trial Of Tanezumab For The Treatment Of Osteoarthritis (OA) Pain
7/18/2018
Tanezumab is also being evaluated for chronic low back pain (CLBP) and cancer pain (due to bone metastases).
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CTI BioPharma Announces Pacritinib Program Update Following Type B Meeting with U.S. FDA
7/18/2018
Regulatory path to include Phase 3 trial expected to begin in 2019
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Emmaus Life Sciences Announces the New England Journal of Medicine has Published the Phase 3 Trial Results of Endari™ (L-Glutamine Oral Powder) in Sickle Cell Disease
7/18/2018
Results showed a significant improvement in these measures: lower median number of sickle cell crises, fewer hospitalizations, lower cumulative days in hospital, and lower incidence of acute chest syndrome
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Fresh off its first Pipeline Day last week, Vivek Ramaswamy’s Roivant Sciences is taking aim at breaking into the Chinese market. Roivant has launched another company called Sinovant Sciences.
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The good news keeps coming for Janssen Pharmaceuticals’ SGLT2 diabetes drug Invokana. Late Monday the company said it was halting its Phase III chronic kidney disease trial early due to the fact that the drug had already achieved pre-specified efficacy data.
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With flu season fast approaching, Genentech has some good news for people who are at high risk of complications from the illness.
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Pulmatrix Announces Positive Top-Line Preliminary Results from Part 3 of the 3-Part Phase 1/1b Clinical Trial of Pulmazole - an Inhaled Dry-Powder iSPERSE™ Formulation of Itraconazole
7/17/2018
Single dose of Pulmazole safe and well tolerated in subjects with asthma
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Phase III CAPSTONE-2 Study Showed That Baloxavir Marboxil Reduced Symptoms in People at High Risk of Complications From the Flu
7/17/2018
Baloxavir marboxil – an investigational oral, single-dose antiviral – is the first flu medicine with a novel proposed mechanism of action in nearly 20 years and to demonstrate significant efficacy in high-risk populations
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One year after Vivek Ramaswamy launched Urovant Sciences to develop urological therapies, the company is now seeking $150 million from an initial public offering.
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Four months after filing a supplemental New Drug Application with the U.S. Food and Drug Administration, Astellas and Pfizer snagged regulatory approval for Xtandi as a treatment for non-metastatic Castration-Resistant Prostate Cancer (CRPC).
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Fusion Pharma Announces Formation of Advisory Board
7/16/2018
Inaugural Advisory Board Includes Internationally Renowned Experts In Oncology and Radiation Therapy.
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Pfizer Initiates Pivotal Phase 3 Program for Investigational Hemophilia B Gene Therapy
7/16/2018
Phase 3 lead-in study initiated following completion of the transfer of Spark Therapeutics’ hemophilia B gene therapy program to Pfizer