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 The leading web portal for pharmacy resources, news, education and careers June 25, 2017
Pharmacy Choice - News - Pharmaceutical Development - June 25, 2017

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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6/25/17 - AOP Orphan and PharmaEssentia announce latest clinical results for Ropeginterferon alfa-2b in Polycythemia Vera from 3 abstracts presented at the 22nd Congress of the European Hematology Association (EHA) in Madrid
VIENNA and TAIPEI, Taiwan, June 25, 2017/ PRNewswire/ AOP Orphan Pharmaceuticals AG and PharmaEssentia Corporation announced latest results from 3 clinical studies on Ropeginterferon alfa-2b for patients with Polycythemia Vera presented at EHA 2017.. Ropeginterferon alfa-2b is a novel, long-acting, mono-pegylated proline interferon expected to be
6/25/17 - CytRx Announces Update on the Regulatory Pathway for Aldoxorubicin in Soft Tissue Sarcomas
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA CytRx Corporation a biopharmaceutical research and development company specializing in oncology, announced an update on the regulatory pathway for a New Drug Application submission for aldoxorubicin in soft tissue sarcomas. The Company plans to submit a rolling NDA under secti
6/25/17 - Dasatinib excels in worldwide phase II trial against pediatric CML
By a News Reporter-Staff News Editor at VerticalNews Science In 2002, the FDA approved the drug imatinib as a first-line therapy for adults with chronic myeloid leukemia caused by the fusion gene BCR-ABL, known as the Philadelphia chromosome. Now worldwide phase II clinical trial results presented at the American Society for Clinical Oncology Ann
6/25/17 - Data on Diabetes Detailed by Researchers at University of North Carolina (The Role of the FDA and Regulatory Approval of New Devices for Diabetes...
Data on Diabetes Detailed by Researchers at University of North Carolina. According to news reporting originating from Chapel Hill, North Carolina, by NewsRx correspondents, research stated, "Purpose of Review The Food and Drug Administration is responsible for assuring the safety, effectiveness, and quality of medical devices in the USA.
6/25/17 - IDEAS study spurs related research to impact dementia care
By a News Reporter-Staff News Editor at VerticalNews Health& Science Washington, DC and Chicago, The milestone Imaging Dementia- Evidence for Amyloid Scanning Study is working with government and academic researchers to launch three add-on studies to expand the impact of the core study where more than 18,000 people with cognitive decline but an u
6/25/17 - Investigational vaccine protected monkeys from HIV-like virus
By a News Reporter-Staff News Editor at VerticalNews Health DURHAM, N.C. Building on insights from an HIV vaccine regimen in humans that had partial success during a phase 3 clinical trial in Thailand, a Duke-led research team used a more-is-better approach in monkeys that appeared to improve vaccine protection from an HIV-like virus. "The vac
6/25/17 - Lenvatinib Demonstrates Positive Results vs Sorafenib Across All Endpoints in First-Line Phase 3 Non-inferiority Trial of Unresectable Hepatocellular...
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Eisai Inc. announced results from the REFLECT study, a Phase 3 trial evaluating lenvatinib, the company's multiple receptor tyrosine kinase inhibitor, for the first-line treatment of patients with unresectable hepatocellular carcinoma. These data will be presented in an oral..
6/24/17 - Bipartisan Group of Senators Urge FDA Commissioner to Address Prescription Drug Costs
Commissioner Gottlieb recently stated that the FDA will take measures to curb anticompetitive abuses of its regulatory process for the approval of generic drugs. In their letter, the senators advocate for their legislative solution and ask Commissioner Gottlieb to detail the regulatory actions the FDA can and cannot take to address strategies that.
6/24/17 - Bristol-Myers Squibb Announces Availability of New ORENCIA abatacept Subcutaneous Administration Option for Patients 2 Years of Age and Older with...
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week Bristol-Myers Squibb Company announced the availability of a new FDA- approved subcutaneous ORENCIA administration option for use in patients 2 years of age and older with moderately to severely active polyarticular Juvenile Idiopathic Arthritis. 1 The new prefilled syringe o
6/24/17 - Development of New Alzheimer's Drugs Lagging, Cleveland Clinic Report Finds
Alzheimer's disease drug development: pipeline 2017 is Cleveland Clinic's second annual review of Alzheimer's disease drug development and appears in the journal Alzheimer's& Dementia: Translational Research& Clinical Trials Interventions. "The purpose of presenting our annual findings is to help better understand the status of Alzheimer's disease
6/24/17 - FDA Approves CSL Behring`s Self-Administered C1 Esterase Inhibitor HAE Prophylactic [Syrian Arab News Agency]
The FDA approved CSL Behrings subcutaneously administered C1 esterase inhibitor, Haegarda, for routine use in preventing hereditary angioedema attacks in adolescent and adult patients. The FDA approval of Haegarda is an important milestone for the HAE community because it addresses the primary need of patients: to effectively prevent debilitating H
6/24/17 - FDA rejects Pfizer`s Epogen biosimilar for the second time [Arab Finance (Egypt)]
This time around, an FDA complete response letter cited concerns about the same Pfizer fill-finish plant whose problems led the FDA to deny approval of a highly anticipated copy of Tevas Copaxone that was to be finished there. Pfizer late Thursday announced the FDA had issued the CRL for its proposed epoetin alfa biosimilar, a drug that has been on
6/24/17 - Genentechs subcutaneous rituximab approved in US [Sport360]
With cheaper biosimilars of the original Rituxan formulation edging closer to the US market, Genentechs owner Roche is looking for ways to maintain sales. Rituximab biosimilars have already been approved in Europe, where the subcutaneous formulation was approved last year. The FDA noted that the US label will include the following previously approv
6/24/17 - Indivior Presents Phase III data on Potential Drug for Opioid Use Disorder [T-break Tech (Middle East)]
Indivior PLC announced the presentation of results from its pivotal Phase 3 clinical trial evaluating the efficacy and safety of RBP-6000, an investigational once-monthly injectable buprenorphine in the ATRIGEL delivery system for the treatment of adults with moderate-to-severe opioid use disorder as part of a complete treatment plan to include...
6/24/17 - New Data from Phase 1/2 Trial of Oral IDHIFA (enasidenib) Demonstrate Durable Complete Responses in Patients with IDH2 Mutant Relapsed or Refractory AML
Agios Pharmaceuticals, Inc. today announced new efficacy and safety data from the ongoing Phase 1/ 2 dose-escalation and expansion study evaluating investigational oral IDHIFA in patients with relapsed or refractory acute myeloid leukemia and an isocitrate dehydrogenase-2 mutation. Data in an oral session at the 22nd Congress of the European..
6/24/17 - Pfizer scientists devise 2-pronged attack against blood cancers [Arab Finance (Egypt)]
Now, scientists at Pfizer have figured out how to make those cells even more vulnerable to direct attackby driving them from their favorite hiding place. Pfizer has begun a phase 1 trial of a new antibody designed to do just that, called PF-06747143, the company reported Wednesday. The research was published in the American Society of Hematologys j
6/24/17 - Recce constructs automated manufacturing facility to support clinical trials [Sport360]
The new automated manufacturing process developed by Recce has been constructed using off-the-shelf components including the latest bioreactor technology by German pharmaceutical equipment manufacturer, Sartorius Stedim Biotech, saving on development costs, lead times and certifications. The remaining commissioning of the plant will ensure the...
6/24/17 - Roches Top-Selling Cancer Drug Approved in Faster Injection Form [T-break Tech (Middle East)]
The U.S. Food and Drug Administration approved Rituxan Hycela for subcutaneous injection. The FDA approval is for the treatment of adults with three blood cancers: previously untreated or relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously treated chronic lymphocytic leukemia.
6/24/17 - Sen. Grassley Joins Klobuchar, Bipartisan Group of Senate Judiciary Committee Members to Urge FDA Commissioner to Address Abuses in Regulatory Process That Delay Competition and Increase Prescription Drug Costs
Commissioner Gottlieb recently stated that the FDA will take measures to curb anticompetitive abuses of its regulatory process for the approval of generic drugs. In their letter, the senators advocate for their legislative solution and ask Commissioner Gottlieb to detail the regulatory actions the FDA can and cannot take to address strategies that.
6/24/17 - Spark Therapeutics to Present Updated Hemophilia B Data at the International Society on Thrombosis and Haemostasis (ISTH) 2017 Congress [Tehran Times (Iran)]
-Spark Therapeutics, a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, announced today that Lindsey George, M.D., attending physician in the Division of Hematology at Children`s Hospital of Philadelphia, and a clinical investigator in the Phase 1/ 2 clinical trial ofSPK-9001 for hemophilia B, wil
6/24/17 - Takeda Presents Data from Phase 1/2 Studies for NINLARO (ixazomib) in Newly Diagnosed Multiple Myeloma Patients and in the Maintenance Setting [Syrian Arab News Agency]
Takeda Pharmaceutical Company Limited today announced that data from two Phase 1/ 2 clinical trials evaluating NINLARO in patients with newly diagnosed multiple myeloma will be presented during oral sessions at the 2017 European Hematology Association annual meeting on Saturday, June 24, 11:45 a.m. 12 p.m. CEST and Sunday, June 25, 8:15 a.m. 8:30 a
6/24/17 - Tumour characteristics could predict immunotherapy success in lung cancer [T-break Tech (Middle East)]
The molecular make-up of lung tumours could help identify patients who might benefit from immunotherapy treatment up front, a new study has found. The phase 3 clinical trial, run by The Ohio State University Comprehensive Cancer Center in the US, suggests that immunotherapy given before other drugs could improve the outlook for certain patients wit
6/24/17 - U.S. FDA Approves Bevyxxa (betrixaban) First and Only Anticoagulant for Hospital and Extended Duration Prevention of Venous Thromboembolism (VTE) in Acutely Ill Medical Patients [Sudan Tribune]
-Portola Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration has approved Bevyxxa, the first and only anticoagulant for hospital and extended duration prophylaxis of venous thromboembolism in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe...
6/24/17 - US FDA rejects Pfizer`s Epogen biosimilar citing McPherson site warning [T-break Tech (Middle East)]
Pfizer announced that epoetin alfa had been rejected yesterday, explaining the US Food and Drug Administration had issued a complete response letter related to matters noted in a Warning Letter issued on February 14, 2017. In addition, Pfizer made clear the FDA had not asked for additional clinical data, which is something that was requested when t
6/24/17 - With GlaxoSmithKline eager for marketing approval, Shingrix passes revaccination test [T-break Tech (Middle East)]
Awaiting a potential FDA approval, GlaxoSmithKlines much-anticipated shingles vaccine Shingrix met its goal in a phase 3 study examining whether it can protect older adults who have previously received Mercks Zostavax. Since previous studies have shown Zostavaxs protection wanes over time, the results could mean a new option for those whove already
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