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 The leading web portal for pharmacy resources, news, education and careers July 29, 2016
Pharmacy Choice - News - Pharmaceutical Development - July 29, 2016

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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7/29/16 - ACELRX PHARMACEUTICALS INC - 10-Q - Management's Discussion and Analysis of Financial Condition and Results of Operations
Examples of these statements include, but are not limited to, statements related to the process and timing of anticipated future development of AcelRx's product candidates, ARX-04 and Zalviso , including the ARX-04 clinical trial results; ability to fund ARX-04 development from the contract with the Department of Defense; anticipated submission o
7/29/16 - Caladrius Biosciences Receives FDA Fast Track Designation for CLBS03 to Treat Recent Onset Type 1 Diabetes
BASKING RIDGE, N.J.- Caladrius Biosciences, Inc., a cell therapy company combining an industry-leading development and manufacturing services provider, PCT, with a select therapeutic development pipeline, announces today that its product candidate CLBS03 was granted Fast Track designation by the US Food and Drug Administration for the treatment of
7/29/16 - Cosmo reports growth in product revenues and progress in late stage product and corporate development
Dublin, Ireland- 29 July 2016- Cosmo Pharmaceuticals N.V. announced today its half-year results for the period ended 30 June 2016. Revenues increased by 58.3% to EUR 31.6 million. Profits after tax declined to EUR 5.6 million or by 97.6% because last year's results were due to the profits on the placing of Cassiopea shares. The second phase III piv
7/29/16 - Diasome Announces Dosing of First Type 1 Diabetes Patient in Randomized Phase 2b Clinical Trial of Injectable Hepatocyte Directed Vesicle ("HDV") Technology With Insulin
Diasome Pharmaceuticals, Inc., a clinical stage life-sciences company developing novel liver hepatocyte targeting systems for injectable insulin therapies to improve the treatment of Type 1 and Type 2 diabetes, announced that patient dosing has commenced in its ISLE-1 Study, a multi-center, double-blinded, randomized controlled Phase 2 b clinical t
7/29/16 - Edge Therapeutics Announces First Patient Treated in Phase 3 NEWTON 2 Study of EG-1962 in Adult Patients with Aneurysmal Subarachnoid Hemorrhage
Edge Therapeutics, Inc., a clinical-stage biotechnology company developing novel hospital-based therapies in the management of acute, life-threatening conditions, today announced that the first patient has been treated in NEWTON 2, a Phase 3, multi-center, multi-national, randomized, double-blind, placebo-controlled, parallel-group study comparin
7/29/16 - From ketamine to cupboard therapy: the future of mental health treatment
Once upon a time, the future of mental health treatment was drugs. The advent of Prozac and whole class of similar medication in the 1990 s gave doctors an easy option and big pharma easy money. One reason Sergiu Pasca, assistant professor at Stanford University, went into research after completing medical training was his frustration when he saw w
7/29/16 - Galderma Announces FDA Approval of Full Prescription-Strength Differin Gel For Over-the-Counter Acne Use
By a News Reporter-Staff News Editor at Drug Week Galderma, a global leader focused on medical solutions in skin health, announced that its U.S. affiliate, Galderma Laboratories, L.P. received approval from the U.S. Food and Drug Administration for Differin Gel as an over-the-counter treatment for acne. It also marks the first new, FDA- approved
7/29/16 - InVivo Therapeutics Announces Update on the INSPIRE Study and FDA Approval of Expansion of the Study to 20 Evaluable Patients
By a News Reporter-Staff News Editor at Health& Medicine Week InVivo Therapeutics Holdings Corp. today provided an update on the INSPIRE study of the Neuro-Spinal Scaffold?. The implantation was performed by Vidant Medical Group neurosurgeons Stuart Lee, M.D., the Principal Investigator at the site, and Hilal Kanaan, M.D., approximately 40 hour
7/29/16 - Ligand Announces Multi-Program LTP Technology Licensing Agreement with Nucorion Pharmaceuticals
Ligand Pharmaceuticals Incorporated announces the signing of a license agreement for three programs utilizing Ligand s LTP technology with Nucorion Pharmaceuticals, Inc., a venture-funded biotechnology company focused on developing anti-cancer and anti-viral agents initially directed to China. Zucai Suo, Professor of Chemistry and Biochemistry a
7/29/16 - Neon Therapeutics Announces FDA Acceptance of Investigational New Drug Application for Cancer Vaccine NEO-PV-01
Neon Therapeutics, an immuno-oncology company developing neoantigen-based therapeutic vaccines and T cell therapies to treat cancer, today announced that the U.S. Food and Drug Administration has accepted the company s Investigational New Drug application for its lead program, NEO-PV-01. We are in the midst of tremendous momentum for neoantig
7/29/16 - NewLink Genetics Reports Second Quarter 2016 Financial Results
NewLink Genetics Corporation, a biopharmaceutical company focused on bringing novel immuno-oncology medicines to patients, today reported consolidated financial results for the second quarter of 2016 and provided updates on its clinical development programs and operational restructuring. NewLink Genetics is developing two distinct IDO pathway...
7/29/16 - Patent Issued for Pharmaceutical Compositions for Combination Therapy (USPTO 9387184)
By a News Reporter-Staff News Editor at Drug Week A patent by the inventors Hansen, Henrik Bjork; Grunnet, Morten; Bentzen, Bo Hjorth; Hyveled-Nielsen, Lars; Lassen, Jorgen Buus; Sundgreen, Claus, filed on November 10, 2015, was published online on July 12, 2016, according to news reporting originating from Alexandria, Virginia, by NewsRx corresp
7/29/16 - Quark Pharmaceuticals Awarded Key Patent for QPI-1007 Ocular Neuroprotectant
The QRK207 study is already enrolling in several countries, including the US and India with additional sites in Israel, Germany, Australia, Italy, and China opening soon. The clinical study is run by Quark in collaboration with Quark's partners Biocon Ltd in India and the Chinese joint venture company of Quark in China, Kunshan RiboQuark Pharmaceut
7/29/16 - Seres Therapeutics Announces Interim Results from SER-109 Phase 2 ECOSPOR Study in Multiply Recurrent Clostridium difficile Infection
Seres Therapeutics, Inc., a leading microbiome therapeutics company, today announced interim 8- week results from the ongoing SER-109 Phase 2 ECOSPOR TM clinical study for the prevention of multiply recurrent Clostridium difficile infection. Seres continues to gather and analyze study data, and in consultation with the FDA, plans to make appropriat
7/29/16 - Shire's SHP626 (Volixibat) Receives FDA Fast Track Designation for an Investigational Treatment for Adults Who Have Nonalcoholic Steatohepatitis (NASH) With Liver Fibrosis
Shire plc today announced that the United States Food and Drug Administration has granted Fast Track designation for SHP626 for an investigational treatment of adults who have nonalcoholic steatohepatitis with liver fibrosis. Shire is developing SHP626 as a once daily, orally-administered inhibitor of the apical sodium dependent bile acid...
7/29/16 - Shire's SHP626 Gets Fast Track Designation In US
LONDON- Shire PLC's SHP626, or volixibat, has been granted a fast track designation by the US Food and Drug Administration, for the investigational treatment of adults who have nonalcoholic steatohepatitis with liver fibrosis. "Shire' s development plan for SHP626 is designed to address the unmet need in the treatment of adult patients who have NA
7/29/16 - Sunesis Pharmaceuticals Reports Second Quarter 2016 Financial Results and Recent Highlights
Sunesis Pharmaceuticals, Inc. today reported financial results for the second quarter ended June 30, 2016. During the second quarter, we strengthened the foundation of our oncology pipeline through the advancement of our vosaroxin program and lead proprietary BTK kinase inhibitor, SNS-062. We are progressing our regulatory efforts to bring
7/29/16 - Swedish Orphan Biovitrum AB: Health Canada Validates Orfadin Capsule Filing
By a News Reporter-Staff News Editor at Drug Week Swedish Orphan Biovitrum AB announced that Health Canada has initiated review of the application for approval of Orfadin capsules for the treatment of hereditary tyrosinaemia type-1. Canada and Quebec is home to 10 per cent of the world's HT-1 population and has been a priority for Sobi since w
7/29/16 - Syndax Appoints Leading Experts to Scientific Advisory Board (SAB) [Kuwait News Agency]
The SAB is expected to serve as a strategic network of scientific and clinical experts to Syndax as the company progresses the development of entinostat in multiple cancer indications and initiates clinical development of SNDX-6352, a CSF-1R targeted antibody. The SAB is also expected to be an integral part of the companys strategy as it continues
7/28/16 - "Method and Apparatus for Recognition of Patient Activity" in Patent Application Approval Process (USPTO 20160196503)
By a News Reporter-Staff News Editor at Politics& Government Week A patent application by the inventors Guan, Lei; Lai, Dehua, filed on January 6, 2015, was made available online on July 14, 2016, according to news reporting originating from Washington, D.C., by VerticalNews correspondents. This patent application is assigned to AIC Innovations G
7/28/16 - AbbVie Announces Initiation of Phase 3 Study of Venetoclax in Patients with Relapsed or Refractory Multiple Myeloma
AbbVie, a global biopharmaceutical company, today announced the initiation of a Phase 3 clinical trial to study the safety and efficacy of venetoclax in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma who are considered sensitive or nave to proteasome inhibitors and have received one to thr
7/28/16 - Acceleron Pharma to Webcast Conference Call of Second Quarter 2016 Financial Results on August 4, 2016
Acceleron Pharma Inc., a clinical stage biopharmaceutical company focused on the discovery and development of novel therapeutic candidates that engage the body's ability to rebuild and repair its own cells and tissues, today announced that the Company will host a live conference call and webcast on Thursday, August 4, 2016 at 8:00 a.m. EDT to discu
7/28/16 - Adaptimmune Receives Access to Priority Medicines (PRIME) Regulatory Support for its SPEAR T-cell Therapy Targeting NY-ESO for Treatment of Soft Tissue Sarcoma
New Initiative Provides Access to Scientific Advice and Supports Accelerated Assessment for Therapies Targeting Unmet Medical Needs PHILADELPHIA, Pa. and OXFORD, UK, July 28, 2016 Adaptimmune Therapeutics plc, a leader in T-cell therapy to treat cancer, today announced that the European Medicines Agency has granted access to its newly-established
7/28/16 - Adaptimmune Receives Access to Priority Medicines (PRIME) Regulatory Support for its SPEAR T-cell Therapy Targeting NY-ESO for Treatment of Soft Tissue Sarcoma: New Initiative Provides Access to Scientific Advice and Supports Accelerated Assessment
PHILADELPHIA, Pa. and OXFORD, UK, 2016-07-28 17:27 CEST Adaptimmune Therapeutics plc, a leader in T-cell therapy to treat cancer, today announced that the European Medicines Agency has granted access to its newly-established Priority Medicines regulatory initiative for the company s SPEAR T-cell therapy targeting NY-ESO for the treatment of
7/28/16 - Akcea Therapeutics Receives Orphan Designation in Europe for Volanesorsen for the Treatment of Familial Partial Lipodystrophy (FPL)
Akcea Therapeutics, a wholly-owned subsidiary of Ionis Pharmaceuticals, Inc., announced today that the European Commission has designated volanesorsen as an orphan medicinal product for the treatment of familial partial lipodystrophy. The EC's approval follows a positive opinion in June from the European Medicine Agency's Committee for Orphan...
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