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 The leading web portal for pharmacy resources, news, education and careers July 24, 2014
Pharmacy Choice - News - Pharmaceutical Development - July 24, 2014

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 248     Next >>     Go To Page:

7/24/14 - Best Practices for Optimizing Dose Escalation in First in Human Studies, New Webinar August 6th Hosted by Xtalks
The first part of the session on "Best Practices for Optimizing Dose Escalation in First in Human Studies" will cover comprehensive clinical support in early phase studies to make better go/no-go decisions. With increasing R&D costs and declining industry success in getting products to market, pharmaceutical companies need to maximize the knowledge
7/24/14 - BrainStorm's Clinical Trial is Fast-Tracked to Phase IIa; CEL-SCI Expands Its Phase III Head and Neck Cancer Trial
The trial, which will evaluate the safety and preliminary efficacy of BrainStorm s NurOwn stem cell therapy candidate, will be launched immediately at the Hadassah Medical Center in Jerusalem. The Ministry of Health approved acceleration to a Phase IIa trial based on evaluation of only 12 of the initial cohort of 24 patients in the company s
7/24/14 - CorMatrix Receives FDA Approval to Market ECM for Vascular Repair [Health & Beauty Close - Up]
CorMatrix Cardiovascular reported that it has received U.S. Food and Drug Administration clearance to market the CorMatrix ECM for Vascular Repair. Richard F. Neville, Professor of Surgery, Chief, Division of Vascular Surgery at George Washington University said, "CorMatrix ECM for Vascular Repair is an innovative scaffold permitting the patient's
7/24/14 - Freeslate Featured in BioProcess International Article Discussing Challenges and Solutions to Highly Concentrated Protein Formulations
Freeslate, Inc., the leading provider of high throughput research solutions for biopharmaceutical development, today announced its feature in the BioProcess International article "Highly Concentrated Protein Formulations" by Jim Kling. Topics of this article include problematic issues with highly concentrated protein formulations and how automation
7/24/14 - ImmuCell Commences Manufacture of Nisin Necessary for Approval of Mast Out
Once this data has been compiled, the Company expects to make its first submission of the Chemistry, Manufacturing and Controls Technical Section to the FDA around the end of calendar year 2014. At the same time, Company scientists are working with the FDA to transfer the analytical method to detect Nisin in milk to an FDA laboratory. Once this met
7/24/14 - Jazz Pharmaceuticals and Concert Update on Phase 1 JZP-386 Clinical Trial [Manufacturing Close - Up]
Jazz Pharmaceuticals and Concert Pharmaceuticals reported the initiation of the first Phase 1 clinical trial of JZP-386, a deuterium-containing analog of sodium oxybatethe active ingredient in Xyrem oral solution. said Jeffrey Tobias, M.D., executive vice president and chief medical officer of Jazz Pharmaceuticals. "We are pleased to see JZP-386
7/24/14 - Lipocine Announces Issuance Of U.S. Patent For LPCN 1021; La Jolla Pharmaceutical Announces Positive Pre-Clinical Data NASH
We believe oral LJPC-1010 could be an effective treatment option for NASH, which currently has very few treatment options. La Jolla Pharmaceutical Company intends to file an Investigational New Drug application and initiate a Phase 1/ 2 clinical trial in NASH in the first half of 2015. Also Tuesday: ActiveCare, Inc., a leader in diabetes managem
7/24/14 - Medicines360 and Actavis Gets FDA Acceptance for Filing of NDA for Levosert IUD [Professional Services Close - Up]
Medicines360 and Actavis reported that the U.S. Food and Drug Administration has accepted for filing Medicines360's New Drug Application for Levosert, a hormonal intrauterine contraceptive for use by women to prevent pregnancy. According to a media release, in June 2013, Medicines360 and Actavis announced that they had entered into a partnership th
7/24/14 - NIH launches Phase I clinical trial of novel drug to treat Clostridium difficile infection
By a News Reporter-Staff News Editor at Politics& Government Week The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has launched an early-stage clinical trial of CRS3123, an investigational oral antibiotic intended to treat Clostridium difficile infection. The medication is being provided by its
7/24/14 - Novartis - FDA accepts Sandoz application for biosimilar filgrastim
Release date- 23072014- Holzkirchen- Sandoz, a Novartis Group company, announced today that the US Food and Drug Administration has accepted its Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009. 'This filing acceptance represents a...
7/24/14 - Proteon Therapeutics Initiates Phase 3 Clinical Study of PRT-201 [Health & Beauty Close - Up]
Proteon Therapeutics reported that the first patient has been treated in a pivotal Phase 3 clinical study of its lead product, PRT- 201, in chronic kidney disease patients undergoing surgical placement of an arteriovenous fistula. PRT-201 has received fast track and orphan drug designations from the U.S. Food and Drug Administration and orphan medi
7/24/14 - Puma Bio More Than $100 After-Hours On Trial PB272; CEL-SCI Receives Regulatory Clearance To Expand Phase III Head And Neck Cancer Trial
A list of the 32 studies found for Puma Biotechnology at CEL-SCI Corporation announced Turkey s Ministry of Health has cleared the company to begin patient enrollment in CEL-SCI s global pivotal Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatme
7/24/14 - Regeneron, Sanofi Offer Positive Results from Phase 2b of Dupilum; Celgene's Drug OTEZLA Fails Phase III Trial Endpoint
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 9, 2014.{ nfg} Regeneron Pharmaceuticals, Inc. and Sanofi announced positive results from a Phase 2 b dose-ranging study of dupilumab, an investigational therapy, in adult patients with moderate-to-severe atopic dermatitis, a serious, chronic form
7/24/14 - Shire Enters Strategic Licensing and Collaboration Agreement with ArmaGen; Strengthens Leadership Position in Treatments for Hunter syndrome and Commitment to MPS II Patient Community
Release date- 23072014- Lexington, Massachusetts, US- Shire plc, the global specialty biopharmaceutical company, and ArmaGen, a US privately held biotechnology company, today announced a worldwide licensing and collaboration agreement for AGT-182, an investigational enzyme replacement therapy for the potential treatment of both the central nervous.
7/24/14 - Strides Arcolab receives USFDA approval for Tacrolimus Capsules; Product to be launched immediately
Release date- 23072014- Strides Arcolab today announced that it has received approval from the United States Food& Drug Administration for Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg. According to IMS data as on September 2013, the US market for generic Tacrolimus is approximately USD 676 Million. The product will be manufactured at the Company
7/24/14 - Study Data from McGill University Update Knowledge of Drug Resistance [A tamoxifen derivative, N,N-diethyl-2[4-(phenylmethyl) phenoxy] ethanamine,...
Study Data from McGill University Update Knowledge of Drug Resistance. By a News Reporter-Staff News Editor at Women's Health Weekly Investigators publish new report on Drugs and Therapies. Our news journalists obtained a quote from the research from McGill University, "In this study we examined the effects of DPPE alone on the growth of drug sen
7/24/14 - Synta Announces Ganetespib Into Phase 3 Extension Of AML LI-1 Study; Ignyta Announces Phase I/II Clinical Trial Of RXDX-101
The Company is currently in discussion with study investigators, and anticipates providing additional details, including the timing of study milestones, as they become formalized. The AML LI-1 trial is the first of three multicenter, randomized studies supported by the Leukemia& Lymphoma Research Fund and Cancer Research UK to include a ganetespib.
7/24/14 - Synta Reports Advancement of Ganetespib into Phase 3 Extension of AML LI-1 Trial [Health & Beauty Close - Up]
Synta Pharmaceuticals Corp. reported the advancement of ganetespib into the Phase 3 extension of the AML LI-1 trial. AML LI-1 is a multicenter, randomized Phase 2/ 3 clinical study evaluating several novel treatment regimens, including the combination of ganetespib with low dose cytarabine, in newly diagnosed elderly patients with acute myeloid leu
7/24/14 - Targacept's Key Drug Failed Phase 2b Trial; ARIAD Announces Continuation of Iclusig Review Related to Article 20 Procedure in Europe
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 14, 2014.{ nfg} Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics?, announced top-line results from a Phase 2 b monotherapy clinical trial of TC-1734 as a treatment for mild to moderate Alzheimer s
7/23/14 - A collection of approx..1100 FDA approved drugs in pre-dissolved 100ul of DMSO solution for high throughput screening (HTS) and high content... [TendersInfo (India)]
A collection of approx.. 1100 FDA approved drugs in pre-dissolved 100 ul of DMSO solution for high throughput screening and high content screening. Contract awarded for A collection of approx.. 1100 FDA approved drugs in pre-dissolved 100 ul of DMSO solution for high throughput screening and high content screening. Contractor address: 211 Henderson
7/23/14 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Food and Drug Administration Rapid...
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Food and Drug Administration Rapid Response Surveys. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Generic FDA Rapid Response Surveys" has been approved by the Office of Management and Budg
7/23/14 - Alios BioPharma Reports Positive Results of Its Anti-RSV Nucleoside Analog AL-8176 in a Phase 2 Challenge Study in Adults Infected With Respiratory Syncytial Virus (RSV)
Alios BioPharma, Inc., a biotechnology company developing proprietary therapeutics for respiratory viral diseases, today announced positive results from a randomized, double-blind, placebo-controlled Phase 2 challenge study of its oral anti-RSV nucleoside analog AL-8176. "With no available effective therapies for RSV, results from this trial...
7/23/14 - Astellas Submits U.S. New Drug Application for Isavuconazole for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis
By a News Reporter-Staff News Editor at Biotech Week Astellas announced it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis, life-threatening fungal infections predominantly occurring in immunocompromised patients.
7/23/14 - Batu Biologics Reaches 50% of Crowdfunding Goal
By a News Reporter-Staff News Editor at Biotech Week Batu Biologics announced that the company successfully rose over 50% of its crowdfunding target to assist in completion of preclinical studies to support the FDA submission of its novel cancer vaccine, ValloVax?. Alan Lewis to our scientific advisory board, "said Samuel Wagner, President and
7/23/14 - Biosceptre Announces Positive Phase I Results for BIL-010t to Treat Basal Cell Carcinoma
Biosceptre, the oncology company developing antibody products that target the nf-P2X 7 receptor, announces positive results from its Phase I trial to assess the safety and tolerability of BIL-010t, a topically administered, highly purified sheep antibody therapy, to treat Basal Cell Carcinoma. The Phase I trial, conducted in the US, was an open-lab
Articles(s): 1 - 25 of 248     Next >>     Go To Page:

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