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 The leading web portal for pharmacy resources, news, education and careers February 13, 2016
Pharmacy Choice - News - Pharmaceutical Development - February 13, 2016

Pharmacy News

 Pharmaceutical Development
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2/13/16 - "Genetically Detoxified Pertussis That Maintains Intrinsic Adjuvant Activity" in Patent Application Approval Process (USPTO 20160015806)
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week A patent application by the inventor Kapre, Subhash V., filed on July 15, 2015, was made available online on January 28, 2016, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application has not been assigned to a company o
2/13/16 - Blend Therapeutics Secures $38 Million in Series C Financing led by Novo A/S and NEA and Changes Name to Tarveda Therapeutics
By a News Reporter-Staff News Editor at Investment Weekly News Tarveda Therapeutics, Inc., formerly Blend Therapeutics, announced that it has secured $38 million in Series C financing co-led by new investor Novo A/S and existing investor New Enterprise Associates. The company also announced the change of its corporate brand to clearly highlight t
2/13/16 - FDA Says OMB Approves Info Collection of Samples and Protocols
WASHINGTON, Feb. 13 The Department of Health and Human Services published the following notice in the Federal Register from the Food and Drug Administration:. A Notice by the Food and Drug Administration on 02/12/2016. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
2/12/16 - "Stable Dosage Forms of Imatinib Mesylate" in Patent Application Approval Process (USPTO 20160015708)
By a News Reporter-Staff News Editor at Drug Week A patent application by the inventors KOCHHAR, Ravi; RAMESH, Annavarapu; VASIREDDY, Suneel Kumar; SANDAL, Roshan Lal, filed on February 15, 2013, was made available online on January 28, 2016, according to news reporting originating from Washington, D.C., by NewsRx correspondents. Currently, it is
2/12/16 - Achillion Initiates Phase 1 Study of ACH-4471, First Orally-Administered Small Molecule Complement Factor D Inhibitor [Saudi Press Agency (Saudi Arabia)]
-Achillion Pharmaceuticals, Inc. today announced the initiation of a phase 1 study with ACH-4471, the Companys first orally-administered, highly potent and specific small molecule that has been shown to inhibit complement factor D. The phase 1 study is being conducted in healthy volunteers and is evaluating single ascending doses of ACH-4471 to ass
2/12/16 - ADHD drug Adzenys addresses unmet need for patients, says GlobalData
The recent FDA approval of Adzenys will provide patients who have problems swallowing pills with easy-to-administer drug options, according to GlobalData analyst...
2/12/16 - Aegerion Pharmaceuticals Announces Reduction in Workforce as Part of Cost Reduction Plan [Saudi Press Agency (Saudi Arabia)]
-Aegerion Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, today announced that it is reducing approximately 25% percent of its global workforce. This reduction in force is part of a broad program taken by Aegerion to...
2/12/16 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Meetings With...
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Guidance for Industry on Formal...
2/12/16 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Labeling of Certain Beers Subject to the Labeling...
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Labeling of Certain Beers Subject to the Labeling..
2/12/16 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration of Producers of Drugs and Listing of...
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Registration of Producers of Drugs and Listing of Drugs in Commerci
2/12/16 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Request for Samples and Protocols
SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Request for Samples and Protocols" has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995.. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville
2/12/16 - Alnylam Pharmaceuticals Reports Fourth Quarter and Full Year 2014 Financial Results and Highlights Recent Period Progress [Global Data Point]
In addition, we filed three Clinical Trial Applications for ALN-PCSsc, ALN-CC5, and ALN-AS1, and have initiated Phase 1 studies for two of those programs, "said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "Alnylam continues to maintain a very strong balance sheet, ending 2014 with approximately $882 million in cash," said Michael M
2/12/16 - Alnylam Pharmaceuticals Reports Fourth Quarter and Full Year 2015 Financial Results and Highlights Recent Period Progress [Global Data Point]
"In 2015, including the fourth quarter, we made strong progress advancing our pipeline and executing on our broader business objectives. Through our focused efforts, we grew our pipeline to eight clinical stage programs, achieved human proof of concept in multiple programs, and accrued patients in our two pivotal Phase 3 trials, including the APOLL
2/12/16 - Ashland's manufacturing plant in Calvert City, Kentucky, is first U. S. excipient facility to receive EXCiPACT certification
Release date- 11022016- WILMINGTON, Delaware- Ashland today announced that its Calvert City, Kentucky, facility has earned EXCiPACTTM certification for Good Manufacturing Practice. Since both the U.S. Food and Drug Administration and the European Medicines Agency require that excipient suppliers be qualified by drug producers, EXCiPACTTM certificat
2/12/16 - Biofrontera AG: Pivotal Phase III Data Demonstrate Significant Efficacy and Excellent Safety for BF-200 ALA Treatment of Superficial Skin Cancer [Arab News (Saudi Arabia)]
-Biofrontera AG, the specialist for sun-induced skin cancer, presents data from three pivotal Phase III trials for its lead drug candidate BF-200 ALA at the 14th Annual South Beach Symposium. The results are being presented in a poster on display February 11-14 and will be highlighted during two oral presentations on Friday, February 12 by two memb
2/12/16 - Bionor Q4 and Full Year 2015 Interim Financial Report
Bionor Pharma ASA Interim Financial Report 1 January- 31 December 2015 Unaudited Oslo, 12 February 2016 HIGHLIGHTS Q4 2015 In the fourth quarter of 2015, Bionor accelerated the company's revitalization by executing the updated business strategy and development plans presented at the company's Capital Markets Day in October 2015. *21 December, Biono
2/12/16 - BRIEF: New Law Would Let Terminally Ill Try Non-Approved Drugs [The Times-News, Twin Falls, Idaho]
Feb. 12 BOISE Terminally ill people in Idaho would be able to try medications that have not yet been fully approved by the Food and Drug Administration, if a bill introduced Thursday passes. The "Right to Try" act would let them use drugs that have passed the FDA's Phase I, which is the first of three stages in the years-long process before a m
2/12/16 - Clovis Oncology Announces Rociletinib New Drug Application Scheduled for Presentation at Upcoming FDA Oncologic Drugs Advisory Committee Meeting
Clovis Oncology, Inc. announced today that the U.S. Food and Drug Administration has scheduled the New Drug Application for rociletinib for discussion by the Oncologic Drugs Advisory Committee on April 12, 2016. We are actively preparing for this advisory committee meeting and look forward to the discussion about rociletinib, said Patrick J.
2/12/16 - Clovis Oncology Issues Update On Rociletinib, Will Meet With FDA On April 12
Clovis Oncology Inc announced on Friday that the U.S. Food and Drug Administration has scheduled a date of April 12, 2016 to discuss a New Drug Application for its rociletinib therapy. Clovis Oncology will meet with Oncologic Drugs Advisory Committee which reviews and evaluates data concerning the safety and effectiveness of marketed and and...
2/12/16 - DELMAR PHARMACEUTICALS, INC. - 10-Q - Management's Discussion and Analysis of Financial Condition and Results of Operations.
You should review the factors and risks we describe under "Risk Factors" in our report on Form 10- K/A for the year ended June 30, 2015 and in the Company's other filings with the Securities and Exchange Commission, available at www.sec.gov. DelMar Pharmaceuticals, Inc. is a clinical stage drug development company with a focus on the treatment of c
2/12/16 - eClinical Solutions Market 2016 - Global Forecast to 2020 - Product, Delivery Mode, Clinical Trial Phases, End User Analysis of the $5.9 Billion... [Saudi Press Agency (Saudi Arabia)]
-Research and Markets has announced the addition of the "eClinical Solutions Market by Product, Delivery Mode, Clinical Trial Phases, End User- Global Forecast to 2020" report to their offering. On the basis of geography, this market is classified into four regions, namely, North America, Europe, Asia-Pacific, and the Rest of the World. In 2015, th
2/12/16 - ESSA Pharma Inc. reports financial results for the first quarter ended December 31, 2015
HOUSTON and VANCOUVER, Feb. 12, 2016/ PRNewswire/- ESSA Pharma Inc. today reported financial results for the three months ended December 31, 2015. Details relating to the Phase 1/ 2 clinical trial are now available on the US National Institutes of Health clinical trials website. On January 14, 2016, the Company completed a private placement of 4,54
2/12/16 - Global eClinical Solutions (Product, Delivery Mode, Clinical Trial Phases, End User) Market 2016-2020 - Growing Adoption of Software Solutions During Clinical Trials
Research and Markets has announced the addition of the "eClinical Solutions Market by Product, Delivery Mode, Clinical Trial Phases, End User- Global Forecast to 2020" report to their offering. Emerging markets including China, Korea, Taiwan, and India have become attractive destinations for outsourcing of clinical trials due to presence of large p
2/12/16 - INCYTE CORP - 10-K - Management's Discussion and Analysis of Financial Condition and Results of Operations
JAKAFI is our first product to be approved for sale in the United States. Under our collaboration agreement with Novartis International Pharmaceutical Ltd., Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications and sells ruxolitinib outside of..
2/12/16 - Japan : akeda and Zinfandel Pharmaceuticals Complete Enrollment in TOMMORROW Trial [TendersInfo (India)]
Takeda Pharmaceutical Company Limited and its partner, Zinfandel Pharmaceuticals, Inc., today announced the completion of enrollment in the TOMMORROW trial, the largest Phase 3 trial of its kind. TOMMORROW is a global Phase 3 clinical trial investigating a genetic-based biomarker risk assignment algorithm and evaluating the safety and efficacy of..
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