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 The leading web portal for pharmacy resources, news, education and careers July 28, 2016
Pharmacy Choice - News - Pharmaceutical Industry Trends and Policy - July 28, 2016

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 Pharmaceutical Industry Trends and Policy
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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 - ALEXION PHARMACEUTICALS INC FILES (8-K) Disclosing Results of Operations and Financial Condition, Financial Statements and Exhibits
On July 28, 2016, Alexion Pharmaceuticals, Inc. issued a press release relating to its results of operations and financial conditions for the quarter ended June 30, 2016. 99.1 Press Release issued by Alexion Pharmaceuticals, Inc. on July 28, 2016 relating to its results of operations and financial conditions for the quarter ended June 30, 2016.
7/28/16 - ALKERMES PLC. - 10-Q - Management's Discussion and Analysis of Financial Condition and Results of Operations
Executive Summary Net loss for the three months ended June 30, 2016 was $47.2 million, or $0.31 per ordinary share- basic and diluted, as compared to a net loss of $46.1 million, or $0.31 per ordinary share- basic and diluted for the three months ended June 30, 2015. Net loss for the six months ended June 30, 2016 was $124.6 million, or $0.82 per o
7/28/16 - Anger At Huge Price Tag for Life-Saving Medicine
Delegates at last week's international AIDS conference protested drug manufacturer Gilead Sciences, over the price of its extremely effective hepatitis C medication, sofosbuvir. In the United States the cost of sofosbuvir is $84,000. It would therefore cost approximately R13, 500 in South Africa.
7/28/16 - AngioSoma, Inc. Welcomes Dr. Tom Garcia to Scientific Advisory Board
AngioSoma, Inc., announces the formation of its scientific advisory board with the addition of A. Tomas Garcia III, MD, a practicing physician in the field of cardiology for the past 35 years and the immediate past president of the Texas Medical Association. Liprostin? is an important step towards helping many patients in my field, and I am pl
7/28/16 - Angle PLC: Preliminary Results
ANGLE plc, the specialist medtech company, today announces audited preliminary results for the year ended 30 April 2016. Sales pipeline developing in the research use market Analytical and clinical study programmes developed to progress FDA clearance for Parsortix planned initial FDA clearance in metastatic breast cancer three world-leading US canc
7/28/16 - ANGLE plc: Use of Parsortix in GANNET53 Drug Trial
ANGLE plc, the specialist medtech company, is delighted to announce that its Parsortix system has been formally adopted in the ongoing European wide GANNET53 drug trial, an ovarian cancer study. The Medical University of Vienna, under the leadership of Professor Robert Zeillinger is responsible for the Companion Diagnostics part of the trial, which
7/28/16 - ARRAY BIOPHARMA INC FILES (8-K) Disclosing Change in Directors or Principal Officers, Financial Statements and Exhibits
Prior to joining Array, Mr. Haddock was the Chief Financial Officer and Chief Operations Officer of BERG Health, a Boston- based biopharmaceutical company, since June, 2015. Prior to joining BERG, Mr. Haddock was at Bristol-Myers Squibb for over 13 years in a variety of accounting, planning, commercial, analytical and business development capacitie
7/28/16 - Aytu BioScience, Inc. Announces Common Stock Purchase Agreement for up to $10.5 Million
Aytu BioScience, Inc., a specialty pharmaceutical company focused on global commercialization of novel products in the field of urology, announced today that it has entered into a $10.5 million common stock purchase agreement with Lincoln Park Capital Fund, LLC, a Chicago- based institutional investor. Upon execution of the agreement, LPC initial
7/28/16 - Bavarian Nordic Announces Initiation of NIH Sponsored Phase 1 Trial of MVA-BN-based Yellow Fever Vaccine [Qatar Tribune]
-COPENHAGEN, Denmark, July 27, 2016- Bavarian Nordic A/S today announced the initiation of a Phase 1 clinical trial of MVA-BN YF, a new vaccine candidate based on the Company`s proprietary MVA-BN platform, designed to protect against yellow fever virus. We remain a dedicated partner to the NIH and the U.S. government, and look forward to assisting
7/28/16 - Big pharma firm that warned Brexit would be `bad for business` invests 275m in Britain [Arab News (Saudi Arabia)]
A pharmaceutical giant that said Brexit would be "bad for business" has just announced a 275 million investment in Britain. GlaxoSmithKline will pour the funds into making respiratory drugs at three manufacturing plants in Durham, Hertfordshire and Angus, Scotland. A Tory Cabinet minister welcomed the investment in the sites, which employ 2,750 peo
7/28/16 - Biosimilar User Fee Rates for Fiscal Year 2017
The Federal Food, Drug, and Cosmetic Act, as amended by the Biosimilar User Fee Act of 2012, authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain applications and supplements for approval of biosimilar biological products, establishments where approved biosimilar
7/28/16 - Biotie Therapies Corp.'s Interim Report for the reporting period January 1 - June 30, 2016
INTERIM REPORT July 28, 2016 at 9.00 a.m. Biotie Therapies Corp.' s Interim Report for the reporting period January 1- June 30, 2016 Biotie Therapies Corp. announces its interim report for the six month period ended June 30, 2016. Company Highlights April- June 2016* On January 19, 2016 Biotie announced that it entered into a combination agreement
7/28/16 - BUSINESS UPDATE - SECOND QUARTER 2016
Completion of 5- year stability assays of GTL001 and Roche's cobas HPV test evaluation. Genticel, a clinical-stage biotechnology company and developer of innovative immunotherapies to prevent cancers caused by the human papillomavirus, today announced its cash& cash equivalents and liquid investments position and its highlights from the second..
7/28/16 - Caladrius Biosciences Receives FDA Fast Track Designation for CLBS03 to Treat Recent Onset Type 1 Diabetes
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 type 1 diabetes mel
7/28/16 - Can-Fite Catapults NASH Indication Into Phase II Aiming for $35 Billion Market
NEW YORK, NY/ ACCESSWIRE/ July 28, 2016/ Newsweek magazine called NASH "The 21st Century's Looming Public Health Threat". Diabetes, a recognized epidemic in the U.S. because 29 million people live with the disease, actually pales in comparison to the number of people with NAFLD. An astonishing 67 million people in the U.S. have NAFLD.
7/28/16 - Catabasis Pharmaceuticals to Report Second Quarter 2016 Financial Results and Recent Corporate Developments on Thursday, August 11
Catabasis Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, will report second quarter 2016 financial results after the NASDAQ Global Market close on Thursday, August 11, 2016. Jill C. Milne, Ph.D., Chief Executive Officer, will host a conference call and webcast at 4:30pm ET to provide an update on corporate developments and to di
7/28/16 - Chugai's Emicizumab Showed Continued Benefits in Patients with Hemophilia A
Chugai Pharmaceutical Co., Ltd. announced today that latest data from an ongoing Japanese Phase I/II study of emicizumab was presented at the World Federation of Hemophilia 2016 World Congress in Orlando, Florida, United States. Emicizumab was designated as a Breakthrough Therapy by the US Food and Drug Administration in September 2015.
7/28/16 - Codexis Completes Obligations Under Research and Development Agreement with Leading Biopharmaceutical Company
Codexis, Inc., a leading protein engineering company, announces the successful completion of its obligations under a collaborative research and development agreement with a leading global biopharmaceutical company. Under the agreement, Codexis employed its CodeEvolver protein engineering platform technology to develop a novel enzyme for use in
7/28/16 - ContraVir Pharmaceuticals to Present at the 2016 Canaccord Genuity Growth Conference
ContraVir Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that it will present at the 2016 Canaccord Genuity Growth Conference being held August 10- 11, 2016, in Boston, MA.. James Sapirstein, chief executive officer of ContraVir, will provide an o
7/28/16 - Curis to Release Second Quarter 2016 Financial Results and Hold Conference Call on August 4, 2016
Curis, Inc., a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers, today announced that the Company will release its first quarter 2016 financial results on Thursday, August 4, 2016, before the U.S. financial markets open. About Curis, Inc. Curis is a biotechnolo
7/28/16 - DGAP-News: RedHill Biopharma Ltd.: RedHill Biopharma Reports 2016 Second Quarter
DGAP-News: RedHill Biopharma Ltd./ Key word: Quarter Results RedHill Biopharma Ltd.: RedHill Biopharma Reports 2016 Second Quarter 28.07. 2016/ 12:00 The issuer is solely responsible for the content of this announcement.- Press Release RedHill Biopharma Reports 2016 Second Qu
7/28/16 - EDITORIAL: Fleecing of Medicare (and taxpayers) must stop [Walla Walla Union-Bulletin, Wash.]
July 27 Medicare is a great program that's saved millions of lives and kept millions from being financially ruined by medical costs. It appears U.S. taxpayers are being fleeced by Big Pharma as drugmakers are taking advantage of a well-intended change in the Medicare program aimed at protecting older people with multiple chronic conditions from t
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