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 The leading web portal for pharmacy resources, news, education and careers April 28, 2015
Pharmacy Choice - News - Pharmaceutical Industry Trends and Policy - April 28, 2015

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 Pharmaceutical Industry Trends and Policy
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4/28/15 - Aeterna Zentaris: Data Safety Monitoring Board Recommends Continuation of Phase 3 Study of Zoptarelin Doxorubicin in Advanced Endometrial Cancer
Release date- 27042015- Quebec City, Canada,- Aeterna Zentaris Inc. today announced that the independent Data Safety Monitoring Board for the pivotal Phase 3 ZoptEC study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer, has completed a pre specified first interim futility analysis. We believe that zopt
4/28/15 - Akorn Announces Recent Executive Appointments [Kuwait News Agency]
-Akorn, Inc., a leading specialty generic pharmaceutical company, announced the following recent executive appointments for roles on the Akorn management team:. In this newly-created role, Mr. Kafer will oversee all commercial functions for all of Akorn's business units. Mr. Pollard joins Akorn from Novartis Pharmaceuticals, where he most recently
4/28/15 - AMARIN CORP PLC\UK FILES (8-K) Disclosing Other Events
Amarin Corporation plc announced today receipt of the anticipated Complete Response Letter from the U.S. Food and Drug Administration regarding its Vascepa capsules ANCHOR trial supplemental New Drug Application. Vascepa remains FDA approved for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe...
4/28/15 - Australia : ACCC authorises Medicines Australia code subject to strengthening individual reporting [TendersInfo (India)]
The ACCC commends Medicines Australia for introducing transparency to payments provided to individual doctors by drug companies, ACCC Commissioner Dr Jill Walker said. The ACCC and interested parties have been anticipating this change for a number of years now. The ACCC accepts that this new transparency regime is a significant and important change
4/28/15 - Bayer Advances Clinical Development Program for Investigational Cancer Drug Copanlisib
By a News Reporter-Staff News Editor at Cancer Weekly Bayer HealthCare announced the expansion of its global clinical development program for the investigational oncology compound copanlisib, which now includes two new Phase III studies in indolent non-Hodgkin's lymphomas and one additional Phase II study in diffuse large B-cell lymphoma, an...
4/28/15 - Bio Products Laboratory, Ltd. Announces Results from Phase III Registration Study of its Factor X Coagulation Product
Release date- 27042015- ELSTREE, UK AND DURHAM, NC- Bio Products Laboratory, Ltd., a leading manufacturer of plasma-derived protein therapies, today announced the results from a phase III registration study examining the pharmacokinetics, efficacy, and safety of its FACTOR X coagulation product in subjects with hereditary FACTOR X deficiency.
4/28/15 - Biological Safety Testing Market, By Application Product & Test Global Forecast 2019 - Report Released by MarketsandMarkets
Between 2001 and 2010, the FDA approved 225 drug applications and Health Canada approved 99. In addition, according to WIPO, Europe accounted for 3,822 of the pharmaceutical and 1,998 of the biotechnology patents granted in 2012. Furthermore, according to OECD estimates, in 2011, the total number of biotechnology companies in the U.S. was 7,970. Th
4/28/15 - BioMarin Completes Rolling NDA Submission to FDA for Drisapersen; MannKind to Manufacture 12 Unit Cartridge Strength of AFREZZA(R)
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 27, 2015.{ nfg} BioMarin Pharmaceutical Inc. announced completion of the rolling submission of a New Drug Application to the United States Food and Drug Administration for drisapersen, an investigational exon-skipping drug candidate for the treat
4/28/15 - Certara and CISCRP Join Forces [Health & Beauty Close - Up]
Certara and CISCRP, an independent nonprofit organization dedicated to educating and informing the public and patients about clinical research, reported that they are partnering to produce lay summaries of clinical trials. Synchrogenix CEO Kelley Kendle said, "Biopharmaceutical companies want to address proactively the growing demand for...
4/28/15 - CITY BREAKTHROUGH IN BREAST CANCER ; Drug company also finds treatment for osteoarthritis [Liverpool Echo (England)]
And Evgen Pharma, based at Liverpool Science Park, also says it has made a major step forward in developing a treatment for osteoarthritis. The company unveiled its findings at the American Association of Cancer Research annual conference this week, where it revealed the drug could help treat the most common type of breast cancer, affecting 70% of
4/28/15 - Critical Path Institute Secures Regulatory Support for Parkinson's and Alzheimer's Disease Biomarkers
The Critical Path Institute announced that the U.S. Food and Drug Administration has issued three Letters of Support to C-Path s Coalition Against Major Diseases consortium for the use of certain biomarkers as tools to help select clinical trial participants in the earliest stages of Parkinson s and Alzheimer s diseases. These Letters o
4/28/15 - CRY Has A Reason To Smile, MDXG Lifts Outlook, MYL Rejects Teva Bid
CANONSBURG- BioMarin Pharmaceutical Inc. has completed the rolling submission of a New Drug Application to the FDA for Drisapersen for the treatment of Duchenne Muscular Dystrophy. Drisapersen has been granted Orphan and Fast Track status, as well as Breakthrough Therapy designation by the FDA. CryoLife Inc. has resolved the FDA warning letter that
4/28/15 - DanDrit Biotech Teams with Riyadh Pharma [Professional Services Close - Up]
DanDrit Biotech A/S, the subsidiary of DanDrit Biotech USA, reported that DanDrit and the Pharmaceutical Company Riyadh Pharma have signed a partnership agreement in Saudi Arabia. Ryiadh Pharma will be responsible for the manufacturing of MCV in the Middle East. Eric Leire, CEO and Riyadh Pharma by Dr.
4/28/15 - DGAP-News: amp biosimilars AG appoints Professor Dr. Dr. Rolf G. Werner as chairman of the Scientific Board
DGAP-News: amp biosimilars AG/ Key word: Change of Personnel amp biosimilars AG appoints Professor Dr. Rolf G. Werner as chairman of the Scientific Board 28.04. 2015/ 07:30- amp biosimilars AG appoints Professor Dr. Rolf G. Werner as chairman of the Scientific Board- Former head of
4/28/15 - DGAP-News: amp biosimilars AG ernennt Prof. Dr. Dr. Rolf G. Werner zum Vorsitzenden des Scientific Boards
DGAP-News: amp biosimilars AG/ Schlagwort: Personalie amp biosimilars AG ernennt Prof. Rolf G. Werner zum Vorsitzenden des Scientific Boards 28.04. 2015/ 07:30- amp biosimilars AG ernennt Prof. Rolf G. Werner zum Vorsitzenden des Scientific Boards- Ehemaliger Leiter des weltweiten
4/28/15 - ERYTECHReceives the EnterNext Tech 40 Label
ERYTECH Pharma, a French biopharmaceutical company that develops innovative tumor starvation treatments for acute leukemia and other oncology indications with unmet medical needs, has received the EnterNext Tech 40 Label and announces its inclusion in the Tech 40 index.. Gil Beyen, Chairman and CEO of ERYTECH Pharma, comments: After being
4/28/15 - Ethics and Integrity in pharma industry [Pakistan Observer]
The relevance of ethics to pharmaceuticals and healthcare is even more paramount, it is our responsibility to ensure that we operate with the highest levels of ethics and integrity in everything that we do, as our treatments directly touch the lives of patients and with this comes greater responsibility, this was stated by Arshad Saeed Hussain, Cha
4/28/15 - FDA Grants Fast Track Designation To Genzyme's GZ/SAR402671
PARIS- Genzyme, a Sanofi company, announced that the Food and Drug Administration has granted Fast Track designation for the development of GZ/ SAR402671, a new investigational oral substrate reduction therapy for the treatment of Fabry disease. FDA's Fast Track Drug Development Program is designed to facilitate frequent interactions with the FDA r
4/28/15 - FDA Grants Fast Track Designation to Genzyme's Investigational Substrate Reduction Therapy for the Treatment of Fabry Disease
Genzyme, a Sanofi company, announced today that the Food and Drug Administration has granted Fast Track designation for the development of GZ/ SAR402671, a new investigational oral substrate reduction therapy for the treatment of Fabry disease. Genzyme is currently enrolling patients in its Phase 2 a trial of GZ/ SAR402671, and plans to enroll nine
4/28/15 - GW Pharma In US Offering Of American Depositary Shares (ALLISS)
LONDON- GW Pharmaceuticals PLC Tuesday said it intends to sell 1.3 million American Depositary Shares in an underwritten US public offering. Morgan Stanley, BofA Merrill Lynch and Cowen and Co are acting as joint book-running managers for the offering, while Piper Jaffray& Co. is acting as lead manager. GW Pharma shares were down 6.8% at 622.58 pen
4/28/15 - Hemispherx Biopharma Inc. Files SEC Form 4, Statement of Changes in Beneficial Ownership of Securities (Apr. 15, 2015)
By a News Reporter-Staff News Editor at Life Science Weekly According to news reporting originating from Washington, D.C., by NewsRx journalists, a U.S. Securities and Exchange Commission filing by Hemispherx Biopharma Inc. was posted on April 15, 2015. The SEC file number is 0001450324-15-000001.. A U.S. Securities and Exchange Commission filing
4/28/15 - La Jolla Pharmaceutical Company Appoints Lakhmir S. Chawla, M.D., as Chief Medical Officer [Kuwait News Agency]
I am delighted to be joining this highly innovative company, added Dr. Chawla. La Jolla has assembled an exceptional team of professionals, and I look forward to working with them in developing novel therapeutics for life-threatening diseases.. Dr. Chawla is currently an Associate Professor of Medicine at the George Washington Universit
4/28/15 - Lexicon to Report First Quarter 2015 Financial Results on April 29, 2015
Release date- 27042015- The Woodlands, Texas,- Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on developing breakthrough treatments for human disease, will release its first quarter 2015 financial results on Wednesday, April 29, 2015 after the financial markets close. Lexicon management will hold a conference call and webcast to
4/28/15 - Merck Posts Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney... [Health & Beauty Close - Up]
Merck, known as MSD outside the United States and Canada, reported the first presentation of data from C-SURFER, the company's Phase 2/ 3 clinical trial evaluating the investigational once-daily treatment regimen of grazoprevir and elbasvir in patients with advanced chronic kidney disease infected with chronic hepatitis C virus genotype 1.
4/28/15 - Moffitt develops new method to characterize the structure of a protein that promotes tumor growth
By a News Reporter-Staff News Editor at Cancer Weekly TAMPA, Fla.- Moffitt Cancer Center researchers have developed a new method to identify a previously unknown structure in a protein called MDMX. MDMX is a crucial regulatory protein that controls p53- one of the most commonly mutated genes in cancer. Known as the tumor suppressor gene, p53 prot
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