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 The leading web portal for pharmacy resources, news, education and careers February 10, 2016
Pharmacy Choice - News - Front Page Healthcare News - February 10, 2016

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 Front Page Healthcare News
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2/10/16 - 4D Pharma Acquires University Start-Up Company Tucana Health (ALLISS)
LONDON- 4 D pharma PLC Wednesday said it has acquired a start-up company from University College Cork which is focused on investigating the use of microbiome signatures to aid the diagnosis and treatment of diseases. 4 D pharma said it plans to immediately build on the research being conducted by the company, Tucana Health Ltd, and will invest in t
2/10/16 - ACMC ventures into accountable care [West Central Tribune, Willmar, Minn.]
Although the effort is aimed primarily at the Medicare population, all patients can expect to benefit, ACMC leaders said. The new Affiliated ACO was among 100 new accountable care organizations across the U.S. 10 of them in Minnesota that were launched last month. "We're seeing it on the federal level with Medicare.
2/10/16 - Agilis Biotherapeutics Names Former Lundbeck Executive, Christopher J. Silber, MD, as Chief Medical Officer
Prior to joining Agilis, he spent seven years at H. Lundbeck A/S, a company specializing in brain disease, in senior management positions, including most recently Vice President US Clinical Development Center. Mark Pykett, President and CEO of Agilis. "I am thrilled to join Agilis at this exciting stage of the Company's growth," stated Dr. Silber.
2/10/16 - ALK's partner, MSD, submits US license application for investigational house dust mite SLIT-tablet
ALK announced today that its partner for North America, MSD has submitted a Biologics License Application to the U.S. Food and Drug Administration for its house dust mite sublingual allergy immunotherapy tablet. The application to the FDA is based on results from an extensive clinical development programme that has involved approximately 4,400 pa
2/10/16 - ALK's partner, MSD, submits US license application for investigational house dust mite SLIT-tablet
Copenhagen, 2016-02-10 08:30 CET ALK announced today that its partner for North America, MSD has submitted a Biologics License Application to the U.S. Food and Drug Administration for its house dust mite sublingual allergy immunotherapy tablet. The application to the FDA is based on results from an extensive clinical development programme that ha
2/10/16 - Avanir Pharmaceuticals Announces FDA Approval of ONZETRA Xsail AVP-825 for the Acute Treatment of Migraine in Adults
By a News Reporter-Staff News Editor at Biotech Week Avanir Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved ONZETRA? Xsail?, formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. Given this high dissatisfaction, there remains an unmet need to provide patients wit
2/10/16 - BLPH Heartened, More Trouble For CTIC, Remicade Biosimilar Gets FDA Panel Nod
NEW BRUNSWICK- Axovant Sciences Ltd. expects results from a phase II study of Nelotanserin in Lewy body dementia subjects experiencing visual hallucinations in the second half of calendar year 2016.. AXON closed Tuesday's trading at $10.07, up 5.89%. Shares of Bellerophon Therapeutics Inc. surged more than 43% on Tuesday, following positive data fr
2/10/16 - BPC Statement on FDA Arthritis Advisory Committee Meeting
WASHINGTON, Feb. 9, 2016/ PRNewswire-USNewswire/ On Tuesday, February 9th, the U.S. Food and Drug Administration met with its Arthritis Advisory Committee to discuss Celltrion's Remsima, a proposed biosimilar of Johnson& Johnson's Remicade and most likely the second biosimilar to be approved in the U.S. The Biologics Prescribers Collaborative alo
2/10/16 - CTI BioPharma Provides Update On Clinical Hold Of Investigational Agent Pacritinib And New Drug Application In U.S.
Following the issuance of the Company's February 8, 2016, press release describing the partial clinical hold issued by the U.S. Food and Drug Administration regarding those clinical studies, the Company received an oral communication from the FDA followed by a letter notifying the Company that the Company's IND for pacritinib has been placed on ful
2/10/16 - CTI BioPharma Withdraws Pacritinib NDA As FDA Places Full Clinical Hold
WASHINGTON- CTI BioPharma Corp. said that it has withdrawn its New Drug Application for pacritinib as the FDA has revised the partial clinical hold imposed on February 8, 2016 to full clinical hold. The FDA made recommendations that supersede the recommendations made by the FDA in connection with the partial clinical hold imposed by the FDA on Febr
2/10/16 - Deep Brain Stimulators (DBS) Market Size To Reach $1.59 Billion By 2020 : Radiant Insights,Inc
Global Deep Brain Stimulators Market is expected to reach USD 1.59 billion by 2020. Deep brain stimulators are FDA approved when it comes to treating Parkinson's, dystonia and OCD etc. Moreover, the use of these devices for diseases such as trigeminal neuralgia, Tourette syndrome, Alzheimer's, refractory epilepsy, cluster headache and movement di
2/10/16 - Exelixis Announces U.S. FDA Deems New Drug Application Sufficiently Complete and Grants Priority Review for Cabozantinib as a Treatment for Advanced...
By a News Reporter-Staff News Editor at Biotech Week Exelixis, Inc. announced that the U.S. Food& Drug Administration has determined the company's New Drug Application for cabozantinib as a treatment for patients with advanced renal cell carcinoma who have received one prior therapy to be sufficiently complete to permit a substantive review.
2/10/16 - FDA approves Adaptimmune Therapeutics 'breakthrough' cancer treatment [The Philadelphia Inquirer]
Feb. 10 Adaptimmune Therapeutics, a biopharmaceutical company with U.S. operations in Philadelphia, said Tuesdaythe Food and Drug Administration has granted "breakthrough therapy designation" for its TCR engineered T-cell therapy to treat cancer. Adaptimmune, which has a collaboration and licensing agreement with GlaxoSmithKline to commercialize
2/10/16 - Federal Register Table of Contents
The correct index entry should read Pole Attachment Rates. Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7118-7119 Requests for Measures: Health Care Organization Quality Improvement Activities to Improve Patient Understanding, Navigation, Engagement, and Self-...
2/10/16 - Fraunhofer ITEM Acquires Surfactant and CPA Program Assets from Takeda
Deal Type: Asset Transaction Deal Country: Germany Deal Status: Completed Deal Value: 0.0000 USD. The Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, a contract research organization, has acquired surfactant and continuous powder aerosolization program assets from Takeda GmbH, a pharmaceutical company and a subsidiary of Takeda.
2/10/16 - Immunocore's IMCgp100 Granted Orphan Drug Designation by US FDA for the Treatment of Uveal Melanoma
By a News Reporter-Staff News Editor at Biotech Week Immunocore, a world-leading biotechnology company developing novel T cell receptor based biological drugs to treat cancer, infectious diseases and autoimmune disease, announced that the US Food and Drug Administration has granted Orphan Drug Designation to its lead programme, IMCgp100, for the.
2/10/16 - Massachusetts prepares for aging population
"On Dec. 31, 2016, 11 months from now, the number of adults age 60 and older will be greater for the first time in recorded history than the number of children age 20 and younger," said David Stevens, executive director of the Massachusetts Association of Councils on Aging. COA directors, the Executive Office of Elder Affairs and others have been r
2/10/16 - New Movement Disorders Findings from F. Preda and Co-Authors Described (Switching from constant voltage to constant current in deep brain...
New Movement Disorders Findings from F. Preda and Co-Authors Described. By a News Reporter-Staff News Editor at Biotech Week New research on Central Nervous System Diseases is the subject of a report. According to news reporting originating from Trento, Italy, by NewsRx correspondents, research stated, "For many years deep brain stimulation devic
2/10/16 - OptiNose Announces FDA Approval for ONZETRA? Xsail? sumatriptan nasal powder, a New Treatment for Acute Migraine Using Bi-Directional? Breath...
By a News Reporter-Staff News Editor at Biotech Week OptiNose, a privately-held specialty biopharmaceutical company, announced that its licensing partner, Avanir Pharmaceuticals, Inc. has reported that the U.S. Food& Drug Administration approved ONZETRA? Xsail?, formerly AVP-825, for the acute treatment of migraine with or without aura in adu
2/10/16 - Researchers from Robarts Research Institute Detail Findings in Radiotherapy (Validation of a novel robot-assisted 3DUS system for real-time planning...
By a News Reporter-Staff News Editor at Biotech Week Investigators publish new report on Drugs and Therapies. According to news reporting out of London, Canada, by NewsRx editors, research stated, "In current clinical practice, there is no integrated 3 D ultrasound guidance system clinically available for breast brachytherapy. Our news journalist
2/10/16 - Sinovac Biotech Announces Issuance of GMP Certificate for EV71 Vaccine
By a News Reporter-Staff News Editor at Biotech Week Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced that the China Food and Drug Administration has issued the Good Manufacturing Practices certificate to Sinovac for the Company's Enterovirus 71 vaccine. With the clinically-proven strong efficacy profile
2/10/16 - Studies from Memorial Sloan-Kettering Cancer Center in the Area of Thyroid Cancer Reported (Integration of a postoperative calcitonin measurement...
Studies from Memorial Sloan-Kettering Cancer Center in the Area of Thyroid Cancer Reported. According to news reporting out of New York City, New York, by NewsRx editors, research stated, "Staging systems applied to medullary thyroid cancer rely on initial clinical and pathological features and do not consider the response to treatment.
2/10/16 - US FDA Accepts Green Cross' Biologics License Application for IVIG-SN
By a News Reporter-Staff News Editor at Biotech Week Green Cross Corporation, a South Korean biopharmaceutical company, announced that the United States Food and Drug Administration has accepted for review the Company's Biologics License Application for IVIG-SN intended for the treatment of primary immunodeficiency diseases, a class of inherited.
2/9/16 - 3 parent embryos approved
The committee, which was convened last year at the request of the US Food and Drug Administration, concluded it is ethically permissible to go forward, but with caution with mitochondrial replacement techniques, said chairman Jeffrey Kahn, a bioethicist at Johns Hopkins University. But the advisory panel s conclusions have slammed into a c
2/9/16 - Aidin and Tri-City Medical Center Partner to Transform Post Acute Patient Transitions
Using Aidin, Tri-City will create a marketplace for post acute providers in Southern California to openly compete for patient selection based on quality and satisfaction. John Laursen, head of business development for Aidin, said: "We are excited to partner with Tri-City as they provide their patients with best possible support during their transit
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