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 The leading web portal for pharmacy resources, news, education and careers June 28, 2017
Pharmacy Choice - News - Pharmaceutical Development - June 28, 2017

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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6/21/17 - AXIM Obtains More Financing for Its Cannabinoid Therapies for MS and Bowel Diseases [Arab News (Saudi Arabia)]
AXIM Biotechnologies has secured an additional $4 million in institutional financing to advance clinical trials of its cannabinoid therapies for multiple sclerosis and irritable bowel syndrome. Some of the trials involve a chewing-gum therapy delivery system. AbbVie developed Marinola as a gel capsule.
6/21/17 - bluebird bio and Celgene Corporation Announce Updated Clinical Results from Ongoing First-in-Human Multicenter Study of bb2121 Anti-BCMA CAR T Cell...
By a News Reporter-Staff News Editor at Biotech Week bluebird bio, Inc., and Celgene Corporation announced that updated results from the ongoing CRB-401 Phase 1 clinical study of bb2121, an investigational anti-BCMA CAR T cell therapy, in 18 patients with relapsed/refractory multiple myeloma will be presented at the American Society of Clinical O
6/21/17 - Clarify Medical Core Technology Receives FDA Clearance
By a News Reporter-Staff News Editor at Biotech Week Clarify Medical, Inc. announced that it has received FDA Market Clearance for the Clarify Medical Phototherapy System, the core technology of its Clarify Home Light Therapy service, which it plans to offer to patients in November. "For people with chronic skin conditions that respond to light
6/21/17 - Clovis rockets on maintenance data in ovarian cancer [T-break Tech (Middle East)]
The company`s shares rocketed 46% on the announcement of the new clinical trial results for Rubraca in second- line and later maintenance treatment for women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy, with Clovis suggesting it would file the data with the US FDA within the next four months.
6/21/17 - CTI BioPharma Appoints David R. Parkinson, M.D., Leader in Oncology Clinical Development, to Board of Directors and Announces Board Member...
By a News Reporter-Staff News Editor at Biotech Week CTI BioPharma Corp. announced that David R. Parkinson, M.D., has been appointed a Director of CTI BioPharma effective June 5, 2017. Richard L. Love, a CTI BioPharma director, will act as Interim Chairman of the Board until the Board selects a permanent successor. "We are pleased to have David
6/21/17 - Data at ASCO Show Consistent Progression-Free Survival Benefit in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma...
By a News Reporter-Staff News Editor at Biotech Week Janssen Research& Development, LLC announced longer follow-up of up to four years from the pivotal Phase 3 RESONATE? trial of IMBRUVICA vs. ofatumumab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. These results will be presented today at the
6/21/17 - Development of New Tuberculosis Treatment RegimensScientific and Clinical Trial Design Considerations; Public Workshop; Request for Comments
This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. Government Agencies, academic experts, industry, and other stakeholders regarding scientific and clinical trial design considerations related to the development of new TB regimens. DATES: The public workshop will be held on July 1
6/21/17 - Dr REDDY'S MAY FILE 2 NEW DRUGS WITH FDA BY 2019
Dr Reddy's Laboratories is likely to file two new drug applications with the US Food and Drug Administration by 2019. The company is presently working on 16 active product development programmes. Out of the two applications to be filed, one drug to treat migraines has completed Phase-III trials, while another anti-cancer biologic agent is currently
6/21/17 - DR REDDY'S NEW DRUG APPLICATION
Indian pharmaceutical major Dr Reddy's Laboratories, has 16 drug applications in its research pipeline. Among them migraine treatment drug has completed Phase III trials, while phase III trials is underway for an anticancer drug. The company anticipates to submit, New Drug Application to the US Food and Drug Administration for migraine treatment in
6/21/17 - Dr Reddy`s may file two new drugs with FDA by 2019 [Tehran Times (Iran)]
According to filing with the US Securities and Exchange Commission, the city-based pharma company is expected to file the New Drug Application with US Food and Drug Administration with regard the migraine drug in 2018 while it is expected to submit license application for the cancer drug, it may approach the drug regulator in 2019.. The company`s p
6/21/17 - FDA approves ReNeurons cryopreserved formulation of retinal stem cell therapy candidate [Tehran Times (Iran)]
The FDA has approved the cryopreserved formulation of ReNeuron Groups human retinal progenitor cell therapeutic candidate, according to a company press release. We are delighted that the FDA has approved the use of the cryopreserved formulation of our hRPC retinal cell therapy candidate in our ongoing clinical development programs, Olav Helleb, CEO
6/21/17 - Grassley Encourages FDA Commissioner to Consider Proposals to Expand Access to Affordable Prescription Drugs
Gottlieb previously testified that the FDA would work to curtail gaming of FDA regulations by drug makers, improve the approval process for generic drugs and eliminate the FDA's backlog of applications for generics. The Creating and Restoring Equal Access to Equivalent Samples Act, which Grassley introduced with Senator Patrick Leahy, would address
6/21/17 - Hologic Announces FDA Clearance of Aptima Assay to Detect Herpes Simplex Virus 1 & 2 [Syrian Arab News Agency]
Hologic, Inc. announced today that it has obtained FDA clearance to market the Aptima Herpes Simplex Virus 1& 2 molecular assay on the fully automated Panther system. The test will be commercially available in the 50 United States, U.S. territories and Puerto Rico. "Helping our clinical lab customers consolidate testing on the Panther system enabl
6/21/17 - Immune Pharmaceuticals announces initiation of enrollment in clinical trial with Ceplene/ low-dose IL-2 in Chronic Myelomonocytic Leukemia (CMML) [Sudan Tribune]
This Ceplene/CMML trial is being financed by the University of Gothenburg, Sweden. Cytovia Inc., Immune`s immuno-oncology subsidiary, has agreed to provide a non-restricted grant to the University of Gothenburg to cover costs for IL-2 treatment. "CMML cells exert immunosuppression that is targeted by Ceplene," added Professor Kristoffer Hellstrand
6/21/17 - Integral Molecular Announces the Expansion of Its Membrane Proteome Array Technology for Improving Antibody Safety and New Target Discovery
By a News Reporter-Staff News Editor at Biotech Week Integral Molecular announces the expansion of its proprietary Membrane Proteome Array? to now consist of 5,300 unique human membrane proteins, representing nearly the entire human membrane proteome, making it the broadest platform of its kind for antibody specificity profiling and de-orphanin
6/21/17 - Novartis interim results from global, pivotal CTL019 trial show durable complete responses in adults with r/r DLBCL
By a News Reporter-Staff News Editor at Biotech Week Novartis announced findings from an interim analysis of its multi-center Phase II JULIET study of CTL019 in adult patients with relapsed or refractory diffuse large B-cell lymphoma, which will be presented at the International Conference on Malignant Lymphoma meeting, Lugano, Switzerland.
6/21/17 - Novavax RSV F Vaccine Phase 2 Clinical Trial Data in Women of Child Bearing Age Published in Vaccine
By a News Reporter-Staff News Editor at Vaccine Weekly Novavax, Inc., announced that data from the second of two Phase 2 trials of its RSV F protein recombinant nanoparticle vaccine candidate in women of child bearing age have been published in the journal Vaccine. Novavax is developing the RSV F Vaccine with the goal of protecting infants from R
6/21/17 - Olon SpA P&R Group Acquires Ricerca Biosciences Chemical Division In Ohio USA
By a News Reporter-Staff News Editor at Biotech Week Olon S.p.A., a world leading Active Pharmaceutical Ingredients contract development and manufacturing organization and Generics supplier, announced the acquisition of Ricerca Biosciences' Chemical Division of the contract research and CDMO based in Concord, Ohio, USA. This acquisition strengthe
6/21/17 - Outcome Capital Announces UCB Pharma Has Acquired Beryllium Discovery
By a News Reporter-Staff News Editor at Biotech Week Outcome Capital, an investment banking firm that serves middle market growth companies in the life science and technology segments, announced that UCB Pharma, Ltd. has acquired privately held Beryllium Discovery, LLC. Outcome Capital served as the exclusive strategic and financial advisor to Be
6/21/17 - Paradigm Biopharmaceuticals enters US$18 billion global heart failure market [Syrian Arab News Agency]
Paradigm Biopharmaceuticals has expanded its drug development pipeline by in-licensing Pentosan Polysulfate Sodium for the treatment of heart failure from the University of Oslo, Norway. Paradigm will utilise PPSs well-established safety data to fast-track development under the FDA 505 pathway. The agreement comes ahead of Paradigm presenting and..
6/21/17 - Regulatory Approval
U.S. FDA Approves MydayisTM- A New Once-Daily Option for ADHD Symptom Control in Patients 13 Years and Older Mydayis demonstrated improvements lasting up to 16 hours post-dose, beginning at 2 or 4 hours post-administration, compared to placebo, in total score on a skill-adjusted math test that measures attention in ADHD Lexington, Mass., USA- June
6/21/17 - Shire : FDA Approves Mydayis, New Once-Daily Option For ADHD Symptom Control
SAINT HELIER- Shire plc announced that the U.S. Food and Drug Administration has approved MYDAYIS, a once-daily treatment comprised of three different types of drug-releasing beads for patients 13 years and older with Attention Deficit Hyperactivity Disorder or ADHD. Mydayis is not for use in children 12 years and younger. Shire expects to make Myd
6/21/17 - SHIRE PLC - Regulatory Approval
Lexington, Mass., USA June 20, 2017 Shire plc announced today that the U.S. Food and Drug Administration has approved MYDAYIS TM, a once-daily treatment comprised of three different types of drug-releasing beads for patients 13 years and older with Attention Deficit Hyperactivity Disorder. Shire expects to make Mydayis commercially available
6/21/17 - Sidel gains FDA approval for aseptic blow fill sealer for manufacturing of low acid products [Observer, The (Uganda)]
Sidel gained the FDAs approval after successfully completing test runs at one its North American dairy customers facilities. This FDA approval officially qualifies the Sidel aseptic solution with dry preform sterilization technology to produce and distribute shelf-stable low acid products in PET bottles for the US market, Guillaume Rolland, sensiti
6/21/17 - The Alzheimer's Drug Discovery Foundation and Science Exchange Launch ADDF ACCESS to Advance CNS Research
By a News Reporter-Staff News Editor at Biotech Week The Alzheimer's Drug Discovery Foundation, the only public charity solely focused on funding the development of drugs for Alzheimer's, and Science Exchange announced the launch of ADDF ACCESS, a first-of-its-kind online platform designed to match scientists working on central nervous system dis
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