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 The leading web portal for pharmacy resources, news, education and careers December 12, 2017
Pharmacy Choice - News - Pharmaceutical Development - December 12, 2017

Pharmacy News

 Pharmaceutical Development
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12/12/17 - 42 Biggest Movers From Yesterday
Gainers Yield10 Bioscience Inc shares jumped 183.59 percent to close at $5.53 on Monday after the company reported granting of research license to Monsanto for evaluation of 2 novel yield traits in soybean. ARGENX SE/ S ADR shares climbed 78.88 percent to close at $54.47 after the company reported positive topline results from Phase 2 proof-of-conc
12/12/17 - AbbVie Announces Phase 3 Study of VENCLEXTA?/ VENCLYXTO? (venetoclax) in Combination with Rituxan (rituximab) Meets its Primary Endpoint
AbbVie, a research and development based global biopharmaceutical company, today announced the first presentation of efficacy and safety results from MURANO, an international, multicenter, open-label, randomized Phase 3 study of VENCLEXTA?/ VENCLYXTO? in combination with Rituxan compared with bendamustine in combination with Rituxan in pat
12/12/17 - Acceleron Announces Updated Results from Ongoing Phase 2 Trials of Luspatercept in Myelodysplastic Syndromes at the 59th Annual Meeting of the American Society of Hematology
CAMBRIDGE- Acceleron Pharma Inc., a leading biopharmaceutical company in the discovery and development of TGF-beta therapeutics to treat serious and rare diseases, today announced preliminary results from the ongoing Phase 2 trials with luspatercept in patients with lower-risk myelodysplastic syndromes at the 59th Annual Meeting of the American...
12/12/17 - Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug
All comments should be identified with the OMB control number 0910-0001. Also include the FDA docket number found in brackets in the heading of this document. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Under section 505 of the Fede
12/12/17 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Products Development; Food and Drug Administration Orphan Drug Designation Request Form and The Common European Medicines Agency/
All comments should be identified with the OMB control number 0910-0167. Also include the FDA docket number found in brackets in the heading of this document. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Sections 525 through 528 of t
12/12/17 - Alembic Pharma gains 1% as associate company gets US FDA approval [Arab News (Saudi Arabia)]
Rhizen Pharmaceuticals SA, an associate company of Alembic Pharmaceuticals, today announced that the US FDA has granted Fast Track Designation for RP6530, the company`s highly selective and orally active dual PI3K delta/ gamma inhibitor, for the treatment of patients with relapsed/ refractory peripheral T-cell lymphoma. In the morning session, Alem
12/12/17 - Alembic Pharma gains on USFDA approval for Darifenacin [India Infoline News Service]
Alembic Pharmaceuticals Limited today announced that the company has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application Darifenacin Extended- Release Tablets, 7.5 mg and 15 mg. Alembic Pharmaceuticals, a leading pharmaceutical company, is a market leader in the macrolides segment of anti-infective dr
12/12/17 - Allergan Receives FDA Clearance For the CoolSculpting Treatment To Improve Appearance Of Lax Tissue In The Double Chin
Allergan plc today announced that the CoolSculpting treatment is the first and only non-surgical fat reduction technology to be FDA- cleared for improved appearance of lax tissue in conjunction with submental fat, or double chin, treatments. "A 2017 American Society for Dermatologic Surgery survey revealed that 73 percent of patients are both
12/12/17 - Alnylam Completes Submission of New Drug Application to U.S. Food and Drug Administration (FDA) for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today the completion of the rolling submission of a New Drug Application to the U.S. Food and Drug Administration for patisiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of adults with hereditary transthyretin-mediated amyloidosis.
12/12/17 - Aprecia Pharmaceuticals and Cycle Pharmaceuticals Partner to Develop 3D-Printed Orphan Drugs
CINCINNATI and CAMBRIDGE, England, Dec. 12, 2017/ PRNewswire/ Aprecia Pharmaceuticals, LLC, The 3 DP Pharmaceutical Company, and Cycle Pharmaceuticals, Ltd. today announced they have signed a partnership agreement to develop and commercialize orphan drugs using three-dimensionally printed technology. The planned products will deliver quality-of-l
Unless otherwise noted, the term "Arrowhead" refers to Arrowhead Pharmaceuticals, Inc., a Delaware corporation, the terms "Company," "we," "us," and "our," refer to the ongoing business operations of Arrowhead and its Subsidiaries, whether conducted through Arrowhead or a subsidiary of Arrowhead, the term "Subsidiaries" refers collectively to Arrow
12/12/17 - AstraZeneca's CALQUENCE demonstrates activity in relapsed or refractory mantle cell lymphoma trial
AstraZeneca and Acerta Pharma, its hematology research and development center of excellence, today presented results from the open-label, single-arm Phase II ACE-LY-004 clinical trial, which served as the basis for the recent US Food and Drug Administration accelerated approval of CALQUENCE. CALQUENCE was granted accelerated approval by the US Food
12/12/17 - AstraZeneca's CALQUENCE shows potential in chronic lymphocytic leukemia trials
AstraZeneca and Acerta Pharma, its hematology research and development center of excellence, today presented results from the Phase Ib/II ACE-CL-003 clinical trial and updated results from the Phase I/II ACE-CL-001 clinical trial that are evaluating acalabrutinib alone and in combination for the treatment of chronic lymphocytic leukemia in multiple
12/12/17 - AXIM Biotech Announces Successful Completion of Pre-IND Meeting with FDA on Comparable Product to Marinol; Green Light from FDA for IND Submission
AXIM Biotechnologies, Inc., a world leader in cannabinoid research and development, announced today that it has successfully completed a pre-investigational New Drug Application meeting with the U.S. Food and Drug Administration for a dronabinol-based functional, controlled-release chewing gum product it s developing to help treat patients
12/12/17 - AXON Meets the First Milestone in an nfvPPA Phase 1 Study With AADvac1
AXON has announced the initiation of open recruitment in the currently running Phase 1 study in patients suffering from the non-fluent variant of Primary Progressive Aphasia. In August 2017, AXON launched in cooperation with the German FTLD consortium a Phase I study assessing its active tau vaccine in patients with nfvPPA. Markus Otto, the co-ordi
12/12/17 - BeiGene Presents Updated Preliminary Phase 1b Data on BTK Inhibitor Zanubrutinib Combined with GAZYVA at the 59th American Society of Hematology Annual Meeting
CAMBRIDGE, Mass. and BEIJING- BeiGene, Ltd., a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, today presented updated preliminary clinical data from an ongoing Phase 1 b trial of its investigational Bruton's Tyrosine Kinase..
12/12/17 - BioMarin Provides 1.5 years of Clinical Data for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A
SAN RAFAEL- BioMarin Pharmaceutical Inc. announced today an update to its previously reported results of an open-label Phase 1/ 2 study of valoctocogene roxaparvovec, an investigational gene therapy treatment for severe hemophilia A. The updated results will be presented during an oral presentation at the 59th American Society of Hematology Annual.
12/12/17 - Botanical and Plant-Derived Drugs - Analysis, Trends & Forecasts to 2022 - Research and Markets
The "Botanical and Plant-Derived Drugs: Global Markets" report has been added to Research and Markets' offering. The Global Market for Botanical and Plant-Derived Drugs will Grow from $29.4 Billion in 2017 to around $39.6 Billion by 2022 with a CAGR of 6.1%.. For the purposes of this report, botanicals are those drugs that are FDA- approved under t
12/12/17 - CAR T, Immunotherapy Bring New Hope for Multiple Myeloma Patients
The University of Pennsylvania's Perelman School of Medicine issued the following news release:. Researchers from the University of Pennsylvania's Abramson Cancer Center administered CAR T cells to patients following chemotherapy, with 64 percent of patients responding in a clinical trial. These studies will be presented as oral abstracts at the 59
12/12/17 - Cardiome Announces Strategic Licensing Agreement To Commercialize Aggrastat In Russia
-Cardiome Pharma Corp., a revenue-generating, specialty pharmaceutical company focused on commercializing patent-protected hospital drugs, today announced that its affiliate Correvio has entered into an exclusive license and distribution agreement with ZAO Firma Euroservice that will advance Aggrastat toward commercialization in Russia.
12/12/17 - Celgene Corporation and bluebird bio Announce Updated Results from Ongoing Multicenter Phase 1 Study of bb2121 Anti-BCMA CAR T Cell Therapy
SUMMIT- Celgene Corporation and bluebird bio, Inc. today announced that updated results from the ongoing CRB-401 Phase 1 clinical study of bb2121, an investigational anti-B-cell maturation antigen CAR T cell therapy, in 21 patients with late-stage relapsed/refractory multiple myeloma will be presented in an oral presentation at the American Society
12/12/17 - Clementia Initiates Pivotal Phase 3 MOVE Trial for Palovarotene in Patients with Fibrodysplasia Ossificans Progressiva
Clementia Pharmaceuticals Inc., a clinical-stage biopharmaceutical company innovating new treatments for people with ultra-rare bone disorders and other diseases, today announced the start of the MOVE Trial, its Phase 3 registration study evaluating the safety and efficacy of palovarotene for the treatment of patients with fibrodysplasia...
12/12/17 - Clinical Laboratory Test Market Anticipated Witnessing A Fast Track Growth By 2022
Market Research Future published a cooked research report on "Clinical Laboratory Test Market Research Report- Global Forecast Till 2022"- Market Analysis, Scope, Stake, Progress, Trends and Forecast to 2022.. In 2014 According to office of inspector general, three test all of blood test accounts over $400 million each which include complete blood
12/12/17 - CMC Biologics Announces Development and Manufacturing Agreement with Harpoon Therapeutics
BOTHELL, Wash., BERKELEY, Calif., and SOUTH SAN FRANCISCO, Calif., Dec. 12, 2017/ PRNewswire/ CMC ICOS Biologics, Inc., a global leader in clinical and commercial manufacturing of therapeutic proteins, and Harpoon Therapeutics, an immuno-oncology company using its proprietary TriTAC? technology platform to discover and develop novel biologics f
12/12/17 - Constellation Pharmaceuticals Announces First Patient Dosed in Phase 1b/2 PROSTAR Combination Study of CPI-1205 in Advanced Form of Prostate Cancer
Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing tumor-targeted and immuno-oncology therapies based on its pioneering research in cancer epigenetics, today announced that the first patient has been dosed in its Phase 1 b/2 PROSTAR study of C P I-1205, a small-molecule inhibito r of EZH2, c o mbined with...
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