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 The leading web portal for pharmacy resources, news, education and careers August 1, 2014
Pharmacy Choice - News - U.S. Pharmaceutical Industry - August 1, 2014

Pharmacy News

 U.S. Pharmaceutical Industry
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8/1/14 - "Catheter" in Patent Application Approval Process
By a News Reporter-Staff News Editor at Health& Medicine Week A patent application by the inventors GERDTS, MICHAEL D.; LARSON, KAREN, filed on March 24, 2014, was made available online on July 17, 2014, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application is assigned to Boston Scientifi
8/1/14 - 60+ Doctors and Leading Medical Experts Sign an Open Letter Urging the FDA to Approve First-Ever Drug to Treat Women's Most Common Form of Sexual Dysfunction, notes Even the Score
Michael Krychman, a renowned physician and sex therapist who has been a leading champion of FDA action on a treatment for HSDD, includes 62 signees consisting of gynecologists, psychiatrists, psychologists, nurses and others on the front lines of treating women with the condition. The signees represent a multitude of well-known and influential medi
8/1/14 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco...
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications. Submit written comments on the collection of information to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 2085
8/1/14 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs:...
Under the Paperwork Reduction Act of 1995, Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. Submit written comments on the collectio
8/1/14 - Alnylam Pharmaceuticals Assigned Patent
ALEXANDRIA, Va., Aug. 1 Alnylam Pharmaceuticals, Cambridge, Massachusetts, has been assigned a patent developed by four co-inventors for "compositions and methods for inhibiting expression of the HAMP gene." The co-inventors are Tomoko Nakayama, Cambridge, Massachusetts, Anke Geick, Bayreuth, Germany, Pamela Tan, Kulmbach, Germany, and Herbert Y.
8/1/14 - AMAG Pharmaceuticals, Inc. to Participate in Jefferies Boston Healthcare Summit
AMAG Pharmaceuticals, Inc. today announced that Frank Thomas, chief operating officer, and Scott Holmes, senior vice president of finance and investor relations, will host one-on-one meetings at the Jefferies 2014 Boston Healthcare Summit on Wednesday, August 6, 2014 at the Boston Harbor Hotel in Boston, Massachusetts. AMAG Pharmaceuticals, Inc.
8/1/14 - Amarantus Announces Positive Top-Line Interim Clinical Data for Alzheimer's Blood Diagnostic LymPro Test(R)
Amarantus Bioscience Holdings, Inc., a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced positive interim clinical performance data for the Company's proprietary cell cycle...
8/1/14 - Arrien Pharmaceuticals Assigned Patent
ALEXANDRIA, Va., Aug. 1 Arrien Pharmaceuticals, Somerset, New Jersey, has been assigned a patent developed by Hariprasad Vankayalapati, Draper, Utah, Rajendra P. Appalaneni, Stamford, Connecticut, and Y. Vekata Krishna Reddy, Hyderabad, India, for the "substituted 5- -1 H-pyrazolo pyridine and pyrazolo pyridine derivatives as protein kinase inhib
8/1/14 - Atlantic Information Services Webinar to Offer Health Plan, Employer Strategies for Implementing Narrow Pharma Networks
Narrow networks that vary in size and approach offer health plans and employers effective options to trim pharmacy costs and improve outcomes. The Aug. 12 webinar from Atlantic Information Services, Inc., "Health Plan/Employer Strategies for Implementing Narrow Pharmacy Networks," will provide strategies and considerations around adopting narrow...
8/1/14 - Bharat Book Bureau: Pharmaceutical Packaging Products
S demand to reach $22.1 billion in 2018. Demand for pharmaceutical packaging products in the US will rise 4.9 percent annually to $22.1 billion in 2018. Growth will accelerate slightly from the pace of the 2008-2013 period as drug makers upgrade the barrier, security, and functional properties of their packaging systems. Among all pharmaceutical pa
8/1/14 - Biota Reports Top-Line Data From Its Phase 2 "IGLOO" Trial of Laninamivir Octanoate
Biota Pharmaceuticals, Inc. today announced top-line data from a randomized, double-blind, placebo-controlled, parallel-arm Phase 2 clinical trial comparing the safety and efficacy of a 40 mg and 80 mg dose of laninamivir octanoate to placebo. "It is disappointing that the rapid and significant onset of antiviral activity against the influenza v
8/1/14 - Celladon Corporation Secures $25 Million Credit Facility From Hercules Growth Capital
Celladon Corporation, a clinical-stage biotechnology company applying its leadership position in the field of gene therapy and calcium dysregulation, today announced that it has entered into a credit facility with Hercules Technology Growth Capital, Inc. and its affiliate lenders. Celladon drew a first tranche of $10 million at the closing of the
8/1/14 - FDA Approves Boehringer Ingelheim's Striverdi Respimat (olodaterol) Inhalation Spray for Maintenance Treatment of COPD
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration has approved Striverdi Respimat Inhalation Spray 5 mcg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema.
8/1/14 - FDA approves Lilly, Boehringer diabetes drug
Federal regulators have approved a new treatment from U.S. drugmaker Eli Lilly and Co. and its German counterpart, Boehringer Ingelheim, for the most common form of diabetes. The Food and Drug Administration said Friday it will permit Jardiance tablets to be used by adult patients with type 2 diabetes who also are trying to control their condition
8/1/14 - Federal Register Table of Contents
,44858-44860 Health and Human Services Department SeeCenters for Disease Control and Prevention SeeCenters for Medicare& Medicaid Services SeeChildren and Families Administration SeeFood and Drug Administration SeeNational Institutes of Health SeeSubstance Abuse and Mental Health Services Administration NOTICES Findings of Research...
8/1/14 - Genentech Alzheimer's drug misses goals in studies [Malta Independent, The]
An experimental drug from the biotech company Genentech failed to slow mental decline in mid-stage studies on more than 500 people with mild to moderate Alzheimer's disease, but showed some promise in the least impaired participants who received a higher dose. "We're very encouraged" by the hint of benefit for patients with milder dementia and wil
8/1/14 - Generic Drug User FeeAbbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active...
SUMMARY: The Food and Drug Administration is announcing the rates for abbreviated new drug applications, prior approval supplements to an approved ANDA, drug master files, generic drug active pharmaceutical ingredient facilities, and finished dosage form facilities user fees related to the Generic Drug User Fee Program for fiscal year 2015. The Fed
8/1/14 - Genzyme Receives Label Expansion for Lumizyme (alglucosidase alfa) in the United States for the treatment of Pompe Disease
Genzyme, a Sanofi company, today announced that the U.S. Food and Drug Administration approved a supplement to expand the indication for Lumizyme . Previously, in the United States, Lumizyme had been approved only for patients with late onset Pompe disease. Based on the biochemical and clinical data provided as part of the submission, FDA conclud
8/1/14 - Health & Wellness Industry Gets Excited by Recent Federal Medical Marijuana Legalization Efforts - Company Initiates Cannabis Drug Development Plan
Pharmaceutical, Wellness and Cannabis companies stand out in health sector with continual growth and significant acquisitions of resources: Crown Baus Capital Corp., Cannabis Sativa, Inc., GW Pharmaceuticals plc, Avalanche Biotechnologies Inc. and Healthequity Inc.. Crown Baus Capital Corp., a global acquisition-based conglomerate targeting five...
8/1/14 - ImmunoGen, Inc. Reports Fourth Quarter and Fiscal Year 2014 Financial Results
ImmunoGen, Inc., a biotechnology company that develops novel anticancer therapeutics using its antibody-drug conjugate technology, today reported financial results for the three-month period ended June 30, 2014 the fourth quarter of the Company s 2014 fiscal year. This certainly includes the expected disclosure by Roche of the findings from t
8/1/14 - Incyte Reports 2014 Second-Quarter Financial Results and Updates Shareholders on Key Clinical Programs [Global Data Point]
The Company also highlighted additional clinical trial agreements for its investigational IDO1 inhibitor INCB24360 with Bristol-Myers Squibb, AstraZeneca/ MedImmune and Genentech, as well as the initiation of the clinical trial of INCB24360 in combination with Merck's pembrolizumab.&# x0D;. For the quarter ended June 30, 2014, net product revenues
8/1/14 - Insys Shares Fall Following Publication Of Cleveland Research Report; Halozyme Receives Favorable FDA Decision
ESRX may look to exclude Gilead's Sovaldi or other competing products in Hepatitis C once new drugs reach the market later this year. Shares of Insys Therapeutics closed at $27.03, down 10.14 percent.======================== Halozyme Therapeutics received notice Thursday that the Blood Products Advisory Committee of the U.S. Food and Drug Administr
8/1/14 - Isis Pharmaceuticals Initiates Phase 3 Study of ISIS-SMN Rx in Infants with Spinal Muscular Atrophy
Isis Pharmaceuticals, Inc. announced today the initiation of a pivotal Phase 3 study evaluating ISIS-SMN Rx in infants with spinal muscular atrophy, the most common genetic cause of infant mortality. Isis plans to dose the first infant in this study within the next few weeks, at which time Isis will earn an $18 million milestone payment from its
8/1/14 - MEDICREA's K-JAWS Obtains FDA Approval for Its Marketing in the United States
MEDICREA has just obtained FDA approval to market its K-JAWS Cervical Compression Staple in the United States Given this technology s highly innovative aspect and its unique design on the market, this approval process was the longest and most complex we have every had to administer with the FDA, but we have now reached a decisive milestone
8/1/14 - New Pharmacoeconomics Study Findings Have Been Reported by Researchers at Tufts Medical Center (A survey of individuals in US-based pharmaceutical...
New Pharmacoeconomics Study Findings Have Been Reported by Researchers at Tufts Medical Center. According to news reporting out of Boston, Massachusetts, by NewsRx editors, research stated, "We surveyed US-based leaders in health economics and outcomes research departments in drug and device companies to examine their views on the state of the fiel
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