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 The leading web portal for pharmacy resources, news, education and careers October 6, 2015
Pharmacy Choice - News - Front Page Healthcare News - October 6, 2015

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 Front Page Healthcare News
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10/6/15 - 3M Drug Delivery Systems and Impel NeuroPharma Form a Strategic Alliance; 3M signs strategic agreements with Impel to accelerate commercialization and cost effectiveness of POD technology platform and Impel's growing portfolio of enhanced CNS product
The alliance further solidifies 3 M's presence as a clear leader in the drug delivery sector and shows its continued commitment to cutting-edge technology. The alliance with 3 M will enable Impel to expedite the development and commercialization of the POD technology and accelerate Impel's internal pipeline into late-stage clinical trials and...
10/6/15 - A.M. Best Special Reports: U.S. Health Stocks Maintain Momentum During Second-Quarter 2015; Life/Annuity Stocks Turn Positive
According to two special reports by A.M. Best, despite the second-quarter 2015 slowdown, U.S. health stock price movements remained favorable and life/annuities outperformed the broad market in 2015, although still lagging. Similarly, the average operating margin of the group improved to 4.7% from 4.5%.; Driven by the implementation of the health i
10/6/15 - Acceptability of Draft Labeling To Support Abbreviated New Drug Application Approval; Guidance for Industry; Availability
SUMMARY: The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Acceptability of Draft Labeling to Support ANDA Approval." It explains FDA's interpretation of the regulatory provision related to submission of copies of applicants' proposed labeling and clarifies that FDA's Office of Generic Drugs will a
10/6/15 - AcelRx Pharmaceuticals Announces Initiation of Clinical Study with ARX-04 in Emergency Room Patients with Moderate-to-Severe Acute Pain
AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute and breakthrough pain, today announced the initiation of an open-label Phase 3 study of ARX-04 for the treatment of adult patients who present in the emergency room..
10/6/15 - Actinium Pharma Targets Q4 IND Filing For Iomab-B
WASHINGTON- Actinium Pharmaceuticals Inc. announced that subsequent to its pre-IND or Investigative New Drug meeting with the U.S. Food and Drug Administration for its Iomab-B drug candidate, the Company is finalizing the IND filing for submission to the FDA to support the start of the Phase 3 clinical study. The Company established an agreement wi
10/6/15 - Actinium Targets Fourth Quarter IND Filing for Iomab-B Subsequent to Pre-IND Meeting With FDA
Actinium Pharmaceuticals, Inc., is a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium announced today that subsequent to its pre-IND meeting with the U.S. Food and Drug Administration for its Iomab-B drug candidate, the Company is finalizing the IND filing for...
10/6/15 - Aetna Introduces New Medicare Advantage Plan with Main Line Health
Aetna today announced a new Aetna Medicare Advantage plan with a $12 monthly premium that will give Medicare beneficiaries access to coordinated care in Chester, Delaware and Montgomery counties. Aetna Medicare Advantage Prime members who receive care from Main Line Health and affiliated providers will experience more coordinated care and will bene
10/6/15 - Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on...
All comments should be identified with the OMB control number 0910-0727. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
10/6/15 - Akebia Reaches Agreement with FDA and EMA on Vadadustat Global Phase 3 Program
Akebia Therapeutics, Inc., a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia inducible factor, today announced the successful completion of the End-of-Phase 2 Meeting process with the United States Food and Drug Administration and the Scientific Advice Process with.
10/6/15 - Alkermes: FDA Approves ARISTADA For Treatment Of Schizophrenia
WASHINGTON- Alkermes Plc. said the U.S. Food and Drug Administration has approved ARISTADA extended-release injectable suspension for the treatment of schizophrenia. Alkermes is preparing to launch ARISTADA immediately. ALKS, which closed down 1.2 percent on Monday at $59.77, gained 6.2 percent in pre-market activity.
10/6/15 - Axovant Sciences Announces Start Of Confirmatory Phase 3 MINDSET Study And Special Protocol Assessment (SPA) Agreement With FDA
Axovant Sciences Ltd., a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced the first patients screened in MINDSET, a confirmatory global phase 3 study of Axovant's lead product candidate, RVT-101. The primary efficacy evaluations are the Alzheimer's Disease Assessment Scale cognitive subscal
10/6/15 - BD Celebrates National Health Information Technology (NHIT) Week
Franklin Lakes, NJ- BD, a leading global medical technology company, today announced its participation in National Health Information Technology Week. During the week of Oct. 5-9, BD will join hundreds of health information technology enthusiasts across the United States to recognize the impact digital health plays in improving healthcare delivery,
10/6/15 - BD MAX Enteric Parasite Panel Receives FDA Clearance for Detection of Common and Pathogenic Intestinal Parasites
By a News Reporter-Staff News Editor at Life Science Weekly BD Life Sciences, a segment of global medical technology company BD, announced the availability of the U.S. Food and Drug Administration cleared BD MAX? Enteric Parasite Panel for use on the BD MAX System. The BD MAX Enteric Parasite Panel is the latest panel in the BD MAX Enteric suit
10/6/15 - Becker's Hospital Review Names 100 Hospitals and Health Systems With Great Oncology Programs [Seven Days (United Arab Emirates)]
-The list features organizations dedicated to treating cancer patients as well as researching the deadly disease. These hospitals and cancer centers stand out in terms of quality patient care, clinical outcomes and research achievements. Specifically, the Becker's team examined U.S. News& World Report's hospital rankings for treating cancer, CareCh
10/6/15 - Biotech stocks fall on trade deal and drug price scrutiny
Biotech stocks slipped Tuesday on concerns about patent protection overseas and on continued scrutiny of the cost of some medications. The S&P 500' s biotech index slid 4 percent in afternoon trading, with big names including Gilead Sciences Inc., Amgen Inc., Celgene Corp. and Vertex Pharmaceuticals Inc. all losing ground. The biotech industry g
10/6/15 - Bristol-Myers Squibb Gets FDA's Priority Review For Daklinza SNDAs
NEW YORK CITY- Bristol-Myers Squibb Co. Tuesday announced today said FDA accepted its three supplemental New Drug Applications or sNDAs for Daklinza for filing and priority review. The company said FDA will review the three Daklinza sNDAs within a six-month timeframe. The new sNDAs accepted by the FDA for review include data from the ALLY-1 and ALL
10/6/15 - Catalyst Pharmaceuticals Announces a Clinical Trial for Pediatric Patients With Congenital Myasthenic Syndromes
Catalyst Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced a clinical trial with Firdapse in pediatric patients with congenital myasthenic syndromes. Firdapse has received Breakthrough Therapy Designation from the FDA...
10/6/15 - Compass Biomedical Announces FDA Drug Master File Acceptance for PLUS? Human Platelet Lysate
Clinical Grade PLUS? has previously been approved by the FDA for use in at least two investigational new drug submissions for expansion of mesenchymal stems cells. A Drug Master File is a confidential detailed document submitted to the FDA by a manufacturer that includes the Chemistry, Manufacturing and Controls information about their product.
10/6/15 - CTRV Grabs Headlines, Watch Out For EXAS Today, ONCE Gets A Spark
FOSTER CITY- Alkermes plc has received FDA approval for ARISTADA extended-release injectable suspension for the treatment of schizophrenia. Shares of ContraVir Pharmaceuticals Inc. rose as much as 197% on Monday after the company revealed that its drug candidate CMX157 is 60- fold more active than Gilead's Viread against the hepatitis B virus based
10/6/15 - Dako, an Agilent Technologies Company, Announces FDA Approval of New Companion Diagnostic for Lung Cancer [Daily Tribune (Bahrain)]
-Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, announced Oct. 2 that the U.S. Food and Drug Administration approval of a new companion diagnostic assay that can reveal whether a patient with advanced non-small cell lung cancer is likely to respond to a new form of treatment. KEYTRUDA is approved by the FDA to
10/6/15 - Data on Life Science Research Reported by Researchers at Cancer Treatment Centers of America (Fatigue as a Driver of Overall Quality of Life in...
Data on Life Science Research Reported by Researchers at Cancer Treatment Centers of America. By a News Reporter-Staff News Editor at Life Science Weekly Research findings on Life Science Research are discussed in a new report. Our news journalists obtained a quote from the research from the Cancer Treatment Centers of America, "A cross-sectional
10/6/15 - DH -UK and India regulators agree deal for closer collaboration to improve public safety
Release date- 05102015- Medicines and Healthcare products Regulatory Agency signs Memorandum of Understanding with its counterpart body in India. This is the first MOU agreed with the Central Drugs Standard Control Organisation, part of the Ministry of Health and Family Welfare of Republic of India and was signed by Dr Gyanendra Nath Singh, India's
10/6/15 - Established Conditions: Reportable Chemistry, Manufacturing, and Controls Changes for Approved Drug and Biologic Products; Draft Guidance for...
SUMMARY: The Food and Drug Administration is reopening the comment period for the "Established Conditions: Reportable Chemistry, Manufacturing, and Controls Changes for Approved Drug and Biologic Products; Draft Guidance for Industry," published in the Federal Register of June 1, 2015. FDA is reopening the comment period to allow interested persons
10/6/15 - FDA approves expanded indication for medical device to treat a form of brain cancer
Release date- 05102015- The U.S. Food and Drug Administration today approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme, an aggressive form of brain cancer. Nearly 23,000 Americans will be diagnosed with brain or other nervous system cancers in 2015, according to the National Cancer..
10/6/15 - FDA approves new treatment for advanced lung cancer
The Food and Drug Administration approved a new drug for patients with advanced non-small cell lung cancer whose tumors have a specific genetic mutation. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a press release. The drug specifically works in patients wi
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