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...
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
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
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..
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
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...
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
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, PRAStaff@fda.hhs.gov.
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.
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.
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
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,
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
-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
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
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
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...
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.
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
-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
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
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
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
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..
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