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 The leading web portal for pharmacy resources, news, education and careers September 30, 2016
Pharmacy Choice - News - Front Page Healthcare News - September 30, 2016

Pharmacy News

 Front Page Healthcare News
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9/30/16 - Pharma Regulatory Expert Dirk Rodgers To Speak At UNIQUITY India Conference
MUMBAI, India and PRINCETON, New Jersey, Sept. 30, 2016/ PRNewswire/ Author, global regulatory expert, and blogger Dirk Rodgers will be a speaker at UNIQUITY India 2016, where he will discuss the global serialization and tracing regulations impacting India's pharmaceutical manufacturers. Systech's one-day conference will provide customers, indust
9/29/16 - AB Science announces the filing of masitinib in the treatment of amyotrophic lateral sclerosis (ALS) to the European Medicines Agency
AB Science SA, a pharmaceutical company specialized in the research, development and marketing of protein kinase inhibitors, announces today the acceptance and validation from the European Medicines Agency of the filing of masitinib in the treatment of amyotrophic lateral sclerosis, also known as Lou Gehrig's disease, for conditional marketing...
9/29/16 - Agency Forms Submitted for OMB Review, Request for Comments
Summary: In accordance with the Paperwork Reduction Act of 1995, the Railroad Retirement Board is forwarding an Information Collection Request to the Office of Information and Regulatory Affairs, Office of Management and Budget. Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose.
9/29/16 - Alcobra Announces IND Clinical Hold Affecting the MDX Phase III MEASURE Study
Alcobra has not yet received written notice of the clinical hold from the FDA, however, based on verbal communications, the FDA indicated that the clinical hold is due to adverse neurological findings in a pre-clinical study. Alcobra plans to work diligently with the FDA to seek the removal of the clinical hold. About Alcobra Ltd. Alcobra Ltd. is a
9/29/16 - Allergan Issues Statement On Namenda XR Patent Litigation
NEW DELHI- Allergan plc issued a statement regarding ongoing litigation on patents related to NAMENDA XR extended release capsules following announcement of FDA final ANDA approval by Lupin. "One of the licensed patent families covering Namenda XR has been held invalid by the Federal District Court for the District of Delaware. If the district cou
9/29/16 - Allergan Issues Statement on Namenda XR Patent Litigation Following Announcement of ANDA Approvals
Allergan plc, today issued the following statement regarding ongoing litigation on patents related to NAMENDA XR extended release capsules following announcement of FDA final ANDA approval by Lupin. "As announced on September 10, 2015, Allergan's Forest Laboratories subsidiaries and its licensors announced a settlement agreement regarding the
9/29/16 - Ampio Updates Clinical and Regulatory Activity
Ampio Pharmaceuticals, Inc. announced the Company has met with the CBER Division of the FDA to seek guidance on the best path forward to obtain a Biological License for Ampion? to treat patients suffering from pain caused by severe osteoarthritis of the knee. Michael Macaluso, Ampio's CEO noted, "We are grateful to CBER for their thorough revie
9/29/16 - AstraZeneca Gets US Approval For Tagrisso Companion Diagnostic Test
LONDON- AstraZeneca PLC said Thursday the US Food and Drug Administration has approved a blood-based companion diagnostic for non-small cell lung cancer treatment Tagrisso. AstraZeneca said the approval provides a new, non-invasive option to identify patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer, ensuring that...
9/29/16 - Athersys Receives FDA Agreement Under Special Protocol Assessment for Phase 3 Study of MultiStem Treatment for Ischemic Stroke [Daily Star, The (Lebanon)]
-Athersys, Inc. announced today that it has received agreement from the U.S. Food and Drug Administration under a Special Protocol Assessment for the design and planned analysis of a Phase 3 clinical trial of Athersys novel MultiStem cell therapy product for the treatment of ischemic stroke. The SPA provides agreement from the FDA that the protocol
9/29/16 - Aurinia Announces That Voclosporin Achieves Primary and All Pre-Specified Secondary Endpoints in Its Phase IIb AURA-LV Study for Lupus Nephritis (LN)
Aurinia Pharmaceuticals Inc. a clinical stage biopharmaceutical company focused on the global immunology market, today announced that in addition to voclosporin achieving its primary endpoint of Complete Remission at 24 weeks, both doses of voclosporin when added to the current standard of care of Mycophenolate Mofetil and a forced oral...
9/29/16 - Awareness Continues to Grow for Medical Uses of Cannabis
There have been numerous scientific studies of the chemicals in marijuana, which has led to as few as only two U.S. Food and Drug Administration approved medications containing cannabinoids. Due to the marijuana plant containing essential chemicals that may help relief illnesses or symptoms, many people have fought to legalize marijuana for medical
9/29/16 - Benzinga's M&A Chatter for Wednesday September 28, 2016
Hearing DealReporter Says Allergan Could Bid for Acadia, Ophthotech. Ophthotech closed at $57.30, down 1.85%. The Rumor: Shares of Viacom and CBS surged higher Wednesday, as controlling shareholder National Amusements was said to push the companies for a merger, according to sources as reported by Reuters.
9/29/16 - Bharat Book Bureau: Partnerships, Licensing, Investments and M&A Deals
"Partnerships, Licensing, Investments and M&A Deals and Trends for July 2016 in Pharmaceuticals" report is an essential source of data and trend analysis on partnerships, licensing, mergers and acquisitions and financings in the pharmaceuticals industry. The report provides detailed information on partnership and licensing transactions, M&As,...
9/29/16 - Biosimilar User Fee Act; Public Meeting; Correction
SUMMARY: The Food and Drug Administration is correcting a notice entitled "Biosimilar User Fee Act; Public Meeting" that appeared in the Federal Register of September 19, 2016. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115,...
9/29/16 - Biotech Stocks Facing FDA Decision In October
The company's DMD drug Translarna, which was given conditional approval in the European Union in 2014, is knocking strongly at the doors of the FDA. In February of this year, the FDA refused to accept the NDA for Translarna for review, stating that the application was not sufficiently complete to permit a substantive review. The FDA has had its han
9/29/16 - Boehringer Ingelheim and Sarah Cannon Research Institute launch strategic collaboration to develop novel immune-oncology therapies
Boehringer Ingelheim and Sarah Cannon Research Institute announced today a new strategic collaboration. This partnership brings together Boehringer Ingelheim's extensive experience in cancer drug development and Sarah Cannon's expertise and leadership in designing and optimizing clinical trials. The joint clinical development program will...
9/29/16 - Bucks County firm gets FDA approval for low-dose weight-reduction medicine [Cyprus Mail]
A low-dose version of a weight-loss medicine that`s been around more than 50 years has been approved by the Food and Drug Administration to be manufactured and sold by a Bucks County generic-drug maker. "The feedback we were getting from patients was they made it through breakfast and lunch, but were hungry again around dinnertime or late in the d
9/29/16 - Bucks County firm gets FDA approval for low-dose weight-reduction medicine []
Sept. 29 A low-dose version of a weight-loss medicine that's been around more than 50 years has been approved by the Food and Drug Administration to be manufactured and sold by a Bucks County generic-drug maker. "The feedback we were getting from patients was they made it through breakfast and lunch, but were hungry again around dinnertime or la
9/29/16 - Can charity, jobs help gap group gain health coverage? Panel hears two sides [The Idaho Statesman]
At issue before the Legislature is how Idaho should address the needs of 78,000 lower-income residents who either don't qualify for standard Medicaid or for subsidized health coverage on the state insurance exchange created under the 2010 Affordable Care Act. The Legislature has been unable to reach consensus on what boils down to two options: appr
9/29/16 - Catabasis Pharmaceuticals and Sarepta Therapeutics Announce a Joint Research Collaboration in Duchenne Muscular Dystrophy
Catabasis Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, and Sarepta Therapeutics, Inc., a commercial-stage developer of innovative RNA-targeted therapeutics, today announced a joint research collaboration to explore a combination drug treatment approach for Duchenne muscular dystrophy. Although we believe edasalonexent has...
9/29/16 - Central Virginia Coalition of Healthcare Providers Selects Smartlink Mobile Systems to Address MACRA, Chronic Care Management
The Central Virginia Coalition of Healthcare Providers, an Accountable Care Organization providing services in Virginia and North Carolina, has selected Smartlink Mobile Systems as their Chronic Care Management solution partner. Smartlink will provide CVCHiP with their comprehensive Value-Based CCM solution that will help the ACO's providers...
9/29/16 - Clinical Genomics Celebrates Ten Years of Innovation
Clinical Genomics was founded by the leadership team from Enterix, the company that successfully developed and commercialized the innovative InSure brush-based Fecal Immunochemical Test in the United States and Australia. The founders sold Enterix to Quest Diagnostics in 2006 and later re-acquired the company in 2013.. Today, Clinical Genomics h
9/29/16 - Doctor accuses UM, Bascom Palmer colleague of Medicare fraud [The Miami Herald]
Sept. 29 A four-year-old lawsuit between a pair of star doctors who had a falling out at the nation's No. 1 ranked eye institute, Miami- based Bascom Palmer, was finally unsealed on Wednesday revealing allegations of "false claims" for procedures billed to Medicare based on "fabricated" patient evaluations. The "university made a deliberate cho
9/29/16 - Enanta Pharmaceuticals Presents Data on a Novel Non-Fusion Inhibitor of Respiratory Syncytial Virus (RSV) at the 10th Annual Respiratory Syncytial Virus Conference
Enanta Pharmaceuticals, Inc.,, a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that a poster presentation on one of the lead compounds in its RSV program was presented today at the 10 th Annual Respiratory Syncytial Virus conference taking p
9/29/16 - EpiPen lesson
The national fury over the fleecing of sick children by Mylan N.V., which bought the rights to the allergy antidote and jacked up the price of a dose from $57 to $600, followed by the Mylan executive's rough treatment in Congress, caused some wonder. Congress will do nothing of the sort. Government, in the persons of Congress, the Food and Drug Adm
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