WOODCLIFF LAKE, N.J., Feb. 5 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for Zuplenz (ondansetron) oral soluble film for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery. [more]
ROCKVILLE, MD., Jan. 12, 2010--The U.S. Food and Drug Administration today unveiled the first phase of its Transparency Initiative which is designed to explain agency operations, how it makes decisions, and the drug approval process. [more]
MINNEAPOLIS, Jan. 7 /PRNewswire/ -- Anyone doubting the commitment of business to compliance and ethics will be surprised by the findings of a survey which reveals spending on compliance has remained stronger than anticipated. Roughly three out of four companies either kept compliance spending even or actually increased it in 2009, and for 2010 the prognosis is even brighter.
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WASHINGTON, Dec. 17 /PRNewswire-USNewswire/ -- Yesterday, an advisory committee to the Food and Drug Administration voted against the approval of Tarceva (erlotinib) as maintenance treatment for advanced lung cancer patients. [more]
WASHINGTON, Dec. 9, 2009-FDA is beginning to address previously identified weaknesses in its oversight of postmarket drug safety issues, but challenges remain. The agency is changing its postmarket decision-making process as part of its Safety First Initiative, which includes formalizing interactions between OND and OSE and providing OSE with added responsibilities. [more]
SAN DIEGO, Dec. 8 /PRNewswire/ -- Eidogen-Sertanty, Inc., a San Diego-based computational drug discovery solutions provider, announced today they have licensed their Target Informatics Platform (TIP) to the U.S. Food and Drug Administration's National Center for Toxicological Research (NCTR). [more]
WILMINGTON, Del., Dec. 3 /PRNewswire/ -- ParagonRx, a Delaware-based company specializing in pharmaceutical risk management and optimal medication use, will host a free webinar on Wednesday, Dec. 9, on the FDA's draft guidance on REMS - Risk Evaluation Mitigation Strategy - programs and its implications for REMS lifecycle management. Dr. Gary Slatko, chief medical officer of ParagonRx and an expert on REMS and risk management programs, will lead the one-hour program beginning at 11 a.m. EST. [more]
SILVER SPRING, Md., Nov. 25 /PRNewswire-USNewswire/ -- An article by Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, titled "A Difficult Balance - Pain Management, Drug Safety, and the FDA," appears in the Nov. 26, 2009 issue of The New England Journal of Medicine. [more]
WASHINGTON--(BUSINESS WIRE)--Nov 13, 2009 - Larry Weber, chairman of W2 Group – a group of digitally driven marketing services companies that help marketers in their new role as builders of communities and content aggregators – is speaking today at the Food and Drug Administration's (FDA) public hearing on “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.” [more]
NEW YORK, Nov. 12 /PRNewswire/ -- Euro RSCG Life today presented findings and insights from proprietary research and analysis of 1,700-plus social media users at the United States Food and Drug Administration hearing "Promotion of Food and Drug Administration-regulated medical products using the Internet and social media tools." [more]
ROCKVILLE, Md., Oct. 14, 2009--The U.S. Food and Drug Administration today launched a Web page for consumers with information on how to dispose of certain drugs, including several high-potency opioids and other selected controlled substances. These medicines have the potential to be harmful, even deadly, in a single dose if taken by someone other than the intended person. [more]
LONDON, 7 October 2009 - Pharmaceutical companies are gearing up for an increase in running late phase cancer vaccine trials following draft guidance issued by the FDA last week. [more]
ROCKVILLE, Md., Sept. 30, 2009--The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics. [more]
SILVER SPRING, Md., Sept. 30 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued its Strategic Plan for Risk Communication, which outlines the agency's efforts to disseminate more meaningful public health information. The plan also lays out a framework for the FDA to provide information about FDA-regulated products to health care professionals, patients and consumers in the form they need it and when they need it, and for how the agency oversees industry communications. [more]
(Washington, DC) – September 28, 2009 -- Join regulators and pharmaceutical industry experts on October 1st and 2nd at the National Press Club where they will discuss their new get-tough approach to risk management and drug safety regulation. The 2nd Annual Risk Management and Drug Safety Summit is a one and a half day-long conference and as a sponsor of the event, United BioSource Corporation invites reporters covering the FDA and the pharmaceutical industry to attend at no charge, any or all sessions. [more]
BOSTON, Sept. 23 /PRNewswire-FirstCall/ -- PAREXEL Consulting, a business unit of PAREXEL International (NASDAQ:PRXL) and a leading global life sciences consultancy serving the biopharmaceutical and medical device industries, today released its second annual study on the state of the U.S. Food and Drug Administration (FDA) drug review process. [more]
WALTHAM, Mass., Sept. 8 /PRNewswire/ -- According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the US market for physician-dispensed cosmeceutical pigment control products will experience considerable growth in sales over the next five years. MRG's US Markets for Physician-Dispensed Cosmeceuticals 2009 report finds, however, that product safety issues involving hydroquinone, the active ingredient in many pigment control products, have led the Food and Drug Administration (FDA) to second guess the use of the compound in such products. [more]
CHICAGO, IL—August 27, 2009—Scientific Voice, a leading provider of biopharma speaker bureau and program management services, today announced that Eileen May has been named Senior Vice President of Operations. Scientific Voice is a Publicis Strategic Solutions Group company. [more]
WASHINGTON, July 17 /PRNewswire-USNewswire/ -- The Food and Drug Law Institute has published the first monograph in its landmark Monograph Series -- Price Reporting Basics under Medicaid, Medicare and the PHS340(b) Program: Planning for Both Compliance and Commercial Success. [more]
READING, Pa., June 17, 2009 -- The 2009 Benchmarking Study of Select Pharmaceutical and Biotech Companies’ Interpretation of the Revised PhRMA Code is now available through PharmaForce International, a leader in pharmaceutical/biotech industry analysis. This much-anticipated report covers key interpretations and PhRMA Code related policies at 13 companies in the U.S. [more]
Mergers & Acquisitions, Partnerships, & Collaborations 2010 – Review and Outlook
This PharmaLive Special Report analyzes the healthcare industry’s M&As of 2009, providing a comprehensive listing of companies’ M&A activity and detailing the top 20 deals within each of the Pharmaceutical, Biotechnology, Specialty, and Medical Device sectors, and previews potential M&A activity within the healthcare arena for 2010.
The introductory rate of $395 expires February 17, 2010.
