Poisons and meds are often the same substances… A little bug can turn out to be more insidious than you expect. Treatment methods have changed over the years and improved as well. Nevertheless, there’s always a catch. A common cold can be avoided or aggravated with the misleading treatment ideas, and grandma’s methods learned from […]

Article preview from “The Pink Sheet”-  February 25 , 2013 New understanding of the spectrum of CNS disorders and rising interest from biotechs have revealed new targets, new biomarkers and new opportunities to treat the fast-acting and deadly neurodegenerative disease. Add to that an open stakeholder forum hosted by FDA Feb. 25 that could clarify regulatory and clinical expectations,

Scientific Advances Increase Potential For Drugs To Treat ALSRead More »

Article preview from “The Pink Sheet”-  February 18 , 2013 FDA still has backlog fees in arrears more than two months past the payment deadline, but cannot forcibly withdraw the applications; facility listings also change consistently because industry can update them as needed. GDUFA Launch Pains: Facility List Fluctuations, Back-Due Backlog Fees Article preview from “The Pink Sheet”-  February 18 ,

GDUFA Launch Pains: Facility List Fluctuations, Back-Due Backlog FeesRead More »

Article preview from “The Pink Sheet”-  February 11 , 2013 FDA asks groups how it can help ensure prescribing is limited for products approved under proposed new pathway, but several say, other than labeling, it may be out of the agency’s hands.  FDA Worries About Off-Label Use, Stewardship With Limited-Population Approval Pathway Article preview from “The Pink Sheet”-  February 11 ,

FDA Worries About Off-Label Use, Stewardship With Limited-Population Approval PathwayRead More »

Business & Finance Covidien to spin off pharma business Mass High Tech (Boston) Dec. 15, 2011 Affymax partner Takeda won’t commercialize anemia drug in Japan The Wall Street Journal Dec. 15, 2011 Government & Legal News Government issues rule to minimize drug-supply disruption Modern Healthcare (subscription required) Dec. 15, 2011 CMS rule would require device,

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Business & Finance ISTA rejects $314M buyout offer from Valeant The Globe and Mail (Toronto) Dec. 16, 2011 Apricus buys Topotarget USA, cancer drug Totect San Diego Union-Tribune Dec. 16, 2011 Bausch & Lomb seeks partners in eye-drug market PharmaTimes (U.K.) Dec. 16, 2011 Alexza considers strategic options as regulators review Adasuve Bloomberg Dec. 16,

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The call for real-world evidence is the “shot heard round the world” in this new decade of global healthcare. Skyrocketing healthcare costs, an unraveling state of global finance and unprecedented technological advances in medicine have both commercial and government payers looking for answers to what seems to be an age-old question: How do we reduce

Market Access in the Era of Specialty & Biotech – An EBI Virtual Conference in Partnership with inVentiv HealthRead More »

The call for real-world evidence is the “shot heard round the world” in this new decade of global healthcare. Skyrocketing healthcare costs, an unraveling state of global finance and unprecedented technological advances in medicine have both commercial and government payers looking for answers to what seems to be an age-old question: How do we reduce

Market Access in the Era of Specialty & Biotech – An EBI Virtual Conference in Partnership with inVentiv HealthRead More »

China has radically altered the structure, economics, and competitive landscape of a host of industries: textiles and garments in the 1980s, consumer electronics and industrial chemicals in the 1990s, and automotives and telecommunications equipment in the 2000s. In most cases, the resulting transformation has been highly disruptive, creating an unexpected new caste of clear winners

China’s New 2020 Approach: Rewriting the Rules of Competition in 2012 and BeyondRead More »

Whether you are handling customer complaints, working on the manufacturing floor, reviewing safety data, or developing products, you may be responsible for solving new problems that arise during the process. Have you found yourself being brought into a meeting to solve a serious problem to find out that everyone is looking for your input on

Pharmaceutical and Medical Device Problem-Solving ToolsRead More »