| July 3, 2013 | ISSUE NUMBER 307 VOL 10 |
Legal
Mutual vs. Bartlett: A Line in the Sand on Side Effects
The Supreme Court ruled on Mutual Pharmaceuticals v. Bartlett that generic drug makers cannot change labeling or the formula of a drug after it has been approved by the FDA. While the ruling provides the certainty lacking in previous cases, some experts say plaintiffs will use dissents from the four opposing justices to make creative pleas. It also ensures that asking companies to shelve their products solely as a consequence of previously unknown side-effects will keep the issue of access to affordable meds front and center ...Read more
SciVigilance – Pharmacovigilance in a box
SciVigilance provides the powerful combination of streamlined processes, domain expertise and robust technology that integrates disparate data and enables the seamless flow, collection processing and analysis of data. SciVigilance delivers significant time and cost savings, efficiency and compliance gains, all while delivering the highest quality outcomes. Read More
Digital Pharma
Why Social Media Won’t Replace Pharma Meetings
Speaker-led events are a long established way for people to learn and share ideas. Big Pharma and upstart social media agencies may be at the opposite end of the evolutionary scale of business, but they definitely have one thing in common — massive, rapid change — and in times of disruption, learning is everything, writes Peter Houston ...Read more
Drug Safety
Assessing Suicide Risk in Clinical Trials
FDA has issued its second draft guidance on how to effectively assess patients for suicidal ideation and/or behavior (SIB) in clinical trials, mainly for drugs that affect the central nervous system ...Read more
Global
Read the New Pharm Exec Global Digest
In the new issue: Patient adherence focus — new policy and technology initiatives from around the globe; Japan — the country that cost containment forgot; Brazil — drug patent crisis; Commercial model design as an enabler of growth ...Read more
Global
China Report
China is the third largest pharmaceutical market in the world and will become the second largest ahead of Japan by 2015. Everything you need to know to do business in the country; key economic sector data and exclusive interviews from regional leaders ...Read more
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 //Mike Miller was appointed Business Development Executive for Penn Pharma’s US operations (Warren, NJ). //Ray Manna was appointed Senior Vice President, North America, at DJM Digital Solutions. He will be based in the company’s sister agency Cooney/Waters Group’s New York office. //Douglas Ingram became Allergan’s (Irvine, CA) first company President.//AMAG Pharmaceuticals (Lexington, MA) appointed Steven Caffe, MD, as Chief Development and Regulatory Officer. //Michael Templin, PhD, joined SNBL USA (Everett, WA) as Field Technical Director.//Clarus Therapeutics (Northbrook, IL) announced two new hires: Theodore Danoff, MD, PhD, and Wael Salameh, MD, FACP, will fill the newly created posts of VP, Clinical Development & Chief Medical Officer and VP Medical Affairs & Chief Scientific Officer, respectively. |
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How optimistic are you about revenue growth in 2013?
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