Advancing Pharma’s Social Media Listening Analytics

Guest blog by Ben Comer of Pharmaceutical Executive.

The pharmaceutical industry still lags other industries in spending on outbound social media programs that engage customers directly, but they are – at least Big Pharma is – spending more on so-called inbound social media software and analytics, which lets them listen to what is being said online about brands and unmet needs and match that up marketing strategies. Read more »

Colored Brain Sparks FDA Warning Letter

Stephanie Sutton Pharm Tech EuropeWarning Letters are a fact of life for the pharmaceutical industry and it can be difficult to avoid them. Not only are warning letters issued by FDA for cGMP deficiencies, letters can also be initiated by marketing or advertising blunders, including the misuse of social media and product websites.

Last week, Eli Lilly received an FDA Warning Letter after the agency’s routine monitoring and surveillance program spotted an image of a colored brain on the website for Amyvid, a diagnostic PET tracer used by healthcare professionals when evaluating Alzheimer’s Disease and other causes of cognitive decline. According to FDA, the brain classifies as misbranding because Amyvid’s product labeling states that images must be displayed and reviewed in black and white. Read more »

How Post-Market Feedback Can Influence Compliance when Using a Quality Management System

Guest blog by Tim Lozier.

In most industries, businesses run the same way. You can either stick your head in the sand and pretend that everything is going fine, or you can stand up and take the feedback—whether positive or negative—and react to it. This is especially true with Quality Management Systems (QMS).

In today’s dynamic and demand-driven world, businesses are challenged with speeding their product-to-market strategies to remain competitive. In the pharmaceutical industry, regulatory and compliance pressure add another dimension to the QMS. Organizations want to bring their products to market quickly, but need to ensure quality and compliance standards are met—it’s a paradox of “hurry up, but take your time doing so.” Read more »

Winds of Change at the International Society of Automation Summit

The International Society of Automation’s (ISA’s) 7th Marketing and Sales Summit, held Aug. 15–17, 2012 in Austin, Texas, was themed “New Rules of Customer Engagement: Riding the Winds of Change”, and emphasized the need to adapt to the changing needs, expectations, and behaviors of marketplace decision makers, according to an Aug. 27, 2012 press release. Read more »

Knowing When to Stay the Blade

Erik Greb PharmTech editorConcern about the federal government’s budget deficit is reaching a crescendo. Assorted Cassandras warn that failing to address this problem could have dire consequences, and members of both parties seem to agree that spending must be cut. But before Congress tightens its purse strings too zealously, I’d like to remind it of the valuable and necessary work that the national budget funds. Two drug-related stories that emerged last week provide particularly good examples. Read more »

More Japanese Interest in Potential Obesity Drugs

Alexis Brekke Pellek PharmTech editorLast week, Japanese drugmaker Takeda (Osaka, Japan) struck a deal with biopharmaceutical company Orexigen (La Jolla, CA) for the commercialization of its investigational obesity drug Contrave (naltrexone SR/bupropion SR). Under the terms of the agreement, Takeda will pay Orexigen $50 million cash up front, more than $1 billion in milestone payments, and royalties for rights to commercialize the drug in the US, Canada, and Mexico (Orexigen will co-promote the drug in the US). Read more »

Pharma Accused Of Misleading Regulators

Stephanie Sutton Pharm Tech Europe“The pharmaceutical industry is a ‘market for lemons’; a market in which the seller knows much more than the buyer about the product and can profit from selling products less effective and less safe than consumers are led to believe”. Read more »

AstraZeneca: Unwitting Advocate for Disclosure?

Erik Greb PharmTech editorHealthcare-reform legislation is not the only federal initiative that is affecting pharmaceutical manufacturers these days. US Attorney General Eric Holder is cracking down on healthcare fraud, including false claims against Medicare and Medicaid. AstraZeneca (London) felt the sting of Holder’s campaign when it agreed last week to pay $520 million to resolve accusations that it marketed its atypical antipsychotic Seroquel illegally. Read more »

Pfizer Fights Transparency

Erik Greb PharmTech editorPatients rely on doctors to make impartial decisions about the most effective treatments for their conditions. In recent years, public advocates have agitated for restrictions on pharmaceutical companies gifts’ (e.g., meals, honoraria, or entertainment) to medical professionals on the grounds that they could unduly influence prescribing habits. In what seems like a fight against transparency, Pfizer (New York) sent employees to Connecticut’s capitol to protest a state bill that would restrict such gifts and require reporting. Read more »

Don’t Delay Affordable Healthcare

Erik Greb PharmTech editorPresident Obama’s plan for lowering the cost of healthcare relies partly on ensuring that affordable generic drugs are available to patients. This strategy is not likely to be palatable to innovator companies, who have tried various ways of delaying generic drugs’ introduction to the market. Read more »

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