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LONDON & BOSTON & TOKYO--(BUSINESS WIRE)--Life science market intelligence firm, Evaluate Ltd, has partnered with AdverseEvents, Inc. (AEI), a leading healthcare informatics company focused on drug safety data, to fill a critical gap in commercial insight by enabling detailed FDA post-approval drug safety analysis. Historically, pharmaceutical professionals have lacked convenient, accurate and timely access to the FDA’s Adverse Event Reporting System (FAERS), a key set of over 5 million post-approval adverse event reports for marketed drugs across all demographic groups. The FDA uses FAERS analyses to make post-marketing regulatory decisions such as the issuance of label warnings/changes or market withdrawals. AEI has developed a rigorous proprietary method to standardize and analyse FAERS post-marketing safety data to provide accessible, actionable, and predictive drug safety measures derived from real-world, patient populations. Its proprietary analytics determine a drug’s potential risk to a patient, identify future safety alerts/labeling changes by the FDA, and enable the determination of a drug’s total medical cost and the long-term economic impact of prescribing a particular drug. The integration of adverse event analyses within EvaluatePharma® empowers the industry with new drug safety and healthcare economic insights to support strategic and operational decision-making. Examples of some of the standard propriety analyses available in EvaluatePharma include: “The AdverseEvents module in EvaluatePharma reveals the evolving adverse event profile on new FDA approved drugs. This insight can finally be leveraged in commercial assessments, licensing/M&A, competitive positioning and safety monitoring,” said Anthony Raeside, Head of Research at Evaluate. A new series of reports by Evaluate demonstrates how the data can be applied by clinical, business development, and launch teams to gain competitive advantage: To download Part I of the report series, please visit: www.evaluategroup.com/AdverseEvents. For more information or a demo, please contact the Evaluate team. Evaluate is the trusted source for life science market intelligence and analysis with exclusive consensus forecasts to 2020. Our services include EvaluatePharma, EvaluateClinical Trials and EvaluateMedTech. Our award-winning editorial team, EP Vantage, leverages our strategic analysis to cut through the noise, giving you daily opinion and insights. The Evaluate services enable the life science community to make sound business decisions about value and opportunity. For more information please visit www.evaluate.com. On Twitter: @evaluatepharma, @evaluatemedtech, @evaluateJP @epclinicaltrial, @epvantage. AdverseEvents is a California-based healthcare informatics company that improves patient safety and reduces systemic healthcare costs through the comprehensive analysis of post-marketing drug side effect data. Utilizing data-mining and analysis technology, through its proprietary RxSuite™ of analytics, AEI makes post-marketing drug safety data accessible, actionable, and predictable. For more information please visit www.adverseevents.com. On Twitter: @adverseevent

News Article | October 7, 2013
Site: www.xconomy.com

Taxes aren’t usually the stuff of high drama. But a story that began last year when a California state appeals court unexpectedly struck down an old tax incentive for small-business investors—and that unfolded, in part, here in the pages of Xconomy—has, after numerous twists and turns, reached its end. On Friday California Governor Jerry Brown signed a bill quashing the state tax board’s move to levy up to $120 million in back taxes and penalties on entrepreneurs who’d taken advantage of the investment incentive in past tax years. “The sense of relief is indescribable,” Brian Overstreet, co-founder of a group lobbying for the bill, said in a statement released Sunday. Members of Overstreet’s group, California Business Defense, spent much of 2013 in Sacramento, meeting with lawmakers to find a way to undo the Franchise Tax Board’s plan. “We thank the Governor for reassuring the state’s innovators and risk-takers that California is still the place where the companies of tomorrow should be built,” Overstreet said. In a commentary published today on Xconomy, Overstreet says Governor Brown’s office called him at 1:15 pm on Friday to tell him Brown had signed Assembly Bill 1412, a bill hastily carved together to reverse the tax board’s plan after lawmakers introduced amendments that watered down a similar measure, Senate Bill 209. Brown had to choose which of the two bills to sign; in the end, he endorsed the one providing full relief. In the commentary, Overstreet shares the behind-the-scenes story of the lobbying efforts leading up to the signing. “In short, we succeeded by doing what we do best: being entrepreneurial,” Overstreet writes. California Business Defense organized a coalition of entrepreneurs, friendly lawmakers, and attorneys familiar with the ways of Sacramento, then approached the effort to reverse the tax ruling as a sales campaign, Overstreet says. “In countless trips to Sacramento, we met with over 50 legislators and other government officials. In each meeting, we identified the problem, presented our solution, elicited feedback, and overcame objections.” It was Overstreet who first brought the retroactive tax plan to widespread notice, in an op-ed published on Xconomy on Jan. 15. After selling his previous business in 2012, Overstreet had noticed a little-publicized announcement from the Franchise Tax Board, the state’s equivalent of the IRS. In a lawsuit decided last August, a state appeals court had ruled unconstitutional a portion of the state tax code that allowed investors selling stock in California-based small businesses such as startups to exclude 50 percent of their gains when computing their taxable income. The tax board’s interpretation of the ruling was that taxpayers who claimed the benefit would have to pay taxes on the formerly excluded income, retroactive to 2008. (Xconomy detailed the complex history of the tax board’s move in a Jan. 24 news analysis.) That meant entrepreneurs and other investors who had sold their interest in small businesses in the state would soon get bills totaling an estimated $120 million. The tax board refused to revise its ruling, but said in February that it would delay collection of the back taxes, giving California Business Defense time to seek a legislative solution. The group turned to lawmakers for help, notably Senator Ted Lieu, a Democrat from Torrance, CA. Lieu’s bill, SB209, temporarily restored the income exclusion in a way that wouldn’t run afoul of the Constitution. But after attracting early support, the bill ran into a snag this summer, when members of the Senate Appropriations Committee expressed concern that it might oblige the state to pay retroactive refunds to some taxpayers. To cover those potential costs, committee members introduced amendments to SB209 that reduced the 50 percent exclusion to 38 percent, meaning investors would still be on the hook for partial retroactive payments. “With technical snafus and political pressure weighing down SB209, we worked with legislators [including Assembly member Raul Bocanegra, Democrat of Los Angeles] to gut an unrelated bill, AB1412, insert our desired language, and push that through both the Senate and Assembly,” Overstreet recounts in his commentary. Both bills passed by large margins in the Senate and the Assembly, leaving the Governor to decide which one to approve. Brown’s office had remained silent on the issue throughout the year, leaving Overstreet and his coalition members uncertain about the governor’s intentions. But on Friday he signed AB1412, along with 17 other bills designed to boost economic development in the state. Under AB1412, the restored 50 percent exclusion is only effective through 2016. So investors and legislators may have to revisit the issue within a few years, or find different ways to encourage investment in California small businesses. For now, Overstreet says he’s relieved to be able to get back to his real job, as CEO of drug safety startup AdverseEvents, and hopeful that the episode has demonstrated to entrepreneurs that they can have a voice in state politics. “As entrepreneurs we’ve accumulated unique, transferable skills from starting and running successful businesses,” Overstreet writes today. “Let’s do more than just denigrate our government in clever 140-character missives. Let’s actually work to influence policy and re-craft the institutions and mindset of our government from within.”

News Article | February 27, 2014
Site: www.bloomberg.com

Thousands of times each day, the U.S. Food and Drug Administration receives reports about unwanted side effects of the prescription and over-the-counter medications it oversees. They stream in from patients and doctors—and from drugmakers, which are required to relay accounts of problems. This data, cataloging reactions as mild as rashes and headaches and as serious as internal bleeding and death, help the agency monitor drug safety. With millions of records created since the system began in 1998, it’s the world’s most extensive record of how drugs interact with the human body. It’s also almost impossible for anyone outside the agency to use. The FDA publishes quarterly bulk files—the most recent one covers to the end of 2012—but they’re a blizzard of cryptic information that can only be deciphered with expertise and complicated software. Patients or doctors who want to see a report on a specific drug have to file a Freedom of Information Act request with the government. “If you’re someone who’s trying to make an informed decision about which drug should I take … it’s not well-formulated that way,” says Dr. Taha Kass-Hout, the FDA’s chief health informatics officer. In January the agency quietly unveiled plans to make these records, known as adverse event reports, more widely available through a project called openFDA. Instead of simply publishing unwieldy quarterly files, openFDA will let software makers tap directly into the data to build user-friendly and easily searchable programs for doctors and consumers. The agency is also opening up records of product recalls and drug labels. More transparency could make it easier to detect problems in cases like Vioxx, the painkiller that Merck (MRK) pulled from the market in 2004 because of heart risks. A handful of entrepreneurs have struggled to translate the FDA’s current stockpile of drug information. AdverseEvents, a startup in Santa Rosa, Calif., sells reports based on the agency’s bulk data releases to insurers and hospitals trying to figure out which drugs have lower rates of complications. President Brian Overstreet says the files are full of duplicate records and misspelled drug names. Patients and physicians trying to use the FDA’s database on their own are in the wilderness, he says. “You don’t know whether Lipitor or Crestor is safer for you,” Overstreet says, “and neither does your doctor, frankly.” Two medical researchers in Virginia, Alex Mayers and Dan Murphy, used the FDA’s archives to create DrugCite, a website that lets users search for side effects by medication. Since each file from the FDA covers three months, creating a complete record of problems associated with a particular drug over a period of years means deciphering and piecing together dozens of monster files. “Right now the data’s kind of locked up,” Mayers says. Launched in 2011, the site gets thousands of hits a day. “It’s obvious that this data is wanted just by the response we’ve gotten,” says Murphy. Once the information is easier to use, the FDA’s Kass-Hout predicts that many other Web and software developers will step in to meet the public’s demand for drug information. He envisions mobile apps that let consumers compare over-the-counter drugs while they shop in the pharmacy, and software to immediately alert pharmacists when a company issues a recall. The pharmaceutical industry is cautiously supportive. More informed doctors and patients “have to be a good thing,” says Jeff Francer, senior counsel at the Pharmaceutical Research and Manufacturers of America. But he says reports about side effects need context: “We wouldn’t want patients to be scared by just receiving adverse event information in absence of a more full discussion of both the benefits and the risks of a medicine.” Kass-Hout, a physician, is looking for ways to improve the reliability of information the FDA collects. His background is in monitoring infectious diseases. Previously at the Centers for Disease Control and Prevention, he tracked emergency room visits related to the H1N1 flu outbreak in 2009; finding problems with medications involves similar public health detective work. The FDA is also considering skimming tweets and Facebook (FB) posts that might signal problems with drugs, though he calls the idea exploratory. “You’ve got to look at this as a mosaic,” he says. “All these pieces are telling you something, and it’s just a matter of how you can stitch it together.”

News Article | April 16, 2014
Site: www.finsmes.com

AdverseEvents Inc., a Santa Rosa, CA-based healthcare informatics company focused on drug safety and side effects, closed $2M in Series A financing. The round was led by Evaluate Ltd., with participation from Trevor Fenwick, founder and Executive Chairman of Euromonitor International, and Michael Tansey, former president and CEO of Jobson, and former CEO of the Scientific and Healthcare group at Thomson Reuters, the global information provider. In conjunction with the financing, Jonathan de Pass, the founder and CEO of Evaluate and Michael Tansey will be joining AdverseEvents’ board of directors. The company intends to use the funds to expand its sales force and analyst teams, and to continue to build its marketing presence among health insurers, health systems and hospitals. Led by CEO Brian Overstreet, AdverseEvents provides managed care organizations with a comprehensive technology, analytics, and product platform for post-marketing drug side effect data. In addition, the company publishes comparative drug studies, industry white papers, topical special reports, and platform validating research papers in academic journals and provides services to enterprise markets including the pharmaceutical industry and financial institutions.

News Article | April 17, 2014
Site: www.xconomy.com

AdverseEvents is a California-based healthcare informatics company that improves patient safety and reduces systemic healthcare costs through the comprehensive analysis of post-marketing drug side effect data. The company intends to use the funds to expand its sales force and analyst teams, and to continue to build its marketing presence among health insurers, health systems and hospitals.

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