Deaths from unintentional overdoses of prescription drugs have reached epidemic proportions in the US, outnumbering deaths from motor vehicle crashes or suicides in 20 states. Approximately 27,500 people died from unintentional drug overdoses in 2007, driven to a large extent by prescription opioid overdoses. This is according to a press release from the University of North Carolina (UNC), referring to a publication in the Journal of Clinical Psychiatry describing the phenomenon, and offering advice to prescribers on how to deal with it.

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I just finished writing an article on over-the-counter (OTC) drugs and how their safety and market approvals are managed (look for it in the May issue of PharmTech). As a consumer, something stood out in my research. Read more »

An alliance of researchers at the University of California, Berkeley earlier this month formed the UC Berkeley Synthetic Biology Institute (SBI) to advance efforts to engineer cells and biological systems. Agilent Technologies is providing infrastructure, expertise, and funding for the new institute. The move signals growing research and commercial interest in the nascent field of synthetic biology. Read more »

This blog post was written  by Christina I. Ortiz

You might want to rethink buying that bulk-sized hand sanitizer if you’re trying to protect you and your family from Methicillin Resistant Staphylococcus Aureus bacteria (MRSA) and other diseases. FDA is cracking down on over-the-counter (OTC) drug companies that are claiming their products prevent infection from MRSA.  The agency has sent letters to firms Tec Laboratories, JD Nelson and Associates, Dr. G.H. Tichenor Antiseptic Co., and Oh So Clean, Inc. (who also does business as “CleanWell Company”), among others. Read more »

The America Invents Act, a major patent reform bill, was passed by a large majority vote in the Senate on March 8, 2011, in a rare display of bipartisanship.  The major provision of the bill was to change the way in which patents are issued from first-to-invent basis to a first-to-file basis. The Act contains provisions intended to safeguard inventors, such as the ability to request a post-grant review during the first nine months after issue, and a provision allowing third parties to submit prior art during patent examination. It also reforms funding for the Patent and Trade Office, allowing them more flexibility in setting fees and allowing them to keep what they collect in order to fund the office’s activities. Read more »

As Earth Day (April 22) approaches, many environmentalists and policymakers are discussing steps for the future with regard to reducing carbon footprints, saving energy, and restoring the world’s deteriorating ecosystems. In fact, a key debate on the blogosphere and news wires this week surrounds the issue of the environmental refugee—a term used by the UN and others to define a person that has been displaced because of environmental causes, notably land loss and degradation of land, and natural disaster, according to the UN Statistics Division. Read more »

To make up for weak pipelines, and to take arms against a sea of generic-drug competitors, many large pharmaceutical companies have pursued mergers and acquisitions. This strategy began to gain popularity about 10 years ago, and the industry’s new motto seems to be “When the going gets tough, the big get bigger.” Has this strategy improved drugmakers’ pipelines or bottom lines? Read more »

Biosimilars can be considered a controversial subject because of safety concerns related to immunogenicity. Despite this, the biosimilars industry seems to be booming. Recent research from industry analysts Datamonitor estimated that the value of the global market for biosimilars would jump from $243 million in 2010 to $3.7 billion in 2015, and the biosimilars have now been used safely for 5 years, according to the European Generic Medicines Association (EGA). Read more »

Shared value. Partnerships. Collaborative innovation. We hear these words a lot in defining the ideals of successful business relationships, but they also are very much at the center of public, joint public–private, industry, and individual efforts in developing solutions for broader global concerns. The connections, energy, talents, and resourcefulness that are at the heart of those solutions were the focus of the Women in the World Summit, held in New York last month. Organized by the Daily Beast and Newsweek, the summit generated an instructive and meaningful dialogue on the diversified approaches that are and can be used to advance the role of women, particularly in developing countries, inclusive of global health initiatives.  Read more »

This blog post was written by Tracey Cooley, Director of Events Communications at BIO.

BIO and MacroGenics CEO favor reauthorization and expansion of programs

On April 7, the House Subcommittee on Healthcare and Technology held a hearing on “The Creating Jobs Through Small Business Innovation Act of 2011,” a bill that would reauthorize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, which help fund small innovative companies on the brink of new technologies and discoveries. Read more »