BIOtechNow

Opsona Therapeutics will be participating in the upcoming BIO Investor Forum, and will be giving a presentation on their work in the autoimmune/inflammatory diseases and oncology space (among other indications). To learn more about their company, please read one of our final company snapshots below. Company Snapshot What is your company’s lead product or technology? Opsona’s lead product OPN-305 is a fully humanized monoclonal IgG4 antibody targeting Toll-like-receptor-2 (TLR2), which is in clinical development as Read More 

Patent troll litigation alarmist were likely disappointed by the GAO report.  While the public discourse may have already concluded that patent trolls have laid waste to the innovative landscape by creating a patent litigation crisis, the GAO report does not find much evidence to support such claims. Patent troll litigation is not running rampant.  The GAO analyzed a sample of 500 patent infringement lawsuits from 2007 to 2011 and found that companies that make products (operating Read More 

On Tuesday, August 27th, the FDA finalized its Guidance for Institutional Review Boards, Clinical Investigators and Sponsors on Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug/Investigational Device Exemption is Needed.  In an article published earlier today, the Pink Sheet’s Sarah Karlin summarized the goals of this guidance as strengthening human subject protection during clinical research and increasing the efficiency of Read More 

The Biotechnology Industry Organization filed an amicus brief at the Federal Circuit in the case of Fresenius v. Baxter: BIO is concerned that the panel decision could have a number of unintended consequences, such as incentivizing defendants (or declaratory judgment plaintiffs) to employ dilatory tactics in the federal courts while re-arguing already-decided issues under claim construction more favorable to the patent challenger and lower burden-of-proof standards in the PTO.  Courts and parties may be forced Read More 

The Transatlantic Trade and Investment Partnership (TTIP) initiative holds tremendous promise for the long-term competitiveness of the Transatlantic economy by supporting research and development of innovative technologies. A concerted effort through the TTIP to unleash the potential of biotechnology in the Transatlantic economy can help bring innovative products to consumers, create jobs, and improve economic prospects on both sides of the Atlantic. The recent (TTIP) negotiations focus on several principles that BIO promotes to boost Read More 

Ernst & Young recently released a study to determine the potential impact of three tax proposals to help innovative small companies secure sustained private investment. The study models the direct, indirect, and induced impact that the three legislative proposals would have on investment and employment in small, R&D-intensive companies. Below is a summary of the proposals, as well as the potential impact if enacted: Proposal 1:  Section 469 R&D Partnership Structures. Reforming the passive activity Read More 

The FDA released its final guidance governing clinical trial oversight and urges a risk-based approach to monitoring. The Agency builds on the main tenets described in the original 2011 draft guidance, urging drug and medical-device sponsors to utilize more remote and targeted risk-based monitoring rather than relying solely on on-site methods. The guidance provides various risk-based monitoring strategies and clarifies that while the Sponsor can transfer monitoring responsibilities to contract research organizations (CROs), the CROs Read More 

The Association of University Technology Managers released the 2012 AUTM U.S. Licensing Activity Survey Highlights which provides data on respondents from “161 universities, 32 hospitals and research institutes, and one third-party technology investment firm” (a response rate of 65%).  Here are some of the highlights: Start-Ups and Products: • 705 startup companies formed (+5.1% [over last year]), 554 of which had their primary place of business in the licensing institution’s home state (+13.8% [over last Read More 

A few weeks ago, BIO submitted a letter and white paper (PDF) to the U.S. Trade Representative outlining recommendations for policies to pursue with TPP negotiating partners to ensure intellectual property protection for innovative biologic products. Standards that enable biotechnology companies to protect and leverage their intellectual property are of critical importance to companies seeking breakthrough treatments and cures for patients in need worldwide. Implementing standards of protection that effectively protect innovation for biological products within the TPP region Read More 

Hurricane season has grown to last six months – running June through November. This means we are well into 2013′s hurricane season. Although the Eastern and Southern United States have seen their fair share of bad storms in the last few years, the most recent major hurricane to strike the U.S. was Hurricane Wilma in 2005. Surprisingly Hurricane Sandy in October of 2012 was not technically was not a hurricane, but a confluence of major Read More 

“The web has become a sewer channeling scare mongering about crop biotechnology,” says Jon Entine, executive director of the Genetic Literacy Project (GLP), and a senior fellow at the Center for Health & Risk Communication and STATS (Statistical Assessment Service) at George Mason University. “We at the GLP have come to think that anti-biotech campaigners do not respond well to reasoned discussion and complex logic,” says Entine.  So, the GLP is launching a new project:  Read More 

BIO is surveying members on their interactions with the FDA during the various stages of drug development prior to submitting an NDA/BLA. The survey can be accessed here. In an increasingly competitive and fiscally-constrained environment, it is more important than ever for all stakeholders to work together to promote effective R&D for innovative medicines. This initial survey is designed to assist in the implementation of the Prescription Drug User Fee Act (PDUFA V) program on Read More 

The National Patient Advocate Foundation (PAF) has seen a notable rise in calls for assistance from both Medicare beneficiaries and cancer doctors regarding difficulty accessing certain cancer drugs in the physician office setting, where most patients receive their care. As a result, patients are being forced to seek cancer treatment in the hospital setting to access their life-saving cancer medicines; this displacement disrupts their continuum of care, is inconvenient, and is more costly to the Read More 

Just this month physicians who administer lifesaving therapies in their offices are seeing their reimbursements cut due to the sequestration.  That’s because while some government spending was exempted from the sequestration, reimbursements under Medicare Part B were not. And yet, some continue to call for additional cuts to this important program, where some of the sickest patients receive their therapies under the administration of a physician.  Additional cuts to Medicare Part B would have a Read More 

The eighth annual Global Impacts Study released this week by PG Economics quantifies the environmental benefits gained from the use of biotech crops. “We’ve seen a significant reduction in the use of chemical insecticides with biotech crops,” said Dr. Cathleen Enright, BIO’s executive vice president for food and agriculture. “Since 1996 and the advent of agricultural biotechnology, farmers growing these crops have switched to more benign herbicides to help control weeds.” Enright adds, “The shift Read More