News Archive

The US Food and Drug Administration (FDA) DA has published draft guidance describing plans on how to handle serious drug safety issues with marketed drugs, which is now open for comment.

The guidance is intended to lay out a framework for the agency’s response to post-marketing safety issues including serious adverse events, product quality issues and medication errors, with a ranking system to help prioritise each issue according to its level of risk.

The FDA has been criticised in a string medical journal articles in the last 18 months for not monitoring its own adverse event reporting (AER) database effectively enough and failing to communicate safety issues in a timely and effective way to healthcare professionals and the public.

The US Food and Drug Administration (FDA) has approved MedImmune’s, the global biologics arm for AstraZeneca PLC, FluMist Quadrivalent (Influenza Vaccine Live, Intranasal), a vaccine to prevent seasonal influenza in people ages 2 years through 49 years. The company submitted the sBLA early in the second quarter of last year.

FluMist Quadrivalent is the first influenza vaccine to contain four strains of the influenza virus, two influenza A strains and two influenza B strains. All other currently available licensed seasonal influenza vaccines are trivalent, containing three strains [two strains of type A influenza (A/H1N1 and A/H3N2) and one B lineage strain].

A proposal accepted Thursday by the University System of Maryland’s board of regents creates an alliance between its flagship institution in College Park and the professional school in Baltimore centered around combining research initiatives, blending public health programs and expanding course offerings in Montgomery County.

Chancellor William E. “Brit” Kirwan introduced the $45 million proposal, the result of an eight-month study ordered last year by the General Assembly, in Annapolis, calling it “a strategic alliance, a very significant set of initiatives and activities.”

Jim Hughes and Phil Robilotto see more than 100 ideas each year from scientists at the University of Maryland, Baltimore, potential innovations with a promise to better diagnose disease, alleviate pain, make medical care delivery more efficient, even save lives.

The biggest challenge is selling investors on the merits of research still in its infancy.

The Maryland Technology Development Corporation (TEDCO) announced the creation of the Maryland Entrepreneurs Resource List (MERL), a listing of Maryland entrepreneurs available to take on a management role with a start-up company within the next 18 months or those interested in mentoring start-up companies. Compiled with the goal of fostering entrepreneurial activity in the State, MERL serves as a one-stop shop for entrepreneurs interested in joining a start-up opportunity or entrepreneurs willing to provide advice and guidance on a pro bono basis. TEDCO is looking to grow the list, which already includes entrepreneurs in the areas of biotechnology, chemistry, medical devices, network and wireless solutions, physics, engineering and software.

“The Maryland Entrepreneurs Resource List will be a tremendous asset for this community as it will nurture new entrepreneurs and start-up companies,” said Robert Rosenbaum, president and executive director of TEDCO. “Maryland is fortunate to have a rich network of entrepreneurs spanning various disciplines and industries, and now these individuals have an invaluable resource when looking for guidance, direction and opportunity. With Governor O’Malley’s proposed Maryland Innovation Initiative slated to provide additional and much-needed funding to entrepreneurs, we hope this unique and credible list will further connect the entrepreneur community and facilitate growth for an innovation-driven economy.”

“We can’t afford to rest on our laurels” was the message County Executive Ike Leggett delivered as he received a bold new bioscience strategy designed to position Montgomery County as a “globally recognized leader in advancing bioscience research and development, and in translating scientific discoveries into commercially available products that benefit human health.” The strategy was developed by the Biosciences Task Force, formed by Leggett in October 2008.

Joining the Executive in the announcement were Montgomery County Biosciences Task Force Chair David Mott, members of the County Council, Montgomery County Department of Economic Development Director Steve Silverman, members of the Task Force, and public and private sector stakeholders from the local biotech community.

Steady progress toward broader adoption of BENLYSTA treatment

Human Genome Sciences, Inc. HGSI +1.18% will today announce its priority goals for 2012 and report on progress with the commercialization of BENLYSTA(R) (belimumab), the first approved drug for systemic lupus in 56 years, during a presentation this afternoon by H. Thomas Watkins, President and Chief Executive Officer, to financial analysts and investors at the 30th Annual JPMorgan Healthcare Conference in San Francisco.

“Thousands of patients with systemic lupus are now being treated with BENLYSTA,” said Mr. Watkins. “We are pioneering a treatment in a market that has not seen a new option for patients in decades. Although we are still in the early adoption phase of our launch, our experience in the market to date reinforces our belief that BENLYSTA will ultimately play a major role in improving the standard of care for SLE patients.”