Innovative drug approvals up sharply in 2011, gov’t increasingly funds infectious disease R&D
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January 25, 2012 |
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Associated Press |
WASHINGTON — The pharmaceutical industry won approval to market a record number of new drugs for rare diseases last year, as a combination of scientific innovation and business opportunity spurred new treatments for diseases long-ignored by drug companies.
Drug companies are increasingly taking advantage of the commercial benefits of developing so-called orphan drugs, which include extra patent protections, higher pricing and a streamlined review process by FDA. Among the innovative treatments approved in the past year were the first new drug for lupus in 50 years and the first new drug for Hodgkin’s lymphoma in 30 years.
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U.S. FDA guidance on biosimilars may be imminent
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September 23, 2011 |
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Reuters |
The U.S. Food and Drug Administration appears to be on the verge of issuing long-awaiting guidelines for the development of generic versions of complex biotechnology medicines. space. Read more...
Developing the Nation's Biosimilars Program
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August 4, 2011 |
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New England Journal of Medicine |
Biologic products developed over the past three decades and approved by the Food and Drug Administration (FDA) now provide important therapeutic options for a variety of serious clinical conditions. Therapeutic biologics such as genetically engineered recombinant proteins and monoclonal antibodies represent a large portion of newly approved therapies for conditions such as chronic inflammatory diseases and cancer. Biologic enzyme-replacement therapies provide clinical benefits in previously untreatable genetic disorders. Although typically more structurally complex than the small-molecule drugs more prevalent in today's market, biologics vary in complexity from cellular therapies to small, highly purified proteins. Unfortunately, access to such products may be limited, not infrequently because of their cost.. Read more...
Biotech Guru G. Steven Burrill Offers his Predictions on What Lies Ahead for the Biotech Industry in 2011
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December 31, 2010 |
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FierceBiotech |
SAN FRANCISCO, Dec. 30, 2010 /PRNewswire/ - Renowned biotech specialist, venture capitalist, author and keynote speaker Mr. Burrill offers his predictions for biotech. He sees a dynamic industry writing a new "play book" in response to an environment that: favors risk mitigated companies rather than earlier stage development companies that have a much higher risk profile; emerging biotech markets, particularly in Brazil, Chile, China, India, Malaysia and Russia, growing faster than the United States and Europe; challenges created by healthcare reform; and opportunities for companies operating in the biogreentech space. Read more...
Nasal delivery: the future of the flu vax
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November 11, 2010 |
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By Erica Teichert |
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FierceVaccines |
WASHINGTON, DC - A fear of needles has kept many from getting optional vaccines, including the one for pandemic flu. And panel members at this year's Influenza Congress USA believe the future of the industry lies in more painless, less invasive procedures, especially nasal vaccine delivery.
According to Douglass Given, chairman and CEO of Vivaldi Biosciences, stimulating the nasal mucosa via vaccine delivery provides a higher immune response, making the product more effective. And using their live attenuated influenza vaccines, they hope to outperform FluMist with higher immunogenicity. Read more...
Advanced BioScience Laboratories, Inc. and PATH Enter New Agreement to Conduct IND-Enabling Toxicology Program for Evaluating an ETEC Vaccine Candidate That Targets Broad Protection
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October 7, 2010 |
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Kensington, MD |
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PATH, a non-profit global health organization, has contracted Advanced BioScience Laboratories, Inc. (ABL) to perform an Investigational New Drug (IND)-enabling toxicology program in support of the development of a new enterotoxigenic E. coli (ETEC) vaccine candidate developed by investigators at the Naval Medical Research Center (NMRC). The vaccine is designed to induce more broadly reactive immune responses against conserved ETEC tip adhesin proteins and the heat-labile toxin produced by approximately 60 percent of the ETEC strains associated with diarrheal illness among children in the developing world and international travelers. The goal of this effort is to advance this novel vaccine candidate toward IND submission and into clinical trials. According to the World Health Organization, diarrheal diseases are the third leading cause of death by infectious disease worldwide and the second leading cause of death among children under age five. ETEC is the leading cause of travelers’ diarrhea, which affects an estimated 10 million people annually, according to the United States Centers for Disease Control and Prevention.
ABL will be managing a Good Laboratory Practice (GLP) toxicology study in rabbits at AVANZA Laboratories (AVANZA). The study will examine the safety and immunogenicity of the anti-adhesin-LT toxin-based vaccine when delivered via a transcutaneous patch either alone or in combination. Scientists from the Naval Medical Research Center (NMRC) will also contribute to the study by providing immunoassay and analytical chemistry support. Read more...
Pfizer May Gain as U.S. Devises Speedy Alternative to Animal Safety Tests
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August 5, 2010 |
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By Anna Edney |
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Drugmakers led by Pfizer Inc. will soon gain access to a new testing system that can shrink by months to years the time needed to determine an experimental drug’s safety, potentially adding millions of dollars in research savings and revenue. Since 1938, U.S. regulators have required pharmaceutical companies to test for toxicity using animal studies before costly human testing begins. That can take months for most compounds, and years for cancer medicines. The new system, developed by three federal agencies, uses computers to test products against human and animal cells, rather than living creatures, to find chemical reactions linked to toxicity. Read more...
FDA worried about dangers of excess drugs on skin patches
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August 3, 2010 |
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By Howard Lovy |
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Drug delivery patches always include more of the drug than the patient actually needs, which helps make sure the proper amount is delivered. But that also means there is always some amount of residual drug left over, and that can become a serious problem. Not only does the patient risk getting more of the drug than he or she actually needs, but it can also put caregivers or patients' family members at risk if a drug-delivery patch is left laying around. Read more...