This week’s headlines include, a review of Alzheimer’s drugs in development, monoclonal antibody for Anthrax receives biodefense funding, the Fierce 15, advice on the use of scientific advisory boards and new vaccine developments.
Cell Culture Events:
Attend Innovations in Cell Culture: Cells, Media and Therapies
Cell culture has been the workhorse of biotechnology with large scale biomanufacturing of therapeutic antibodies, recombinant proteins and vaccines. Now, cells are themselves becoming medicine in the emerging field of regenerative medicine and cellular therapy. Learn how this new era of biomedicine is developing and take a guided lab tour of two companies who are at the forefront of this exciting industry.
A new study, which finds that immunity from the whooping cough vaccine fades sharply over time, underscores the urgent need to develop new vaccines and consider additional booster shots for children, health experts say. Authors say the study in today’s New England Journal of Medicine helps explain part of the resurgence in whooping cough, or pertussis, which has sickened more than 26,000 this year, the largest outbreak in more than 50 years. The current vaccine, in use since the 1990s, doesn’t protect people as long as previously believed, losing 42% of its effectiveness with each passing year, says author Nicola Klein, co-director of the Kaiser Permanente Vaccine Study Center in Oakland, Calif. So even some fully vaccinated children, who have received all five doses recommended by age 4 to 6, would still be vulnerable to the disease by age 10.
If you like this story, please see our blog titled “Improving Media to Increase Virus Yield in Vaccine Production”
97 new drugs are currently in development for patients with Alzheimer’s disease and other dementias, including 83 for Alzheimer’s, 12 for cognition disorders and two for dementias, according to a new US industry report. However, between 1998 and 2011, 101 such treatments failed to reach patients, and only three medicines were approved to treat symptoms of the disease, representing a 34:1 ratio of setbacks, says the report, which is published by the Pharmaceutical Research and Manufacturers of America (PhRMA).
If you like this story, please see our blog titled “Venture Capital Investment in the Life Science Sector is Down for 2012 – Is There a Light at the End of the Tunnel?”
The influenza pandemic of 1918–1919 killed approximately 50 million people. The unusually severe morbidity and mortality associated with the pandemic spurred physicians and scientists to isolate the etiologic agent, but the virus was not isolated in 1918. In 1996, it became possible to recover and sequence highly degraded fragments of influenza viral RNA retained in preserved tissues from several 1918 victims. These viral RNA sequences eventually permitted reconstruction of the complete 1918 virus, which has yielded, almost a century after the deaths of its victims, novel insights into influenza virus biology and pathogenesis and has provided important information about how to prevent and control future pandemics.
If you like this story, please see our blog titled “FDA Issues Guidance for Warning Labels on All Drugs Produced Using Blood Products including Plasma Derived Albumin”
Biodefense biopharma firm Elusys Therapeutics was awarded an additional $14.5 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to support expanded human safety trials with ETI-204 (Anthim), its Phase II-stage monoclonal antibody candidate for treating antrax infection. The firm has now received $149 million under two advanced development contracts from BARDA, and could receive up to $211 million in funding for the project. Last month the firm banked $50.2 million in BARDA funding to conduct definitive efficacy studies in animals and complete validation of the commercial manufacturing process for ETI-204.
If you like this story, please see our blog titled “Defined Supplements – The Role of Recombinant Proteins in Biopharmaceutical Manufacturing”
There’s more than one way to build a biotech company. And this year’s Fierce 15 companies reflect a range of companies operating with a spectrum of business models. There are development programs for interferon-free hepatitis C drugs, pioneering early-stage work on Alzheimer’s, next-gen obesity treatments, gene therapies and more.
If you like this story, please see our blog titled “Ten Companies with Innovative Stem Cell Therapies in Clinical Trials – Part I”
The Melbourne-based healthcare giant is one of five companies awarded government contracts to produce and store flu shots for use in the event of an influenza pandemic in America. They have received $11.3 million in initial funding from the US Department of Health and Human Services to produce and store influenza seed stock, from which vaccines are manufactured. The five-year contract is expected to provide CSL Biotherapies – the Australian group’s US subsidiary – with up to $500 million in revenue from the ongoing manufacture of flu shots for the US stockpile.
If you like this story, please see our blog titled “New Vaccines – Coming Soon to a Doctor’s Office Near You”
Pros, cons, and best practices when it comes to utilizing a Scientific Advisory Board, written by Bruce Booth. Almost every biotech has a Scientific Advisory Board, but few use them particularly well. Although SABs can be hugely valuable in helping shape a program or portfolio, or raising the visibility of a startup, they can also be a colossal distraction and huge time sink, burning resources and creating post-meeting fire drills.
If you like this story, please see our blog titled “Lean Development Approaches in the Era of Quality-by-Design, Mission Impossible?”