This week’s headlines include, vaccine updates, stem cell developments, FDA compassionate use program faces challenges, and a new study finds that many new drug benefits reported in early studies begin to shrink or vanish as more studies are done.
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GlaxoSmithKline Plc (GSK) is applying Shinya Yamanaka’s Nobel Prize-winning discovery in stem cells to identify heart risks linked to experimental drugs earlier in the development process. Yamanaka was awarded the Nobel Prize in medicine this month for his work in turning ordinary skin cells into induced pluripotent stem, or iPS, cells with the potential to become any cell in the body. That breakthrough has enabled the London-based drugmaker to study iPS cells transformed into heart-muscle cells that may be used to test compounds for cardiovascular safety, said Jason Gardner, head of Glaxo’s early-stage regenerative medicine research.
If you like this story, please see our blog titled “Cultureware – A New Generation of Products Step Up to the Plate”
Next time a research finding leaves you slack-jawed, thinking it’s too good to be true, you might just be right, according to a massive new analysis tracking the fate of splashy medical studies. It turns out that 90 percent of the “very large” effects described in initial reports on medical treatments begin to shrink or vanish as more studies are done. “If taken literally, such huge effects should change everyday clinical and public health practice on the spot,” Dr. John Ioannidis of the Stanford School of Medicine in California told Reuters Health by email. “Our analysis suggests it is better to wait to see if these very large effects get replicated or not.”
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”
Italy and Switzerland halted sales of Novartis AG’s (NOVN) flu vaccines after the company informed Italian authorities of a buildup of particles in the shots. Novartis said the products are safe. Novartis didn’t provide enough information for officials to know the exact makeup of the proteins found in the Agrippal and Fluad shots, or their impact on the quality and safety of the vaccine, Italy’s Health Ministry said in a statement today. There have been no reports of illness because of the particles, officials said. The vaccines present “quality defects that are potentially dangerous for public health,” the ministry said. Italy’s medicines agency AIFA “has established the need for further tests regarding the quality and security” of the vaccines, according to an earlier statement from the ministry.
If you like this story, please see our blog titled “Manufacturing Strategies for Improving Viral Yield and Lowering Production Cost in Vaccine Manufacturing”
Last year, nearly 1,200 patients received treatment with experimental drugs through the compassionate-use program for conditions including hepatitis C, cancer and rare diseases like cystic fibrosis, the FDA says. That is up from about 1,000 patients in 2010, the first year the agency compiled data on the program. The FDA says it has been trying to increase participation, including by helping to set up a Web-based seminar that trains doctors how to make use of the program. The agency allows manufacturers to make their drugs available, but can’t require them to do so, and some companies are reluctant to participate before their products have received marketing approval. The FDA says it has been working to win over more companies. It revised its regulations in 2009 to effectively open the program to a greater number of small drug manufacturers. Most companies that provide drugs for the program do so free of charge, but some seek to recoup their expenses, the FDA says. Health insurers generally don’t reimburse patients for the cost of the drugs.
If you like this story, please see our blog titled “FDA Strives to Provide Faster Approval Time for Drugs by Employing “Special Medical Use” Category”
Researchers in South Africa have learned something new about how antibodies fight off HIV in research that could advance the quest to develop a vaccine against the virus. In a paper published online Sunday in Nature Medicine, researchers from the Centre for the AIDS Programme of Research in South Africa tracked how the evolution of the virus in two infected woman shaped the antibodies they produced to fight it. Several months after infection, the researchers saw that the patients had developed more “broadly neutralizing antibodies,” which target different versions of the virus.
If you like this story, please see our blog titled “Improving Media to Increase Virus Yield in Vaccine Production”
San Diego-based ViaCyte Inc. received a $10.1 million grant from California’s stem cell agency to prepare for clinical trials of a living artificial pancreas for diabetics. Called Pro-Islet, the implanted device contains encapsulated pancreatic cells. If it works, the artificial pancreas would change the lives of millions of diabetics. They now must monitor their insulin levels closely, and often have to inject themselves with insulin several times a day. “Essentially, what we’re really doing is replacing the pancreas,” said Paul Laikind, ViaCyte’s chief executive. “It should replace what a normal pancreas should do.”
If you like this story, please see our blog titled “Stem Cell Therapy for Type 1 Diabetes is on the Horizon”