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The Dish’s Weekly News Wrap Up – April 5, 2013
This week’s headlines include, vaccines news, Italy continues with controversial stem cell therapy, challenges on the horizon for biosimilars, Alzheimer tops healthcare costs, biotech licensing deals cool and Fierce’s 10 top biotech billionaires.
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“For the first time, scientists have tracked in a patient the evolution of a potent immune molecule that recognizes many different HIV viruses. By revealing how these molecules — called broadly neutralizing antibodies — develop, the research could inform efforts to make vaccines that elicit similar antibodies that can protect people from becoming infected with HIV. The researchers, led by Barton Haynes of Duke University School of Medicine in Durham, North Carolina, found that broadly neutralizing antibodies developed only after the population of viruses in the patient had diversified — something that had been suspected of occurring in patients, but had not actually been observed.”
If you like this story, please see our blog titled “Biologics Have a Robust Pipeline According to Latest PhRMA Report”
“Italian health officials are allowing a handful of patients to continue with a controversial stem cell therapy amid protests from scientists that the treatments are unproven and unsafe. The Stamina Foundation has been administering the therapy at the public hospital Spedali Civili of Brescia to people with a range of degenerative diseases. Their approach is based on mesenchymal stem cells, derived from bone marrow, which can become mature bone and connective tissue. In 2011 the hospital agreed to host the research and assist with cell extraction and patient treatments, stirring protests from the medical community. “The hospital is not even listed among the 13 Italian authorised stem cell factories,” says Michele de Luca, director and gene therapy programme coordinator at the Centre for Regenerative Medicine in Modena. After an inspection in 2012, Italian drug regulator AIFA ordered an immediate halt to Stamina’s stem cell treatments at the hospital.
If you like this story, please see our blog titled “Fifteen Cell and Stem Cell Therapies in Phase III Clinical Trials Part I
“Swiss specialty chemicals and life sciences group Lonza is reviewing whether it is still worth investing in its joint venture with Teva in “biosimilar” drugs, its Chief Executive said. The expiry of patents on expensive biotech medicines to treat cancer and autoimmune diseases is opening up a new market for lower-cost copies known as “biosimilars” because they are not identical matches of branded medicines. But uncertainty over the regulatory framework for such drugs in the United States as well as the defense strategies from innovator companies have caused delays and prompted some developers to halt projects.”
If you like this story, please see our blog titled “Comments on Biosimilar Guidance Indicate Discontent on Both Sides of the Issues”
“Once upon a time, not too terribly long ago, getting the chicken pox was practically a rite of passage for kids. But now, nearly 20 years after approval of a vaccine for the varicella virus, which causes the itchy illness, chicken pox is a rarity. A new study conducted by researchers at Kaiser Permanente in Northern California and published online Monday in the journal Pediatrics confirms that the vaccine is, indeed, effective — reducing cases of chicken pox in one large cohort of kids as much as tenfold over a 14-year study period.”
If you like this story, please see our blog titled “Severe Flu Season Puts Spotlight on New Vaccine Technologies and Existing Challenges”
“Cancer and heart disease are bigger killers, but Alzheimer’s is the most expensive malady in the U.S., costing families and society $157 billion to $215 billion a year, according to a new study that looked at this in unprecedented detail. The biggest cost of Alzheimer’s and other types of dementia isn’t drugs or other medical treatments, but the care that’s needed just to get mentally impaired people through daily life, the nonprofit RAND Corp.’s study found.”
If you like this story, please see our blog titled “Biologics Take Top Spots in Best Selling Drugs of 2012”
“Scientists in the Dutch city of Rotterdam know precisely what it takes for a bird flu to mutate into a potential human pandemic strain – because they’ve created just such mutant viruses in the laboratory. So as they watch with some trepidation the emergence in China of a strain of bird flu previously unknown in humans, they also argue it vindicates their controversial decision to conduct these risky experiments despite fierce opposition. Above all else, what the world needs to know about this new strain of H7N9 bird flu is how likely it is to be able to spread efficiently among human populations.
If you like this story, please see our blog titled “A First – Cell culture Based Seasonal Influenza Vaccine Approved by the FDA”
“The virtual elimination of rubella is one of the many great vaccine success stories. In the last big rubella epidemic in the U.S., there were 11,250 abortions and 2,100 neonatal deaths. Since that outbreak in the mid-1960s, vaccinations have ended endemic rubella transmission in the U.S. Other countries, however, have less developed vaccination programs. Consequently, the U.S. still sees some rubella cases most years as people bring the virus from overseas. Last year there were three cases, bringing the total since 2004 up to 79, the Centers for Disease Control and Prevention reports. The three cases in 2012–all of which were linked to Africa–caused an array of conditions in the affected infants, including cataracts, cardiac defects and impaired hearing. None of these cases spread, but the CDC warns that clusters of unvaccinated people are at risk, as was seen in outbreaks in the Netherlands and Canada in recent years.”
If you like this story, please see our blog titled “New Vaccines Coming Soon to a Doctor’s Office Near You”
“After all but waxing rhapsodic in recent years about the value of partnerships and collaborations, biopharma giants are showing more caution about doing licensing deals, according to a just-released state-of-industry report. According to Biotech and Pharma: 2012 Year in Review, published by EvaluatePharma’s publishing arm EP Vantage, big biopharma spent $20.9 billion on licensing deals in 2012, a 19% drop from 2011. The number of products licensed also fell significantly, to 759 in 2012 from 1,037 a year earlier. A possible reason, the report posited, was that biopharma giants had less of a need to plug holes in pipelines through increased licensing activity, as companies slowly navigated the “patent cliff” expirations of several brand-name drugs.
If you like this story, please see our blog titled “Part II – Fifteen Cell Therapies/Stem Cell Therapies in Phase III Clinical Trials”
“For the first time, FierceBiotech has rounded up 10 deep-pocketed players whose names should ring a bell with readers.”
If you like this story, please see our blog titled “Continuous Processing: From Cookie Preparation to Cell-Based Production”