The Dish’s Weekly News Wrap Up – July 13, 2012

“President Signs Legislation On Device, Drug Company User Fees,” Bloomberg

President Obama July 9 signed into law the Food and Drug Administration user fees bill(S. 3187, Pub. L. No. 112-144).  The law reauthorizes the user fees paid by medical device and drug companies: device companies are expected to pay $595 million over five years (fiscal years 2013 through 2017), while drug companies will pay $693 million in the first year. The new law also creates user fee programs for generic drugs and biosimilar (or follow-on biologic) drugs. The user fees supplement congressional appropriations for FDA.

If you like this story, please see our blog titled “The House Passes FDA User Fee Reauthorization Bill; Senate Next


“HPV Vaccine Protects Even Those Who Skip It,” ABC News

The vaccine against the human papilloma virus (HPV) is not only effective in decreasing the rate of high risk types of HPV infections in girls and women, but it also shows evidence of bestowing what is known as “herd immunity” — an indirect protection against the virus for those who have not been vaccinated — in a community at large, researchers said Monday.

If you like this story, please see our blog titled Manufacturing Strategies for Improving Viral Yield and Lowering Production Cost”


“Amniotic Fluid Offers Alternative Stem Cell Source,” Reuters

Stem cells taken from amniotic fluid can be transformed into a more versatile state similar to embryonic stem cells and may offer an alternative to the medically valuable but controversial cells, scientists said on Tuesday.

If you like this story, please see our blog titled New Strategies Key to the Clinical Manufacturing of Stem Cells for Therapeutic Use”


“Ranbaxy Puts Biosimilars into Gear,” Reuters

Ranbaxy Laboratories Ltd will launch at least three copies of biotech medicines in India by 2015, mostly to treat cancer, and needs to develop such high-tech drugs to remain a serious player in the global generics business, Chief Executive Arun Sawhney said on Tuesday.  Sawhney said that Ranbaxy, majority-owned by Japanese drugmaker Daiichi Sankyo, will introduce a “biosimilar” cancer treatment in India next year and follow up with at least two other biosimilars in the same market over the following year or two.

If you like this story, please see our blog titled “Comments on Biosimilar Guidance Indicate Discontent on Both Sides of the Issues”


“R&D Changes Foreseen After Supreme Court Obamacare Decision,” Genetic Engineering News

By upholding PresidentBarack Obama’s healthcare overhaul, the U.S. Supreme Court set the stage for several key changes to drug development, industry executives and observers agreed in interviews.  Craig A. Dionne, Ph.D., president and CEO of GenSpera, told GEN that biopharma startups won’t win the funding they need without showing investors solid results earlier in development. Those companies, he said, must offer investors clear evidence that their new drugs offer “clearly superior” efficacy than existing products, or else risk reduced reimbursement from government and private insurance programs under thePatient Protection and Affordable Care Act.

If you like this story, please see our blog titled “Supreme Court Upholds Affordable Care Act – What it Means for Healthcare”


“FDA Grants Orphan Drug Designation to Multistem Hurler’s Syndrome Therapy,” Pharmaceutical Business Review

Athersys has received FDA orphan drug designation for its proprietary Cell Therapy, MultiStem, to treat Hurler’s syndrome, also known as mucopolysaccharidosis type I or MPS-I.

If you like this story, please see our blog titled “Culture and Expansion of Stem Cells in Stirred Suspension Bioreactors Could Provide Key in Large Scale Manufacturing”


“Silky Scheme for Vaccine Storage Without Refrigeration,” New Scientist

Silkworms may provide a novel way to store vaccines. Preventable infections kill millions of children in poor countries, partly because reliable refrigeration for vaccines isn’t always available.

If you like this story, please see our blog titled Strategies for Improving Viral Yield in Vaccine Manufacturing”




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