The Dish’s Weekly News Wrap Up – March 29, 2013

This week’s headlines include, 465 drugs in R&D for chronic disease for over 65 year olds, stem Cell Therapy news, challenges on the horizon for biosimilars, and vaccine news.

Cell Culture Events:

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“US Pharma: 465 Drugs in R&D for Chronic Diseases Affecting Over 65s,” PharmaTimes

“US biopharmaceutical companies are currently developing 465 new medicines that target the 10 leading chronic conditions affecting people aged 65 and over, according to new industry data. The medicines, which are all now in clinical trials or under review by the Food and Drug Administration (FDA), are diverse in scope, notes the Pharmaceutical Research and Manufacturers of America (PhRMA), which has published the data.”

If you like this story, please see our blog titled Biologics Have a Robust Pipeline According to Latest PhRMA Report”


“Aastrom Biosciences Ends Drug Trial, To Cut Half its Workforce,” Reuters

“Aastrom Biosciences Inc said it would end the late-stage trial of its drug to treat critical limb ischemia (CLI), a form of peripheral arterial disease, and cut about half of its workforce, driving its shares to an all-time low. The stock was down 34 percent at 75 cents in morning trade on the Nasdaq. The company now plans to focus on developing the drug, ixmyelocel-T, as a treatment for a heart condition called dilated cardiomyopathy (DCM), in which the heart becomes weak and cannot pump blood efficiently.”

If you like this story, please see our blog titled “Fifteen Cell and Stem Cell Therapies in Phase III Clinical Trials Part I


“Do You Think Biosimilars Will Reduce Heathcare Expenditures? Think Again,” Forbes

“Generic medicines are a critical element of Americans’ health care.  Since 1984, the marketing of generic versions of chemically synthesized, relatively simple “small molecule” drugs such as those used commonly to control diabetes, blood pressure, cholesterol and pain has been expedited by legislation commonly known as the Hatch-Waxman Act. By allowing approval of generics through an abbreviated and less costly pathway than for innovator, or brand-name, drugs – a route that does not require new clinical trials — this legislation has balanced the need to preserve industry’s incentive to innovate with the benefits of competition.”

If you like this story, please see our blog titled “Biologics Take Top Spots in Best Selling Drugs of 2012


“U.S. Delays Approval of GSK Bird Flu Vaccine,” Reuters

“U.S. regulators have delayed approval of an H5N1 bird flu vaccine from GlaxoSmithKline, designed to be used in a pandemic. A spokesman for Britain’s biggest drugmaker said the delay was not related to recent controversy over links between a similar flu vaccine made by the company and narcolepsy. Rather, the U.S. Food and Drug Administration (FDA) decided it needed more time to assess the product “due to an administrative matter that has recently been rectified”, GSK said in a statement on Monday.”

If you like this story, please see our blog titled “Severe Flu Season Puts Spotlight on New Vaccine Technologies and Existing Challenges”


“Va. Governor Signs First State Bill to Limit Biosimilars,” Drug Store News

“Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015. McDonnell signed House bill 1422 and the identical Senate bill 1285, which would prevent a pharmacist from dispensing a biosimilar to substitute for the original, branded biologic if the prescriber indicated that substitution was not allowed or if the patient insisted on receiving the branded product.”

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


“$91 Million Vaccine Center Planned for Texas A&M,” Star-Telegram

“State leaders announced the construction Tuesday of a $91 million vaccine-manufacturing center at Texas A&M University that they say will create thousands of jobs while protecting the country against future biological threats and influenza pandemics. Gov. Rick Perry, A&M System Chancellor John Sharp and others gathered at the Capitol to discuss the collaboration among A&M, pharmaceutical giant GlaxoSmithKline and the federal government.”

If you like this story, please see our blog titled “A First – Cell culture Based Seasonal Influenza Vaccine Approved by the FDA”


“Swansea Measles Epidemic: MMR Vaccine Take-up Disappointment,” BBC News

“Public Health Wales said only 100 of the 3,800 susceptible children aged over two in the Swansea area had the vaccine last week. At that rate, it will take two years to vaccinate all those at risk. So far there are 432 cases of measles in total and of those 116 have been reported in the last week alone. Parents have been warned the outbreak could spread to other parts of Wales with fears it could top 1,000 cases. Public Health Wales (PHW) said the epidemic was spreading at an “alarming rate” and that 51 people have been hospitalised so far.”

If you like this story, please see our blog titled “New Vaccines Coming Soon to a Doctor’s Office Near You


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