The Dish’s Weekly News Wrap Up – June 21, 2013

This week’s headlines include, call for overhaul of drug industry business model, NIH looks to resurrect abandoned drugs, HPV vaccine effective in cutting infections in teenage girls, new companion diagnostics partnership, changes to orphan drug regulations, ThermoGenesis picks up UK customer, and news on California stem cell bank.

Cell Culture Events:

ESACT (European Society for Animal Cell Technology) June 23rd-26th, Lille, France

If you are attending, please visit our sponsors:

ATMI LifeSciences – Booth number C7

GE Healthcare – Booth number 30


“Call for Overhaul of Drug Industry Business Model,” Reuters

“Pharmaceutical companies need to boost the benefits of drug research by working with regulators and healthcare providers to overhaul the way medicines are approved and paid for, a thinktank backed by investors says. After years of disappointing research and development (R&D) productivity, a new report backed by leading institutional investors sees “early indications of a recovery”, with U.S. approvals of new drugs last year the highest since 1996. The PharmaFutures thinktank said on Wednesday that getting the most out of an improving flow of novel – and costly – drugs in areas such as oncology will require a more flexible approach to developing, licensing, using and paying for medicines.”

If you like this story, please see our blog titled “Ensuring Integrity and Sterility of Single-Use Assemblies

“NIH Funds Effort to Resurrect Abandoned Drugs for New Uses,” Nature News Blog

“The most visible project of the new translational medicine centre at the US National Institutes of Health (NIH) came a little closer to reality today, with the announcement of nine awards that pair academic scientists with compounds cast off by the pharmaceutical industry. The aim of the plainly named Discovering New Therapeutic Uses for Existing Molecules programme is to re-employ abandoned drugs for new uses — and in the process, show Congress that NIH’s youngest centre is delivering for the US taxpayer. The fledgling National Center for Advancing Translational Sciences (NCATS) says that it will oversee the spending of US$12.7 million on the ambitious projects, which aim to produce treatments for ailments including Alzheimer’s disease, schizophrenia, alcoholism and calcified heart valves. As Nature wrote last October, the awardees have their work cut out for them: all the compounds, donated by big pharmaceutical firms, have been shown to be safe in humans but were discarded for lack of effectiveness against their original targets or for business reasons.”

If you like this story, please see our blog titled “Perfusion Bioreactors – With so much to offer they deserve a closer look

“Vaccine Against HPV Has Cut Infections in Teenage Girls,” NPR

“A vaccine against human papillomavirus — the most common sexually transmitted infection and the cause of almost all cervical cancer — is dramatically reducing the prevalence of HPV in teenage girls. The first vaccine against HPV, Merck’s , was approved by the Food and Drug Administration in 2006. Cerverix, from GlaxoSmithKline, was approved in 2009. In the first four years of immunizations, infections from the four strains of targeted by the vaccines plummeted by more than half among 14-to-19-year-olds in the United States.”

If you like this story, please see our blog titled Interesting Late Stage Viral Vaccine Candidates

“Siemens, Janssen Team Up on Companion Diagnostics for Heart Failure Candidate,” Genetic Engineering News

“Siemens Healthcare Diagnostics is partnering with Janssen Pharmaceutical in an effort to develop and commercialize a companion diagnostic test for an early-stage compound being developed by Janssen. The compound targets autoantibodies directed against the human β1-adrenergic receptor (β1-AR), which may contribute to the development of heart failure.”

If you like this story, please see our blog titled “Companion Diagnostics – The Power of Personalized Medicine

“FDA Finalizes Changes to Orphan Drug Regulations with Emphasis on Clarifying Existing Policies,” Regulatory Focus

“FDA’s orphan drug regulations are intended to create market-based incentives for manufacturers of products for populations with rare diseases. Per the Orphan Drug Act of 1983, a rare disease is defined as any disease affecting fewer than 200,000 individuals in the US in any given year. The act allows FDA to give the products approved to treat the orphan conditions special marketing protections (7 years of market exclusivity), tax credits to offset some of the costs of development, faster regulatory reviews and additional assistance from FDA reviewers during the development and review process. The regulations stemming from the Orphan Drug Act have remained relatively constant in recent years, but in October 2011 FDA announced it wanted to make a number of minor revisions to bring its definitions up to date and to make a number of other “minor” tweaks.”

If you like this story, please see our blog titled “Gene Optimization and Synthesis as Generic Tools for Streamlined Workflows and Expression Enhancement

“Rancho Cordova’s ThermoGenesis Picks Up UK Customer,” The Sacramento Bee

“Rancho Cordova-based medical equipment firm ThermoGenesis Corp. said today that its AXP AutoXpress system has been selected for use by a customer in the United Kingdom. The AXP is an automated device used for processing stem cells from umbilical cord blood.”

If you like this story, please see our blog titled “Continuous Processing: From Cookie Preparation to Cell-Based Production

“Cellular Dynamics, Coriell to Create California Stem Cell Bank,” Xconomy

“One of the main goals of California’s $3 billion Stem Cell Research agency is to draw companies into the state so they can vie for a share of the funding. With a recently funded $32 million initiative, the California Institute for Regenerative Medicine CIRM) has attracted two of the biggest US players in stem cell banking to Novato, CA, to form one of the largest biobanks of induced pluripotent stem cells (iPS cells) in the world.”

If you like this story, please see our blog titled “From Product Candidate to Product: The Road to Commercialization in Regenerative Medicine

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