This week’s headlines include, stem Cell Therapy news, key drug approvals coming soon, possible FDA budget cuts, orphan drugs, biosimilars hitting challenges, new companion diagnostic for Alzheimer’s, vaccine news and Tamiflu resistance found in 2% of H1N1 cases.

Cell Culture Events:

Attend World Vaccine Congress and Expo in Washington D.C., April 16-18th

The World Vaccine Congress & Expo is now in its 13th year and is the biggest and most comprehensive event for the industry. Covering everything from the latest R&D to manufacturing to the corporate development strategies you’ll be sure to find answers to all your questions

Cool Tool:

Life Technologies’ Cell Culture App for iPhone or iPad

Ever wish you had a portable, easy way to capture data in the lab that can be easily exported to your computer? If so, Life Technologies’ new Gibco® Cell Culture Companion app for iPhone or iPad may be able to help. The app allows you to record cell culture data and store experiment information on your iphone or ipad in the lab as you count cells, perform cell culture calculations and generate growth curves. Then when you return to your desk, export all the information to your computer.  Check the app out here

Headlines:

“Mayo Clinic to Hold Trial for BrainStorm’s ALS Stem Cell Therapy,” Reuters

“BrainStorm Cell Therapeutics said the Mayo Clinic in Minnesota has agreed to conduct a clinical trial of the company’s adult stem cell treatment for ALS. The Mayo Clinic is the third leading U.S. clinical site to sign a letter of understanding, following the University of Massachusetts and Massachusetts General, BrainStorm said on Monday. Israel-based BrainStorm is developing NurOwn for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease, a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. Initial results from Phase I studies suggest that patients with ALS experience a positive clinical outcome after treatment with NurOwn cells, the company said.”

If you like this story, please see our blog titled “The Value of Cord Blood Stem Cells in Healthcare and Research”

“4 Key Drug Approvals Expected in the Next 30 Days,” Investors Business Daily

“Investing in drug stocks isn’t quite like investing in other stocks. While drugmakers’ shares can move on earnings and buyout news like anyone else’s, what really gets investors excited is an FDA decision allowing a new drug on the market. Here are some of the most important drugs awaiting approval in the next month.”

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

“FDA Chief Warns Budget Cuts Could Slow Drug Approvals,” Boston Herald

“The head of the Food and Drug Administration today said the federal agency is working to expedite the approval of safe new drugs, but across-the-board federal budget cuts threaten to hamper its efforts. “Sequestration has added an unexpected (challenge),” Commissioner Margaret Hamburg told about 400 biotechnology leaders at the MassBio annual meeting in Cambridge. Hamburg added that she is hoping Congress will enable the FDA to access user fees the industry pays for the agency’s operating expenses.”

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

“Has the Pendulum Swung Too Far in Favor of Rare Diseases?” Xconomy

“Until fairly recently, people afflicted by rare diseases grappled with the depressing realization that pharma companies would not invest their considerable resources in trying to develop new medicines for these disorders. For most of the last century people burdened with these illnesses had little hope that new drugs would become available to treat them or a loved one. It was truly heartbreaking to see people (usually children) suffer from one of these unusual illnesses, many of which were fatal and whose cause was often unknown. The desperate search for a cure for these enigmatic diseases made for such a compelling narrative that it led Hollywood to produce at least two films on the subject, Lorenzo’s Oil and Extraordinary Measures. Everything changed in 1983 with the passage in the U.S. of the Orphan Drug Act, which was put in place to encourage drug makers to develop new medicines for rare diseases. This successful piece of Federal legislation included incentives for pharma companies in the form of exclusivity provisions and tax incentives. It increased the likelihood that companies could achieve a good financial return if they embarked on a program to come up with new drugs to treat these disorders. Similar incentives were put in place in Europe as well.”

If you like this story, please see our blog titled “How Stem Cells Can Play a Major Role in Developing New Therapeutics”

“Biosimilars: Not So Far So Fast,” Genetic Engineering News

“Until very recently, biosimilars were expected to become an increasingly large part of the world market for global pharmaceuticals, potentially reaching up to a 50% market share. By 2020 twelve of the top-selling biologicals will have lost patent protection, opening up an estimated $24 billion in E.U. sales and $30 billion in U.S. sales. But despite a spate of deals and several potential market entrants the WSJ reported apparent reduced “momentum” on the part of some key players on track to produce biosimilars. Biosimilar development is not for the faint-hearted, as barriers to introducing these large and complex biomolecules range from significant technical difficulties, potential regulatory issues, surfacing submarine patents, halted clinical trials, and particularly, potential product pricing. Recent activity among pharma companies and biosimilar production enterprises indicates the potential volatility in the field, with clear commercialization successes yet to emerge.”

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

“Stem Cell Therapy Shows Promise for Parkinson’s Treatment,” Fierce Biotech Research

“Scientists may be one step closer to using stem cells to treat patients with. Parkinson’s disease. Carlsbad, CA-based International Stem Cell Corp. ($ISCO) has developed a method to treat the common neurodegenerative disease by replacing lost neurons with new neuronal cells derived from human parthenogenetic stem cells (hpSC). Researchers manufactured highly pure populations of neural brain cells differentiated from hpSCs and transplanted them into the brains of African Green monkeys and rats with animal versions of Parkinson’s disease. These neuronal cells functioned similarly to adult cells, and the researchers said they expressed greater levels of dopamine –the neurotransmitter that is essential to Parkinson’s disease–than previously reported approaches.”

If you like this story, please see our blog titled “Identifying Options for Stem Cell Based Therapy Scale Up”

“Despite Evidence, Parents’ Fears of HPV Vaccine Grow,” Reuters

“More parents of teen girls not fully vaccinated against human papillomavirus (HPV) are intending to forgo the shots altogether – a trend driven by vaccine safety concerns, new research suggests. That’s despite multiple studies showing the vaccine isn’t tied to any serious side effects but does protect against the virus that causes cervical cancer, researchers said.”

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

“Tamiflu Resistance in 2% of H1N1 Flu Cases Globally, Study Finds,” Bloomberg News

“Tamiflu-resistant swine flu is turning up in about 2 percent of cases globally, researchers in Australia found, raising the risk that Roche Holding AG (ROG)’s pill may become ineffective in fighting the pandemic H1N1 virus. Drug resistance in the flu strain that sparked the 2009 influenza pandemic is being detected in virus samples collected from patients who haven’t been treated with Tamiflu, suggesting the mutant germs have spread, said Aeron Hurt, head of antiviral susceptibility research at the World Health Organization’s Collaborating Centre for Reference and Research on Influenza in Melbourne.”

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

“Merck Signs Deal for Luminex Device to Aid Alzheimer’s Study,” Fox Business News

“Merck & Co. (MRK) has inked a deal with Luminex Corp. (LMNX) to develop a device that could help screen patients for recruitment into a clinical development program for its lead investigational candidate for Alzheimer’s disease. Financial terms of the deal weren’t disclosed. The study is focused on MK-8931, a novel oral beta amyloid precursor protein site cleaving enzyme inhibitor. Merck noted the accumulation of beta amyloid in the brain is a key pathological characteristic related to Alzheimer’s. It said recent clinical evidence supports the idea that measuring certain investigational biomarkers may be useful in identifying patients at greater risk of developing the disease.

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