This week’s headlines include, new drug approvals, best biotech CEO of 2012, whole genome sequencing and gene patents, focus on treatment for ALS, and pediatricians change their position on Thimerosal. Happy Holidays: Happy Holidays from The Cell Culture Dish! Please check back with us in the New Year to see our new look. We are updating our website to improve the experience for our readers and further build the community.
As companies begin their fourth-quarter tabulations, Deloitte and Thomson Reuters took their third annual look at industry’s R&D-ROI balance and found that things are…OK—could be better, could be worse. The firms did not name names, but assessed the industry’s financial success based on 12 companies, of which 10 showed net gains in their pipelines, and five “reported net commercial success.”
If you like this story, please see our blog titled “Venture Capital Investment in the Life Science Sector is Down for 2012 – Is There a Light at the End of the Tunnel”
The best biotech CEO of 2012 is Leonard Schleifer of Regeneron Pharmaceuticals. Schleifer was the top pick of TheStreet readers for his execution of one of the most successful new drug launches in history. Eylea was approved in November 2011 to treat a common cause of blindness. In just nine months, Eylea sales have already reached $562 million with an annual run rate close to $1 billion, well above the company’s — and investors’ — initial forecasts.
If you like this story, please see our blog titled “Best Selling Biologics for 2011 – CHO Still the Top Manufacturing Choice”
Raxibacumab injection has been approved by the U.S. Food and Drug Administration to treat inhalational anthrax, an infectious disease caused by breathing in deadly anthrax spores, the agency said Friday. Raxibacumab neutralizes the toxins produced by the anthrax bacterium Bacillus anthracis. This infection can cause “massive and irreversible tissue injury and death,” the FDA said in a news release. Raxibacumab is a monoclonal antibody, acting like a human antibody that attacks foreign bacteria and viruses. Anthrax, the FDA said, “is a potential biological terrorism threat because the spores are resistant to destruction and can be easily spread by release in the air.”
If you like this story, please see our blog titled “The Number of FDA Drug Approvals for the 2012 Fiscal Year Remains High”
What happens when, during the course of whole-genome sequencing (WGS) a patient or research subject, an investigator sequences and analyzes a disease gene that has been patented? The U.S. Supreme Court will shed some light on this question next year when it issues its ruling in the long-running Myriad Genetics saga. Last month, the Supreme Court voted to hear the case of Association for Molecular Pathology v. Myriad Genetics to consider the question whether human genes are patentable. The plaintiffs—doctors, patients, researchers, and the American Civil Liberties Union—have challenged Myriad’s patents on the breast cancer genes BRCA1 and BRCA2, which cover, among other things, isolated DNA molecules with the sequences of those genes. A federal district court in New York ruled that the patent claims on isolated DNA molecules were invalid, but that ruling was reversed on appeal by the Federal Circuit in D.C. The Supreme Court decided to review the Federal Circuit’s decision and will likely rule on whether isolated human gene sequences are patentable next summer.
If you like this story, please see our blog titled “Is Personalized Medicine the Future? How Genetic Sequencing is Enabling New Treatments”
U.S. health regulators have approved a new four-strain seasonal influenza vaccine made by GlaxoSmithKline Plc, the company said on Monday. The U.S. Food and Drug Administration has approved Fluarix Quadrivalent to immunize children age 3 and older and adults against flu virus subtypes A and B contained in the vaccine. It is the first intramuscular vaccine to protect against four influenza strains. Three-strain flu vaccines currently administered help protect against the two most common A virus strains and the B strain expected to be predominant in a given year, the company said.
If you like this story, please see our blog titled “A First – Cell Culture-based Seasonal Influenza Vaccine Approved by the FDA”
Biogen Idec, Inc. said Thursday that it has formed a consortium with several academic research centers that looks to identify new approaches to treating amyotrophic lateral sclerosis, or ALS, which is also known as Lou Gehrig’s disease. In a press release, Weston-based Biogen Idec said that it has committed more than $10 million over three years to fund research projects by members of the consortium. The initiative will complement a collaboration the company announced earlier this year with Duke University and the Hudson Alpha Institute to sequence the genomes of 1,000 people living with ALS.
If you like this story, please see our blog titled “Tumor Cell Panels Help Researchers Develop New Cancer Treatments”
A mercury-containing preservative should not be banned as an ingredient in vaccines, U.S. pediatricians said Monday, in a move that may be controversial. In its statement, the American Academy of Pediatrics (AAP) endorsed calls from a World Health Organization (WHO) committee that the preservative, thimerosal, not be considered a hazardous source of mercury that could be banned by the United Nations. Back in 1999, a concern that kids receiving multiple shots containing thimerosal might get too much mercury – and develop autism or other neurodevelopmental problems as a result – led the AAP to call for its removal, despite the lack of hard evidence at the time.
If you like this story, please see our blog titled “Cell Culture-based Optiflu on List of Top Selling Flu Vaccines”