This week’s headlines include, big biotech outpacing big pharma, stem cell news, Sanofi vaccine approved in EU, war on cancer moves into gene mapping, Merck gets breakthrough designation for melanoma treatment candidate, and a new testing process for aseptic validation.
With the increase in single-use assemblies that incorporate flexible containers (plastic bags), complex tubing and other disposable subcomponents, concerns about system integrity and sterility have been raised. Microscopic defects, even ones too small to cause a visable leak can allow bacteria to enter and compromise sterility. In response, ATMI has created the Helium Integrity Testing (HIT™) System, which is designed to test defects in single-use assemblies that conventional pressure decay methods cannot detect. Orignially developed for ATMI in-house use; the system is now available for use at end-user facilities for integrity testing prior to use. This testing is particularly useful in the most crucial applications including high-value API, final fill, and Cell Therapy applications.
“As healthcare shifts to a new value-based focus, Big Biotech companies are demonstrating they are better positioned than their pharmaceutical industry counterparts to meet changing demands, according to an analysis by Burrill & Company. Big Biotech has outpaced Big Pharma in terms of growth of sales, income, investment in R&D, and market cap during the past three years, the financial services company reports. “As the industry migrates away from an era of the one-size-fits all blockbuster, the biotechnology industry’s strength at developing innovative therapies that meet unmet medical needs and target the molecular mechanisms of diseases gives it an upper hand in creating value,” says G. Steven Burrill, CEO of Burrill & Company.”
If you like this story, please see our blog titled “Biologics Have a Robust Pipeline According to Latest PhRMA Report”
“Mesoblast has completed a six-month follow-up for a phase II trial of its mesenchymal precursor cells (MPCs) in intervertebral disc repair. The company expects to be able to report the full results from the 100-patient trial of its adult stem cells in the third quarter. A positive outcome will allow Mesoblast to proceed to phase III studies. Mesoblast also revealed it has concluded an interim analysis of the results, which commenced when 50% of patients had completed the six-month follow-up. The results so far suggest that a single dose of the adult stem cells significantly reduced back pain and improved function when compared to the control group.”
If you like this story, please see our blog titled “ From Product Candidate to Product: The Road to Commercialization in Regenerative Medicine”
“French drug maker Sanofi SA said on Monday the European Commission has approved its primary and booster vaccine for infants from six weeks of age. The vaccine protects infants against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type B.”
If you like this story, please see our blog titled “Severe Flu Season Puts Spotlight on New Vaccine Technologies and Existing Challenges”
“Major academic medical centers in New York and around the country are spending and recruiting heavily in what has become an arms race within the war on cancer. The investments are based on the belief that the medical establishment is moving toward the routine sequencing of every patient’s genome in the quest for “precision medicine,” a course for prevention and treatment based on the special, even unique characteristics of the patient’s genes.”
If you like this story, please see our blog titled “Is Personalized Medicine the Future? How Genetic Sequencing is Enabling New Treatments“
“Biotechnology Companies worldwide boosted profit by 37 percent to a record $5.2 billion in 2012, partly by tempering growth in research-and-development spending, according to Ernst & Young. Drugmakers led by Amgen Inc. and Gilead Sciences Inc. increased R&D investment 5 percent last year, down from growth of 9 percent in 2011, the London-based consulting firm said today in its annual biotechnology industry report. At the same time, revenue at companies across the U.S., Europe, Canada and Austraila rose 8 percent to $89.8 billion.
If you like this story, please see our blog titled “Biologics Take Top Spots in Best Selling Drugs of 2012“
“Merck & Co. (MRK) has received breakthrough therapy designation from the U.S. Food and Drug Administration for its lambrolizumab drug as a treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting Programmed Death receptor that is currently being evaluated for the treatment of patients with advanced melanoma, and other tumor types.”
If you like this story, please see our blog titled “Continuous Processing: From Cookie Preparation to Cell-Based Production“
“Aseptic Validation in Single-Use Technology A New Testing Process May Improve Results,” Contract Pharma
“Quality is the word on everyone’s lips in the biopharmaceutical market. The outcry from end users (patients) regarding highly publicized contamination events has effected a great amount of transformation in the industry. New regulations have been — and will continue to be — brought to the market in an effort to effectively monitor and increase quality for the industry. With these new regulations, the structure of accountability has changed and drug manufacturers are now more accountable than ever to meet and exceed regulations, from sourcing of raw materials through to putting the product “on the shelf.”
If you like this story, please see our blog titled “Identifying Options for Stem Cell Based Therapy Scale Up“