This week’s headlines include, biotech employment up, FDA discusses tweets for drugmakers, biosimilars, Novartis submits meningitis B vaccine for FDA approval, FDA to issue off-label guidelines, chikungunya virus reported in US from travelers, Novartis facility receives FDA license.
Cell Culture Events
BIO International Convention – June 23-26, 2014 – San Diego, CA
Informa Life Sciences’ 7th Annual Viral Safety for Biologicals 2014– June 24-25, 2014 – Pullman Hotel, Cologne, Germany
Informa Life Sciences’ 7th Annual Viral Safety for Biologicals 2014 conference will provide you with the latest technological developments and practical strategies to screen and detect new adventitious agents, optimise viral clearance and implement upstream and downstream viral risk mitigation measures to manage and prevent potential contaminations as quickly as possible.
Informa Life Sciences’ 3rd Annual Biopharmaceutical Raw Materials 2014 – June 24-25, 2014 – Hotel Pullman Cologne, Cologne, Germany
Effective raw materials and supply chain quality management is crucial to ensure appropriate material quality and to enhance the safety and consistency of a pharmaceutical product. Informa Life Sciences’ 3rd Annual Biopharmaceutical Raw Materials is Europe’s only dedicated conference focused on optimising raw material and supply chain quality, with 10+ industry experts and first-hand regulatory advice from Paul-Ehrlich-Institut.
“Swiss drugmaker Novartis said on Tuesday it had submitted its meningitis B vaccine Bexsero for adolescents and young people to the U.S. Food and Drug Administration (FDA) for marketing approval.”
If you like this story, please see our blog titled “CHO Cell Culture – Ten Tips from the Experts on Expression, Media and Bioprocessing”
“In a few years, the first blockbusters of the biotech age will begin to face generic competition. Big drugs like Amgen’s Epogen and Neulasta, Roche and Biogen Idec’s Rituxan, and Erbitux, from Eli Lilly and Bristol-Myers Squibb could eventually face cheaper competitors. But they won’t be exact substitutions, because these drugs will be so much harder to make. Most will not be true generics but biosimilars — products with a similar profile that are still seen as slightly different from the original.”
If you like this story, please see our blog titled “Biologics Still on Top in Best Selling Drugs of 2013”
“After getting the FDA’s OK for cell-culture vaccine Flucelvax back in November 2012, Novartis ($NVS) now has a U.S. facility licensed by the agency to produce it. The drugmaker’s Holly Springs, NC, plant is now the country’s first pandemic-ready site with the regulator’s green light to make cell-culture flu vaccines, it said Monday.”
If you like this story, please see our blog titled “Improving the Efficiency and Performance of your Transfection”
“A painful, mosquito-borne viral illness has surfaced across the United States, carried by recent travelers to the Caribbean where the virus is raging.”
If you like this story, please see our blog titled “Highlights from the 14th World Vaccine Congress – A Cell Culture Perspective”
“A new jobs report published by EP Vantage revealed that big pharma employment dropped by 3% between 2003 and 2013, relieving fears that industry consolidation and restructuring would lead to significantly reduced headcounts and payrolls.”
If you like this story, please see our blog titled “10 Things You Should Know About Dry Shippers Before Shipping High Value Biologics”
“Not a Moment Too Soon? FDA to Issue Rules for Distributing Off-label Info,” Wall Street Journal Pharmalot
“By the end of this year, the FDA will take steps that have been awaited eagerly by the pharmaceutical industry – the agency will issue guidelines to drug makers for distributing information about unapproved uses of medicines and for presenting data about the economic value of their products.”
If you like this story, please see our blog titled “Aastrom CEO Discusses How Recent Acquisition Strengthens Current Manufacturing Capability and Clinical Pipeline”
“Don’t use Viagra if your heart isn’t healthy enough for sex.” After that warning, Pfizer Inc. (PFE) will have just 81 letters left to tweet about the benefits of its erectile dysfunction drug, say U.S. regulators.
If you like this story, please see our blog titled “Key Tools and Technology Hurdles in Advancing Stem-Cell Therapies – Part I”