This week’s biotechnology news headlines include, Tufts report on drug costs, Cystic Fibrosis Foundation’s deal to raise money, FDA approves Phase III cell-based therapy, FDA grants fast-track for pancreatic cancer candidate, FDA approves Sanofi’s MS drug, and Activis to acquire Allergan.
“The estimated average cost of developing an approved new drug has more than doubled to over $2.5 billion from a 2003 estimate by Tufts University, but critics questioned the figure and noted the school’s strong financial ties to the pharmaceutical industry.”
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“About 15 years ago, the Cystic Fibrosis Foundation made what was considered a risky foray for a nonprofit organization into the world of business. It began giving money to a small biotechnology company to entice it to develop drugs for the deadly lung disease.”
If you like this story, please see our blog titled “The Benefits of Implementing Bioprocess Monitoring and Quality by Design in Process Development“
“San Carlos, Calif.-based BioCardia has received a green light from the FDA to begin a Phase III study of its combination bone marrow-derived CardiAMP therapy and in vitro diagnostic for heart failure. The product is the first heart stem Cell Therapy to go through the FDA’s medical device approval process rather than the biologics pathway.”
If you like this story, please see our blog titled “Where’s the Beef!?”
“The FDA granted fast track designation to an investigational nanoliposomal irinotecan injection as a potential treatment for patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy, the drug’s manufacturer announced.”
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“Much of the recent press about drug pricing has taken a narrow view of the topic. As the chief medical officer of a global pharmaceutical company, I view patients’ access to medicines as an issue of such importance that it demands a broader perspective. I also see the matter from two other vantage points: as a physician who has cared for patients and as an academic who led a Boston teaching hospital and medical school. With these complementary perspectives, I assess the value of a medicine not in isolation, but as part of an interlocking system with the patient at its center.”
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“The U.S. Food and Drug Administration has approved Sanofi’s multiple sclerosis treatment Lemtrada, Sanofi said in a statement on Saturday.”
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“Actavis PLC said Monday that it would pay $66 billion in cash and stock for Allergan Inc. in a deal that appears to have thwarted a hostile takeover of the Botox maker.”
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