This week’s headlines include, biotech mergers and acquisitions in 2012, companion diagnostics advance personalized medicine, FDA to release new guidances in 2013, cord blood cell research, biopharma R&D talent gap, and FDA looks to new measures to prevent drug shortages.
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“The quick summary from a venture-backed biotech perspective: it was a good year although not a great one. Upfront and total deal values for venture-backed M&A of $3.5B and $8.5B, respectively in 2012. Those total upfronts are smaller than 2011, but larger than 2008-2010 annual numbers. Total annual deal numbers for VC-backed private acquisitions have been relatively steady since 2005 around ~30 deals, except for 2009 when only 19 occurred. About two-thirds of those deals have financials disclosed.”
If you like this story, please see our blog titled “In Celebration of Chinese Hamster Ovary CHO Cells – a Biopharmaceutical Manufacturing Powerhouse”
“The medical world took little notice earlier this month when Qiagen (NASDAQ: QGEN), a German maker of diagnostics equipment, asked the Food & Drug Administration to approve its test for a certain gene mutation associated with lung cancer. The mutation, involving the epidermal growth factor receptor (EGFR) found on the surface of cells, plays an important role in the rapid spread of tumor cells and is found in about 10 percent to 15 percent of Caucasians and 40 percent of Asians with non-small cell lung cancer.
If you like this story, please see our blog titled “How Stem Cells Can Play a Major Role in Developing New Therapeutics”
“FDA to Release Long-Awaited Guidance on CMO Agreements, Biosimilars in 2013,” in-Pharma Technologist.com
“Highly sought-after guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers is expected in 2013, according to a list of future guidance documents released by the US Food and Drug Administration (FDA).”
If you like this story, please see our blog titled “Comments on Biosimilar Guidance Indicate Discontent on Both Sides of the Issues”
“A talent gap in the scientific workforce has biopharmaceutical companies searching outside for fresh skills and alternate approaches to R&D staffing, according to a new report. New R&D organisational models based on partnerships, alliances and even crowd sourcing are changing talent needs, challenging traditional talent management strategies and redefining the role of human resources (HR) in R&D productivity, says the study, from PricewaterhouseCoopers (PwC) Health Research Institute (HRI).”
If you like this story, please see our blog titled “Innovative Products Featured at the ASCB Conference Part I”
“As concerns persist over prescription drug shortages, the FDA is looking for ways to perform a tricky balancing act – maintain a commitment to enforcement while encouraging manufacturing quality so shortages can be avoided. The problem, in particular, has involved sterile injectable medicines, since the production process can be vulnerable to contamination. And remediation, of course, can lead to production slowdowns and shutdowns.”
If you like this story, please see our blog titled “The Number of FDA Drug Approvals for the 2012 Fiscal Year Remains High”
“These cells are being used to treat patients with more than 75 diseases, including various cancers, traumatic brain injury, autism, pediatric stroke, cerebral palsy, Type 1 diabetes, and blood, immune and metabolic disorders, said Dr. Mary Laughlin, a physician and expert in marrow and stem transplants at the University of Virginia School of Medicine. Laughlin thinks the future of Stem Cell Research depends on better preservation of stem cells collected from newborns after birth.”
If you like this story, please see our blog titled “Best Practices in Cell Therapy Manufacturing”
“Johnson & Johnson tops the list of drugmakers successfully commercialising their new molecules in a report from consultants at IDEA Pharma. The latter has released its third annual Productive Innovation Index (PII), which claims to measure firms’ ability to deliver innovation to market by evaluating their performance using publicly-available data based on a five-year period (2007-2012). Last year Amgen took the top spot with J&J ranking second, but the companies have switched places in the latest list.”
If you like this story, please see our blog titled “Part II Innovative Products Featured at the ASCB Conference”