This week’s headlines include, late-stage biosimilar trial begins, biopharm collaboration news, genomics, kidney cells from stem cells, and GSK’s melanoma drug wins accelerated approval.

Cell Culture Events

6th Annual Biomanufacturing Summit 2014

Now in its 6th year, the Biomanufacturing Summit 2014 attracts senior and executive level industry professionals working within manufacturing, process development and product operations. Through a combination of panel discussions, case studies, keynote sessions, interactive workshops and networking activities, attendees will come to network and exchange knowledge on the latest strategies and technologies available to improve their organizational performance.

Headlines:

“GSK Melanoma Drug Combination Wins Accelerated US Approval,” Reuters

“A combination treatment from GlaxoSmithKline for melanoma, the deadliest form of skin cancer, has won accelerated approval from U.S. regulators. The green light for the combined use of Tafinlar, also known as dabrafenib, and Mekinist, or trametinib, from the Food and Drug Administration (FDA) is the first of its kind for a form of the disease with a specific genetic profile. Both drugs are already approved for separate use but GSK believes they will have a longer-lasting effect if given together. Industry analysts also see a combination offering the greatest commercial potential.”

If you like this story, please see our blog titled “A Review of Best Practices For Cell Culture Media Design And Processes”

“Aiming to Push Genomics Forward in New Study,” The New York Times

“Pharmaceutical companies invested heavily in genetic studies in the frenzy after the sequencing of the human genome a decade ago, only to find it did not lead to the expected bonanza of new drugs. Now, however, Regeneron Pharmaceuticals, a fast-growing biotechnology company, is undertaking an ambitious new genomics effort, in partnership with the Geisinger Health System, which treats three million people in Pennsylvania.”

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“Regeneron, Bayer to Co-Develop Eylea Combination Treatment,” Reuters

“U.S. based-Regeneron Pharmaceuticals Inc and Germany’s Bayer AG said they would co-develop an antibody for use in combination with Eylea, their treatment for a form of age-related blindness. Bayer’s unit, Bayer HealthCare, will pay Regeneron $25.5 million upfront and share global development costs for the program, the companies said in a joint statement. Both the Eylea injection and the new combination treatment is to treat wet age-related macular degeneration (wet AMD) – the leading cause of blindness in the elderly.”

If you like this story, please see our blog titled “3-D Bioprinting – When cells become ink”

“Big Pharma’s “Firepower” Effectively Dropped by 20% in 2013, Says Report,” PharmExec.com

“Although Big Pharma’s ‘firepower’ increased last year by $100 billion in absolute terms, it declined in comparison with that of Big Biotech and specialty pharma, according to a new report from EY. EY’s Firepower Index measures companies’ capacity for conducting M&A deals. Firepower is diminished as a company’s market value, cash and equivalents fall, or as its debt levels rise. Big Pharma may have seen a 15% increase in firepower in 2013, but the EY report reveals that its portion of the combined firepower of Big Pharma, Big Biotech and specialty pharma has fallen steadily from 85% in 2006 to 70% today. Adjusting for the higher valuations of Big Biotech and specialty pharma means Big Pharma’s firepower has actually declined by more than 20%. It is now on a level last seen before the impact of the 2008 global financial crisis.”

If you like this story, please see our blog titled “Cell Culture, More Science Than Art – A Call For Care in Cell Culture Practices”

“Kidney Cells Generated from Stem Cells,” MedPage Today

“Regenerative medicine researchers have made an important advancement in their quest to grow functional kidneys from stem cells, which could lead to better treatments for patients with chronic kidney disease (CKD). Investigators from Brigham and Women’s Hospital and the Harvard Stem Cell Institute in Boston reported that they coaxed both embryonic and adult skin stem cells to become kidney tubular cells, according to their article in the Journal of the American Society of Nephrology. The researchers were able to differentiate the stem cells into expressing key markers of the intermediate mesoderm, which are the early cells that form the kidneys, and then induce them further into expressing the marker SIX2, which is critical in kidney differentiation.”

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“Sandoz Starts Late-Stage Trial of Humira Biosimilar,” Drug Store News

“Drug maker Sandoz has started a late-stage clinical trial of a biotech drug used to treat autoimmune disorders, the company said. Sandoz, the generics division of Swiss drug maker Novartis, announced the start of a phase-3 clinical trial of biosimilar adalimumab. The drug is a version of AbbVie’s Humira, used to treat rheumatoid arthritis, psoriasis and Crohn’s disease. “This latest advancement in our pipeline represents our unwavering commitment to expanding patient access to biologics, particularly in disease areas where there is a significant need for more treatment choices,” Sandoz head of global biopharmaceutical and oncology injectables development Mark McCamish said. “We look forward to bringing a high-quality and affordable biosimilar version of adalimumab to individuals around the world living with psoriasis and other debilitating autoimmune diseases, such as rheumatoid arthritis.”

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“Sanofi to Buy 12 pct of Alnylam,” Reuters

“French drugmaker Sanofi will buy a 12 percent stake in Alnylam Pharmaceuticals Inc for $700 million and deepen their partnership to develop drugs for rare genetic diseases. The companies said in a joint statement on Monday that Sanofi would buy Alnylam shares for about $80 each, representing a 27 percent premium compared to their average price over the past 30 days. The partnership between Sanofi and Alnylam began in 2012, the year after Sanofi jumped into the business of treating rare genetic diseases by paying more than $20 billion for U.S. biotechnology company Genzyme, a leader in the field.”

If you like this story, please see our blog titled “2013 FDA New Drug Approvals”