In a move that heralds greater momentum toward regulating biosimilars, the Food and Drug Administration has published its first-ever “Purple Book” – a list of all FDA-licensed biologics and the biosimilars that can be used in their stead. It’s meant to be equivalent to the FDA’s “Orange Book” – the go-to list for physicians, regulatory agents and […]
Next-gen fecal transplant company Rebiotix seems to be in the midst of a rather hefty funding round. The Minnesota-based startup filed equity-raising paperwork with the Securities and Exchange Commission to the tune of $25 million. According to the filing, Rebiotix has raised $18 million thus far. Rebiotix was founded in 2011, and raised about $5 million then from angel investors. […]
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The La Jolla, California, biotech formerly known as Anaphore is looking a little different these days. Under the leadership of former Fate Therapeutics CEO Paul Grayson, Anaphore changed its name to RuiYi Inc., honed its focus from developing broader classes of proteins to new biologic drugs for the Chinese market, and set up a four-way […]
A biologics startup developing a way to help patients with bladder cancer by using their own cells to regenerate tissue and to reconstruct a urinary tract has expanded a Phase 1 trial to five sites and has performed the procedure on its seventh patient. But despite getting a $15 million private placement last fall, Tengion […]
Biologic drugs are filling the pipelines of big pharmaceutical companies and niche biotech companies, and many expect the market for these drugs to soar. But discovery and development of biologics is complex, time-consuming and expensive because they’re derived from living organisms. A new drug discovery company called Invenra Inc. says it has a platform that […]
For the thousands of adults and children with growth hormone deficiencies, daily injections of replacement hormones are their best bet for preventing the cardiovascular, muscular and metabolic abnormalities associated with the condition. But a few companies are on the hunt for ways to make those injections last longer so that they would require less frequent […]
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Diminished resources and fierce competition from growing biotech and specialty pharma companies will drive smaller and more selective M&A deals by Big Pharma companies in 2013 and beyond. That’s the thesis that Ernst & Young’s life sciences team put forth in a new report called Closing the gap? Big pharma’s growth challenges and implications for […]
Rapid growth of biopharmaceuticals will boost the global market for active pharmaceutical ingredients over the next five years, according to a new report. GBI Research’s new analysis of the API market, which is currently dominated by synthetics, saw the market grow 17 percent annually between 2005 and 2011, and predicts it will continue growing from […]