| Merck Shows a Generics Hurdle A Merck decision to end efforts to copy an Amgen anemia drug shows how it won't be easy to develop biosimilars, or generic versions of biotechnology therapies. online.wsj.com |
A Delay in Protalix's Uplyso FDA Review Is Not a Disaster EP Vantage submits:Unlike the World Cup, in the race to get a product on the market in an orphan indication there are no silver or bronze medals, only a standard 10-month regulatory review period. This is what Protalix (PLX) has learned as the FDA handed it a standard review, with a February 25, 2011, PDUFA date, for the Gaucher’s disease drug Uplyso.With the continued uncertainty over the supply of Genzyme’s (GENZ) Cerezyme (Genzyme moves on but faces uncertain future, May 25, 2010), many observers had been expecting an expedited review for Uplyso. However, the entrance of Shire’s (SHPGY) Vpriv into the marketplace may be filling the gap. With Genzyme having told analysts and investors that Cerezyme production will slowly increase from current 50% levels in late summer, perhaps the FDA believed market demand was being met and another expedited review was unnecessary.Complete Story » seekingalpha.com |
Quarterly Results Suggest Charles River May Have Missed Big With Wuxi ChinaBio Today submits: In the aftermath of the breakup of the Charles River Labs (NYSE: CRL) and WuXi PharmaTech (NYSE: WX) merger (see story), the two companies each reported final reports for their respective 2010 second quarter financial performances. The results? The rejected company, WuXi PharmaTech, increased its guidance for 2010 slightly. Charles River, after deciding WuXi wasn’t worth the money, announced its own revenues declined and trimmed its 2010 outlook.Ultimately, the collapse of the transaction was about the price Charles River was paying for WuXi and not its financial fortunes (although part of the equation concerned WuXi’s growth). Still, Charles River had to admit last week it couldn’t convince its investors that the WuXi merger would add value. Now it has to tell the world its own results are declining.Complete Story » seekingalpha.com |
Will the FDA Give Vivus More Time Before the Final Judgment on Qnexa? David Greene submits:What a conundrum for Vivus (VVUS) and the FDA.Vivus announced last week what I am sure they wish they could have announced prior to the FDA panel meeeting in July--the results of a two year study monitoring 675 obese or overweight patients using the company's Qnexa drug, showing an average weight loss of 11.4 percent with much less threatening side effects than what was presented with the results of a one year study. The one year trial ended up with the Food and Drug Administration panel in July recommending against approving Qnexa due to concerns of negative side effects such as memory lapses, suicidal thoughts, heart palpitations, and birth defects.Complete Story » seekingalpha.com |
ShangPharma offering up to $52.8 million in IPO [AP] - Clinical research company ShangPharma Corp. expects to raise between $46.4 million and $52.8 million in an initial public offering this week. us.rd.yahoo.com |