Sistemic closes Series A; Keryx, FDA agree on late-stage study design

 @FierceBiotech:  Bioheart launches first FDA approved trial of gene-modified stem cell therapy in congestive heart failure. Release [1] | Follow @FierceBiotech [2]

 @JohnCFierce: You have to give Schwan credit for R&D vision, but I still see Genentech losing more than Roche gains. Report [3] | Follow John on Twitter [4]

> Scottish biotech company Sistemic Ltd today announced that it had closed a $1 million Series A round with lead investors ChimeraBio and the Scottish Enterprise Scottish Co-Investment Fund. The company will use the funding to further develop its SistemRNA compound-centric drug discovery technology. Release [5]

> Keryx Pharmaceuticals and the FDA have agreed on a trial design for a late-stage study of its cancer drug perifosine. Report [6]

> AMAG Pharmaceuticals shares slid this morning after an analyst downgraded the company's stock citing concerns that patients on Feraheme--an iron replacement therapy--are landing in the hospital with severe allergic reactions. Story [7]

> The Belgian chemicals company Taminco has cancelled its planned IPO, citing a poor market for new offerings. Report [8]

Pharma News

  @FiercePharma: Globes (Israel): Supreme Court bars Sun from buying more Taro shares. Article [9] | Follow @FiercePharma [10] 

> The pace of biopharma dealmaking has increased so much that the U.S. Federal Trade Commission is asking for more funding to help handle the workload. Story [11]

> Former Novartis CEO Dan Vasella's 2009 bonus will be close to three times the amount he would be due based on relative earnings growth among large-cap peers, according to a new corporate-governance report. Story [12]

> Two pieces of news on federal healthcare spending today could give a forward-looking pharma executive pause. Item [13]

> Here's another cost-cutting move at a drugmaker that managed to grow sales in 2009 but expects big competition once a major drug hits the patent cliff. Report [14]

> Over the last week or so, we've seen three Big Pharmas announce big changes to their research operations--and those big changes include big job cuts. Big cost savings, too, the companies say. Story [15]

Pharma Manufacturing News

> Some creative thinking in the business development group has positioned a maker of modernized traditional Chinese medicine for entry into the traditional medicinal liquor business. Report [16]

> Airlines are showing a kinder face to drugmakers than they have been to consumers recently. Cold chain initiatives are underway at major air carriers, thanks to the growing global market for pharmaceuticals. Story [17]

> The FDA's 2011 budget request, as reported earlier [18], includes $25 million for a 50-person regulatory science initiative to help the watchdog catch up with industry capabilities in the life sciences. Nanotechnology is a prime target for expertise development, according to the budget request, as is stem cell technology. Item [19]

> While the FDA studies up on nanotechnology and stem cells, assuming its 2011 budget request is approved (see related story [19]), the regulator will simultaneously update its drug review processes. Report [20]

> Better means of sharing cargo theft information came online this week. Freight carriers, shippers, insurers and law enforcement are collaborating on maintaining a database and secure network to help law enforcement react faster when thefts occur. Story [21]

> Pall Corp has unveiled the PallSep Biotech system for separating target molecules from process fluids via vibrating membrane filtration technology. Report [22]

Vaccines News

> Twelve years ago, Dr. Andrew Wakefield published a study in the Lancet that linked autism with childhood vaccines, triggering an explosive controversy that continues to influence public opinion about the potential side effects of vaccines. Story [23]

> An experimental malaria vaccine originally developed by GlaxoSmithKline and the U.S. Army has produced dramatic results in an early-stage trial in Mali. Story [24]

> The nonprofit group PATH is seeking help from the FDA to develop a vaccine against diseases caused by the Streptococcus pneumoniae bacteria, which kills almost 1 million children each year. Report [25]

> Paul Bogorad at Putnam Associates is bullish about the vaccine business. Report [26]

And Finally... After lying in what doctors termed a vegetative state for five years, researchers in Belgium say that their patient is exhibiting brain activity that indicates a direct ‘yes' or ‘no' response to specific questions. And the discovery opens an avenue of communication even as it also raises serious new ethical considerations. Article [27]