Stem cell fight over The US Supreme Court rejected a request to hear a case about the legality of federal funding for research involving human embryonic stem cells. The high court’s decision, announced on 7 January, puts an end to an almost four-year legal challenge that has threatened to derail such work in the country. The US National Institutes of Health currently spends around $120 million per year on embryonic stem cell research. “Science can now continue to move forward, knowing the threat to promising research and funding has been eliminated,” Amy Comstock Rick, president of the Coalition for the Advancement of Medical Research in Washington, DC, said in a statement.
Heart drug withdrawn The New Jersey drug giant Merck has suspended global sales of its heart drug Tredaptive. The decision, announced on 11 January, comes after a nearly 26,000-person trial conducted in Europe and China found that adding the drug—niacin combined with an agent called laropiprant that counters the facial flushing induced by the vitamin—to standard statin therapy did not further reduce the risk of stroke, heart attack or other types of coronary disease. At the same time, the study showed that Tredaptive increased the incidence of various nonfatal but serious side effects. “We don’t have good evidence of any beneficial effects in the contexts of current therapies, and now there’s a suggestion of safety problems,” says study investigator Jane Armitage, a cardiovascular epidemiologist at the University of Oxford’s Clinical Trial Service Unit in the UK. The medicine was sold in about 40 countries worldwide but was never approved in the US.
New TB drug On 28 December, the US Food and Drug Administration (FDA) approved the first tuberculosis drug specifically indicated for multidrug-resistant forms of the disease. Sirturo (bedaquiline), from New Jersey’s Johnson & Johnson, kills the Mycobacterium tuberculosispathogen by inhibiting a proton pump enzyme that’s essential for energy generation. Most other tuberculosis drugs work by obstructing the formation of the bacterium’s cell wall. “After years of stagnation in TB drug development, this is the first novel TB drug that promises to become part of standard treatment regimens,” says Andreas Diacon, a pulmonologist at the University of Stellenbosch, South Africa, who has studied the drug.
Rival remonstration Teva Pharmaceuticals, the Israeli drug company behind the blockbuster multiple sclerosis drug Copaxane (glatiramer acetate), has asked the FDA not to approve an experimental multiple sclerosis pill developed by Massachusetts’s Biogen Idec until the drug has been evaluated by a panel of outside advisors. In its petition submitted to the agency on 31 December, Teva said there was “troubling information” posted on a publicly accessible website related to kidney toxicity in animal models following long-term administration of the drug, known as BG-12. No such problems have been observed in humans, although the clinical trials have typically been short. The FDA is slated to rule on BG-12’s approval by the end of March without a scheduled advisory committee meeting review. Marshall Urist, a biotechnology analyst with Morgan Stanley in New York, expects that decision to go ahead as planned. “We see little new here and remain positive on approval,” he wrote in an investor note.
AZ shakes up R&D AstraZeneca reshuffled its executive deck last month, eliminating its president of research and development (R&D), Martin Mackay, and replacing him with three senior officials responsible for early small-molecule R&D (Mene Pangalos), early biologics R&D (Bahija Jallal) and late-stage development (Briggs Morrison). The London-based drugmaker also swept aside commercial chief Tony Zook and created three new senior management positions for commercial activities in North America (Paul Hudson), Europe (Ruud Dobber) and the rest of the world (Mark Mallon). Notably, the pharma giant filled all those roles with company insiders, including from its Maryland-based subsidiary MedImmune. Another position designed to connect sales and R&D had not yet been filled as Nature Medicine went to press.
Reed comes to Roche Roche has looked to California again to help revive its flagging R&D operations. In 2009, the Swiss drug giant purchased South San Francisco–based Genentech, best known for its cancer drugs. And last month, Roche tapped John Reed, chief executive of the Sanford-Burnham Medical Research Institute in La Jolla, to lead its pharmaceutical research and early development group (which does not include Genentech). Reed (pictured), a pioneer in the field of cell death who has sat on the boards of drug companies but never had a full-time industry job before, will start working in Basel, where Roche is based, in April. “It’s definitely a positive for Roche,” says Odile Rundquist, a pharmaceutical analyst at Helvea in Geneva. “We know that the R&D from the Roche group has been lagging compared to Genentech, and John Reed is a leading researcher.”
Stemming ALS The strategy of transplanting neural stem cells is showing early promise for treating amyotrophic lateral sclerosis (ALS). At a conference in mid-December, Jonathon Glass, director of the Emory ALS Center in Atlanta, presented autopsy data from an ongoing phase 1 trial sponsored by Maryland-based Neuralstem that demonstrated long-term survival of transplanted spinal cord stem cells among participants who had died following treatment. Meanwhile, a team led by Evan Snyder, director of the Sanford-Burnham stem cell program, performed a meta-analysis of 11 previous studies that transplanted human and mouse neural stem cells into the spinal cords of mice with ALS-like disease. The introduced cells, they reported on 19 December, rescued malfunctioning nerve cells and helped preserve and regenerate brain tissue in the animal models (Sci. Transl. Med. 4, 165–164, 2012). “Our work would support the logic for such clinical trials, assuming the rationale is one of neuroprotection, anti-inflammation and suppression of disease-promoting host cells,” says Snyder.
Study sites struggle to enroll participants in clinical trials Nearly half of all sites involved in mid- to late-stage clinical trials fail to meet their enrollment targets, and those sites that do sign up study participants for one trial are no more likely to meet recruitment measures for the next trial, according to a study published in the January/February 2013 issue of the Tufts Center for the Study of Drug Development (CSDD) Impact Report. “The entire site selection process is very, very inefficient, and site performance is volatile and unpredictable,” says study author Ken Getz, director of sponsored research at the Tufts CSDD in Boston, who looked at 150 multicenter trials involving nearly 16,000 investigative sites around the world for his analysis. “In this current environment, where companies are constantly looking for ways to operate more efficiently, the findings suggest that investigative site selection and management is probably one of the most important areas where they should focus.
Privacy compromised Cross-referencing DNA sequence data with public-record and genealogy databases on the Internet can unmask the identity of supposedly anonymous research donors. The findings, reported last month in Science (339, 321–324, 2013), are the latest in a series of reports that have highlighted the potential for privacy breaches in public repositories of genomic data. “We need [sponsors of genomic studies] to be respectful to participants, to tell them the truth: that someone can identify you,” says study author Yaniv Erlich, a geneticist at the Whitehead Institute for Biomedical Research in Cambridge, Massachusetts. See go.nature.com/wtHCHS for more.
Shipwreck yields ancient eye remedy Talk about a long shelf life. Italian archeologists have discovered six well-preserved, grey tablets, each about the shape of a circular makeup sponge, inside an airtight tin container stored aboard a Roman vessel that was shipwrecked off the coast of Tuscany more than 2,000 years ago. Chemical analyses revealed starch, pine resin, beeswax and fats in the ancient drugs, with zinc compounds as the most abundant ingredient (Proc. Natl. Acad. Sci. USA 110, 1193–1196, 2013). The authors propose that this early medicinal preparation of zinc might have been used to treat eye infections. See go.nature.com/IVR47U for more.
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