POLICY

No mice aboard The ship has sailed for animal researchers in the UK. Following a high-pressure campaign from animal rights activists, all the ferry companies that run between Britain and mainland Europe have decided to stop carrying laboratory mice and other animals, a coalition of trade groups representing drug companies, academic funding agencies, medical research charities and animal breeders announced last month. The Channel Tunnel, which links the UK and France, had long refused to transport lab animals, and previous lobbying efforts had caused all domestic airlines, including British Airways, to withdraw from the business. Now, only a select group of foreign airlines will continue to bring animals into the country for biomedical research. “I don't think we've quite reached the crisis point, but we're getting close,” says David Pruce, interim chief executive of Understanding Animal Research, a London-based advocacy group. “What we don't want is to get to a stage where we have to ask the government to help and call in military aircraft. That would be mad.”

Upping antibiotics Infectious disease specialists are putting the squeeze on US lawmakers to speed the drug approval process for new antibiotics. At a congressional subcommittee hearing on 8 March, the Infectious Diseases Society of America (IDSA) proposed a new pathway, called the 'special population limited medical use' mechanism, that would allow companies developing antimicrobial drugs to run much smaller trials than are currently needed for people who lack other treatment options. “The benefit of this is that it provides rapid access for patients with the most serious infections,” says Robert Guidos, the IDSA's vice president of public policy and government relations. Under the proposal, drugs approved via this pathway would carry a special label restricting their use to a prespecified population while drug companies perform the larger studies needed for broad approval.

Drugmaker doctrine In an effort to crack down on unethical and unprofessional dealings with physicians, research institutions and patient organizations, the world's pharmaceutical industry is adopting a new code of conduct. On 1 March, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), a Geneva-based trade group, outlined revised guidelines for its 79 research-based members that include distinctions between gifts and promotional aids, rules about hiring healthcare professionals as consultants and restrictions on foreign travel and entertainment at sponsored events. “Importantly, it also provides guidance for supporting continuing medical education and a provision on disclosure of clinical trial information,” notes Tamara Music, the IFPMA's manager of code compliance. Member companies and associations must adopt the new regulations by 1 September.

FUNDING

A hire calling Job growth in the US may continue to stagnate, but at least one major biomedical employer is going on a hiring spree. On 15 March, the Howard Hughes Medical Institute (HHMI), a nonprofit research organization based in Chevy Chase, Maryland, announced plans to appoint 30 new scientists to its HHMI Investigator Program. The $200 million initiative will help grow the HHMI's flagship research program, which already provides five-year renewable research support to around 340 scientists at some 70 institutions throughout the country. “Our endowment is doing well enough that it really makes sense to do an open competition,” says HHMI chief scientific officer Jack Dixon. “This is going to be completely open in terms of the fields we're interested, covering the entire spectrum of broadly defined biological sciences.”

PEOPLE

New SFDA chief On 20 February, China's former representative to the World Health Organization, Yin Li, was appointed director of the Chinese State Food and Drug Administration (SFDA), replacing Shao Mingli, who had led the agency for the past seven years. Since 2006, Yin held several positions in the country's Ministry of Health, where he worked on food and drug safety, public health emergencies and healthcare reforms, among other issues. Robert Makuch, a biostatistician at the Yale University School of Public Health in New Haven, Connecticut who organizes yearly conferences on US regulatory structure for SFDA officials, thinks that Yin's background should help the agency rebuild its image, which has been tarnished in recent years by several tainted food and drug scandals. “The leadership is very focused on safety now,” he says.

Credit: PR NEWSWIRE/Newscom

J&J jump start Johnson & Johnson has announced a new chief executive to replace outgoing leader William Weldon. Company insider Alex Gorsky (pictured), head of the medical device and diagnostics business, will take over on 26 April, and Weldon, who is retiring this month after a decade at the helm, will remain chairman of the board. The change comes as the New Jersey–based company struggles to recover from a string of product recalls, manufacturing problems and FDA inquiries that have dogged the healthcare firm over the past few years. “I think we'll see an acceleration in growth in the coming year as they manage to get products back on the shelves,” says Linda Bannister, an analyst at Edward Jones, an investment firm based in St. Louis. Gorsky's expertise and success running the company's large medical devices arm will equip him well for handling its sprawling retail and pharmaceutical branches, Bannister adds.

RESEARCH

Top caliber In the latest collaborative effort between big pharma and academia, New Jersey drug giant Merck announced plans last month to bankroll a nonprofit research institute aimed at transitioning university discoveries into marketable therapeutics. Led by chemist Peter Schultz of the nearby Scripps Research Institute, the La Jolla–based California Institute for Biomedical Research—nicknamed 'Calibr'—will host a 150-person staff that will work collaboratively with academic scientists to advance translational research projects. Merck, which is fronting $90 million over seven years, will then have the first right to negotiate deals for any promising drug compounds that emerge. “This is a new paradigm,” says James Schaeffer, executive director of external scientific affairs at Merck Research Laboratories in San Diego. “This will open up a larger number of early-stage opportunities that we will have access to and help academics to drive their programs forward and potentially profit from that.”

An NCATS accord Less than three months after its inception, the US National Institutes of Health's drug development hub has announced its first major collaboration with a pharmaceutical partner. On 13 March, the National Center for Advancing Translational Sciences (NCATS) unveiled a partnership with Eli Lilly to use the Indiana-based company's proprietary drug screening panels to profile close to 4,000 molecules from the nascent center's collection of approved and investigational compounds. The results of the assays, which will be conducted over the next 12 to 18 months, will be made freely available to the research community. "What we're really looking for is to learn from the data we generate and see if that leads to some new directions for research," says Alan Palkowitz, vice president of discovery chemistry research and technologies at Lilly.

Credit: Universidad del Valle de Guatemala

Influenza virus found in Guatemalan fruit bats Bats harbor a range of virus types that also infect humans, including rabies, Ebola, the virus responsible for severe acute respiratory syndrome—and now, it seems, influenza as well. Reporting in the Proceedings of the National Academy of Sciences United States of America (doi:10.1073/pnas.1116200109, 2012), a team led by Ruben Donis of the US Centers for Disease Control and Prevention in Atlanta discovered a new subtype of flu virus—H17—in little yellow-shouldered bats (pictured) in Guatemala. “This reopens the debate about what other hosts are potentially carrying the influenza virus,” says Donis. “Who knows what else is out there?” Although the virus is probably not capable of infecting humans in its current form, it could theoretically exchange genes with other viral subtypes and become dangerous.

CNS drugs take 35% longer to develop than others The global market for drugs that treat neurological and psychiatric conditions is valued at more than $100 billion. But, in recent years, many large pharmaceutical companies have pulled the plugs on their neuroscience research and development programs. One explanation for this disconnect is that it takes a long time to develop central nervous system (CNS) agents. According to a study published in the March-April issue of the Tufts Center for the Study of Drug Development Impact Report, between 1996 and 2010 the typical neuropsychiatric drug spent 8.5 years in human testing and another 1.7 years awaiting regulatory clearance—a total clinical-plus-approval time that was 2.7 years more than the average for all other drug classes. To make matters worse, the development gap is increasing: in the late 1990s, CNS agents took only two years longer to bring to market; now the discrepancy is greater than four years.

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