Dublin-based Icon has signed a collaborative agreement with the Central Manchester University Hospitals Foundation Trust (CMFT) to develop a translational medicine facility. Icon is designing the unit, scheduled for completion in 2012. Before that, Icon is transferring its current pharmacology services into research facilities at CMFT's Manchester Royal Infirmary. Said Mike Deegan, chief executive of CMFT: “This exciting new collaboration with Icon is a major step for the trust and will accelerate the translation of research discoveries into new medicines.” Icon's release on the agreement is here.

Imaging IT firm Merge Healthcare's acquisition of etrials is proceeding smoothly. This week, Merge began an exchange offer for the outstanding shares of etrials common stock, another step of the merger agreement announced on June 1. Stockholders of etrials who tendered their shares received 80 cents per share and .34 shares of Merge common stock. The company had initially announced it was being acquired by BioClinica for $10 million, but then Merge offered $18 million. Here's an article about those events.

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Vancouver-based Protox Therapeutics, a developer of receptor-targeted fusion proteins, has appointed Alexander Giaquinto to its board. Giaquinto is senior VP of regulatory affairs and quality assurance for Regado Biosciences and is an independent consultant to several pharma companies. He's been in the industry for 35 years, including 30 years at Schering-Plough where he was most recently senior VP of worldwide regulatory affairs. “His extensive regulatory expertise will add significant depth to our board and will provide invaluable leadership and guidance as we continue to advance our novel drug candidates towards commercialization," says Frank Holler, Protox's board chairman. Here is a release.

Suppose a therapy without FDA approval has 800 adverse events. Must they be reported? This is a legal gray area, it seems. It's an issue buried in a New York Times story about a homeopathic cold medicine from Matrixx Initiatives that has cost some patients their sense of smell. A related issue is, if a company collects adverse event data but would rather not share it, how much additional funding should be diverted to legal expenses and public relations?

Cupertino, Ca.-based specialty pharmaceutical company Durect has named Joseph Stauffer chief medical officer and executive VP of corporate strategy. Formerly, Stauffer led clinical research and medical affairs for pain products at Alpharma (now owned by King Pharmaceuticals) and Abbott Laboratories, and worked for the FDA reviewing applications for opiate, non-opiate, anti-inflammatory, and novel pain compounds. Here's a release on the hire. Peter Langecker, Durect's former CMO, resigned to become executive VP and chief development officer of Waltham, Ma.-based biotech Oxigene. Here's a release on Langecker's hire.

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Phase Forward and INC Research announced a partnership. The contract research organization will use the technology firm's integrated services to combine different technologies. Here's the release.

International medical device maker Norian, its parent company Synthes, and four top executives have been charged with felonies in connection with unlawful clinical trials. If convicted, they face $26 million in fines and prison time. The U.S. Attorney in Philadelphia is charging the West Chester, Pa.-based parties with multiple crimes around the science and promotion of Norian XR and Norian SRS devices used to treat vertebral compression fractures. The parties allegedly conducted trials without the authorization of the FDA, and then sold the products despite evidence that they weren't safe. In some cases, U.S. military personnel received the firm's devices. "It is never acceptable for the health care industry to place the profit motive over people's well being," said Patrick Doyle, Office of Investigations special agent-in-charge. The federal statement is sobering and likely to contribute to additional scrutiny of spine surgery.

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