November 27, 2014Bulletins

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Big Data Deal

GSK to Open Clinical Files

December 07, 2012

Aetna, Covance and GNS Healthcare are joining forces to use so-called big data software tools to create a model of diabetes. In plainer English, they'll mine large numbers of medical records in an effort to link individual health status, prescribed medications and treatment outcomes. "Using data, we will now know very quickly which of these strategies works…more...

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With FDA in Serbia

Korea Deal For Parexel

July 24, 2012

FDA surveillance of its own employees was approved by agency lawyers. Some of the intercepted communications may have been with Washington politicians. The surveillance program is no longer ongoing, but unearthed some 80,000 pages of documents, some of which were inadvertently posted online by an FDA contractor. Here are articles from Slate and the Washington PostIs…more...

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Roche Safety Lapse?

Internal Surveillance At FDA

July 17, 2012

Roche and its biotechnology division in California, Genentech, failed to report or analyze approximately 103,000 adverse events and 15,000 deaths. In an apparent breach of regulations on both sides of the Atlantic, the firm had been supplying needy patients with treatment on compassionate grounds but never processed any of the associated data. "Possible side-effects picked up by…more...

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With Covance, Parexel earnings

SAS Links Industry, Healthcare

May 16, 2012

Covance reported quarterly revenue that rose 5.7 percent to $531 million. Profits rose 9 percent to $35.7 million. Late stage projects are doing considerably better for the company than early-phase work. Lab testing remains strong. "Our strategic information technology projects are progressing according to the plan we outlined," CEO Joe Herring told analysts. "We continue to forecast…more...

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IMS Buys Recruitment Tool

Cancer Site Chooses Oracle

April 27, 2012

Decision View, a San Francisco firm specializing in advanced patient recruitment algorithms, announced that it has been acquired by IMS Health. Terms were not disclosed. The news release says Decision View helped design and monitor recruitment campaigns for 1,200 trials since the company's inception. "We will enhance clinical trial productivity–transforming the way patient studies are planned and…more...

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Plus FDA on Generics

Pfizer: Web-Only Recruitment Falters

March 21, 2012

Almac announced improvements to its randomization and drug supply management system. Randomization for clinical research thus appears to be moving into an era of modern technology, not phone-based code that is decades old. In a statement, the company said: "Almac’s intuitive and user-friendly aXcess system gives clients the full benefit of a web-based randomization system, including state…more...

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Plus 2 New FDA Guidances

JNJ Hip Email Leak

February 23, 2012

Icon reported sharply lower quarterly earnings. Net service revenue for the period rose 4.5 percent, to $243 million. Profits fell 81 percent, to $4.1 million. CEO Ciaran Murray put the results in a positive light: "I am encouraged with our performance in the quarter. Net new business awards were $308 million." Here are the numbers. …more...

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Plus: A Diary NDA

Adaptive Tools from Aptiv

February 17, 2012

ER Squared, a clinical trial technology consultancy founded by ex-Bayer executive Robert Musterer, has added another employee. John Fontenault will serve the Connecticut firm as VP of operations. ER Squared advises clients about eclinical challenges, software vendors, biostatistics staffing and data management, among other topics. Says Musterer: "I'm very optimistic. Companies are starting to feel a little…more...

Plus: A Diary NDA

Adaptive Tools from Aptiv

With news about ER Squared, the NIH, China, Oklahoma, Insys, invivodata, and Aptiv

Friday News

Biotech Funding Trends

With news about Theorem Clinical Research, Parexel, FDA, BMS, AstraZeneca, BBK, TrialReach and Ernst & Young

Hedge Fund Deal

PPD Sold for $3.9 Billion

With news about CRF, FDA biosimilars, Merge, Dell, Pointcross, Bio-Optronics, Quintiles and PPD

Tuesday News

New PPD CEO

With news about SMS, ePharmaSolutions, Quintiles, public knowledge of FDA, BioClinica, OmniComm, PharmaPros and PPD

With Devices News

PPD In Play

News about FDA, medical devices, Pfizer, Quintiles, the Carylyle group and PPD

Monday News

FDA: App Regs for Devices

With news about China, CROs, obesity, BioClinica, biotechnology and device-related app regulations


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