• Biosimilars: Not So Similar to FDA Generic Drug Approvals

    Bio-IT World | Guest Commentary | If you’re a generic drug manufacturer looking to commercialize a generic biologic product, or biosimilar, in the U.S. market, you’re in a tough spot.  As the pharmaceutical and biotechnology industries prepare for a range of key biologics U.S. patents to expire (including Amgen’s Neupogen in 2013, Biogen Idec’s Avonex in 2013 and Genentech’s Herceptin in 2014), the jury is still out on how the FDA will regulate the commercialization of biosimilars. 

    Jan 4, 2013

  • Tech Market Predictions for 2013 and Beyond

    eWeek | 2013 will look better, but the tech market will fully rebound in 2014, a report from Forrester predicts. Cloud computing will continue to grow, along with mobility and smart computing.

    Jan 4, 2013

  • Wellcome Trust Launches Investment Group

    Bloomberg | The Wellcome Trust has started an investment arm with 200 million pounds ($326 million) of initial capital for biotech. Syncona Partners will support new businesses in the medical-device, therapeutics, diagnostics and information-technology industries.

    Jan 4, 2013

  • Biogen Applies for FDA Approval of Hemophilia Med

    News Brief | Biogen Idec has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of a treatment for hemophilia B.

    Jan 4, 2013

  • Genepeeks’ Sperm Bank Acquisition Heralds Genome Screening of ‘Virtual Progeny’

    Bio-IT World | It all began five years ago when Anne Morriss, an economic development consultant, and her partner decided to use a sperm bank to conceive a child. They studiously reviewed the profiles of hundreds of potential donors, but genetics was an afterthought. “We chose a wonderful donor,” says Morriss, “but he was a carrier for a rare Mendelian disorder called MCADD.” Unbeknownst to Morris, she was a carrier too.   

    Jan 4, 2013

  • Diet and DNA: More on Epigenetics and the Genome

    Discover Magazine | Researchers were able to turn off the agouti gene in mice--responsible for making most carrier mice overweight and prone to diabetes and cancer--with maternal diet.

    Jan 3, 2013

  • Pricing Orphan Drugs

    Forbes | NPS Pharmaceuticals is pricing Gattex, its drug for short bowel syndrome, at $295,000 per patient per year. How did they arrive at that number?

    Jan 3, 2013

  • Cloud Storage for Enterprise IT

    Computerworld | Gartner says that cloud storage is a viable alternative to traditional options, but not all providers can meet the needs of enterprise IT.

    Jan 3, 2013

  • FDA Approves Record Number of Drugs

    Bloomberg | FDA closed a record year this week; US drug approvals in 2012 reached their highest level in 15 years. The Food and Drug Administration cleared 39 novel medicines last year.

    Jan 2, 2013

  • Predictions of Medicine's Future

    Wall Street Journal | At the intersection of medicine and technology, six innovations are poised to transform medicine: growing a heart, DNA sequencing in the clinic, matching tumors to drugs, smartphone health care, gene therapy, and more.

    Jan 2, 2013

  • Omicia Names New CEO, Prepares Genome Interpretation Platform Launch

    Fort Mills Times | Omicia (a 2012 Bio-IT World Best Practices awards winner) has appointed Mike Aicher as CEO.

    Jan 2, 2013

  • Genomics 2012: Narcissomes, Neonates and ENCODE

    Bio-IT World | FIRST BASE | From clinical exomes to the clamor over the ENCODE Project, 2012 was a packed year for genomics in both the research and clinical arena, and seemingly sets the stage for a barnstorming, anniversary-rich 2013.

    Jan 2, 2013

  • BGI-Complete Deal Gets Security Clearance

    New York Times | The U.S. Government has granted national security clearance to the BGI-Complete Genomics deal. The Committee on Foreign Investment in the United States, which reviews the national security implications of foreign takeovers of American companies, gave its approval to the deal over the weekend.

    Jan 2, 2013

  • Encyclopedia Genomica: UK Scientists Print the Book of Life in 130 Volumes

    Bio-IT World | Nowadays it is cheaper to sequence the human genome than to print out a full hard copy. We know this because earlier this year, Cas Kramer and a group of scientists at the University of Leicester decided to print out a complete version of the human genome.

    Dec 28, 2012

  • Parexel Acquires Regulatory Information Management Software

    Boston Business Journal | Parexel has acquired Liquent, a provider of regulatory information management software, for $72 million. Parexel says the acquisition will give its clients access to Liquent's InSight software.

    Dec 28, 2012

  • 2013 - The Year of Data-Driven Decisions

    Bio-IT World | Guest Commentary | Clinical trials (for the most part) are run by talented study managers who rely on experience, anecdotal knowledge, and "gut" instinct to plan and execute them.  While these study managers get trials over the finish line as close as possible to plan, it’s reckless and increasingly difficult to take a cottage-industry approach to managing these multi-million dollar projects.  As trials become more complex, expand globally and extend into new markets, even the most experienced and talented study managers struggle, resulting in highly unpredictable trial costs and timelines across the portfolio.  It’s time to take a fresh approach.

    Dec 27, 2012

  • IT Spending in 2013

    eWeek | With about half IT heads expecting a budget increase in 2013, outsourced IT resources (read: cloud) and wireless technologies will probably account for most of the increased spending.

    Dec 26, 2012

  • 2012 in Review: Sequencing and Personalized Medicine

    Technology Review | Technology Review covers the year's advances in biomedicine. Sequencing continues to get cheaper and more accessible and its implications for medicine continue to evolve.

    Dec 26, 2012

  • 2012 in Review: Cloud Computing and IT

    Computerworld | The year of the cloud. Three new major players entered the Infrastructure-as-a-Service scene--Google, HP, and Microsoft--but Amazon kept its #1 spot.

    Dec 26, 2012

  • AWS Data Pipeline Ready for Use

    AWS Blog | Amazon Web Services has launched its Data Pipeline. The new services allows users to automate the movement and processing of any amount of data using data-driven workflows and built-in dependency checking.

    Dec 21, 2012