 | EvaluatePharma World Preview 2013, Outlook to 2018
In this sixth annual edition report, Evaluate brings together many of our analyses to provide top level insight into the expected performance of the industry between now and 2018. The report highlights trends in Rx drug sales, patent risk, R&D spend and sales by therapy area as well as a brief review of 2012 performance. Download your complimentary report now. |
 | FDA reviewers back approval of Bayer's lung drug at lower dose The FDA should approve Bayer's experimental pulmonary hypertension drug riociguat but at lower doses than what the company sought, the agency's medical reviewers said. The drug, which will be marketed as Adempas once approved, is designed to enhance the exercise ability of patients with chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. Reuters (8/2) FDA delays action date for GSK's diabetes drug albiglutide The FDA has postponed its decision for three months on GlaxoSmithKline's type 2 diabetes drug albiglutide, saying now that a decision will come on April 15. The approval process in Europe for the once-weekly, injectable GLP-1 drug is moving ahead on schedule. Reuters (8/2) Celgene's Revlimid prolongs survival in asymptomatic myeloma trial A late-stage trial found that Celgene's Revlimid, or lenalidomide, in combination with dexamethasone, was effective in delaying progression and extending survival in patients with high-risk asymptomatic smoldering myeloma. The drug is approved for the treatment of multiple myeloma and mantle cell lymphoma as well as for transfusion-dependent anemia related to certain myelodysplastic syndromes. PharmaTimes (U.K.) (8/2) Biohit unveils blood-based test to diagnose celiac disease Biohit has introduced an assay that uses blood sample from a patient's fingertip to diagnose celiac disease, which affects about 1% of Americans and is more common in northern Europe. The device eliminates the need for endoscopy and takes 10 minutes to generate results. Reuters (8/1)  | Report Track & Traceability
Commerce in Motion and JDA, surveyed 130 quality control, supply chain and operations professionals. The goal was to understand their ability to effectively track, trace, and recall products. Per the study financial cost is the greatest risk associated with the inability to trace items. Download the free report now to see where the Life Sciences industry stands on traceability. |
 | Pa. firm behind esophageal cancer test lands $1.4M investment Pennsylvania-based molecular diagnostics firm Cernostics has secured $1.4 million in a funding round. The company has developed the TissueCipher Pathology test, which combines fluorescence biomarkers, digital imaging pathology, electronic medical records and informatics to determine whether a precancerous condition may lead to esophageal cancer. MedCityNews.com (8/1) | | Industrial & Environmental | INEOS Bio's milestone revives hopes for stalled waste-to-ethanol project in Ind. INEOS Bio's announcement that it has begun production at its cellulosic ethanol plant in Florida is reviving Powers Energy of America's hopes to move forward with its stalled waste-to-ethanol project in Indiana despite the cancellation of its deal with the Lake County solid waste district's board. Powers Energy of America CEO Earl Powers said that now that the process is tested and proven, he will try to move forward. David Hamm, the board's chairman, said its position is unchanged, adding that INEOS Bio uses wood and plant waste, not the household waste that Powers Energy envisions in its project. Post-Tribune (Merrillville, Ind.) (8/2) | Secure document sharing services optimized for life science organizations ShareVault, a leading provider of highly secure and controlled document sharing solutions and virtual data rooms (VDR), has aligned with BIO to provide companies with significant discounted pricing and complimentary extra features. ShareVault's VDR platform is optimized for life science companies of all sizes and flexibly priced so that even small biotech companies can afford and benefit from its technology. The ShareVault solution is intended for due diligence required during bio-pharma partnering, licensing, fundraising, M&A, clinical study management or other applications that require secure sharing of documents with third parties. Learn more and sign up for a free trial. | Correction A summary in last week's brief incorrectly described a study on the relation of orphan drug access and regulatory oversight. The study was reported in the journal Therapeutic Innovation & Regulatory Science. SmartBrief regrets the error. |  | We make way for the man who boldly pushes past us." -- Christian Nestell Bovee, American writer | | | The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com. | Please contact one of our specialists for advertising opportunities, editorial inquiries, job placements, or any other questions.
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