Manufacturing, regulatory complexities slow biosimilars

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March 19, 2013 More than 2,700 companies nationwide are saving on lab supplies, shipping, news distribution, office products and more through the BIO Business Solutions cost-savings program. Find out how. 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.   Today's Top Story    Manufacturing, regulatory complexities slow biosimilars Merck, Teva, Lonza and Samsung are among the companies that have scaled back plans to produce biosimilar versions of brand-name biologic drugs amid regulatory uncertainty, market volatility and high development and manufacturing costs. Bringing a biosimilar to market can cost up to $250 million by some estimates and can take six to nine years, compared with $1 million to $2 million and three years for a generic small-molecule drug. Genetic Engineering & Biotechnology News/Insight & Intelligence blog (3/18)      White Paper: Improving Total Cost of Ownership with EQMS Companies are looking for ways to improve product quality, customer satisfaction and profitability while dealing with rising costs, competition and regulatory pressures. This white paper details how utilizing an EQMS backbone enables a broader organizational view of these issues, allowing for increased revenues and margins, operational efficiencies and global standardization for stakeholders. Read it now!   Health Care & Policy  Novartis' lung cancer drug gets breakthrough designation The FDA granted breakthrough therapy status to Novartis' LDK378 for treatment of patients with anaplastic lymphoma kinase positive metastatic nonsmall-cell lung cancer when crizotinib can't be used. The drug is being tested in two midstage trials, and Novartis plans to initiate several late-stage studies this year. An initial regulatory application is expected early next year. PharmaTimes (U.K.) (3/18)      Orexo sells pain medication Abstral to Galena Biopharma Galena Biopharma acquired Orexo's Abstral, a sublingual formulation of fentanyl used for managing breakthrough pain. Aside from milestone fees and sales royalties, Orexo will get $10 million upfront and $5 million in the year after the deal closes. Genetic Engineering & Biotechnology News (3/18)      Diffusion's brain cancer drug enters midstage development Diffusion Pharmaceuticals has completed enrollment for a midstage trial of trans sodium crocetinate in patients with newly diagnosed glioblastoma multiforme. The study will assess survival in patients taking the drug in combination with current treatments. Pharmaceutical Business Review Online (3/18)        Company & Financial News  AstraZeneca consolidates its drug development work AstraZeneca plans to restructure its research and development operations to bring together drug development activities in three major facilities in the U.S., England and Sweden. A Gaithersburg, Md., facility will become the main hub for biotech research. The changes, meant to cut costs and increase productivity, will eliminate about 1,600 positions. Reuters (3/18), USA Today/The Associated Press (3/18)        Global Developments  ThromboGenics-Alcon's Jetrea wins EU nod for vitreomacular traction ThromboGenics and Novartis unit Alcon obtained approval from the European Commission to market Jetrea, or ocriplasmin, as a therapy for vitreomacular traction. The approval triggers a milestone payment of about $58 million from Alcon to ThromboGenics with another of the same amount to come with the first sale in the EU. PharmaTimes (U.K.) (3/18), Reuters (3/18)      EU widens approval of Roche's hep C drug Pegasys The European Medicines Agency approved Roche Holding's Pegasys, or peginterferon alfa-2a, in combination with ribavirin, to treat chronic hepatitis C in pediatric patients 5 and older. Fox Business/Dow Jones Newswires (3/18), Reuters (3/18)      Canada issues final rules on classifying products as drugs, devices Health Canada has finalized guidelines for classifying therapeutic products as drugs or devices. The guidance sheds light on the considerations for determining whether a product is a medical device or drug, and it aims to promote a standardized and transparent process when deciding the appropriate regulatory pathway. The guidance notes that a product cannot be considered both a device and a drug. Clinica (subscription required) (3/15)      The Buzz(CORPORATE ANNOUNCEMENTS) Trevena to Present First-in-Man Study Results for Mu-Opioid Biased Ligand TRV130 Interested in learning more about advertising in BIO SmartBrief? Contact Meryl Harold at (202) 407-7828 or mharold@smartbrief.com.    Food & Agriculture  Biotech potato trial planned in Ireland Irish researchers plan to begin a field trial of more than 2,000 blight-resistant potatoes in Carlow, Ireland. A strain known as A15-031 was developed by researchers at Wageningen University using donor genes from wild potato species in Mexico and Argentina. The Washington Post (3/16)        Industrial & Environmental  Chinese steelmaker, U.S. firm team up for $70M ethanol project China's Tangshan Iron and Steel Group and U.S.-based industrial service firm Harsco have agreed to cooperate to produce ethanol using gas discharged from steel mills in China. Under the deal, the two companies will develop a $70 million facility with the capacity to produce 30,000 metric tons of ethanol annually. China Daily (Beijing) (3/15)        News from BIO  Ship with FedEx FedEx is now offering member companies discounts of up to 35% off select FedEx services, both U.S. and international services. The BIO program with FedEx is one of the many cost-savings programs offered by BIO through its Business Solutions program. There is no charge for BIO member companies to participate in any of the BIO Business Solutions programs -- it is a benefit of membership. Learn more about the BIO and FedEx program.      Learn more about BIO -> Conferences  |  Join BIO  |  Media  |  Issues  |  Industry   SmartQuote  You may have to fight a battle more than once to win it." --Margaret Thatcher, British prime minister          This SmartBrief was created for jmabs1@gmail.com   Subscriber Tools       Update account information | Change e-mail address | Unsubscribe | Print friendly format | Web version | Search past news | Archive | Privacy policy Advertise Account Director:  Meryl Harold (202) 407-7828 Download Media Kit   Read more at SmartBrief.com A powerful website for SmartBrief readers including: Industry Home Readers' Choice Search Archive Grab our News Widget Get this RSS Feed Publish your Press Release Download a SmartBrief Mobile app today       Recent BIO SmartBrief Issues: Monday, March 18, 2013 Friday, March 15, 2013 Thursday, March 14, 2013 Wednesday, March 13, 2013 Tuesday, March 12, 2013     Lead Editor:  Tom Parks       Mailing Address: SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004     © 1999-2013 SmartBrief, Inc.® Legal Information