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February 14, 2013
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News on diagnostic and therapeutic innovations and regulatory science

  Top Story 
  • GSK, others eyeing acquisition of Brazil's 4th largest drugmaker
    Several drugmakers, including GlaxoSmithKline and likely Novartis, Pfizer and Abbott Laboratories, are looking at acquiring Brazil's Ache Laboratorios Farmaceuticos for up to $4 billion to increase their share in Latin America's pharmaceutical industry. Ache is the fourth-largest drugmaker in Brazil, but it ranks first in prescription drugs and is growing its over-the-counter business. Reuters (2/12) LinkedInFacebookTwitterEmail this Story
  • Consortium unveils drug development project in EU
    The European Lead Factory, a global consortium that includes drugmakers, research groups and academics, introduced plans for a platform that will search half a million compound libraries to help support drug discovery in Europe. The project "will give European researchers unprecedented access to industry chemical collections and facilitate the translation of their findings into actual treatments for patients," said Michel Goldman, executive director of Europe's Innovative Medicines Initiative. (2/11) LinkedInFacebookTwitterEmail this Story
  • EU's medical device regulations to face public scrutiny
    Over the next two weeks, the EU's reworking of its medical device and in vitro diagnostics regulatory system will undergo public scrutiny. While many critics of the EU's regulation of medical devices look to the U.S. FDA premarket approval system for guidance, others, such as the German industry group Spectaris, caution against overestimating the effectiveness of the FDA, saying the EU should take a measured, cautious approach to revamping its medtech regulation. Clinica (subscription required) (2/11) LinkedInFacebookTwitterEmail this Story
  • Sanofi plans to buy more shares in Regeneron
    Sanofi plans to increase its stake in longtime drug development partner Regeneron Pharmaceuticals by purchasing shares on the open market. Sanofi holds a 16.7% stake in Regeneron. An agreement gives Sanofi the right to boost its stake in Regeneron to up to 30%. The two companies are jointly developing drugs for rheumatoid arthritis and cholesterol. Reuters (2/11) LinkedInFacebookTwitterEmail this Story
  Asia Pacific 
  • Pfizer announces plans to close Singapore research facility
    Pfizer announced it will close a clinical research facility in Singapore as part of an effort to streamline its R&D efforts and increase efficiency, a company spokesperson said. About 30 employees will be laid off in the process, which follows similar moves in the U.K. and U.S. and suggests the company might be shifting its focus toward China. (2/11) LinkedInFacebookTwitterEmail this Story
  North America 
  • Early trials may be enough for experimental drugs to get FDA OK
    The FDA granted "breakthrough" status to three promising experimental drugs as part of efforts to speed market entry for treatments of life-threatening conditions. "We expect many of these would come available very quickly with Phase I data," FDA Center for Drug Evaluation and Research Director Janet Woodcock said. Applications for breakthrough status have been made for 18 other treatments, she said. Bloomberg Businessweek (2/12) LinkedInFacebookTwitterEmail this Story
  • Footnote in court brief hints at new FDA rules for generic warnings
    The FDA may revise regulations so that makers of generic drugs can update labels to warn patients about risks, Ed Silverman writes. The Justice Department filed a friend-of-the-court brief in a case concerning generic drugs, and it carried this footnote: "This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances." Blog (2/11) LinkedInFacebookTwitterEmail this Story
  • FDA submits device data gathering proposal for OMB review
    The FDA has submitted a proposal to renew its program for gathering data about medical devices to the Office of Management and Budget for approval. The program is part of its system to identify and ban devices that are harmful or risky. The agency also is requesting public comment on its process for banning medical technologies. (Boston) (2/8) LinkedInFacebookTwitterEmail this Story
  • Clear meetings, better management improve biotech partnerships
    Drug developers increasingly find themselves in partnerships that can be improved through more effective meetings and management, writes William Ronco, director of the Biotech Leadership Institute. Improve partnerships by applying project management techniques, such as assigning leaders, clarifying roles and responsibilities, setting clear goals and schedules, and establishing processes for exchanging information, Ronco suggests. Specificity improves meetings as do meeting agendas that take stock, build trust, clarify goals and implement processes, Ronco writes. Genetic Engineering & Biotechnology News/BioPerspectives (2/8) LinkedInFacebookTwitterEmail this Story
  DIA News 
  • Collaboration — The hot topic at LARC 2013
    Global regulators, industry professionals and academia will gather at the Latin American Regulatory Conference (LARC) 2013, to be held in Colombia, May 15 to 16. The event, titled "Pharma-co-vergence," aims to assist drug regulatory authorities to work in a collaborative way to best utilize resources for promoting improved public health globally. Attendees will discuss the current regulatory landscape, future research and drug development in Latin America. Find out more. LinkedInFacebookTwitterEmail this Story

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