Takeda mulls generics buy in emerging markets; Multaq gets nod for marketing in E.U.;

> Takeda Pharmaceutical may buy a generics company to help it enter the copycat drug business in emerging markets, particularly in South America, a company executive said. Report

> Sanofi-Aventis said its cardiovascular drug Multaq has been approved for marketing in the European Union. Report

> Belgian pharma UCB has begun discussions with banks to refinance loans it took on three years ago to buy German peer Schwarz Pharma. Report

> Countries should phase out Stavudine, the most widespread antiretroviral, because of "long-term, irreversible" side-effects in HIV patients including wasting and a nerve disorder, WHO said. Report

> GlaxoSmithKline will provide anti-doping laboratory equipment to the 2012 Olympics after signing on as the London Games' latest sponsor. Report

> Genzyme Chief Executive Henri Termeer sold 200,000 shares of the company for $50.47 apiece on Nov. 23, according to a regulatory filing. Report

> Novartis got the FDA nod for its seasonal flu vaccine Agriflu. Report

> Johnson & Johnson announced that its HIV drug Intelence gained full approval from the FDA. Report

Biotech News

> Roche's battle to preserve and protect Genentech's research culture includes a full court press to convince BusinessWeek that the pharma giant is doing everything in its power to sustain an R&D culture with a stellar track record. Article

> Developers of brand biologics are close to securing a win with the potential passage of healthcare overhaul legislation that includes provisions prohibiting generic competition for their products for 12 years. But companies hoping to make generic copies of these complex drugs haven't given up hope yet, according to the Wall Street Journal. Report

> Just before checking out for the Thanksgiving vacation, Human Genome Sciences announced that it had filed for FDA approval of its promising hepatitis C drug Zalbin, adding that Novartis is expected to file for European approval within the next few weeks. HGS Report

> Theravance said last Friday that the FDA had declined to provide an approval to use Telavancin for the treatment of nosocomial pneumonia, but hastened to add that it had already completed the extra analysis work that the FDA is seeking. Story

> Austin-based Terapio, a tiny biotech company developing a new drug delivery technology, picked up $5 million in a Series A round today. The four-year-old biotech has four employees working on a protein-based approach to transporting molecules through cell membranes. Terapio story

> Over the past year Endo's new CEO, David Holveck (photo), has been steadily shifting the company's focus from pain management to new therapeutic arenas like oncology, doing $900 million worth of deals. And the CEO says he's far from done with the makeover. Endo report

IT News

> The pharma/social media attraction has its difficulties, even beyond the regulatory issues involving drug branding and marketing. Upsides in clinical trial recruitment are countered by downsides in adverse event reporting. Report

> Contract researcher Beadsworth has tapped OmniComm's TrialMaster EDC solution for use in a Phase II vaccine study. Investigators plan to enroll 340 subjects in the 3-year, 10-site study. Report

> MIT's 2009 International Genetically Engineered Machine (iGEM) competition has yielded an open source, Internet-based cellular engineering program to assist in synthetic biology design, and software tools for creation and assembly of DNA-sequence parts. Article

> Argentinean CRO KLIXAR has signed onto Health Decisions' Agile Clinical Network for adaptive trial design. As a network member, KLIXAR will be able to tap best practices information and partnership opportunities. Report

> Daily text-message reminders have yielded a 2x improvement in adherence to a treatment regimen among subjects in a dermatology study. Report

And Finally... A "worrisome spike" in bacterial infections among Americans with swine flu prompted federal health officials to urge more people to get an underused vaccine against those infections. Report

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.