Glaxo looks to Japan for more growth; Lupin wins FDA nod for Lotrel copy;

 @FiercePharma: FDA orders Ranbaxy to reassess operations. Article | Follow @FiercePharma

> While the emerging markets such as Brazil, Russia, India and China are regularly mentioned as the best areas for growth, GlaxoSmithKline's chief executive has put the spotlight on Japan as a land of rising sales. Report

> Lupin got final approval from the FDA to make and sell generic versions of Novartis AG's heart drug, Lotrel. Report

> Today is the deadline for FDA to decide on whether to allow AstraZeneca the chance to market cholesterol drug Crestor to a much wider universe of patients. Report

> Most Americans do not intend to get the swine flu vaccine, assume the pandemic is over and think the flu threat was overblown, according to a poll by the Harvard School of Public Health. Report

> The U.S. Department of Defense will begin making the morning-after pill Plan B available at all of its hospitals and health clinics around the world, officials announced. Report

> Spanish drug firm Almirall won European Commission approval to sell silodosin to treat BPH, the enlargement of the prostate gland which affects middle-aged and elderly men. Report

> An attempt by a pharmaceutical company to register an antibiotic drug similar to a product of Glaxo Group has been thwarted by a Kenyan court. Report

Biotech News

 @FierceBiotech: Diagnostics group predicts biotech doom with loss of gene patents. Report | Follow @FierceBiotech

  @JohnCFierce: So most American adults won't get vaccinated against H1N1? If this country gets hit with a bad, bad virus, we're in deep.... Follow @JohnCFierce

> Ahead of Wednesday's advisory committee meeting, FDA staffers have raised questions about Cell Therapeutics' lymphoma drug pixantrone. Story

> Solace Pharmaceuticals has closed its Cambridge, MA-based office following disappointing results from a Phase II trial of its pain treatment pill SLC022. Report

> In a terse statement, Novavax said today that it's halted negotiations in its pursuit of the previously announced collaboration with ROVI Pharmaceuticals to develop Novavax's virus-like-particle (VLP)-based vaccines against influenza in Spain. Item

> Unable to complete necessary plant inspections in India, Strativa Pharmaceuticals and Par Pharmaceuticals said today that the FDA couldn't approve the NDA for Zuplenz (ondansetron). Story

> Not surprisingly, there are talks of takeover at Optimer Pharmaceuticals, which on Friday announced promising data from a Phase III trial of its antibiotic, fidaxomicin. Report

> As the tough economy forces biotechs to halt projects or declare bankruptcy, the industry is looking to a provision in the Senate's version of the healthcare reform bill to keep research going. Item

Biotech IT News

> "It's like managing a large clinical trial," says University of Washington computer science professor Gaetano Borriello, of an HIV monitoring project in Kenya. Report

> An imaging capability integrated with its clinical software suite has earned trial technology provider PharmaVigilant a contract with TissueGene. Article

> Researchers need to seek informed consent about sharing data from patients before studies begin--that's the advice of Iain Hrynaszkiewicz and co-authors in BMJ, the British Medical Journal. Hrynaszkiewicz is managing editor at BioMed Central, a publisher of peer-reviewed, open access journals. Story

> Systematic protocol development is the goal of a collaboration between the Mayo Clinic and Centerphase, a clinical service provider. Item

> As the drugmaker rumblings grow louder for business intelligence that reaches the level of individual clinical trials, automation products to the meet the need are beginning to appear. Report

And Finally... The recession is over, if sales of cosmetic drugs and surgeries in the fourth quarter are to be believed. Report

Suggested Articles

After years of having first-line liver cancer market to itself, Bayer’s Nexavar is getting major competition from Roche's Tecentriq.

Most of the recent enthusiasm around AbbVie’s new drugs has centered on Skyrizi and Rinvoq, but elagolix wants a piece of the spotlight, too.

During David Loew's tenure, Sanofi Pasteur bought Protein Sciences, whose recombinant technology is being applied to a COVID-19 vaccine.