Why Biotech Is Worried About The Fight Over Gene Patents
Podcast: February 22, 2010

It would have seemed that the question over whether or not genes could be patented was settled long ago, but ongoing legal battles and a report earlier this month from an advisory committee to the U.S. Secretary of Health and Human Services threaten, in the words of one industry group, to “unravel” the foundation of life science innovation in this country. Opponents say gene patents impede critical research and make important new diagnostics unnecessarily expensive, but industry argues they fuel innovation and bring important breakthroughs to patients. We spoke to Ken Chahine, visiting professor of law at the University of Utah about the recent report, the ongoing legal battles, and what’s at stake for the biotech industry, as well as patients. Read More Here

Biotech, Je t'adore
Sanofi-Aventis enters $67 public-private partnership with leading academic researchers in France.
Sanofi-aventis has scored a wide-reaching research partnership with France's leading academic investigators, committing the Paris-based company to invest as much as $67 million (€50 million) over five years in French public-private partnerships. Pharmaceutical and life science companies are externalizing their R&D programs at a increasing clip. But broad-based collaborations with public sector institutions are notable, since they have the potential to identify drug candidates and technology platforms with promising commercial prospects at their earliest possible stage, before their value has risen in response to commercial interests. Read More Here

A Potential Blockbuster
Astra nets global rights to Rigel’s RA treatment in deal worth up to $1.25 billion.
AstraZeneca will pay Rigel Pharmaceuticals up to $1.25 billion for rights to its rheumatoid arthritis drug, R788, delivering a much-needed victory for the company, which sacrificed staff and other programs to forge ahead with the drug. Read More Here

Basilea Gets Rights to Antibiotic Back from J&J after European Regulators Reject Application
The weekly round-up of failed trials, missed targets and other business mishaps.
Basilea Pharmaceutica said Johnson & Johnson returned the full rights to its antibiotic Ceftobiprole after the European Committee for Medicinal Products for Human Use rejected its application to begin marketing the drug for treatment of complicated skin and soft tissue infections. The committee said that inspections showed that the phase 3 studies supporting the application had not been conducted in compliance with Good Clinical Practices in some sites. Read More Here

Targeting Delivery
Netherlands research groups form $38 million personalized medicine partnership.
Three top life sciences research institutes in the Netherlands have formed a $38 million (€28 million) partnership to advance personalized medicine. The groups say they will focus on funding projects that seek to develop new ways of targeting drug delivery to specific disease sites within the body as a means of reducing dosages and minimizing side effects while boosting the effectiveness of medication. The BioMedical Materials program, the Center for Translational Molecular Medicine and Top Institute Pharma say the development of tailored drug therapies along with the imaging guided and targeted drug delivery techniques that these newly funded projects aim to develop, are widely regarded as one of the keys to highly personalized medicine. Read More Here

Fighting Cancer Gets Personal
Next generation sequenincing opens the door to new ways to track cancer and indentify personalized biomarkers from tumor DNA.
Next-generation sequencing technology is poised become an important tool in the new era of personalized management of cancer patients, according to researchers at Johns Hopkins. In a new study published in the journalScience Translational Medicine, they say they have developed a new technique for tracking cancer by identifying personalized biomarkers from tumor DNA. Read More Here

Formalizing Warnings
FDA places new requirement on makers of anemia drugs.
A new FDA-mandated risk management program charges Amgen with responsibility for apprising doctors and patients of the pitfalls and benefits of treating chemotherapy-related anemia with some of its best-selling drugs. The drugs, sold as Epogen and Aranesp, brought in $5.8 billion in sales to Amgen in 2009 . Together with Procrit, which is sold by Johnson & Johnson, the drugs are known as known as erythropoiesis-stimulating agents and help alleviate anemia by stimulating bone marrow to make red blood cells. Read More Here

No Sweat
New method makes vaccines stable at tropical temperatures.
A cheap and simple way of making vaccines that remain stable even at tropical temperatures has been shown to work by scientists at Oxford University. The technology, developed by Nova Bio-Pharma Technologies, removes the need for refrigerators freezers and associated health infrastructure. It has the potential to significantly advance vaccination efforts in the developing world where infectious diseases kill millions of people every year. Read More Here

Bad Medicine
Medical shows on TV often don’t depict proper first aid for seizures.
To learn how to respond to someone having a seizure it’s probably a good idea to check sources other than prime time television shows. Researchers who screened the most popular medical dramas found that doctors and nurses on these programs failed to properly respond to patients having seizures almost half the time, according to a study that will be presented at the American Academy of Neurology's 62nd Annual Meeting in Toronto April 10 to April 17, 2010. Read More Here

Commentary: Ambiguity is Power
FDA official's recent comments add mirkiness to the industry's use of social media when clarity is needed.
When regulators give speeches or interviews that announce new regulatory expectations, it is never a good idea—and least of all when the policy implicates First Amendment values and involves potential criminal enforcement. The issue at hand is the pharmaceutical industry’s use of social media—an issue where there is already significant confusion. And now, thanks to comments from an FDA official, Peter Pitts argues there’s more. Read More Here

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