Most Clicked BIO SmartBrief Stories

1. Obama announces initiative to expedite development of personalized cures

BIO SmartBrief | Jan 21, 2015

President Barack Obama will ask Congress for funds to launch a "precision medicine initiative" to accelerate the development of personalized treatments against diseases such as cancer and diabetes and give all Americans access to personalized information needed to improve their health. "I want the country that eliminated polio and mapped the human genome to lead a new era of medicineā€Š -- one that delivers the right treatment at the right time," the president said Tuesday during his State of the Union address. Obama is expected to share details of the initiative in his fiscal 2016 budget, which will be released next month. Bloomberg Businessweek (01/20)

2. Report: FDA remains world's fastest in new drug approvals

BIO SmartBrief | Jan 23, 2015

A report from the Centre for Innovation in Regulatory Science revealed that the FDA is still the world's fastest regulator in terms of new drug approvals, but its counterparts in countries such as Japan, Canada, Europe and Australia are closing in. The FDA's median approval time for new active substances was reduced to 304 days in 2013 from over 400 days in 2004. FDAnews (01/21)

3. Johnson & Johnson receives $115M for Ebola vaccine development

BIO SmartBrief | Jan 20, 2015

Johnson & Johnson will receive a total of $115 million from Europe's Innovative Medicines Initiative to expedite the development and testing of its two-injection Ebola vaccine that uses a booster from Bavarian Nordic. J&J will form a new consortium that includes the London School of Hygiene & Tropical Medicine, the University of Oxford and the Institut National de la Sante et de la Recherche Medicale to work on the product. Reuters (01/16)

4. Novartis drug for plaque psoriasis gets FDA nod

BIO SmartBrief | Jan 22, 2015

Novartis has obtained the FDA's approval to market its monoclonal antibody drug Cosentyx, or secukinumab, for the treatment of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic treatment. The injectable drug was approved for the same indication in Europe earlier this month. Yahoo (01/21) Medscape (free registration) (01/21)

5. Biotechs turn corner on treating illnesses

BIO SmartBrief | Jan 21, 2015

Investors and executives are claiming biotech companies have made major strides in research and technology that are resulting in treatment advances and lower failure rates. New York Times (tiered subscription model), The (01/19)

6. Report: U.S. biotech companies raised $6B in VC funding last year

BIO SmartBrief | Jan 19, 2015

A PricewaterhouseCoopers report found that U.S. biotech firms secured $6 billion in venture capital investments last year, a 29% increase from 2013. The number of deals, however, declined 4% to 470. Overall, the life sciences sector obtained $8.6 billion in VC funding, the highest amount since 2008. (01/16)

7. Roche boosts neuromuscular drug pipeline with Trophos buy

BIO SmartBrief | Jan 19, 2015

Roche agreed to pay as much as $543 million to purchase Trophos, a France-based drugmaker funded by the French Muscular Dystrophy Association and several private equity investors. Roche will pay about $139 million to shareholders plus $404 million in milestone payments. The deal will give Roche access to Trophos' pipeline of neuromuscular disease drugs including the experimental spinal muscular atrophy treatment olesoxime. Genetic Engineering & Biotechnology News (01/16)

8. What might Obama's precision medicine initiative look like?

BIO SmartBrief | Jan 23, 2015

A precision or personalized medicine initiative suggested by President Barack Obama in his State of the Union address might call for better computational tools, smartphones that diagnose disease and advances in tissue-on-a-chip technology, says Lee Hood, who led the development of the automated DNA sequencer. Other focus areas might include research on the consequences of genetic changes, development of gene sequencing standards and improvements in how mutations are identified, says geneticist David Mittelman, chief scientific officer at Tute Genomics. Xconomy (01/21)

9. BIO, PhRMA press for removal of non-abuse deterrent generic opioids

BIO SmartBrief | Jan 22, 2015

The FDA should decline to approve or revoke approval for easily abused generic opioid drugs if an abuse-deterrent version exists, BIO and the Pharmaceutical Research and Manufacturers of America said. "We believe that permitting the approval of generic products that lack comparable abuse deterrence not only undermines the incentive for innovative biopharmaceutical companies to invest in important new abuse deterrent technologies, but more importantly, fails to mitigate a public and societal health risk," the groups wrote in a letter to the FDA. Regulatory Focus (01/20)

10. Gene therapy developer raises $30M in funding round

BIO SmartBrief | Jan 22, 2015

A funding round has pulled in $30 million for Regenxbio, a Washington D.C.-based biotech firm focused on developing gene therapies for central nervous system disorders. Proceeds from the round will be used to advance the company's drugs into the clinical trial stage. Washington Post (tiered subscription model), The (01/21)

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