Report: Value of U.S. pharmaceutical market to hit nearly $550B in 5 years | New deadline set for comments on drug-device combo GMP rules | FDA gives tentative approval to Aurobindo's generic seizure treatment
March 20, 2015
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Report: Value of U.S. pharmaceutical market to hit nearly $550B in 5 years
A GlobalData report shows that the U.S. pharmaceutical industry will be worth $548 billion by 2020, compared with $395 billion last year. The anticipated market growth will be spurred by factors such as higher health care spending, increasing rates of lifestyle-related chronic diseases and easily accessible reimbursement for drug costs. (U.K.) (3/19)
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New deadline set for comments on drug-device combo GMP rules
The FDA has moved the deadline from March 30 to April 29 for comments on the draft good manufacturing practices guidance for products combining medical devices and drugs. The FDA agreed to the extension after receiving a request asking for more time to respond to the draft guidance. FDAnews (3/18)
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FDA gives tentative approval to Aurobindo's generic seizure treatment
Aurobindo Pharma obtained tentative FDA approval for its Lacosamide pills in four strengths to treat partial-onset seizures in people who are 17 and older and are diagnosed with epilepsy. The pills are a generic version of Vimpat, developed by USB. The Economic Times (India)/Press Trust of India (3/19)
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FDA orphan designation granted to Selten's pulmonary arterial hypertension drug
The FDA granted orphan drug status to Selten Pharma's experimental drug SPI-026, or tacrolimus, as a treatment for pulmonary arterial hypertension. The firm said animal studies show the drug holds promise in reversing the effects of PAH by activating the bone morphogenetic protein receptor type II pathway. Pharmaceutical Business Review Online (3/19)
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GSK's asthma drug wins FDA panel's backing for use in adults
An FDA advisory panel voted 16-4 Thursday to endorse the approval of GlaxoSmithKline's chronic obstructive pulmonary disease drug Breo Ellipta for adult asthma patients. The panel did not recommend the medication for use in patients ages 12 to 17 and suggested conducting a large safety trial in adolescents and adults. A final decision from the FDA is expected by April 30. Reuters (3/19)
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Amicus to file for accelerated approval of Fabry disease drug
Amicus Therapeutics will seek accelerated FDA approval for its experimental Fabry disease drug migalastat in the second half of 2015 and will request approval from European regulators in the second quarter. The decision comes after a late-stage trial yielded positive results in treating the disease. The Washington Times/The Associated Press (3/19)
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Combating Identity Theft in a Mobile, Social World
Mobile connectivity threats extend from consumers to the business environment. But who is really responsible for securing sensitive information? Smart business leaders are becoming proactive on the matter. Learn how to get protected in this white paper. Download the white paper now.

Company & Financial News
AbbVie announces $30M expansion in Puerto Rico
AbbVie plans to spend $30 million to expand its operations in Barceloneta, Puerto Rico, possibly generating 100 new jobs in the next two years. "This investment demonstrates our commitment to Puerto Rico as a key element of our global manufacturing network," said Stephen Muldoon, AbbVie vice president of engineering and operations. BioSpace (San Francisco) (3/18)
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Lucigen pulls in $2.2M from private financing round
A private financing round has brought in $2.2 million for Wisconsin-based Lucigen. The company will use the fund for its ClariLight molecular diagnostics platform, to further develop the technology, finish preclinical studies and initiate a clinical trial of the platform with Clostridium difficile as the target. GenomeWeb Daily News (free registration) (3/18)
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Food & Agriculture
Maine legislator introduces new biotech food-labeling bill
A bill that would require the labeling of foods with biotech ingredients was introduced in Maine by Democratic state Rep. Michelle Dunphy. The new proposal removes the requirement of a 2013 bill that calls for four other states in the Northeast to pass similar bills before Maine's bill would be enacted. The Washington Times/The Associated Press (3/19)
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Industrial & Environmental
Researchers working to improve biofuel production efficiency
At a federal lab in Washington state, scientists are working to improve the techniques used to create biofuel from microalgae. Scientists at Pacific Northwest National Laboratory have trademarked a process named "AlgaeAirFix" that could enlarge the transfer of carbon dioxide into large algal ponds from the air. "If it works, it would revolutionize the microalgae biofuel industry," said Michael Huesemann, project lead and research engineer at the location's Marine Sciences Laboratory. Sequim Gazette (Wash.) (3/24)
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News From BIO
Registration is open for the BIO Asia International Conference!
The BIO Asia International Conference, on March 24-25 in Tokyo, co-hosted by BIO and BioCentury and the Japan Bioindustry Association (JBA), brings together the global biotechnology and pharmaceutical industry to explore licensing and research collaborations in the current Asia-Pacific business and policy environments. Gain insights into the changes, challenges and opportunities key opinion and policy leaders foresee for the Japanese biotech market.
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