- Biotech IPOs make return on investments
Biotech companies that issued IPOs this year are either trading above their initial price or holding steady, beating many tech IPOs, and biotech stocks have generally done well this year, Luke Timmerman writes. "This kind of solid, steady performance is critical to the overall health of biotech, which creates most of the valuable advances in medicine," he writes. The trend is driven in part by better relations between industry and the FDA, says John Maraganore, CEO of Alnylam Pharmaceuticals. Xconomy (8/13)       | Will New RA Therapies Cause Paradigm Shift? | | August could be the month when all patients suffering from rheumatoid arthritis (RA) have a new treatment alternative to injectable TNF-inhibitors, such as Humira (adalimumab, Abbott), Enbrel (etanercept. Amgen, Inc.) and Remicade (infliximab, Johnson & Johnson). Find out the details. |  |
- Analysis: PDUFA V takes program back to its original focus
The Prescription Drug User Fee Act V, which was signed into law in July as part of the FDA Safety and Innovation Act, enacts regulatory changes intended to improve patient access to drugs. Industry representatives see the law as going "back to basics" because it focuses more on the goal of the original PDUFA program, "which was about timely and expeditious review of drugs," said Andrew Emmett, BIO's managing director of science and regulatory affairs. Nature Reviews (subscription required)/Drug Discovery (8/2012) - AstraZeneca's chemo drug Caprelsa works against thyroid cancer in trial
A Phase II study showed that AstraZeneca's chemotherapy drug Caprelsa, or vandetanib, might slightly prolong life for certain patients with thyroid cancer. Patients receiving the treatment lived 11 months without cancer progression, compared with six months for those on placebo. Lead researcher Martin Schlumberger said Caprelsa "should be used as first-line treatment in patients with progressive, untreatable thyroid cancer." HealthDay News (8/13) - Nanotechnology allows in vivo drug manufacturing
An experimental technique uses nanotechnology and ultraviolet light to produce drugs in vivo in lab mice. The technique could allow for targeted, timed treatment of strong chemotherapy drugs while minimizing damage to healthy cells. Further work is needed to stop protein production when it is no longer needed and to ensure that the nanoparticles are safe. The Scientist online (8/13)  | Company & Financial News |  |  | |
| Food & Agriculture | | | | - Monsanto's biotech soybean approved in Argentina
Argentina is in the process of approving Monsanto's biotech Roundup Ready 2 soybean to help improve the country's crop production, according to Agriculture Secretary Lorenzo Basso. The resolution was expected to take effect this week. Reuters (8/13) | Industrial & Environmental | | | | - EPA issues registration to Fla. waste-to-energy plant
The Ineos New Planet BioEnergy plant in Indian River County, Fla., has secured Parts 79 and 80 registration from the Environmental Protection Agency for the production and sale of advanced biofuels. Once fully operational, the facility is expected to produce 8 million gallons of cellulosic ethanol and 6 megawatts of power from materials such as household waste. "We have completed this new facility on schedule and on budget and look forward to further advancing this bioenergy technology and making it commercially available around the world," said Peter Williams, CEO of Ineos Bio and chairman of Ineos New Planet BioEnergy. DomesticFuel.com (8/13)  | |  | | The Buzz(CORPORATE ANNOUNCEMENTS)
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| News from BIO | | | | - Are you taking full advantage of your membership?
BIO's cost-savings program, BIO Business Solutions, is helping 2,700 companies nationwide save on the cost of essential products and services. Members of BIO and 43 state and regional biotech associations are eligible to receive preferential pricing and other benefits at no additional cost beyond their membership dues. VWR International, FedEx, Office Depot and Business Wire are just a few of the industry leading providers that offer special pricing through this members-only program. Learn more or enroll here.
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