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- Analysis: Ruling reduces uncertainty for biotech and pharma
The Supreme Court's decision to uphold the health care law greatly benefits the pharmaceutical industry by reducing risk and uncertainty that would have come with reversal, Moody's analyst Michael Levesque said. The ruling also means that drugmakers face having to pay $80 billion in rebates and fees over 10 years. Canceling part or all of the law would have meant reopening proposals that drugmakers managed to avoid during drafting of the Patient Protection and Affordable Care Act. The Wall Street Journal
(6/28)
| Examining the ACA Ruling |  |  |
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- BIO reacts to ruling on Affordable Care Act
BIO will collaborate on the implementation of the Affordable Care Act to help the biotech industry develop "lifesaving cures and other medical breakthroughs," said BIO President and CEO Jim Greenwood in reaction to the Supreme Court's decision to uphold the health care law. Greenwood said BIO will work with the FDA in the implementation of the biosimilars pathway under the act. "We will work to ensure that biotech researchers can continue to address the diseases of today while conducting the research and investment required to develop the advanced medicines and cures of tomorrow," he said. Read BIO's statement. Mass High Tech (Boston)
(6/28)
- How court decision will affect the biosimilar market
The Supreme Court's affirmation of the health care law upheld the Biologics Price Competition and Innovation Act, which was incorporated into the Affordable Care Act and which mandated the creation of an abbreviated biosimilars approval pathway. "The biosimilar market will proceed in the same course as it has," said Maria E. Gonzalez Knavel of law firm Foley & Lardner. Genetic Engineering & Biotechnology News
(6/28)
- How the ruling will affect health care
The U.S. Supreme Court ruling to uphold the Affordable Care Act will have significant effects on a variety of groups, including individuals who are insured and uninsured, people with pre-existing conditions and small businesses. For health care providers, the ruling will allow physicians and hospitals to continue to veer away from the conventional fee-for-service approach to more efficient health care models, according to the Reuters analysis. The ruling also lets doctors avoid the confusion that would have accompanied the rejection of the health care law, said Bob Doherty of the American College of Physicians. Reuters
(6/28), CNN
(6/28)
| Health Care & Policy |  |  |
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- FDA receives biologics application for Dynavax hepatitis B vaccine
The FDA received Dynavax Technologies' biologics license application for its Heplisav vaccine against infection from all hepatitis B virus subtypes in patients age 18 to 70. The company may file a supplemental BLA for chronic kidney disease patients. "We look forward to working with the FDA in moving Heplisav through the regulatory review process over the next few months," said Tyler Martin, Dynavax's president and chief medical officer. Pharmaceutical Business Review Online
(6/27)
- Soligenix and IDRI collaborate on biodefense vaccines
Soligenix and the Infectious Disease Research Institute agreed to develop biodefense vaccines using the latter's synthetic adjuvants and the former's ThermoVax
proprietary subunit proteins and thermostabilization platform. For the initial project, the partners will assess the combination of IDRI's adjuvant compound that has shown to improve immune response to the anthrax toxin with Soligenix's VeloThrax, a vaccine candidate against anthrax. ProactiveInvestors.co.au (Australia)
(6/28)
- Study: Genzyme's sevelamer cuts CV risk of hemodialysis patients
A study found that Genzyme's hyperphosphatemia drug sevelamer might greatly benefit patients on hemodialysis by lowering risk for cardiovascular events. Patients who received sevelamer had about a 10-fold reduced risk of cardiovascular death than those who took phosphorus-binding agents at 36 months of follow-up. Sevelamer also reduced the risk for all-cause mortality by more than 70%. Medscape (free registration)
(6/27)
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| Food & Agriculture |  |  |
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- U.S. firm to supply cellulosic technology to Brazilian cane mills
South Dakota-based Blue Sugars, formerly known as KL Energy, will provide cellulosic-ethanol technology to three Brazilian sugarcane mills that are aiming to produce the fuel using bagasse. The cellulosic-ethanol producer projects that when the three facilities go online in 2015, bagasse-based ethanol will be competitive with the sugarcane-based variety. Bloomberg Businessweek
(6/28)
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- 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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