Gene-therapy makers consider alternative payment model | FDA expedites review of melanoma drug from Genentech | Seattle Genetics applies for expanded approval of Adcetris
February 20, 2015
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Gene-therapy makers consider alternative payment model
Some makers of gene-therapy drugs are considering amortized reimbursement plans that are contingent upon the demonstration of effectiveness. Therapies that fix a faulty gene responsible for inherited diseases are expected to be extremely expensive, though they could save money over time. Reuters (2/19)
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Getting Paid: How to Get Customers to Pay Up
Dealing with the money isn't fun, but it's a necessary evil for staying in business. While every business has their ups and downs, the key to positive cash flow is collecting payments in full and on time to keep the cash coming in as predictably as possible. Seem impossible? Learn how these small-business owners did it.

Health Care & Policy
FDA expedites review of melanoma drug from Genentech
Genentech's experimental drug cobimetinib, in combination with Zelboraf, or vemurafenib, secured priority-review status from the FDA for use in patients with BRAF V600-positive advanced melanoma. The approval was based on data from a late-stage trial that showed the combination was more effective than vemurafenib alone in reducing mortality risk and disease progression. Healio (free registration) (2/19)
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Seattle Genetics applies for expanded approval of Adcetris
Seattle Genetics has filed a supplemental biologics license application with the FDA for brentuximab vedotin, or Adcetris, as consolidation therapy after autologous stem cell transplantation in patients with Hodgkin lymphoma. The application was based on data from a Phase III trial. Pharmaceutical Business Review Online (2/19), RTT News (2/18)
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EU grants orphan status to muscular dystrophy drug from aTyr Pharma
Resolaris, an experimental first-in-class therapeutic protein developed by aTyr Pharma, received orphan-drug status from the European Commission as a treatment for facioscapulohumeral muscular dystrophy. A Phase Ib/II trial will be carried out at several sites in Europe to assess the drug's efficacy in about 44 patients with FSHD. Pharmaceutical Business Review Online (2/19)
Scientists map human epigenome
An international consortium of scientists has mapped 111 patterns of gene expression in an effort to understand the process of tissue differentiation and how epigenomic modification affects illness. The new map was published online in the journal Nature with simultaneous publication in six sister journals. The New York Times (tiered subscription model) (2/18), Nature (free content) (2/18), HealthDay News (2/18)
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Company & Financial News
Mass. glaucoma drug developer raises $40M in IPO
Inotek Pharmaceuticals secured $40 million in an initial public offering, about 60% less than its initial target. The Lexington, Mass.-based firm is developing an eye drop for patients with glaucoma. American City Business Journals/Boston/BioFlash blog (2/18)
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NewLink gets $20M milestone fee as Ebola vaccine trial is set
Merck & Co. agreed to pay NewLink Genetics a $20 million milestone fee after the NIH announced that the firms' experimental Ebola vaccine rVSV-EBOV will be tested in a large Phase II/III trial in Liberia. Merck secured exclusive rights to the vaccine as part of a joint development deal signed with NewLink last year. "This milestone payment will help us continue our significant investment into vaccines for infectious diseases, including Ebola in collaboration with Merck," NewLink Chairman and CEO Charles Link said. Genetic Engineering & Biotechnology News (2/19)
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Molecular Dx firm obtains $12.2M boost
Lineagen has raised $12.2 million in the second tranche of its Series C funding round led by HealthQuest Capital, bringing the total for the round to $15.8 million. The funding will be used to support the molecular diagnostics firm's NextStepDx Plus, a sequencing-based test, and FirstStepDx Plus, a chromosomal microarray test, CEO Michael Paul said. It will also be used to expand the firm's research to additional neurological and neurodevelopmental indications, Paul said. GenomeWeb Daily News (free registration) (2/18)
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Food & Agriculture
Corn growers group says biotech labeling bill could ease fears
The Wisconsin Corn Growers Association urged the state's congressional delegation to support a bill that would give the FDA the authority to create a federal standard for the labeling and approval of foods and drinks containing biotech ingredients. The Safe and Accurate Food Labeling Act of 2014 would start a dialogue on biotech crops and could help reduce fears about biotech products, WCGA communications director Tom Thieding said. Brownfield (2/19)
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Industrial & Environmental
Minn. House, Senate panels approve advanced-biofuel incentives
A bill that would provide incentives for the production of advanced biofuels was approved Wednesday by committees in the Minnesota House and Senate. "This bill takes advantage of Minnesota's abundant forest and agriculture feedstocks," said Sen. Tom Saxhaug. Rep. Rod Hamilton said the advanced-biofuels market will exceed $185 billion globally by 2021, "and we want to be leaders right here in Minnesota." Daily Globe (Worthington, Minn.) (2/18)
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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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Your present circumstances don't determine where you can go; they merely determine where you start."
-- Nido Qubein,
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