Allied-Bristol Life Sciences enters licensing deal with Yale University | FDA proposes system of names, suffixes for biologics, biosimilars | Cholesterol drug from Amgen gets FDA OK

August 28, 2015
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Allied-Bristol Life Sciences enters licensing deal with Yale University
Allied-Bristol Life Sciences, a joint venture between Bristol-Myers Squibb and Allied Minds, has signed a global licensing agreement with Yale University centered on the latter's proprietary platform technology and lead associated antibody-recruiting molecules. Allied-Bristol intends to expand the development of ARMs to treat diseases such as prostate cancer. Terms of the agreement were not disclosed. PharmaTimes (U.K.) (8/27)
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Health Care & Policy
FDA proposes system of names, suffixes for biologics, biosimilars
The FDA has proposed attaching suffixes to the generic names of biologic drugs and biosimilars, and the agency is seeking feedback about the names of biologics that are currently on the market without a suffix. The naming convention would help prevent confusion in cases where interchangeability hasn't been determined and help monitor the safety of different manufacturers' versions of the drugs, the FDA said. Bloomberg (8/27)
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Cholesterol drug from Amgen gets FDA OK
Amgen's Repatha, or evolocumab, has obtained approval from the FDA as a treatment for familial hypercholesterolemia, as well as clinical atherosclerotic cardiovascular disease, among patients who need additional cholesterol-lowering treatment. The decision was backed by data from nine studies. Reuters (8/27), Pharmacy Times online (8/27)
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Boehringer, Eli Lilly receive FDA approval for diabetes combination drug
The FDA granted approval to Boehringer Ingelheim's and Eli Lilly & Co.'s Synjardy, a fixed-dose combination of empagliflozin and metformin, for use as adjunctive therapy to treat type 2 diabetes patients. The drug will carry a boxed warning on its label because of the risk of lactic acidosis. Synjardy is already approved in Europe. PharmaTimes (U.K.) (8/27)
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FDA approves Aurobindo hepatitis B treatment
Aurobindo Pharma's abbreviated new drug application to market entecavir tablets, a generic version of Bristol-Myers Squibb's Baraclude, was approved by the FDA. Entecavir is indicated to treat chronic hepatitis B infections of the liver. Business Standard (India) (8/27)
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Allergan reapplies for expanded approval of Botox
A supplemental biologics license application has been refiled by Allergan with the FDA for the use of Botox in patients with lower-limb spasticity. The application was based on data from a clinical trial of 468 patients that showed the drug's effectiveness and safety in cutting post-stroke lower-limb spasticity. FDAnews (8/27)
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Company & Financial News
Funding round pulls in $6.29M for VBI Vaccines
A private funding round has brought in $6.29 million for VBI Vaccines. The Cambridge, Mass.-based firm will use the money to fund the development of hepatitis C and cytomegalovirus vaccines. American City Business Journals/Boston (8/27)
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Nabriva files IPO
Nabriva Therapeutics has filed for an initial public offering without disclosing the amount it hopes to raise. The Vienna, Austria-based firm is conducting a Phase III trial for its lead drug candidate, Lefamulin, for treatment of community-acquired bacterial pneumonia. Aside from general company purposes, Nabriva intends to use the proceeds to support the clinical development of Lefamulin for pneumonia and other indications, and to repay debts. American City Business Journals/Philadelphia (8/27)
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Food & Agriculture
Lack of understanding about biotech crops fuels opposition, expert says
Susan McCouch, a professor at Cornell University's Department of Plant Breeding and Genetics, said opposition to biotech crops is often rooted in fear and a lack of awareness regarding their development, which involves the integration of genes that are toxic for pests but are not harmful for nontarget organisms. Biotech crop critics tend to overlook the use of pesticides, which was reduced in countries that cultivate biotech crops, McCouch said. The New Indian Express (India) (8/28)
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Industrial & Environmental
Clinton wants to increase access to ethanol blends
Democratic presidential candidate Hillary Clinton would like to increase consumer access to ethanol blends such as E15 and E85, according to a fact sheet provided by her campaign before a recent appearance near Des Moines, Iowa. "It's imperative that we have a comprehensive agenda to revitalize rural America," Clinton said in her speech. Clinton's fact sheet also states that she wants to strengthen the Renewable Fuel Standard. The Washington Post (tiered subscription model) (8/26)
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