Relypsa to be acquired by Galenica in $1.53B deal | FDA fast-tracks Advaxis' adjunct therapy for cervical cancer | ProQR's cystic fibrosis drug receives FDA fast-track status
July 22, 2016
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Relypsa to be acquired by Galenica in $1.53B deal
Galenica signed a $1.53 billion acquisition deal to purchase Relypsa and gain global rights to its hyperkalemia drug Veltassa. Galenica, which plans to split its business units Vifor Pharma and Galenica Sante into two independent companies, will merge Relypsa with Vifor in a transaction expected to close in the third quarter of this year.
Reuters (7/21),  Bloomberg (7/21) 
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Health Care & Policy
FDA fast-tracks Advaxis' adjunct therapy for cervical cancer
Advaxis' AXAL, or axalimogene filolisbac, has received fast-track designation from the FDA as an adjuvant treatment for high-risk locally advanced cervical cancer. The treatment is an immunotherapy that is based on the firm's Lm Technology.
Seeking Alpha (free registration) (7/21) 
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ProQR's cystic fibrosis drug receives FDA fast-track status
The FDA granted fast-track status to ProQR Therapeutics' QR-010 as a treatment for cystic fibrosis in patients with deltaF508 mutation. The drug also holds orphan-drug designations in the US and EU and is being evaluated in Phase IB and proof-of-concept studies.
Lung Disease News (7/21) 
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FDA grants breakthrough status to AveXis' spinal muscular atrophy treatment
AveXis has received breakthrough therapy status from the FDA for its lead experimental drug candidate, AVXS-101, which is designed to treat children with spinal muscular atrophy type 1. The designation was backed by data from clinical studies conducted in partnership with Ohio State University and the Research Institute at Nationwide Children's Hospital. (7/20) 
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EMA to review Neulasta biosimilar from Mylan, Biocon
The European Medicines Agency accepted for review Mylan and Biocon's marketing authorization application for a biosimilar version of Amgen's Neulasta, or pegfilgrastim, for the treatment of neutropenia. Data from safety, efficacy, immunogenicity, pharmacokinetic and pharmacodynamic studies of the biosimilar will be presented at the meeting of the European Society of Medical Oncology in October, the companies said.
BioCentury (7/21) 
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NICE backs Lilly's lung cancer drug
In final draft guidance, the National Institute for Health and Care Excellence endorsed Eli Lilly and Co.'s Alimta, or pemetrexed, for National Health Service use as a maintenance treatment for metastatic or locally advanced non-squamous non-small cell lung cancer in adult patients who do not have disease progression after four cycles of treatment with the drug. NICE is expected to release final guidance in August.
PharmaTimes (U.K.) (7/21) 
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PTC's Duchenne muscular dystrophy treatment endorsed by NICE
The use of PTC Therapeutics' Translarna, or ataluren, on England's National Health Service has been recommended by the National Institute for Health and Care Excellence. The drug is indicated to treat Duchenne muscular dystrophy caused by certain genetic mutations in patients who are at least 5 years old are able to walk. (U.K.) (7/21) 
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Company & Financial News
Financing round brings in $34.3M for InflaRx
A Series C funding round has generated $34.4 million for Jena, Germany-based InflaRx. The firm will start two additional midstage studies for its humanized monoclonal antibody IFX-1, which is designed to prevent organ dysfunction and severe systemic inflammation in cardiac surgery patients.
BioCentury (7/21) 
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The Latest From BIO ...
Registration is open for the 2016 BIO Latin America Conference
The BIO Latin America Conference, happening October 26-28 in São Paulo, Brazil, is the ideal venue to explore the innovation and partnering opportunities in Latin America's rapidly-growing life science industry. The conference will bring together more than 600 leaders, executives, researchers and investors from around the world to discuss trends and innovations, attend company presentations, and conduct face-to-face partnering meetings. Register by September 22, 2016 and qualify for the early bird discount rate. Learn more & register.
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Food & Agriculture
Simplot seeks foreign approval of biotech potatoes, plans biotech-only farms
Simplot Plant Sciences sent applications to the 10 top foreign potato markets for its Innate line of biotech potatoes and is hopeful that it will receive approval from Japan before the end of this year. The firm also plans to eventually grant seed propagation contracts to farmers willing to stop growing traditional potatoes.
Herald and News (Klamath Falls, Ore.)/Capital Press (Salem, Ore.) (7/21) 
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Industrial & Environmental
Senators urge EPA to support higher 2018 biodiesel RVOs
A group of 40 Democratic and Republican senators sent a letter to the Environmental Protection Agency urging Administrator Gina McCarthy to increase the requirements of the 2018 Renewable Volume Obligations for biomass-based diesel under the Renewable Fuel Standard proposal. The senators wrote that the biomass diesel requirements should be raised from 2.1 billion gallons to 2.5 billion in 2018.
Morning Consult (7/21) 
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News From BIO
BIO survey to support PDUFA 6 negotiations
PDUFA 6 negotiations are ongoing. As BIO continues our technical discussions with the FDA, we need your help to ensure these vital conversations are reflective of biotech company experiences and a success for the industry. Please take a few minutes to log in to BIO's FDA survey and provide feedback on your company's interactions with FDA. Communications between drug sponsors and drug reviewers will be a key focus of PDUFA 6, and our negotiators need all the phase-specific data possible to support BIO's case. Our survey allows you to provide phase-specific, anonymous feedback on your interactions with FDA for each program your company has in the clinic. Your input on FDA review divisions, communication channels, and specialized approval pathways is crucial to the success of the PDUFA negotiations. Visit to get started today!
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