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.
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.
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.
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.
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.
In final draft guidance, the National Institute for Health and Care Excellence endorsed Eli Lilly and Co.'s Alimta, or pemetrexed, for National Health Service use as a maintenance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.
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.
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.
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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.
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.
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