Industry News

• FDA issues Complete Response Letter for Zynquista™ (sotagliflozin)  The FDA issued a CRL regarding the NDA for investigational Zynquista™ (sotagliflozin)*, a dual SGLT1 and SGLT2 inhibitor for the treatment of adults with type 1 diabetes in combination with insulin. Sanofi and Lexicon will work closely with the FDA to determine the appropriate next steps.
  March 22, 2019  
• Recro Pharma receives Complete Response Letter from FDA for intravenous meloxicam  Recro Pharma announced it has received a second CRL from the FDA regarding their NDA seeking approval for IV meloxicam for the management of moderate to severe pain. The FDA’s comments in the CRL noted that the delayed onset fails to meet the prescriber expectations for intravenous drugs.
  March 22, 2019  
• Dermira announces closing of$149.5 million public offering of common stock  Dermira announced the closing of its underwritten public offering of 11,283,019 shares of its common stock, including 1,471,698 shares sold upon full exercise of the underwriters’ option to purchase additional shares of common stock, at a price to the public of $13.25 per share.
  March 22, 2019  
• Teva announces launch of generic EXJADE® (deferasirox) tablets in the U.S.  Teva announced the launch of a generic version of EXJADE®1 (deferasirox) Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg, in the U.S. Deferasirox Tablets for Oral Suspension are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions.
  March 22, 2019  
• Imaging method reveals long-lived patterns in cells of the eye  Cells of the retinal pigment epithelium form unique patterns that can be used to track changes in this important layer of tissue in the back of the eye, researchers at the National Eye Institute have found. The study was published today in the journal JCI Insight.
  March 22, 2019  
• NIH study finds no evidence that calcium increases risk of AMD  Eating a calcium-rich diet or taking calcium supplements does not appear to increase the risk of age-related macular degeneration, according to the findings of a study by scientists at the National Eye Institute. The study findings are published in JAMA Ophthalmology.
  March 22, 2019  
• SELLAS Life Sciences reports 2018 financial results  SELLAS Life Sciences reports the net loss for the 2018 full year year was $27.7 million versus a net loss of $23.8 million for 2017. As of December 31, 2018, cash and cash equivalents were $5.3 million, compared to $2.3 million as of December 31, 2017.
  March 22, 2019  
• Blunting pain’s emotional component  Pain researchers at the Washington University School of Medicine have shown in rodents that they can block receptors on brain cells that are responsible for the negative emotions associated with pain. Their findings are published March 13 in the journal Neuron.
  March 22, 2019  
• Initiation of phase III clinical trial of BAN2401 in early Alzheimer's disease  Eisai Co. announced that a global Phase III clinical study (Clarity AD/Study 301) of BAN2401, an anti-amyloid beta protofibril antibody, in patients with early Alzheimer's disease has been initiated. BAN2401 is being jointly developed by Eisai and Biogen.
  March 22, 2019  
• bluebird bio opens state-of-the-art gene and cell therapy manufacturing facility in Durham  bluebird bio announced the official opening of its first wholly owned manufacturing facility in Durham, N.C., that will produce lentiviral vector for the company’s investigational gene and cell therapies, including: bb2121 and bb21217 for treatment of multiple myeloma.
  March 22, 2019  

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