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The Pulse of the Pharmaceutical Industry

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House Appropriations Committee Proposes 6% Increase in FDA Funding

The House Appropriations Committee proposed a 2020 draft fiscal year funding bill. The FDA would receive a 6 percent increase in discretionary funding over 2019, amounting to a $184 million bump.

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Takeda Wins FDA Approval for Pediatric Use of Short Bowel Syndrome Treatment

Takeda’s Gattex (teduglutide) won approval for a new indication from the U.S. Food and Drug Administration: for pediatric patients 1 year of age and older with Short Bowel Syndrome who need additional nutrition or fluids from intravenous feeding.

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UCB’s Nayzilam Nasal Spray Wins U.S. FDA Approval

UCB announced that the U.S. Food and Drug Administration approved a New Drug Application for the company’s anti-epileptic drug Nayzilam (midazolam) nasal spray CIV.

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U.S. FDA issues recall of Ethicon’s surgical staplers

The U.S. Food and Drug Administration issued a recall of surgical staplers made by Johnson & Johnson’s Ethicon unit, warning that the use of the devices could cause serious injury or death.

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FDA approves first anticoagulant for pediatric patients to treat potentially life-threatening blood clots

The U.S. FDA approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism in pediatric patients 1 month of age and older.

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Roche: FDA approves drug combo Venclexta plus Gazyva for previously untreated chronic lymphocytic leukemia

The U.S. Food and Drug Administration approved a treatment using Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukemia.

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FDA Approves Bavencio Plus Inlyta Combination for Patients with Advanced Renal Cell Carcinoma

EMD Serono and Pfizer announced that the U.S. FDA approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma.

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FDA advisory panel votes against Daiichi Sankyo’s blood cancer treatment

Independent experts on an advisory panel to the U.S. Food and Drug Administration voted against Daiichi Sankyo Co. Ltd.’s treatment for adults with a type of acute myeloid leukemia.

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FDA Approves Eylea for Diabetic Retinopathy

The U.S. FDA approved Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) Injection for all stages of diabetic retinopathy, which is the leading cause of vision loss in diabetic patients.

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Cellectar Receives FDA Fast Track Designation for CLR 131 in Relapsed or Refractory Multiple Myeloma

Cellectar Biosciences Inc. announced that the U.S. Food and Drug Administration granted Fast Track Designation for CLR 131 in fourth line or later relapse/refractory multiple myeloma.

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April 2019 Focus: Healthcare agency & network profiles, industry overview & awards, and more!


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