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Alexion Pharmaceuticals, Inc. (ALXN) submitted on Tuesday a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of ALXN1210, the Company's investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria...
valeant.jpg Shares of Valeant Pharmaceuticals International Inc. are falling more than 6 percent in Monday's trading following news that the U.S. Food and Drug Administration has failed to approve the Canada-based company's Duobrii lotion for the treatment of plaque psoriasis. Ortho Dermatologics, a division of Valeant Pharmaceuticals, said it has received a Complete Response Letter or CRL from the FDA.
Johnson & Johnson Vision, a unit of Johnson & Johnson (JNJ), said that the U.S. Food and Drug Administration (FDA) has approved of the iDESIGN Refractive Studio, making it the only system to use topography-integrated, wavefront-guided technology. This allows doctors to take a precise measurement of...
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pharma-042318.jpg Today's Daily Dose brings you news about Atossa's progress in phase I study of its proprietary topical Endoxifen in men; the three biopharmaceutical companies that are set to debut on the Nasdaq on June 21, 2018; Kindred Biosciences' financial position; FDA panel review date of Paratek's Omadacycline NDA, and STAAR Surgical's resolution of FDA warning letter.
pharma-daily-060618.jpg Today's Daily Dose brings you news about Alexion's progress in paroxysmal nocturnal hemoglobinuria; Anika's disappointing results of CINGAL in osteoarthritis of the knee; timeline of Kala's submission of New Drug Application for KPI-121 0.25% for the treatment of dry eye disease; Marinus' Marigold study and Pacira's deal with China-based Nuance Biotech.
pharma-june19.jpg Today's Daily Dose brings you news about Royalty Pharma's investment in Biohaven Pharma; Champions Oncology's partnership with NSABP Foundation and Puma Biotechnology; upcoming regulatory catalyst of Myriad Genetics; Valeant Pharma's plaque psoriasis setback; Sarepta's presentation to watch out for the day, and FDA hold on Ziopharm's phase I trial of CD19-targeted CAR T therapy.
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U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS announced that Orocovis, Puerto Rico establishment HF Food Distributors is recalling approximately 142 pounds of sliced cooked ham products that were produced without the benefit of federal inspection. Meanwhile, there have...

The U.S. Department of Agriculture's Food Safety and Inspection Service announced that Tyson Foods Inc. (TSN) is recalling approximately 3,120 pounds of frozen breaded chicken products due to possible contamination with extraneous materials, specifically blue and clear soft plastic. Meanwhile, there...

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The U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS announced that San Sebastián, Puerto Rico firm Supermercado Selectos is recalling approximately 15,315 pounds of various raw, frozen beef, pork and poultry products that were produced without the benefit of federal inspection. A...

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Eddy Packing Co., Inc. is recalling approximately 18,390 pounds of smoked sausage due to potential contamination of extraneous materials, specifically soft plastic. Meanwhile, there have been no confirmed reports of adverse reactions due to consumption of these products.

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Date Company Name Ticker Drug Event Outcome Details
11/05/2018 EyePoint Pharmaceuticals, Inc. EYPT Durasert (NDA) FDA decision on Durasert for posterior segment uveitis
11/05/2018 EyePoint Pharmaceuticals, Inc. EYPT Durasert micro-insert (NDA) FDA decision on Durasert micro-insert for non-infectious posterior segment uveitis
11/03/2018 Coherus Biosciences, Inc. CHRS CHS-1701 (Resubmitted BLA) FDA decison on CHS-1701, a biosimilar version of Neulasta
11/02/2018 Trevena, Inc. TRVN OLINVO (NDA) FDA panel to review OLINVO for management of moderate to severe acute pain
10/28/2018 Regeneron Pharmaceuticals REGN cemiplimab (BLA) FDA decision on cemiplimab for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC
10/28/2018 TherapeuticsMD TXMD TX-001HR (NDA) FDA decision on TX-001HR for vasomotor symptoms due to menopause
10/23/2018 Merck & Co Inc. MRK Doravirine (NDA) FDA decision for use of Doravirine with lamivudine and tenofovir disoproxil fumarate for HIV
10/20/2018 Regeneron Pharmaceuticals REGN DUPIXENT (sBLA) FDA decision on DUPIXENT for moderate-to-severe asthma
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Results Date Company Name Ticker Event Indication Outcome
Late 2018 Akebia Therapeutics, Inc. AKBA Data from phase II trial of Vadadustat (FO2RWARD) Dialysis Patients with Anemia Related to Chronic Kidney Disease
Late 2018 Akebia Therapeutics, Inc. AKBA Data from phase II trial of Vadadustat (FO2RWARD) Dialysis Patients with Anemia Related to Chronic Kidney Disease
Late 2018 ObsEva SA OBSV Initial efficacy results from phase 2a clinical trial of OBE022 (PROLONG) Pre-term labor
Late 2018 VANDA PHARMACEUTICALS VNDA Results from phase III trial of Tradipitant Gastroparesis
Late 2018 VANDA PHARMACEUTICALS VNDA Results from phase III study of HETLIOZ Smith-Magenis Syndrome
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Shares of Krystal Biotech Inc. (KRYS) touched a new high of $13.00 on Thursday, and are up 30% since the beginning of this year.
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In the largest study ever to analyse the possible link between chronotype and mood disorders, researchers have found that early risers are significantly less likely to develop depression.
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The bench to bedside journey of drugs is no easy task. Some drug candidates fail to complete the journey while many make it to the finish line only after undergoing numerous obstacles.
Time is flying, and we are already five months into the year. Thirteen novel drugs have been approved by the FDA so far in 2018 - with 4 being greenlighted in the month of May. Now, let's take a look at the biotech stocks that await FDA word in June 2018.
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Shares of Athenex Inc. (ATNX) have returned nearly 46% over the last 1 year while the iShares NASDAQ Biotechnology Index (ETF) has gained a mere 12% during the same period.
Shares of G1 Therapeutics Inc. (GTHX) have returned a whopping 230% over the last 1 year while the iShares NASDAQ Biotechnology Index (ETF) has gained a mere 11% during the same period.
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