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Novartis (NVS) said the topline results from global Phase III LUSTER-1 and LUSTER-2 studies did not support further development of Fevipiprant in asthma as a primary indication. The pooled analyses of the LUSTER trials did not meet the clinically relevant threshold for reduction in rate of moderate -to-severe...
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Eli Lilly and Co. (LLY) said that the European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP issued a positive opinion recommending a new indication and associated label update for Cyramza or ramucirumab. The Committee agreed that the label should include an indication...
Amgen (AMGN) and UCB said Thursday that the European Commission approved Evenity or romosozumab for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. Evenity is a novel bone-builder with a dual effect that increases bone formation and to a lesser extent reduces...
Genentech, a member of Swiss drug maker Roche Group (RHHBY), announced Wednesday that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application or sBLA for Xolair (omalizumab) to treat nasal polyps in adult patients. The FDA is expected to make a decision...
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dna-dec13.jpg The following are the healthcare stocks that hit a new 52-week high on Thursday.
pharma-061517_12dec19.jpg Today's Daily Dose brings you news about the sweet surprise for Sarepta; spike in Amneal Pharma's stock price; Oncternal Therapeutics' breast cancer trial results and Centene's 2020 outlook.
pharma062917_11dec19.jpg Today's Daily Dose brings you news about Puma Biotech's SUMMIT basket trial results; TransEnterix' reverse stock split; Seattle Genetics' pivotal HER2CLIMB study and the latest update on Intec/Novartis deal.
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Go Raw, LLC recalled Quest Beef Cat Food for possible contamination with Salmonella that can affect pets and humans, the U.S. Food and Drug Administration or FDA said in a statement. The recall involves two-pound frozen bags of cat food distributed nationally through retail stores. The recall was initiated after the company was notified by the Minnesota Department of Agriculture.

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Vitamin Cottage Natural Food Markets, Inc. is recalling Natural Grocers brand Organic Soybeans, citing potential to contain mold, the company said in a statement. The recall involves 2-pound Organic Soybeans with UPC Code 000080663607 with packed on dates of 19-168 & 19-205 only. The product is packaged in clear plastic bags weighing 2 pounds and bearing the "Natural Grocers" label.

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Drug companies in the U.S. have started issuing recalls for heartburn medication Ranitidine, sold under the trade name Zantac among others, on confirmation of contamination with N-Nitrosodimethylamine or NDMA above levels established by the U.S. Food and Drug Administration or FDA. The move follows...

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The FDA has recommended including a boxed warning in breast implant labeling as part of the regulatory agency's continued effort in protecting the health of women who are considering breast implants.

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Date Company Name Ticker Drug Event Outcome Details
06/11/2020 Viela Bio VIE Inebilizumab (BLA) FDA decision on Inebilizumab for treatment of patients with neuromyelitis optica spectrum disorder (
06/11/2020 Viela Bio VIE Inebilizumab (BLA) FDA decision on Inebilizumab the treatment of neuromyelitis optica spectrum disorder
06/02/2020 Foamix Pharmaceuticals Ltd. FOMX FMX103 topical foam (NDA) FDA decision on FMX103 for the treatment of moderate-to-severe papulopustular rosacea in adults.
05/24/2020 PTC Therapeutics Inc. PTCT Risdiplam (NDA) FDA decision on Risdiplam for the treatment of spinal muscular atrophy
05/24/2020 Roche Holding AG RHHBY Risdiplam (NDA) FDA decision on risdiplam for spinal muscular atrophy
05/14/2020 Sumitomo Dainippon Pharma DNPUF Dasotraline (NDA) FDA decision on Dasotraline for the treatment of patients with moderate-to-severe binge eating disorder
05/12/2020 Halozyme Therapeutics, Inc. HALO DARZALEX (BLA) FDA decision on subcutaneous delivery of DARZALEX for patients with multiple myeloma.
04/30/2020 Sanofi SNYNF, SNY Isatuximab (BLA) FDA decision on Isatuximab b for the treatment of patients with relapsed/refractory multiple myeloma
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Results Date Company Name Ticker Event Indication Outcome
Feb 2020 CTD Holdings Inc CTDH.OB Data from Phase I trial of Trappsol Niemann-Pick Disease Type C
1H 2020 Trevi Therapeutics TRVI Topline data from phase II clinical trial of Nalbuphine ER Chronic cough in patients with idiopathic pulmonary fibrosis
2020 BioNTech BNTX Data from phase I trial of BNT111 Advanced melanoma
1H 2020 BioNTech BNTX Data from phase 1 trial of BNT114 Triple-negative breast cancer
Q1 2020 Tonix Pharmaceuticals Holding Corp. TNXP Results from added interim analysis of phase III trial of Tonmya (RECOVERY) Posttraumatic stress disorder,
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2019 saw more than 25 acquisition deals being executed in the biotech sector, of which 14 were billion-dollar deals. Bristol-Myers Squibb (BMY) acquiring Celgene for $74 billion in January remains the most expensive acquisition of this year.
Shares of MEDNAX Inc. (MD) have climbed over 5% in the last 4 trading days.
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SpaceX's Dragon capsule successfully docked with the International Space Station or ISS last Sunday, delivering about 5,700 pounds of cargo that includes supplies for crew living at the space station, genetically enhanced "mighty mice", and a floating robot. The company's next resupply mission to...
Major League Baseball or MLB and the Major League Baseball Players Association on Thursday announced major changes to their drug prevention and treatment program that favors a treatment-based approach to drug use. The changes to the Joint Drug Prevention and Treatment Program include removing marijuana...
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As we begin the final month of the year, it's time to take a look at the drug candidates lined up at the FDA altar awaiting the federal agency's decision.
It's been more than 4 years since the first biosimilar Zarxio was approved in the U.S. Zarxio, developed by Sandoz, a Novartis division, is a biosimilar version of Amgen Inc.'s (AMGN) Neupogen, and it received the regulatory nod in the U.S. in March 2015.
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Shares of Vapotherm Inc. (VAPO) are down nearly 61 percent from a high of $24.63 recorded on July 2, 2019, and trade around $9.
Shares of SI-BONE Inc. (SIBN) are down nearly 32 percent from a high of $23.03 recorded on January 16, 2019, and trade around $15.
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