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The U.S. Food and Drug Administration approved Kisqali or ribociclib in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer,...
Genentech, a member of the Roche Group (RHHBY), announced Wednesday that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for TECENTRIQ (atezolizumab) in combination with Avastin (bevacizumab) as an initial (first-line) treatment for people with advanced or metastatic...
Bristol-Myers Squibb Company (BMY) announced Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. FDA for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high or mismatch...
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pharma-daily-071818.jpg Today's Daily Dose brings you news about the IPO of a cannabis firm; stock offerings of Evolus and Cara, upcoming regulatory catalyst of Immunomedics and an update on CTI Biopharma's Type B meeting with the FDA for its lead product candidate Pacritinib.
pharma-daily-071118.jpg Today's Daily Dose brings you news about IPOs of Crinetics Pharma and Rubius; secondary offerings of Cara, Oragenics and CytomX, and promising efficacy of Cellectar Biosciences' drug candidate CLR 131 observed in a single patient in a phase II trial.
pharma-daily-071618.jpg Today's Daily Dose brings you news about the resignation of Bellicum Pharma's CFO; Evolus' stock offering; Nevro's preliminary revenue figures for the second quarter of 2018 and full year outlook; FDA clearance of Quidel's new test and Spero's BARDA funding.
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Flowers Foods, Inc. (FLO) is voluntarily recalling Mrs. Freshley's and other brands Of Swiss Rolls and Captain John Derst's Old Fashioned Bread due to the potential presence of Salmonella in an ingredient, whey powder. No illnesses have been reported in connection with the recalled items, the company...

The Food and Drug Administration said that Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level....

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An outbreak of Listeria monocytogenes that has been affecting Austria, Denmark, Finland, Sweden and the United Kingdom since 2015 has been linked to frozen corn and possibly other frozen vegetables produced in a company in Hungary.

The U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS announced that Los Angeles, Calif. establishment People's Sausage Co., is recalling approximately 13,554 pounds of elk, bison and beef meat stick products that were produced without an approved voluntary grant of inspection. This...

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Date Company Name Ticker Drug Event Outcome Details
12/24/2018 Roche Holding AG RHHBY Baloxavir Marboxil (NDA) FDA decision on Baloxavir Marboxil for the treatment of acute, uncomplicated influenza in people 12 years and older
12/20/2018 Jazz Pharmaceuticals plc JAZZ Solriamfetol (NDA) FDA decision on Solriamfetol for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
12/19/2018 SAGE Therapeutics, Inc. SAGE Brexanolone IV (NDA) FDA decision on Brexanolone IV for the treatment of postpartum depression
11/09/2018 Merck & Co Inc. MRK KEYTRUDA (sBLA) FDA decision on KEYTRUDA as a treatment for previously treated patients with advanced hepatocellular carcinoma
11/05/2018 EyePoint Pharmaceuticals, Inc. EYPT Durasert micro-insert (NDA) FDA decision on Durasert micro-insert for non-infectious posterior segment uveitis
11/05/2018 EyePoint Pharmaceuticals, Inc. EYPT Durasert (NDA) FDA decision on Durasert for posterior segment uveitis
11/03/2018 Coherus Biosciences, Inc. CHRS CHS-1701 (Resubmitted BLA) FDA decison on CHS-1701, a biosimilar version of Neulasta
11/03/2018 AcelRx Pharmaceuticals Inc. ACRX DSUVIA (Resubmitted NDA) FDA decision on DSUVIA for the management of acute moderate to severe pain in adults in medically monitored settings
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Results Date Company Name Ticker Event Indication Outcome
Q4 2018 PROTEON THERAPEUTICS INC PRTO Top line data from 2nd phase III trial of Vonapanitase (PATENCY 2) chronic kidney disease (CKD)
Q4 2018 Clearside Biomedical, Inc. CLSD Preliminary data from first phase III trial of CLS-TA (SAPPHIRE) Retinal Vein Occlusion
Q4 2018 Zosano Pharma Corporation ZSAN 6-month safety data of long-term study of M207 Migraine
Q4 2018 Biohaven Pharmaceutical Holding Co Ltd. BHVN Topline results 3rd phase III efficacy study of Rimegepant Migraine
Early Q4 2018 GTX Inc. GTXI Top-line results from phase II clinical trial of Enobosarm (ASTRID) stress urinary incontinence in postmenopausal women
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The IPO activity in the U.S. pharma/biotech sector had a strong showing last quarter (Q2) with 24 listings compared to 13 in the year-ago period. There has not been a single biotech IPO for the month of July so far. But that is about to change.
Shares of Ra Pharmaceuticals Inc. (RARX) are up nearly 22% so far this month compared to the 8.5% gain of the iShares Nasdaq Biotechnology ETF (IBB) index during the same period.
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Women are said to experience a more severe outcome from influenza A virus infection and recover slower than men, even when the viral load is the same in both the genders.
Frequent use of digital media is associated with the development of attention-deficit/hyperactivity disorder (ADHD) symptoms during adolescence, finds a new study conducted by a team of researchers of the University of Southern California.
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The process of drug development is challenging. Some drugs pass the FDA muster easily, while some face a host of hurdles before getting the official stamp of approval. As of this writing, 21 novel drugs have been approved by the FDA so far this year. Novel drugs are new molecular entities (NMEs) having...
The development of Alzheimer's drugs has been marred by a high failure rate. Despite the high failure rate, the pharma companies have not shied away from making investments in Alzheimer's research. Let's take a look at the companies whose Alzheimer's drugs are in phase III development.
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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.
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