Biotechnology News

Boston Scientific Corp.'s (BSX) shares gained around 2 percent in the extended trading on Tuesday after the company announced it has received U.S. Food and Drug Administration approval for the LOTUS Edge Aortic Valve System. The transcatheter aortic valve replacement or TAVR technology is delivered...
skyrizi-april24.jpg The therapeutic armamentarium for plaque psoriasis patients is fairly well-stocked, and now there is one more addition to it.
pharma-033017_22apr19.jpg The first medical device to treat attention deficit hyperactivity disorder, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, has been given clearance by the FDA.
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pharma-030118_23apr19.jpg Shares of InflaRx N.V. (IFRX) have been on a roll since the beginning of this year, hitting new highs.
kratom-april22.jpg Kratom, which made news frequently for all the wrong reasons last year, is back in the headlines.
famousfive-041019.jpg The biotech sector got off to a good start in 2019, and the iShares Nasdaq Biotechnology ETF (IBB), a bellwether of investor sentiment, has so far gained 17 percent.
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Yoakum Packing Co. is recalling approximately 12,388 pounds of smoked venison sausage that contains pork products that were not represented on the label. This problem was discovered during routine labeling verification by FSIS on April 10, 2019. Meanwhile, there have been no confirmed reports of adverse reactions due to consumption of these products.


Houston, Texas establishment Great American Marketing, Inc. is recalling approximately 3,329 pounds of ready-to-eat meat and poultry wrap and salad products due to possible Listeria monocytogenes contamination. The problem was discovered when routine testing of a shared FSIS and FDA processing area within the establishment was confirmed positive for the presence of L. monocytogenes.


JBS Plainwell, Inc. is recalling approximately 43,292 pounds of ground beef products due to possible foreign matter contamination, specifically, pieces of hard plastic. This problem was discovered after two complaints of green hard plastic in the ground beef products. Meanwhile, there have been no confirmed reports of adverse reactions due to consumption of these products.

J&J Snack Foods Corp. Handheld Division, is recalling two production dates of Bremer Classic Handheld hot stuffed sandwiches (Pepperoni Pizza and Ham & Cheese) due to possible foreign material contamination, specifically a hard semi-transparent plastic. Meanwhile, there have been no reports of adverse...

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Date Company Name Ticker Drug Event Outcome Details
10/19/2019 Clearside Biomedical, Inc. CLSD XIPERE (NDA) FDA decision on XIPERE for Suprachoroidal Injection for macular edema associated with uveitis
10/14/2019 Flexion Therapeutics, Inc. FLXN ZILRETTA (sNDA) FDA decision on the repeat administration of ZILRETTA for patients with osteoarthritis knee pain
09/27/2019 Intra-Cellular Therapies, Inc. ITCI Lumateperone (NDA) FDA decision on Lumateperone for the treatment of schizophrenia
09/03/2019 Celgene Corporation CELG Fedratinib (NDA) FDA decision on Fedratinib for myelofibrosis
09/02/2019 Roche Holding AG RHHBY Tecentriq (sBLA) FDA decision on Tecentriq plus chemotherapy in metastatic non-squamous non-small cell lung cancer
08/19/2019 Nabriva Therapeutics NBRV Lefamulin (NDA) FDA decision on oral and IV formulations of Lefamulin for bacterial pneumonia
08/16/2019 VANDA PHARMACEUTICALS VNDA HETLIOZ (sNDA) FDA decision on HETLIOZ for the expanded indication of jet lag disorder
07/06/2019 Karyopharm Therapeutics Inc. KPTI Selinexor (NDA) FDA decision on Selinexor for patients with refractory multiple myeloma
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Results Date Company Name Ticker Event Indication Outcome
2H 2019 Conatus Pharmaceuticals Inc CNAT Data from Phase 2b clinical trial of Emricasan (ENCORE-LF) decompensated NASH cirrhosis
2H 2019 Endocyte, Inc. ECYT 1st interim assessment of overall survival in phase III trial of 177Lu-PSMA-617 Metastatic castration-resistant prostate cancer
Q3 2019 The Medicines Co. MDCO Data read-out from 1st Phase III pivotal clinical trial of inclisiran (ORION-10) LDL-cholesterol with atherosclerotic cardiovascular disease
Q3 2019 The Medicines Co. MDCO Data read-out from 2nd pivotal Phase III LDL-C lowering trial of inclisiran(ORION-9) LDL-cholesterol with atherosclerotic cardiovascular disease
Q3 2019 The Medicines Co. MDCO Data read-out from 3rd pivotal Phase III LDL-C lowering trial of inclisiran(ORION-11) LDL-cholesterol with atherosclerotic cardiovascular disease
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Shares of INmune Bio Inc. (INMB) touched an all-time high of $11 on Tuesday (Apr.16), and that represents a gain of nearly 38% since their market debut in February.
Jerusalem, Israel-based Brainsway is a commercial stage medical device company marketing non-invasive neuromodulation products for the treatment of major depressive disorder and obsessive-compulsive disorder.
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The conventional wisdom is that if the brain cells of humans and other mammals are deprived of oxygen for 4-5 min, they begin to die, and that the loss of brain functions after death is irreversible. But the findings of a study conducted by Yale University researchers challenge these long-held assumptions.
Canadian marijuana producer Aurora Cannabis Inc. (ACB, ACB.TO) has agreed to acquire the remaining 48 percent stake in Hempco Food and Fiber Inc. (HEMP.V) that it does not already own, in a deal that values Hempco at about C$63.4 million. Shares of Hempco gained more than 10 percent in Tuesday's trading. Aurora...
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On April 8, the FDA approved Dovato, a two-drug regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral treatment history.
Peanut allergy, a condition in which the immune system mistakenly recognizes a number of proteins from peanuts as potential foreign pathogens, triggering an inflammation, is most common in children. The rate of peanut allergy is on the rise - with approximately 2 percent of children, roughly 1.5 million children in the U.S., being affected, according to the Jaffe Food Allergy Institute.
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Shares of Unum Therapeutics Inc. (UMRX) are down nearly 75% from their all-time high of $17.66 recorded on August 7, 2018.
It's been a year since we started the column "This Day That Year" featuring some of the biotechs that have completed a year of listing. Here's a look back at the journey of those stocks so far and look ahead at some of what's in store for them.
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