Biotechnology News

Baudax Bio Inc. (BXRX) has received FDA approval for ANJESO, which is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.
Genentech, a member of Swiss drug maker Roche Group (RHHBY) said Wednesday that the U.S. Food and Drug Administration or FDA has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab) as a first-line monotherapy for certain people...
Novartis said that European Commission approved Beovu injection for the treatment of wet age-related macular degeneration or AMD, a leading cause of blindness worldwide. Beovu also offers the ability to start eligible wet AMD patients on a three-month dosing interval immediately after the loading...
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Shares of Forty Seven Inc. (FTSV) are up more than 22 percent in pre-market trading on Friday, following reports that Gilead Sciences, Inc. (GILD) is interested in acquiring the clinical-stage, immuno-oncology company.
pharma-032717_27feb20.jpg Today's Daily Dose brings you news about FDA approval of Biohaven's migraine drug, iBio's Annual Meeting, Sangamo's deal with Biogen, and Zogenix's revised FDA decision date.
pharma-050917_27feb20.jpg Today's Daily Dose brings you news about Menlo's Serlopitant trial results, Novavax's update on its efforts to develop a novel vaccine against coronavirus disease COVID-19, Oramed's oral insulin trial results and Vir Biotech's entry into coronavirus vaccine development space.
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California-based Sierra Soups is recalling "Pasta e Fagioli" soup mix for concerns of undeclared gluten, the U.S. Food and Drug Administration said in a statement. The soup mix contained an individually wrapped package of pasta that contains gluten, a known allergen. However, the outer packaging states the product is Gluten Free. The problem was caused by a breakdown in the packaging processes.


Med Man Distribution expanded its recall for dietary supplements including all lots of "Bow and Arrow libido enhancer for men" for the potential undeclared presence of sildenafil, the U.S. Food and Drug Administration said in a statement. Sildenafil is an FDA-approved prescription drug for erectile dysfunction. The company had earlier in November 2019 recalled all lots of Up2 dietary supplement.


Taro Pharmaceuticals U.S.A., Inc., the U.S.-based business of Israeli Pharma firm Taro Pharmaceutical Industries, Ltd., recalled certain lots of seizure medication Phenytoin in the form of oral suspension for potential underdosing or overdosing, the U.S. Food and Drug Administration said in a statement. The company found that the oral suspension may not re-suspend when shaken.


CJ Foods, Inc., a division of CJ America, Inc., recalled Annie Chun's Japanese-Style Teriyaki Noodle Bowls due to undeclared peanuts, the U.S. Food and Drug Administration said. The La Palma, California-based company initiated the recall after discovering that some bowls that were packaged in outer sleeves indicating Teriyaki Noodle Bowls contain Pad Thai noodle, which contains peanuts.

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Date Company Name Ticker Drug Event Outcome Details
08/22/2020 Tricida, Inc. TCDA Veverimer (NDA) FDA decision on Veverimer for treatment of patients with chronic kidney disease
08/20/2020 Seattle Genetics Inc. SGEN Tucatinib (NDA) FDA decision on Tucatinib for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer
08/17/2020 Bristol-Myers Squibb Co. BMY Lisocabtagene maraleucel (BLA) FDA decision on Lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies
08/16/2020 Jazz Pharmaceuticals plc JAZZ Lurbinectedin (NDA) FDA decision on lurbinectedin for patients with SCLC who have progressed after prior platinum-containing therapy
08/13/2020 Deciphera Pharmaceuticals, Inc. DCPH Ripretinib (NDA) FDA decision on Ripretinib for advanced gastrointestinal stromal tumors
08/10/2020 Gilead Sciences Inc. GILD KTE-X19 (BLA) FDA decision on KTE-X19 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma
08/05/2020 DBV Technologies S.A. - DBVT Viaskin Peanut (BLA) FDA decision on Viaskin Peanut for treatment of peanut allergy
07/31/2020 Ultragenyx Pharmaceutical Inc RARE UX007 (triheptanoin) (NDA) FDA decision on for UX007 for treatment of Long-chain Fatty Acid Oxidation Disorders
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Results Date Company Name Ticker Event Indication Outcome
Mid 2020 CohBar, Inc. CWBR Activity readout from Phase 1a/1b clinical trial of CB4211 Nonalcoholic steatohepatitis (NASH) and obesity
Mid 2020 La Jolla Pharmaceutical Co LJPC Topline results from a pivotal study of LJPC-401 Beta Thalassemia Discontinued study; reported on Nov 26; stock down 53.58%
Mid 2020 Vascular Biogenics Ltd. VBLT Data readout from phase II study of VB-111 Recurrent glioblastoma multiforme
Mid 2020 Constellation Pharmaceuticals, Inc. CNST Interim phase II data of CPI-1205 (ProSTAR) Metastatic castration-resistant prostate cancer (mCRPC)
Mid 2020 ChemoCentryx Inc. CCXI Top-line data from phase IIb clinical trial of Avacopan (AURORA) Hidradenitis Suppurativa
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Shares of Vaxart Inc. (VXRT) have gained an impressive 265 percent so far this year on hopes of a vaccine for the novel coronavirus.
Soligenix Inc. (SNGX), a late-stage biopharmaceutical company developing products to treat rare diseases, has multiple potential value drivers, making the stock worth watching.
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Cannabis delivery company Eaze said it has closed a $20 million investment and also secured the ability to raise up to an additional $20 million to complete its Series D funding, which are intended to help the company's verticalization plans. The $20 million in funding from Series D investors, led...
The U.S. Department of Agriculture or USDA said it has approved hemp production plans for two more states and three additional tribes under the U.S. Domestic Hemp Production Program. The agency has now approved hemp production plans for the states of Washington and Wyoming as well as for the Otoe-Missouria...
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The new coronavirus, COVID-19, which originated in China, has now spread to least 47 countries, infecting over 81,000 people and killing 3,000 people, with the majority of them in China.
The World Health Organization has declared the ongoing new coronavirus outbreak a public health emergency of international concern.
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Shares of Hoth Therapeutics Inc. (HOTH) are down 22 percent so far this year, and trade around $5.
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