Biotechnology News

Novartis (NVS) said that the European Commission has approved Enerzair Breezhaler as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist or LABA and a high-dose of an inhaled corticosteroid or ICS who experienced...
Mylan N.V. (MYL) announced Monday that the Drug Controller General of India or DCGI has approved its remdesivir 100 mg/vial for restricted emergency use in COVID-19 patients in India. The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children...
Golden Biotechnology Corp., a Taiwanese biopharmaceutical company, said the FDA approved its investigational new drug application for a Phase II clinical trial of Antroquinonol (Hocena) on COVID-19 patients in USA. The phase II trial will be a randomized, double-blinded, placebo-controlled study of Antroquinonol...
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stockmarkets jan22 07jul20 What's moving these stocks in the pre-market hours today?
pharma 032018 07jul20 Today's Daily Dose brings you news about BLU'S disappointing results from RELIEF trial, FDA hold on CLLS' trial, positive results from Immunomedics' confirmatory trial of Trodelvy, OBSV's phase III studies of Yselty in women with heavy menstrual bleeding due to uterine fibroids, OTIC's tinnitus study results, and clinical progress of REGN's anti-viral cocktail In treatment/prevention of COVID-19.
stockmarkets dec26 06jul20 What's moving these stocks in the pre-market today?
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fda recall 070720

Granules Pharmaceuticals, Inc. recalled twelve (12) lots of type 2 diabetes medication Metformin hydrochloride Extended-Release, in the form of oral film-coated tablets, for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA), above levels of the Acceptable Daily Intake Limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement.

listeriaconcerns july01

Garland Ventures Ltd is recalling Five Cheese Stuffed Shells citing possible presence of Listeria monocytogenes, the U.S. Food and Drug Administration said in a statement. The recall involves 1095 cases of Five Cheese Stuffed Shells trays that was distributed across the nation in limited number of retail stores.

norpac july01

Norpac Fisheries Export is recalling shrimp poke citing potential to be contaminated with Listeria monocytogenes, the U.S. Food and Drug Administration said in a statement.The recall involves all fresh shrimp poke distributed between May 11 and June 25 in the Hawaiian Island. The product was supplied on The Big Island, Maui, Oahu, and Kauai through its retail customers, specifically Safeway Stores

saniderm june30

UVT, Inc. recalled 38,830 liters of Saniderm Advanced Hand Sanitizer following a warning by the U.S. Food and Drug Administration about the potential presence of undeclared Methanol, a toxic chemical. The FDA last week urged consumers not to use any hand sanitizer products made by Mexico-based Eskbiochem SA de CV.

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Date Company Name Ticker Drug Event Outcome Details
12/30/2020 Athenex, Inc. ATNX Tirbanibulin Ointment (NDA) FDA decision on Tirbanibulin Ointment for the treatment of actinic keratosis
12/27/2020 Mylan N.V. MYL MYL-1402O (BLA) FDA decision on MYL-1402O, a proposed biosimilar to Avastin
12/26/2020 Urovant Sciences Ltd. UROV Vibegron (NDA) FDA decision on Vibegron for the treatment of overactive bladder
12/20/2020 AstraZeneca PLC AZN.L, AZN Roxadustat (NDA) FDA decision on Roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent and dialysis-dependent patients
12/20/2020 Myovant Sciences Ltd MYOV Relugolix (NDA) FDA decision on once-daily, oral Relugolix for the treatment of men with advanced prostate cancer
12/20/2020 FibroGen Inc. FGEN Roxadustat (NDA) FDA decision on Roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent and dialysis-dependent patients
12/19/2020 Amgen Inc. AMGN ABP 798 (BLA) FDA decision on ABP 798 (biosimilar rituximab) for Non-Hodgkin's lymphoma and Rheumatoid arthritis
12/18/2020 MacroGenics Inc. MGNX Margetuximab (BLA) FDA decision on Margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy
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Results Date Company Name Ticker Event Indication Outcome
Q4 2020 SOLIGENIX, INC. SNGX Final results from phase III study of SGX942 (dusquetide) Oral mucositis in patients with head and neck cancer
Q4 2020 Catabasis Pharmaceuticals, Inc. CATB Top-line results from phase III trial of Edasalonexent (POLARIS DMD) Duchenne muscular dystrophy
Oct 2020 Tracon Pharmaceuticals, Inc. TCON Completion of Phase 1/2A Study Metastatic castrate resistant prostate cancer
Q4 2020 RHYTHM PHARMACEUTICALS, INC. RYTM Topline data from phase III trial of Setmelanotide BBS and Alström syndrome
Q4 2020 PhaseBio Pharmaceuticals Inc PHAS Results from Phase 2b clinical trial of PB1046 Pulmonary Arterial Hypertension
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Seattle, Washington-based Accolade Inc. is scheduled to list its IPO on the Nasdaq Global Select Market under the symbol "ACCD" on July 2, 2020. The initial public offering price is expected to be between $19.00 and $21.00 per share.
Shares of Vaxart Inc. (VXRT) closed at a two-year high of $6.26 on Thursday, thanks to the Company's pipeline progress, especially the COVID-19 vaccine program.
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Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that the current state of the COVID-19 pandemic in the U.S. is "really not good." The U.S. is the country worst-affected by the coronavirus and has recently seen a surge in coronavirus infections as lockdown restrictions are eased.
With 359 new deaths reporting in the last 24 hours, the total COVID-19 death toll in the U.S. increased to 130306, as per Johns Hopkins University's latest update Tuesday. The daily infection rate rose to 49,896, taking the number of coronavirus cases in the country to 2,888,729. Texas' coronavirus hospitalizations hit new daily high of 10710 on Monday, taking the total number of COVID-19 patie
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The first half of 2020 looks set to end on an encouraging note for new drug approvals despite the ongoing coronavirus pandemic. Let's take a look at the biotech stocks facing FDA decision in July.
When will a safe and effective vaccine for COVID-19 be ready? Vaccine makers are racing against time to develop a vaccine to fight the novel coronavirus. There are more than 130 candidate vaccines in development against SARS-COV-2, the pathogen that causes COVID-19, of which 10 have moved into clinical trials.
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Shares of Adaptive Biotechnologies Corp. (ADPT) have gained over 200 percent from their 52-week low of $15.19, recorded in March of this year, and trade around $46.
Shares of Personalis Inc. (PSNL) are down 61 percent from their 52-week high of $31.88, recorded last June, and trade around $12.
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