Biotechnology News

Vertex Pharmaceuticals Inc. (VRTX) announced Monday that the European Commission has granted approval of the label extension for ORKAMBI (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis or CF aged 2 to 5 years old who have two copies of the F508del mutation, the most common form...
Genentech, a member of the Roche Group (RHHBY), said Thursday that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application or sBLA for Tecentriq (atezolizumab) in combination with Abraxane (albumin-bound paclitaxel; nab-paclitaxel) and carboplatin for...
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pharma-022317_23jan19.jpg Today's Daily Dose brings you news about stock offerings of Ohr Pharma, NuCana, UroGen; General Mills' recall of Gold Medal Unbleached Flour; partial clinical hold on Advaxis' cervical cancer trial; and Ironwood Pharma's progress with central nervous system (CNS)-penetrant soluble guanylate cyclase (sGC) stimulator IW-6463.
pharma-022018_23jan19.jpg Today's Daily Dose brings you news about Green Growth's unsolicited take-over bid for Aphria; the stock offering of Bellerophon, PTC Therapeutics; Accuray's better-than-expected Q2 results; UNITY Biotechnology's progress in osteoarthritis trial; positive data from Ultragenyx Pharma's phase II study of UX007 in patients with long-chain fatty acid oxidation disorder.
pharma-021618_17jan19.jpg Today's Daily Dose brings you news about FDA thumbs down on Immunomedics' breast cancer drug; FDA panel vote on Sanofi/Lexicon's diabetes drug; progress in Zymeworks/ Lilly collaboration; and encouraging data from Zafgen's diabetes trial.
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Wegmans Food Markets Inc., a supermarket chain, is recalling fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower due to potential contamination with Escherichia coli O157:H7 bacteria (E. Coli O157:H7).


The FDA is warning consumers about the risk of rare but serious cases of stroke and tears in the lining of arteries in the head and neck associated with multiple sclerosis drug Lemtrada, chemically known as Alemtuzumab. These problems can lead to permanent disability and even death.


Sprout Creek Farm of Poughkeepsie, New York is recalling 4 wheels of "Kinkead" cheese made on 5-10-18, due to potential Listeria monocytogenes contamination. No illnesses have been reported to date. "Kinkead" is a raw semi-firm, washed natural rind cheese, packaged with an orange label.

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Date Company Name Ticker Drug Event Outcome Details
05/28/2019 Nektar Therapeutics NKTR NKTR-181 (NDA) FDA decision on NKTR-181 for chronic low back pain in adult patients new to opioid therapy
04/28/2019 Sanofi SNYNF, SNY Praluent (sBLA) FDA decision to include the effect of Praluent in reducing overall risk of major adverse cardiovascular events
04/28/2019 Regeneron Pharmaceuticals REGN Praluent (sBLA) FDA decision to include the effect of Praluent in reducing overall risk of major adverse cardiovascular events
04/02/2019 ADMA BIOLOGICS, INC. ADMA RI-002 (BLA resubmission) FDA decision on RI-002 to treat primary immune deficiency disease
04/01/2019 Evoke Pharma, Inc. EVOK Gimoti (NDA) FDA decision on Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis
03/24/2019 Recro Pharma Inc. REPH Resubmitted IV Meloxicam (NDA) FDA decision on resubmitted IV Meloxicam for management of moderate to severe pain
03/22/2019 Lexicon Pharmaceuticals Inc. LXRX Sotagliflozin (NDA) FDA decision on Sotagliflozin for type 1 diabetes
03/22/2019 Sanofi SNYNF, SNY Sotagliflozin (NDA) FDA decision on Sotagliflozin for type 1 diabetes
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Results Date Company Name Ticker Event Indication Outcome
Q2 2019 Celsion Corp. CLSN Data from 1st interim efficacy results from phase III study of ThermoDox (OPTIMA) primary liver cancer
Q2 2019 Heat Biologics Inc. HTBX Interim data from ComPACT trial of HS-130 Non Small Cell Lung Cancer (NSCLC)
Q2 2019 Heat Biologics Inc. HTBX Final data from Phase II readout of HS-110 Non Small Cell Lung Cancer (NSCLC)
Q2 2019 Arbutus Biopharma Corp. ABUS Top line results from phase I trial of AB-506 Hepatitis B Virus (HBV)
Q2 2019 Myovant Sciences Ltd MYOV Top-line data from 1st phase III trials of Relugolix (LIBERTY 1) Heavy menstrual bleeding associated with uterine fibroids in Women
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Shares of AVROBIO Inc. (AVRO) have lost 39% of their value over the last 1 month in sharp contrast to the iShares Nasdaq Biotechnology ETF (IBB) index which has gained 8% during the same period.
Shares of Innoviva Inc. (INVA), which recently touched a new 52-week high of $19.82, are up 12% so far this month, slightly lagging behind the iShares NASDAQ Biotechnology Index (ETF) (IBB), which has gained 14% during the same period.
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Maryland-based Flying Dog Brewery is partnering with cannabis provider Green Leaf Medical Cannabis on a plan to release Maryland's first THC-infused beer in 2019. Flying Dog said in a press release that the beer, a non-alcoholic India Pale Ale named Hop Chronic, will serve as a medical delivery system...
The societal perception of cannabis has undergone a drastic shift, as can be seen from the number of countries jumping on the marijuana legalization bandwagon. Amid this changing scenario, a new study has found that recreational cannabis use, especially in the adolescent period, can bring about structural differences in the brain.
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Cancer is the second leading cause of death in the world, next to heart disease. Let's take a look at some of the companies whose cancer drugs are in phase III /pivotal trials.
2018 marked a record year for new drug approvals, with 59 new molecular entities, or NMEs, getting the FDA's stamp of approval. The only other time the number of new drug approvals crossed 50 was in 1996 when the tally was 53.
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Shares of Cue Biopharma Inc. (CUE) are down nearly 74% from their 52-week high of $17.99 recorded on March 14, 2018.
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