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Novartis (NVS) announced positive results from the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) in combination with fulvestrant. The trial evaluated the efficacy and safety of alpelisib in postmenopausal women with PIK3CA mutated hormone-receptor...
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Allergan plc (AGN) and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, said that the U.S. Food and Drug Administration approved Medicines360's Supplemental New Drug Application or sNDA to extend the duration of use of LILETTA...
AstraZeneca and Merck (MRK) announced the U.S. FDA granted orphan drug designation for LYNPARZA for the treatment of pancreatic cancer. LYNPARZA is currently being investigated as maintenance therapy in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer whose disease has not progressed...
British drug major AstraZeneca (AZN.L, AZN) and Merck & Co., Inc., (MRK) announced Tuesday that they were granted orphan drug designation or ODD by the US Food and Drug Administration for Lynparza (olaparib) for the treatment of pancreatic cancer, a rare, life-threatening disease. Lynparza (olaparib)...
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ipo-aug13.jpg Alzheon is a U.S. clinical-stage biopharmaceutical company developing medicines for patients suffering from Alzheimer's disease and other neurological and psychiatric disorders.
pharma-012518_17oct18.jpg Today's Daily Dose brings you news about Celcuity's clinical trial agreement with Puma; Cerus' upbeat revenue outlook; workforce reduction at Cesca; positive results from pilot study of Cannabics capsules; and Eiger's disappointing results from ULTRA study.
nasdaq-oct16.jpg Clinical trials are major catalysts for biotech/pharma companies as positive study data can boost the stock price while unfavorable results can send the stocks plummeting.
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Ukrop's Homestyle Foods is recalling roughly 18,296 pounds of ready-to-eat meat and poultry deli-sliced products due to possible Listeria contamination, according to the the U.S. Department of Agriculture's Food Safety and Inspection Service.

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JBS Tolleson Inc., a meat producer, is recalling about 6.91 million pounds of various raw, non-intact beef products due to contamination with Salmonella Newport, according to the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS).

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Torrent Pharmaceuticals Ltd.'s recalled Valsartan products have been found to contain a second impurity, N-Nitrosodiethylamine (NDEA), a known animal and suspected human carcinogen. The finding is based on results from FDA tests.

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Date Company Name Ticker Drug Event Outcome Details
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
03/14/2019 Aerie Pharmaceuticals, Inc. AERI Roclatan (NDA) FDA decision on Roclatan for patients with open-angle glaucoma, retina diseases
02/25/2019 Bausch Health Companies Inc. BHC, BHC.TO Loteprednol etabonate ophthalmic gel (NDA) FDA decision on Loteprednol etabonate ophthalmic gel for post-operative inflammation and pain following ocular surgery
02/18/2019 Alexion Pharmaceuticals Inc. ALXN ALXN1210 (BLA) FDA decision on ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria
02/13/2019 MOTIF BIO PLC MTFB Iclaprim (NDA) FDA decision on Iclaprim for acute bacterial skin and skin structure infections
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Results Date Company Name Ticker Event Indication Outcome
1H 2019 Conatus Pharmaceuticals Inc CNAT Results from Phase 2b trial of Emricasan (ENCORE-NF) NASH fibrosis
1H 2019 BeyondSpring Inc. BYSI Final data readout from phase 2/3 trial of Plinabulin ( Study 105) Neutropenia
Q1 2019 Zosano Pharma Corporation ZSAN 12-month safety data of long-term study of M207 Migraine
2019 OncoMed Pharmaceuticals Inc OMED Data from phase 1a single agent study of OMP-336B11 Solid tumors
2019 Calithera Biosciences Inc. CALA primary endpoint analysis from phase II trial of CB-839 in combination with Everolimus ( ENTRATA) Late stage renal cell carcinoma
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Shares of Akorn Inc. (AKRX) have lost nearly 78% of their value year-to-date while the iShares NASDAQ Biotechnology Index (IBB) is up 7% for the same period.
Shares of Epizyme Inc. (EPZM) have lost 50% of their value over the last 7 months compared to the 1.2 % gain of the iShares Nasdaq Biotechnology ETF (IBB) index during the same period.
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As we head into another month of new drug approvals, it's time to take a look at some of the FDA-related news that grabbed headlines in September. Seeking to curb the sharp rise in the number of teens using e-cigarettes, the FDA, has expanded its Youth Tobacco Prevention Plan, which was first introduced last April.
August proved to be a very busy month on the regulatory front, in terms of Novel Drug approvals, the ongoing efforts to restrict opioid abuse, and new efforts to encourage further advances in the rapidly evolving field of gene therapy. Now, let's take a look at the biotech stocks awaiting FDA decision in September.
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Shares of OrthoPediatrics Corp. (KIDS) are down nearly 20% from their 52-week high of $39.81 recorded on October 5, 2018.
Shares of Rhythm Pharmaceuticals Inc. (RYTM) are down nearly 28% from their 52-week high of $37.23 recorded on June 27, 2018.
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