Biotechnology News

AstraZeneca PLC (AZN.L, AZN) and MedImmune announced the US FDA has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval is based on the...
The U.S. Food and Drug Administration approved Erleada or apalutamide for the treatment of patients with prostate cancer that has not spread or non-metastatic, but that continues to grow despite treatment with hormone therapy or castration-resistant. It is the first FDA-approved treatment for non-metastatic,...
Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (VRX, VRX.TO) announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application for JEMDEL™1 (halobetasol propionate 0.01%) IDP-122 lotion. The PDUFA action date is set for October...
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Pharma-022218.jpg Today's Daily Dose brings you news about Mesoblast's steroid refractory acute Graft versus Host Disease trial results; CHMP's positive trend vote for Rucaparib in ovarian cancer and HEPLISAV-B vaccine getting favorable recommendation from the CDC's Advisory Committee on Immunization Practices.
Pharma-022118.jpg Today's Daily Dose brings you news about the outcome of the European Medicines Agency's oral explanation meeting related to Portola's drug candidates; HealthStream's Q4 financial results; Aimmune's PALISADE trial results; Ultragenyx Pharma's upcoming milestones and TherapeuticsMD's pending regulatory catalyst.
Pharma-021618.jpg Today's Daily Dose brings you news about the regulatory catalysts for Akcea; public offering of Amicus' shares; priority review of Agios' Ivosidenib NDA; FDA panel's feedback on the expanded indication for Pacira's EXPAREL, and United Therapeutics' patent litigation with Actavis.
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Ackley, Iowa establishment Triple T Specialty Meats, Inc. is recalling approximately 20,630 pounds of ready-to-eat chicken salad products due to possible Salmonella Typhimurium contamination. About 37 confirmed case-patients have been identified in Iowa. These items were shipped to Fareway grocery stores in Iowa, Illinois, Minnesota, Nebraska, and South Dakota.


A & A Finest is recalling approximately 572 pounds of frozen pork and shrimp dumpling products due to presence of egg, which is not declared on the product label. The problem was discovered on February 20, 2018 during routine FSIS label verification activities. These items were shipped to hotel restaurants in New York.


Pilgrim's Pride Corp. is recalling approximately 101,310 pounds of ready-to-eat breaded chicken patties due to possible contamination of extraneous materials, specifically rubber. This problem was discovered after the firm received a customer complaint on Feb. 13, 2018. Meanwhile, there have been no confirmed reports of adverse reactions due to consumption of these products.


Apace Packaging LLC is recalling one lot of Acyclovir Tablet, USP, 400mg, to the retail level, due to product mix-up. A small number of blister cards containing the product may potentially also include Torsemide, 20mg, Tablets. Apace Packaging said it has not received any reports of adverse events related to this recall.

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Date Company Name Ticker Drug Event Outcome Details
08/11/2018 Alnylam Pharmaceuticals Inc. ALNY Patisiran (NDA) FDA decision on Patisiran for the treatment of hereditary ATTR (hATTR) amyloidosis
06/27/2018 GW Pharmaceuticals PLC GWPH, GWP.L Epidiolex (NDA) FDA decision on Epidiolex for treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome
06/25/2018 Achaogen Inc. AKAO Plazomicin (NDA) FDA decision on Plazomicin for the treatment of complicated urinary tract infections, and bloodstream infections
06/23/2018 scPharmaceuticals Inc. SCPH Furoscix (505(b)(2) NDA) FDA decision on Furoscix for treatment of worsening, or decompensated, heart failure outside of the inpatient setting
06/16/2018 Teva Pharmaceutical Industries Limited TEVA Fremanezumab (BLA) FDA decision on Fremanezumab for the treatment of migraine
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Results Date Company Name Ticker Event Indication Outcome
Mid 2018 Esperion Therapeutics ESPR Topline results from phase 3 study of Bempedoic acid (CLEAR Harmony) LDL-C lowering in hypercholesterolemic patients
Mid 2018 Vital Therapies, Inc VTL Top line data from phase 3 trial of ELAD severe acute alcoholic hepatitis
Mid 2018 Alkermes plc ALKS Results from 2nd phase 3 study of ALKS 3831 (ENLIGHTEN-2) Schizophrenia
Mid 2018 VANDA PHARMACEUTICALS VNDA Data from phase II study of Tradipitant Gastroparesis
Mid 2018 BioLineRx Ltd. BLRX Top-line results of Phase 2 study for BL-8040 Stem-cell mobilization for allogeneic transplantation
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Shares of Inflarx NV (IFRX) are up more than 50% year-to-date while the iShares NASDAQ Biotechnology Index (ETF) has gained only 2% during the same period.
Shares of Catalyst Biosciences Inc. (CBIO) are up an impressive 100% year-to-date in sharp contrast to the NASDAQ Biotechnology Index, which is down nearly 2% during the same period.
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There are a number of interesting facts about naked mole rats, which are natives to East Africa. Of the many interesting facts about naked mole rats, their long cancer-free life has puzzled researchers. The lifespan of naked mole rats is 10-30 years, while its cousins - rat and mice- can live only up to 4 years, and are very prone to tumors.
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