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Drug maker Merck & Co. Inc. (MRK) said Tuesday that the U.S. Food and Drug Administration has accepted and granted priority review for a new supplemental Biologics License Application or sBLA for Keytruda, Merck's anti-PD-1 therapy, as monotherapy for the treatment of patients with advanced small cell...
Novo Nordisk announced that the US Food and Drug Administration has approved the Biologics License Application for Esperoct for the treatment of adults and children with haemophilia A. Esperoct is the brand name for turoctocog alfa pegol, N8-GP. ESPEROCT is indicated for use in adults and children...
Swiss drug major Roche Holding AG (RHHBY) said Tuesday that the U.S. Food and Drug Administration has accepted the company's New Drug Applications or NDAs and granted Priority Review for the company's personalised medicine entrectinib. Entrectinib was granted priority review for the treatment of adult...
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pharma-022618_21feb19.jpg Today's Daily Dose brings you news about Exact Sciences' better-than-expected Q4 financial results; Merck's acquisition of Immune Design; Nevro's lackluster revenue outlook; Opiant Pharma' s disappointing Bulimia Nervosa study results; and near-term catalyst of Zosano Pharma.
pharma-031518_21feb19.jpg Today's Daily Dose brings you news about Achieve Life Sciences' progress in ORCA-1 trial; Agios Pharma's near-term regulatory catalyst; new development related to ARCA biopharma's PRECISION-AF pivotal study; financial outlook of Genomic Health and NuVasive; near-term clinical trial catalyst of Sarepta; and partial clinical hold on Xencor's phase I acute myeloid leukemia trial.
pharma-032317_20feb19.jpg Today's Daily Dose brings you news about Bausch Health's acquisition of the U.S. rights to Eton Pharma's EM-100 eye drop; Cellular Biomedicine's business highlights and financial results for Q4, 2018; CE Mark approval for Edwards Lifesciences' PASCAL transcatheter valve repair system; Invitae's better-than-expected Q4 financial results among others.
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The FDA has added Boxed Warning to the label of gout medicine Uloric that highlights the increased risk of death with the drug.

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The World Health Organization has warned consumers to be on vigil against fake versions of leukemia drug Iclusig sold in Europe and the Americas.

The U.S. Department of Agriculture's Food Safety and Inspection Service announced that City of Industry, Calif. firm Richwell Group, Inc., doing business as Maxfield Seafood, is recalling approximately 55,300 pounds of Siluriformes fish products that were not presented for import re-inspection into the...

The U.S. Department of Agriculture's Food Safety and Inspection Service announced that Lakewood, Calif. firm Q's American Best Trading Inc. is recalling approximately 1,008 pounds of imported Siluriformes fish products that were not presented for import re-inspection into the U.S. This problem was...

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Date Company Name Ticker Drug Event Outcome Details
06/30/2019 Nabriva Therapeutics NBRV CONTEPO (NDA) FDA decision on CONTEPO IV for the treatment of complicated urinary tract infections
06/21/2019 Agios Pharmaceuticals, Inc. AGIO TIBSOVO (sNDA) FDA decision on TIBSOVO for newly diagnosed acute myeloid leukemia with IDH1 mutation
06/10/2019 Merck & Co Inc. MRK KEYTRUDA (sBLA) FDA decision on KEYTRUDA as Monotherapy or in combination with Chemotherapy
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
04/30/2019 Heron Therapeutics Inc. HRTX HTX-011 (NDA) FDA decision on HTX-011 for the management of postoperative pain
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
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Results Date Company Name Ticker Event Indication Outcome
Mid 2019 Sesen Bio Inc SESN 12-month data from phase III trial of Vicinium (VISTA) High grade non-muscle invasive bladder cancer (NMIBC) Positive results announced on Jan 3
Mid 2019 VBI Vaccines Inc. VBIV Pivotal Phase 3 clinical program for Sci-B-Vac to evaluate the safety and immunogenicity (PROTECT) Hepatitis B
Mid 2019 VBI Vaccines Inc. VBIV Pivotal Phase 3 clinical program for Sci-B-Vac to demonstrate lot-to-lot consistency for immune response (CONSTANT) Hepatitis B
Mid 2019 Nightstar Therapeutics plc NITE Preliminary Data from expansion study of phase I/II clinical trial of NSR-RPGR (XIRIUS) X-Linked Retinitis Pigmentosa (XLRP)
Mid 2019 Caladrius Biosciences, Inc. CLBS Final results from phase II clinical trial of CLBS12 Critical limb ischemia
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Eton Pharmaceuticals Inc. (ETON), which made its public debut last November, touched a new high of $7.49 yesterday.
Shares of Bausch Health Companies Inc. (BHC), formerly known as Valeant Pharmaceuticals International Inc., are up 35% since the start of this year.
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In January, the FDA approved two drugs. One is a biosimilar for the treatment of breast cancer and the other is a nasal spray for migraine.
Non-alcoholic steatohepatitis, or NASH, which refers to liver inflammation due to fat buildup in the liver, is said to affect an estimated 16 million Americans. NASH is a more severe form of nonalcoholic fatty liver disease, or NAFLD. The incidence of NASH is on the rise, and even worrying is the fact that there are no approved treatments for the disease, yet.
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Shares of Motus GI Holdings Inc. (MOTS) are down nearly 60% from their 52-week high of $10.66 recorded on July 9, 2018.
Shares of Menlo Therapeutics Inc. (MNLO) are down 86% from their 52-week high of $39.86 recorded on February 6, 2018.
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