Biotechnology News

Seattle Genetics, Inc. (SGEN) and Astellas Pharma Inc. (ALPMY, ALPMY) announced the FDA has accepted the Biologics License Application for enfortumab vedotin and granted priority review for the treatment of patients with locally advanced or metastatic urothelial cancer. The FDA has set a target action...
AstraZeneca (AZN.L, AZN) said the US FDA has granted Fast Track designation for the development of FARXIGA to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction or preserved ejection fraction. The designation is based...
German science and technology company Merck KGaA (MKGAY.PK) announced Wednesday that the US Food and Drug Administration has granted Breakthrough Therapy Designation for the investigational targeted therapy tepotinib. The therapy is for patients with metastatic non-small cell lung cancer or NSCLC...
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pharma-062617_14sep19.jpg The week ending September 14, 2019, witnessed a string of disappointments on the Alzheimer's drug development front. Now, here are some of the pharma/biotech stocks to watch out for in the week starting September 15.
pharmadown-sept12.jpg The following are some of the healthcare stocks that posted the biggest percentage decline on Thursday.
pharmaup-sept12.jpg The following are some of today's top gainers in the pharma/biotech sector.
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The U.S. Department of Agriculture's Food Safety and Inspection Service announced that Pine Bluff, Ark. establishment Tyson Foods Inc. (TSN) is recalling approximately 39,078 pounds of Weaver brand frozen chicken patty product due to extraneous materials contamination. This problem was discovered...


Allergan Plc's (AGN) BIOCELL textured breast implants and tissue expanders are withdrawn from the market worldwide as they have been linked to breast implant-associated anaplastic large cell lymphoma.


Herbal Doctor Remedies has issued a voluntarily nationwide recall for all its drug products that were sold without approval from the U.S. Food and Drug Administration or FDA and did not conform to good manufacturing practices. The recall includes all the Herbal Doctor Remedies brand products and quantities within a three-year expiration date.


Jubilant Cadista Pharmaceuticals has voluntarily recalled one lot of oral contraceptive tablets at the consumer level, citing potential decreased efficacy of the product. The company has recalled one lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg. The product was manufactured by Spain-based Cyndea Pharma under contract from Jubilant Cadista.

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Date Company Name Ticker Drug Event Outcome Details
02/21/2020 ALDER BIOPHARMACEUTICALS INC ALDR Eptinezumab (BLA) FDA decision on Eptinezumab for migraine prevention
02/18/2020 Merck & Co Inc. MRK Keytruda (pembrolizumab) (sBLA) FDA decision on Keytruda for melanoma and multiple other indications
02/04/2020 Alnylam Pharmaceuticals Inc. ALNY Givosiran (NDA) FDA decision on Givosiran for the treatment of acute hepatic porphyria
01/23/2020 Epizyme, Inc. EPZM Tazemetostat (NDA) FDA decision on Tazemetostat for the treatment of Epithelioid sarcoma
01/15/2020 Novartis AG NVS Crizanlizumab (SEG101) (BLA) FDA decision on crizanlizumab for the prevention of vaso-occlusive crises wih sickle cell disease
12/28/2019 Amarin Corp Plc AMRN Vascepa (sNDA) FDA decision on expansion of Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study.
12/27/2019 Intra-Cellular Therapies, Inc. ITCI Lumateperone (NDA) FDA decision on Lumateperone for the treatment of schizophrenia
12/25/2019 Alkermes plc ALKS Vumerity (diroximel fumarate) (NDA) FDA decision on diroximel fumarate for Relapsing Remitting Multiple Sclerosis
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Results Date Company Name Ticker Event Indication Outcome
Dec 2019 Acasti Pharma, Inc. ACST Top line results from phase III trial to evaluate safety and efficacy of CaPre (TRILOGY 1) Severe hypertriglyceridemia
Dec 2019 Apellis Pharmaceuticals, Inc. APLS Top-line data from phase III trial comparing APL-2 against Soliris(PEGASUS) Paroxysmal nocturnal hemoglobinuria
Q4 2019 Prothena Corporation plc PRTA Preliminary data from phase I study of PRX004 hATTR amyloidosis
Q4 2019 Ardelyx, Inc ARDX Results from a phase III clinical trial of Tenapanor as a monotherapy treatment (PHREEDOM) Hyperphosphatemia in patients with end-stage renal disease
Q4 2019 Oncternal Therapeutics Inc. ONCT Additional data from Phase 1/2 study of Cirmtuzumab in combination with Ibrutinib Chronic lymphocytic leukemia
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Mountain View, California-based IGM Biosciences is a biotechnology company developing engineered IgM antibodies for the treatment of cancer patients. Immunoglobulin M (IgM) is a class of antibody naturally produced by the human immune system.
The end of the third quarter is fast approaching. The third quarter IPO activity in the U.S. pharma/biotech sector has been somewhat tepid with around 9 listings so far in the quarter.
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A new study done by researchers from the University of California San Diego School of Medicine suggests that how quickly a person's pupil dilates while taking cognitive tests may reflect the increased risk of Alzheimer's disease.
InterCure said that its subsidiary Canndoc has entered into a medical marijuana products distribution deal with a subsidiary of Israel-based generic drug maker Teva Pharmaceutical Industries Ltd. InterCure holds a valid license in Israel for the entire medical cannabis value chain through its 100...
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A first-in-human trial, which evaluated Nanospectra Biosciences' investigational device AuroLase in men with low-to-intermediate grade tumors within the prostate, has yielded positive results.
The month of August saw some important decisions and a couple of firsts happening on the regulatory front. Let's take a look at what's in store for the month of September.
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Shares of Aridis Pharmaceuticals Inc. (ARDS), which touched a 52-week low of $6.92 on June 14, 2019, have since gained more than 20 percent.
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