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Roche (RHHBY) has received FDA approval for the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation testing. Cobas Babesia detects parasites that live in red blood cells. Roche said the whole blood test to screen donations follows May 2019 FDA-updated industry guidance...
cancerdrugs-sept18.jpg The U.S. Food and Drug Administration on Tuesday unveiled a new international collaboration for simultaneous review and approval of cancer drugs along with the agency's Australian and Canadian counterparts. The simultaneous approval of cancer therapies by the three regulators is intended to accelerate the process of making these new treatments available to patients around the world.
Merck (MRK) reported that the FDA has granted priority review for the company's Biologics License Application for V920, an investigational Ebola vaccine. The PDUFA, or target action date, is set for March 14, 2020. In March 2019, the Marketing Authorization Application for V920 was accepted for review...
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pharmadown-sept19.jpg The following are some of the healthcare stocks that posted the biggest percentage decline on Thursday.
pharmaup-sept19.jpg The following are some of today's top gainers in the pharma/biotech sector.
pharmadown-sept18.jpg The following are some of the healthcare stocks that posted the biggest percentage decline on Wednesday.
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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...

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Allergan Plc's (AGN) BIOCELL textured breast implants and tissue expanders are withdrawn from the market worldwide as they have been linked to breast implant-associated anaplastic large cell lymphoma.

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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.

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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
03/15/2020 Astellas Pharma Inc. ALPMY, ALPMY Enfortumab vedotin (BLA) FDA decision on Enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer
03/15/2020 Seattle Genetics Inc. SGEN Enfortumab vedotin (BLA) FDA decision on Enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer
03/14/2020 Merck & Co Inc. MRK V920 (BLA) FDA decision on Ebola vaccine V920
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
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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
11-Oct-2019 Kodiak Sciences Inc. KOD Additional details of Phase 1b study results including durability of KSI-301 Retinal Vein Occlusion and Diabetic Macular Edema
05-Oct-2019 CAPRICOR THERAPEUTICS, INC. CAPR Expanded interim results from Phase II clinical trial of CAP-1002 (HOPE-2) Duchenne muscular dystrophy in boys and young men
Q4 2019 ASSEMBLY BIOSCIENCES, INC. ASMB Additional data from ongoing long-term Phase 2a trial combining 731 with Nuc therapy HBV
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Shares of Wave Life Sciences Ltd. (WVE) are down over 55% from their 52-week high of $56 recorded on September 24, 2018.
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.
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U.S. cannabis company Cresco Labs Inc. announced a deal earlier this week to acquire Las Vegas-based seed-to-sale cannabis company Tryke Companies LLC for $282.5 million. The purchase consideration is about $252.2 million for Tryke operating assets and $30 million for the company's real estate assets....
Popular mobile games can provide useful information about the user's cognitive function, a new study done by researchers at the University of Kent reveals.
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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 Elanco Animal Health Inc. (ELAN) are down nearly 28 percent from a high of $37.61 recorded on September 27, 2018.
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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