Biotechnology News

AstraZeneca plc (AZN.L, AZN) said the US FDA has approved Farxiga to reduce the risk of hospitalisation for heart failure in adults with type-2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. The approval follows the update to the marketing authorisation in the...
Swiss drug major Roche Group (RHHBY) announced that the US Food and Drug Administration has approved a supplemental New Drug Application or sNDA for Xofluza (baloxavir marboxil) for people at high risk of developing influenza-related complications. The approval is for the treatment of acute, uncomplicated...
genericdrugs-oct17.jpg The U.S. Food and Drug Administration approved an all-time record total of 1,171 generic drugs in fiscal 2019, breaking its previous record of 971 approvals in fiscal 2018. This year's approvals include 935 full approvals and 236 tentative approvals. A generic drug is a pharmaceutical drug that contains the same chemical substance and performs the same functions as a branded drug.
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pharmaup-oct17.jpg The following are some of today's top gainers in the healthcare sector.
biotechonology1-oct17.jpg The following are the healthcare stocks that hit a new 52-week high on Wednesday.
pharmadown-oct16.jpg The following are some of the healthcare stocks that posted the biggest percentage decline on Wednesday.
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Pride of Florida is recalling roughly 64,797 pounds of raw beef products due to possible E.coli O157:H7 contamination, according to the U.S. Department of Agriculture's Food Safety and Inspection Service.


George's Prepared Foods, a producer of fully cooked burgers and sausage patties, is recalling about 6,444 pounds of ready-to-eat pork sausage patty and turkey sausage patty products due to possible Salmonella contamination, the Food Safety and Inspection Service said.


Medical device company Medtronic, on Tuesday, recalled all models of its 6 French Sherpa NX active guide catheters due to separation and fragmentation issues.


Lipari Foods is recalling bulk chicken salads and chicken salad sandwiches citing possible contamination of listeria monocytogenes, a deadly bacteria. As per the Food and Drug Administration's statement, the recall includes various Lipari products such as Lipari Old Tyme brand's Bulk Chicken Salad as well as Bulk Cranberry Almond Chicken Salad, and Premo brand's Chicken Salad Wedge Sandwiches.

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Date Company Name Ticker Drug Event Outcome Details
04/04/2020 Acceleron Pharma, Inc XLRN Luspatercept (BLA) FDA decision on Luspatercept for adult patients with very low- to intermediate-risk MDS-associated anemia
03/28/2020 Rockwell Medical Technologies Inc RMTI IV Triferic (NDA) FDA decision on IV Triferic for iron deficiency in chronic kidney disease patients receiving hemodialysis
03/25/2020 Celgene Corporation CELG Ozanimod (NDA) FDA decision on Ozanimod for Treatment of Relapsing Forms of Multiple Sclerosis
03/17/2020 Eton Pharmaceuticals, Inc ETON ET-105 oral liquid (NDA) FDA decision on ET-105 oral liquid for the treatment of various forms of epilepsy
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
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Results Date Company Name Ticker Event Indication Outcome
2020 Cidara Therapeutics, Inc. CDTX Top line results from phase III pivotal clinical trial of Rezafungin(ReSPECT Prophylaxis) Allogeneic bone marrow transplant
2020 Cidara Therapeutics, Inc. CDTX Top-line data from phase III study of Rezafungin (ReSTORE) modified intention-to-treat (mITT) patients with candidemia and/or invasive candidiasis
1H 2020 Clementia Pharmaceuticals Inc. CMTA 12-month interim data readout from phase II study of Palovarotene (MO-Ped Trial) pediatric patients with multiple osteochondromas (MO) also known as multiple hereditary exostoses (MHE)
2020 BeyondSpring Inc. BYSI Submission of NDA for Plinabulin Non-small cell lung cancer (NSCLC)
Q1 2020 Savara Inc SVRA Top-line results from phase 2a clinical study of Molgradex (OPTIMA) Persistent pulmonary NTM infection
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The following companies belonging to the healthcare sector are slated to debut on the U.S. public market in the week ahead. 1. Happiness Biotech Group Ltd China-based Happiness Biotech Group Limited is a nutraceutical and dietary supplements producer, developing a variety of products made from...
Shares of Carl Zeiss Meditec AG (AFX.F) are up 52 percent year-to-date on the Frankfurt Stock Exchange while the German benchmark index, the DAX, has gained 20 percent for the same period.
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Slang Worldwide Inc., a cannabis consumer packaged goods company, said it has entered into a strategic partnership with Cookies, a California-based cannabis and lifestyle brand, to bring Cookies' products to the Colorado market. Slang expects the first Cookies products to be available for sale in Colorado...
At a time, when e-cigarettes have been getting a lot of bad press, a new study has found a positive association between the number of people using e-cigarettes and the success rate of giving up smoking. The study led by Dr. Emma Beard, UCL Division of Psychology and Language Sciences, showed that...
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New drugs approved in September
It has been an eventful September, with a number of notable firsts achieved on the regulatory front. Now, let's take a look at the companies that await a ruling from the FDA in October 2019.
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Shares of SI-BONE Inc. (SIBN) are down nearly 32 percent from a high of $23.03 recorded on January 16, 2019, and trade around $15.
Shares of Elanco Animal Health Inc. (ELAN) are down nearly 28 percent from a high of $37.61 recorded on September 27, 2018.
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