Biotechnology News

Centogene N.V. (CNTG) said the FDA has issued Emergency Use Authorization for CentoSure, the company's SARS-CoV-2 RT-PCR test. CentoSure SARS-CoV-2 RT-PCR assay is a real-time test based on the reverse transcription polymerase chain reaction for the qualitative detection of SARS-CoV-2, the virus causing...
AstraZeneca Plc. (AZN.L, AZN) announced Monday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has recommended Forxiga (dapagliflozin) for an indication extension of its marketing authorisation in the European Union. The recommendation is for the treatment...
Roche (RHHBY) announced the FDA has granted full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukaemia in adults 75 years or older, or who have comorbidities that preclude use of intensive...
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biotech oct20 Today's Daily Dose brings you news about AbbVie seeking expanded approval of RINVOQ in atopic dermatitis, Aptinyx's positive results in post-traumatic stress disorder trial, Endo International acquiring BioSpecifics Technologies, the merger agreement between Cleveland BioLabs and privately-held Cytocom, and the licensing agreement offer of Liquidia.
stockmarkets dec12 19oct20 What's moving these stocks in the pre-market hours today?
stockmarkets dec21 16oct20 What's moving these stocks in the pre-market hours today?
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meijer oct08

Meijer, a privately-owned retailer, is recalling whole cantaloupe and select cut cantaloupe fruit trays and bowls citing potential risk of Salmonella that causes foodborne illness, according to the Food and Drug Administration. The multi-state recall involves Meijer Brand cantaloupes, as well as Kandy Brand cantaloupes from Aguila, Arizona-based Eagle Produce, LLC.

seneca oct08

Washington-based Seneca Snack Co. is recalling cinnamon flavor apple chips citing possible Salmonella contamination, the U.S. Food and Drug Administration said in a statement. The recall involves Seneca Cinnamon Apple Chips 0.7 ounce Package and 2.5 ounce Package with Individual Package Codes of 26JUN2021 and 28JUN2021, respectively. The company is also calling back Clancy's Cinnamon Apple Chips.

countryfresh 1005

Country Fresh has recalled various cut and sliced fruits distributed mainly by Walmart, citing potential health risk from Listeria monocytogenes, according to the U.S. Food and Drug Administration. In the initial recall, a limited quantity of watermelon chunks from select stores were included. Country Fresh further extended the recall to include various containers of "Freshness Guaranteed" fruits.

fda recall cleaner 100120

DMM Vission is recalling five lots of Cleaner Hand Sanitizer due to potential presence of methanol (wood alcohol), the U.S. Food & Drug Administration said in a statement. The company is yet to receive any reports of adverse events involving the product.

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Date Company Name Ticker Drug Event Outcome Details
04/03/2021 ACADIA Pharmaceuticals Inc ACAD NUPLAZID (sNDA) FDA decision on NUPLAZID for the treatment of hallucinations and delusions associated with dementia-related psychosis
03/31/2021 AVEO Pharmaceuticals, Inc. AVEO Tivozanib (NDA) FDA decision on Tivozanib treatment for relapsed or refractory renal cell carcinoma
03/29/2021 Merck & Co Inc. MRK KEYTRUDA (sBLA) FDA decision on KEYTRUDA for Patients with High-Risk Early-Stage triple-negative breast cancer Based on KEYNOTE-522 Trial
03/27/2021 Bristol-Myers Squibb Co. BMY Idecabtagene vicleucel (BLA) FDA decision on Idecabtagene vicleucel for treatment of adult patients with relapsed and refractory myeloma
03/27/2021 bluebird bio Inc. BLUE Idecabtagene vicleucel (BLA) FDA decision on Idecabtagene vicleucel for treatment of adult patients with relapsed and refractory myeloma
03/17/2021 CytRx Corp. CYTR Arimoclomol (NDA) FDA decision on Arimoclomol for the treatment of Niemann-Pick disease Type C
03/07/2021 Biogen Inc. BIIB Aducanumab (BLA) FDA decision on Aducanumab for Alzheimer's Disease
03/02/2021 KEMPHARM, INC KMPH.OB KP415 (NDA) FDA decision on KP415 for the treatment of attention deficit hyperactivity disorder
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Results Date Company Name Ticker Event Indication Outcome
1H 2021 Retrophin Inc. RTRX Top-line data from 36-week interim endpoint efficacy analysis from pivotal phase III clinical trial of Sparsentan (DUPLEX) Focal segmental glomerulosclerosis
Q1 2021 Otonomy Inc. OTIC Top-line results from phase III trial of OTIVIDEX Ménière's disease
2021 Iovance Biotherapeutics, Inc. IOVA Submission of BLA for Lifileucel Metastatic melanoma
2021 NovoCure NVCR Final data collection from phase 3 pivotal trial of Tumor Treating Fields (METIS) Non-small Cell Lung Cancer patients with Brain metastases
2021 Zealand Pharma A/S ZEAL Results from phase III trial of Glepaglutide Short bowel syndrome
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Shares of Calliditas Therapeutics AB (CALT) have gained nearly 21% so far this month, as the company gears up for a clinical trial catalyst this quarter.
The number of healthcare firms that have gone public on the U.S. stock exchanges so far this month is 9. Let's take a look at the IPOs scheduled for tomorrow.
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Missouri has launched medical marijuana sales in the state, with the first licensed marijuana dispensaries opening over the weekend in St. Louis County. The Missouri Department of Health and Senior Services or DHSS said on Saturday that the first legal sales of medical marijuana in Missouri occurred...
Even as COVID-19 pandemic continues to surge in majority of U.S. states, a lower infection and death rate was recorded nationally in the last 24 hours. With 48,210 new cases reporting, the national total increased to 8155592, as per Johns Hopkins University's latest data. With 388 deaths reported nationally, the total number of COVID casualties in the U.S. increased to 219676. The outbreak is
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As of this writing, the FDA has approved 40 novel drugs so far this year compared to just 27 during the same period (Jan-Sep) last year. Now, let's take a look at the biotech stocks facing FDA decision in October.
So far this year, 36 novel drugs have passed muster with the FDA compared to 26 during the same period (Jan- Aug) in 2019. Let's take a look at the companies that await a ruling from the FDA in September.
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Shares of Innate Pharma S.A. (IPHA) are down nearly 50 percent from their 52-week high of $8.24, recorded in January of this year, and trade around $4.
Shares of 10x Genomics Inc. (TXG), which closed at an all-time high of $125 on Friday, have gained 64 percent so far this year. It was on this day last year, i.e. on September 12, 2019, that the company made its debut on the Nasdaq Global Select Market by setting a public offering at $39 per share.
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