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Science and technology company Merck KGaA (MKGAY.PK) announced Wednesday that the Independent Data Monitoring Committee (IDMC) recommended on Tuesday to discontinue the bintrafusp alfa clinical trial. Based on this recommendation, the Company has made the decision to discontinue the clinical trial, as...
AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo Company Limited (DSKYF.PK) said that the European Union has conditionally approved Enhertu or trastuzumab deruxtecan as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two...
AstraZeneca plc (AZN.L, AZN) and Daiichi Sankyo Co. Limited (DSKYF.PK) announced Monday that Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with previously treated HER2-positive advanced gastric cancer. The approval by the Food and Drug Administration...
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stockmarkets dec27 21jan21 What's moving these stocks in pre-market hours today?
biotech kan21 Today's Daily Dose brings you news about BNT162b2 vaccine's capability to neutralize the new UK coronavirus variant, the resignation of Stephen Hahn, the 24th Commissioner of the FDA, the executive changes at Lineage Cell Therapeutics and registered offering of OncoCyte.
stockmarkets dec21 20jan21 What's moving these stocks in pre-market hours today?
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hilanddairy jan19

Milk supplier Hiland Dairy recalled one-half pint 1% low-fat chocolate milk that was produced at its facility in Norman, Oklahoma, according to the U.S. Food and Drug Administration. The affected milk may contain food-grade sanitizers that could cause illness if consumed. The recall was reported to have been initiated after unexpected illness was noticed among many children at a hospital.

lakechamplain jan18

Lake Champlain Chocolates or LCC has recalled select LCC milk chocolate products citing the possible presence of foreign objects, mainly brittle plastic pieces, according to the U.S. Food and Drug Administration. The affected products include Hazelnut Five Star Bar; Fruit & Nut Five Star Bar; Almond Five Star Bar; Granola Five Star Bar...

lava jan12

EVR Foods, Inc, parent company to plant-based food brand Lavva, has recalled a limited number of Blueberry Plant-Based Yogurt, citing a potential mold contamination, according to the U.S. Food and Drug Administration. The recall involves a single lot of 5.3 ounce Lavva Blueberry Yogurt with expiration date 2/21/21. The product comes in colorful plastic cup with a foil lid, marked with lot #022121

freseniuskabi jan11

Fresenius Kabi USA has recalled a single lot of pain and inflammation medication Ketorolac Tromethamine in the form of injection for the potential presence of particulate matter, the U.S. Food and Drug Administration or FDA said in a statement. The particulate matter was found in reserve sample vials.

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Date Company Name Ticker Drug Event Outcome Details
07/18/2021 Merck & Co Inc. MRK V114 (BLA) FDA decision on V114 for the prevention of invasive pneumococcal disease in adults 18 years of age and older
07/17/2021 Omeros Corp. OMER Narsoplimab (BLA) FDA decision on Narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA)
07/12/2021 Bayer AG BAYZF.PK, BAYRY.PK, BYR.L Finerenone (NDA) FDA decision on Finerenone or patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).
07/07/2021 ChemoCentryx Inc. CCXI Avacopan (NDA) FDA decision on Avacopan for the Treatment of ANCA-Associated Vasculitis
07/02/2021 Provention Bio, Inc. PRVB Teplizumab (BLA) FDA decision on teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals
06/29/2021 Vericel Corporation VCEL NexoBrid (BLA) FDA decision on NexoBrid for the Treatment of Severe Thermal Burns in adults
06/29/2021 MediWound Ltd. MDWD NexoBrid (BLA) FDA decision on NexoBrid for the Treatment of Severe Thermal Burns in adults
06/25/2021 Ascendis Pharma A/S ASND TransCon hGH (BLA) FDA decision on TransCon hGH for the treatment for pediatric Growth Hormone Deficiency
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Results Date Company Name Ticker Event Indication Outcome
Q2 2021 ABIVAX SA ABVX.PA Top-line data from phase IIa clinical trial of ABX464 (ABX464-301) Moderate to severe active rheumatoid arthritis
Q2 2021 Frequency therapeutics FREQ Top-line data from Phase 2a clinical trial of FX-322 Sensorineural hearing loss or SNHL
Q2 2021 Celldex Therapeutics Inc. CLDX Full results from Phase 1b study of CDX-0159 Chronic spontaneous urticaria (CSU)
Q2 2021 Novan Inc. NOVN Top-line efficacy results from phase 3 trial of SB206 (B-SIMPLE4) Molluscum
Q2 2021 AzurRx BioPharma, Inc. AZRX Topline data from phase 2 combination therapy trial of MS1819 with PERT therapy Cystic fibrosis (CF) and chronic pancreatitis (CP) patients with exocrine pancreatic insufficiency (EPI)
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We are hardly two weeks into 2021, and shares of Relmada Therapeutics Inc. (RLMD) have gained 22% so far this year.
Shares of Aurinia Pharmaceuticals Inc. (AUPH) have fallen nearly 35% from their 52-week high of $20.48 recorded on Feb.21, 2020, and trade around $13.
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Amazon.com Inc. has offered to help the newly sworn-in US President Joe Biden with speedy delivery of Covid-19 vaccines across the United States amid the ongoing pandemic crisis. The e-commerce giant, whose majority of workers are in the frontline of the pandemic, reiterated its request to prioritize its essential workers to receive the vaccines at the earliest appropriate time.
Embattled Canadian cannabis company CannTrust Holdings Inc. said it has entered into a Restructuring Support Agreement or RSA with plaintiffs who have commenced litigation in Canada and the U.S. against the company on behalf of CannTrust shareholders. The company noted that the RSA provides a comprehensive...
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As 2020 draws to a close, it's time to take a look back at some of the regulatory news that made headlines in December and look ahead at what's in store for January 2021. As for the novel drug approvals, 53 drugs secured FDA nod in 2020 compared to 48 in 2019. Let's take a look at the biotech companies whose drugs are at the FDA altar awaiting a decision in January 2021.
As November comes to a close, it's time to take a look back at some of the top news stories of the month related to FDA approvals and look ahead at what's in store for December. A couple of firsts happened on the regulatory front in the month. Let's take a look at the biotech stocks that await a ruling from the FDA in December.
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