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AstraZeneca (AZN.L, AZN) said Calquence (acalabrutinib), a monotherapy treatment for adult patients with chronic lymphocytic leukaemia, has been granted Breakthrough Therapy Designation by the FDA. The FDA decision was based on the positive results from the interim analyses of the ELEVATE-TN and ASCEND...
Biotechnology company Regeneron Pharmaceuticals, Inc. (REGN) announced Tuesday that the U.S. Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA (aflibercept) Injection prefilled syringe. The 2 mg, single-dose,...
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pharmadown-aug20.jpg The following are some of the healthcare stocks that posted the biggest percentage decline on Tuesday.
pharmaup-aug20.jpg The following are some of today's top gainers in the pharma/biotech sector.
pharma-032218_20aug19.jpg Today's Daily Dose brings you news about FDA approval of Nabriva's new pneumonia antibiotic; Sarepta's disappointment; Vanda's receipt of Complete Response Letter for the expanded indication of HETLIOZ; and Miragen Therapeutics' anticipated milestones.
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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Allergan Plc's (AGN) BIOCELL textured breast implants and tissue expanders are withdrawn from the market worldwide as they have been linked to breast implant-associated anaplastic large cell lymphoma.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
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
12/25/2019 Alkermes plc ALKS Vumerity (diroximel fumarate) (NDA) FDA decision on diroximel fumarate for Relapsing Remitting Multiple Sclerosis
12/04/2019 Acceleron Pharma, Inc XLRN Luspatercept (BLA) FDA decision on Luspatercept for adult patients with beta-thalassemia-associated anemia
12/04/2019 Celgene Corporation CELG Luspatercept (BLA) FDA decision on Luspatercept for the treatment of MDS and Beta-Thalassemia-Associated Anemias
10/24/2019 Tesaro Inc. TSRO Zejula (sNDA) FDA decision on Zejula for the Late Stage Ovarian Cancer
10/24/2019 Melinta Therapeutics, Inc MLNT BAXDELA (sNDA) FDA decision on BAXDELA seeking to include adult patients with community-acquired bacterial pneumonia,
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Results Date Company Name Ticker Event Indication Outcome
Q4 2019 Myovant Sciences Ltd MYOV Data from phase III trial of Relugolix (HERO) Advanced prostate cancer in Men
Q4 2019 Vascular Biogenics Ltd. VBLT Interim readout from phase III trial of VB-111 (OVAL) Platinum-resistant ovarian cancer
Q4 2019 Kala Pharmaceuticals, Inc. KALA Top-line results from additional phase III trial evaluating KPI-121 0.25% (STRIDE 3) Dry eye disease
Q4 2019 Zosano Pharma Corporation ZSAN Filing of NDA for ADAM zolmitriptan Pain relief by time and recurrence of migraine
Q4 2019 Vascular Biogenics Ltd. VBLT Efficacy interim readout from phase 3 trial of VB-111 (OVAL) Platinum-resistant ovarian cancer.
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Shares of French biotechnology company Abivax SA (ABVX.PA), which hit a 52-week low of EUR 5.20 on October 26, 2018, have since gained 64 percent.
NovoCure Ltd. (NVCR) has come a long way this year, and the shares are up an impressive 178 percent year-to-date.
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Senator Bernie Sanders has called for the legalization of marijuana at the federal level in the U.S. On Sunday, the 2020 Democratic presidential candidate said on Twitter, "We must legalize marijuana nationally, expunge past marijuana convictions and ensure revenue from marijuana is reinvested in...
U.S. cannabis retailer MedMen Enterprises Inc. said Monday that it has launched state-wide delivery service of cannabis products in California, enabling consumers to enjoy the comfort of home delivery. MedMen is offering same-day delivery of cannabis products to customers in California, noting that...
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A first of its kind device to treat pediatric patients with progressive idiopathic scoliosis has won the FDA nod. The device, called The Tether - Vertebral Body Tethering System, developed by Zimmer Biomet Holdings, Inc. (ZBH), is intended to be used in children and adolescents to correct idiopathic scoliosis that has not responded to external bracing.
After having had a banner year for new drug approvals in 2018, hitting a record number of 59, it looks like the pace of FDA approval is slowing down this year. Only 16 new drugs have been greenlighted so far this year compared to 26 during the same period last year. Let's take a look at the companies that await a ruling from the FDA in August 2019.
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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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