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6 Stocks To Watch Amid Monkeypox Outbreak
2022 May 20, 5:08pm | 673A Monkeypox outbreak has been reported in several European countries, two cases in Canada and one confirmed case in a man from Massachusetts. What's going on? Monkeypox, a relative to smallpox, is a rare disease thought to be limited to two regions in Africa and has two main types: the...
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FDA Approves Regeneron and Sanofi's Dupixent (dupilumab) For Eosinophilic Esophagitis (EoE) Ahead of Schedule
2022 May 20, 4:08pm | 272The U.S. Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi’s (NASDAQ: SNY) lead drug candidate Dupixent® (dupilumab) 300 mg weekly for patients with eosinophilic esophagitis (EoE) aged 12 years and older. This regulatory...
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EMA's Advisory Committee Recommends Eiger's Zokinvy In Premature Aging Disorder
2022 May 20, 3:14pm | 297The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending Eiger BioPharmaceuticals Inc's (NASDAQ: EIGR) Zokinvy for Hutchinson-Gilford progeria syndrome (HGPS) and processing-deficient progeroid...
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Zymeworks Turns Down All Blue's Hostile Bid
2022 May 20, 3:13pm | 294Zymeworks Inc's (NYSE: ZYME) board has officially turned down an unsolicited, opportunistic, non-binding proposal from an activist shareholder, All Blue Falcons. The company rejected the buyout at $10.50 per share. All Blue's bid "significantly undervalues its prospects...
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New FDA 510(k) Clearance Expands Anika's Sports Medicine Soft Tissue Portfolio
2022 May 20, 3:07pm | 261Anika Therapeutics Inc (NASDAQ: ANIK) has received FDA 510(k) clearance for the X-Twist Knotless Fixation System, a platform of suture anchors designed to be mechanically robust, easy to use, and support healing for critical repairs such as rotator cuff repair. According to...
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AbbVie Submits FDA Application For Continuous, 24-Hour Infusion Therapy For Parkinson's
2022 May 20, 3:06pm | 290AbbVie Inc (NYSE: ABBV) submitted its FDA marketing application for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy. AbbVie’s theory here revolves around using a...
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BridgeBio Partnered Protein Replacement Therapy Shows Promising Action In Painful Skin Blistering Disorder
2022 May 20, 3:04pm | 278BridgeBio Pharma Inc (NASDAQ: BBIO) and affiliate company Phoenix Tissue Repair announced data from the Phase 2 trial of PTR-01 in recessive dystrophic epidermolysis bullosa (RDEB). PTR-01 is an intravenously-administered recombinant collagen 7 (rC7) protein replacement...
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CHMP Supports Approval Of Merck's Keytruda As Adjuvant In Post Surgery Melanoma Setting
2022 May 20, 2:56pm | 238European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending Merck & Co Inc (NYSE: MRK) Keytruda in melanoma setting. The opinion covers Keytruda as a monotherapy adjuvant treatment for adults and adolescents...
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CHMP Backs Approval of Lilly/Incyte's Olumiant For Patchy Hair Loss
2022 May 20, 2:53pm | 297The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Eli Lilly And Co (NYSE: LLY) and Incyte Corporation's (NASDAQ: INCY) Olumiant (baricitinib) for severe alopecia areata (AA). If...
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Europe's CHMP Backs Approval Of PTC Therapeutics' Gene Therapy In Rare Neurometabolic Disorder
2022 May 20, 1:50pm | 278The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of PTC Therapeutics Inc's (NASDAQ: PTCT) Upstaza (eladocagene exuparvovec, PTC-AADC). Once ratified by the European Commission, Upstaza will be the first...
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Analysis: Should You Be Afraid Of A Monkeypox Pandemic?
2022 May 20, 12:00pm | 666The coronavirus pandemic has yet to be firmly tucked into the history books even as a new health threat emerges: monkeypox, a rare infectious virus that has suddenly become more prevalent in Europe and is now being detected in North America. Should people be concerned that a new health crisis is...
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Altamira's Drug-Free Nasal Spray Shows Benefit In House Dust Mite Study
2022 May 20, 11:24am | 324Altamira Therapeutics Ltd (NASDAQ: CYTO) announced topline data from its clinical trial with Bentrio nasal spray in house dust mite (HDM) allergic rhinitis. The HDM challenge trial demonstrated a statistically significant reduction of nasal symptoms vs. untreated controls and good...
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Novavax Has Limited Pipeline Upside, Says BofA Analyst: What's Next?
2022 May 20, 10:53am | 240Although Novavax, Inc’s (NASDAQ: NVAX) shares have tanked 59% year to date, there is still room for a further decline, according to BofA Securities. The Novavax Analyst: Alec Stranahan initiated coverage of Novavax with an Underperform rating and a price target of $35. The Novavax Thesis:...
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Why TherapeuticsMD Shares Are Trading Higher Today
2022 May 20, 10:52am | 267TherapeuticsMD Inc (NASDAQ: TXMD) shares are trading higher after FDA approved the supplemental application, including minor revisions to Annovera's in vitro release testing specification that allowed for normal manufacturing variability. The FDA approved Annovera in August...
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Athersys-Partnered Japanese Ischemic Stroke Study Disappoints, Shares Plunge
2022 May 20, 10:21am | 283Athersys Inc's (NASDAQ: ATHX) partner, Healios K.K. has reported topline results for its Japan ischemic stroke study, TREASURE. The study included patients with moderate to moderate-severe ischemic stroke administered a single dose of MultiStem cells (invimestrocel) or...