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Puma's Breast Cancer Drug Accorded Orphan Drug Designation For Brain Metastases
2019 Sep 04, 9:53am | 349Read More...Puma Biotechnology Inc (NASDAQ: PBYI) shares advanced in premarket trading Wednesday on the back of an announcement concerning its breast cancer drug Nerlynx before falling after the market open. What Happened The actively traded, small-cap biotech said after the close Tuesday that the FDA...
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The Daily Biotech Pulse: Puma Leaps, Aerie Borrows, Hepion Back In Nasdaq's Good Books
2019 Sep 04, 7:08am | 1296Read More...Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Sept. 3) Ardelyx Inc (NASDAQ: ARDX) (reported positive results from a late-stage of its lead compound tenapanor in combination with phosphate binders to...
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The Week Ahead In Biotech: Cardiology, Analyst Conferences In The Spotlight
2019 Sep 02, 3:13pm | 823Read More...The biotech space saw muted activity in the week ended Aug. 30. Among the notable news of the week: Amgen, Inc. (NASDAQ: AMGN)'s $13.4-billion deal to buy the psoriasis drug Otezla from Celgene Corporation (NASDAQ: CELG) and Johnson & Johnson (NYSE: JNJ)'s $572-million settlement...
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Akari's 2-Day Rally: What You Need To Know
2019 Aug 30, 10:54am | 409Read More...Akari Therapeutics PLC (NASDAQ: AKTX) shares are on track to reclaim the $2 level for the first time since mid-August thanks to two doses of positive tidings from the company. Shares of the nanocap biotech were last seen advancing $6.74% to $2.06 Friday, extending the upward move seen the...
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The Daily Biotech Pulse: Genmab-Novartis Multiple Sclerosis Drug Aces Late-Stage Studies, Akari Nets Orphan Drug Designation
2019 Aug 30, 8:28am | 732Read More...The following is a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks that hit 52-week highs on Aug. 30.) Inspire Medical Systems Inc (NYSE: INSP) NextCure Inc (NASDAQ: NXTC) Radius Health Inc (NASDAQ: RDUS) ResMed Inc. (NYSE: RMD) Stoke...
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The Daily Biotech Pulse: EC Approves Roche's Tecentriq For Breast Cancer, Trevena On Track For NDA Resubmission, Edap Earnings
2019 Aug 29, 7:38am | 1006Read More...Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Aug. 28) Turning Point Therapeutics Inc (NASDAQ: TPTX) Down In The Dumps (Biotech stocks hitting 52-week lows on Aug. 28) Agios Pharmaceuticals Inc (...
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FDA To Re-Open Public Comments On Descheduling Cannabis Under International Treaty
2019 Aug 28, 1:10pm | 300Read More...The U.S. Food and Drug Administration issued a notice Wednesday that it will give people more chances to comment on the question of dropping cannabis from the most restricted class of drugs for the purposes of international treaties. An unpublished notice was filed Wednesday by the FDA in the...
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Attention Biotech Investors: Mark Your Calendar For These September PDUFA Dates
2019 Aug 28, 8:02am | 1293Read More...FDA activity remained brisk in August. The FDA gave its nod for a majority of drugs that came up for review, although Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)'s jet lag disorder drug Hetlioz and Sarepta Therapeutics Inc (NASDAQ: SRPT)'s Duchenne muscular dystrophy drug golodirsen failed to...
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The Daily Biotech Pulse: EC Nod For Bristol-Myers Squibb, Kyowa Kirin's Parkinson's Add-On Therapy Approved
2019 Aug 28, 7:31am | 1537Read More...Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Aug. 27) Castle Biosciences Inc (NASDAQ: CSTL) The Medicines Company (NASDAQ: MDCO) Down In The Dumps (Biotech stocks hitting 52-week lows on Aug. 27)...
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The Daily Biotech Pulse: Nuvectra Explores Strategic Options, J&J To Contend Opioid Ruling, Sesen Bio Gets New CFO
2019 Aug 27, 7:29am | 871Read More...Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech stocks hitting 52-week highs on Aug. 26) DURECT Corporation (NASDAQ: DRRX) Stoke Therapeutics Inc (NASDAQ: STOK) Down In The Dumps (Biotech stocks hitting 52-week lows on Aug. 26)...
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The Week Ahead In Biotech: A Quiet One Ahead Of Labor Day Weekend
2019 Aug 25, 3:06pm | 624Read More...The biotech space saw a few FDA decisions and clinical readouts over the last week. The FDA handed down two verdicts, backing Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV)'s novel antibiotic while turning down Sarepta Therapeutics Inc (NASDAQ: SRPT)'s second Duchenne...
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Edwards Lifesciences Shares Fall As FDA Reports Recall Of Sapien 3 Ultra
2019 Aug 22, 11:29am | 192Read More...The Food and Drug Administration reported Edwards Lifesciences (NYSE: EW) has recalled Sapien 3 Ultra delivery system due to burst balloons during surgery. Reports first emerged in June that the company had issued a field safety notice regarding its Sapien 3 Ultra system for transcatheter...
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Clearside Stock Plummets After Company Hints At Complete Response Letter For Macular Edema Drug
2019 Aug 22, 11:20am | 477Read More...Clearside Biomedical Inc (NASDAQ: CLSD) shares entered penny stock territory Thursday after the company issued an update on what transpired at a meeting with the FDA regarding the new drug application for Xipere. What Happened In a meeting this week, the FDA's Office of...
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The Daily Biotech Pulse: ViiV's Long-Acting HIV Drug Meets Study Goal, Chinese Cheer For FibroGen, Retrophin Flunks Late-Stage Study
2019 Aug 22, 7:18am | 1233Read More...Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Aug. 21) Apellis Pharmaceuticals Inc (NASDAQ: APLS) Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR) AstraZeneca plc (NYSE: AZN)(advanced despite reporting...
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Analysts Unfazed By FDA Snub Of Sarepta's DMD Drug, Pin Hopes On Gene Therapy
2019 Aug 20, 12:59pm | 707Read More...Sarepta Therapeutics Inc (NASDAQ: SRPT)'s new drug application for its second Duchenne muscular dystrophy drug received a a complete response letter from the FDA on Monday. The Analysts Nomura Instinet analyst Christopher Marai maintained a Buy rating on Sarepta with a $230 price...
