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United Therapeutics Pulls Plug On Trevyent Development
Wednesday, March 3, 2021 - 8:38am | 308Read More...Based on the FDA’s written comments, United Therapeutics Corporation (NASDAQ: UTHR) has decided to discontinue the development of Trevyent. Trevyent is a drug-device combination product that combines two-day, single-use, disposable PatchPump technology with...
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Ocugen Shares Are Trading Higher On Its Partner's COVID-19 Vaccine Candidate Showing 81% Efficacy
Wednesday, March 3, 2021 - 8:20am | 260Read More...Ocugen Inc (NASDAQ: OCGN) shares soared in the premarket on heavy volume after Bharat Biotech, the company's COVID-19 vaccine development partner in India, announced Phase 3 results of coronavirus vaccine dubbed as Covaxin (BBV152). Bharat Biotech shots demonstrated interim...
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Novavax Bullish On Potential FDA EUA Nod For COVID-19 Vaccine By May
Tuesday, March 2, 2021 - 6:15am | 391Read More...Novavax Inc’s (NASDAQ: NVAX) COVID-19 shot can probably win FDA emergency use nod as early as May, said the company’s CEO Stanley Erck, in an interview on CNBC’s “Closing Bell”. Dubbed as NVX-CoV2373, its recombinant protein-based vaccine candidate...
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Glaukos' iLink Therapy Meets Primary Endpoint In Late-Stage Vision Disorder Study
Friday, February 26, 2021 - 9:48am | 266Read More...Glaukos Corp (NYSE: GKOS) has announced topline data from the U.S. Phase 3 trial evaluating its corneal cross-linking iLink therapy to treat keratoconus. Keratoconus is characterized by cone-shaped cornea causing blurred vision and sensitivity to light and glare. The study met...
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Karyopharm's Partner Antengene Receives Priority Review For Selinexor Application In China
Wednesday, February 24, 2021 - 8:09am | 179Read More...Karyopharm Therapeutics Inc's (NASDAQ: KPTI) collaborating partner Antengene Corporation Limited has received priority review from China's National Medical Products Administration (NMPA) for ATG-010 (selinexor, XPOVIO). It is a first-in-class selective...
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RedHill Biopharma, Cosmo Pharma In Manufacturing Pact for Movantik, RHB-204
Thursday, February 18, 2021 - 2:00pm | 265Read More...RedHill Biopharma Ltd (NASDAQ: RDHL) has announced agreements with Cosmo Pharmaceuticals NV to manufacture RedHill's largest selling product in the U.S., Movantik, and RHB-204, currently in a Phase 3 U.S. study as a stand-alone, first-line orally-administered treatment for...
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Seagen/Astellas Pharma Seek Approval For PADCEV's Expanded Use In Urothelial Cancer Settings
Thursday, February 18, 2021 - 9:56am | 307Read More...Seagen Inc (NASDAQ: SGEN) and its collaborating partner Astellas Pharma Inc (OTCMKTS: ALPMF) have submitted two supplemental marketing applications to the FDA for PADCEV (enfortumab vedotin-ejfv). Based on phase 3 EV-301 trial, one submission seeks to convert...
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Galapagos, Gilead Sciences Pull Plug On Ziritaxestat Clinical Trials
Wednesday, February 10, 2021 - 12:10pm | 449Read More...Galapagos NV (NASDAQ: GLPG) and Gilead Sciences Inc (NASDAQ: GILD) have decided to stop the ISABELA Phase 3 studies evaluating ziritaxestat in patients with idiopathic pulmonary fibrosis (IPF). All clinical trials with ziritaxestat, including the long-term...
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Opdivo Plus Cabometyx Combo Shows Superior Clinical Benefit Versus Sunitinib In Late-Stage Kidney Cancer Study
Tuesday, February 9, 2021 - 8:13am | 374Read More...Bristol Myers Squibb Co (NYSE: BMY) and Exelixis Inc (NASDAQ: EXEL) have announced updated data from Phase 3 CheckMate 9ER trial, evaluating the combination of former's Opdivo (nivolumab) and latter's Cabometyx (cabozantinib) drug compared to ...
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Janssen's Erleada Plus, Zytiga Plus Prednisone Combo Treatment Shows Clinical Benefit In Late-Stage Prostate Cancer Study
Tuesday, February 9, 2021 - 6:43am | 329Read More...Johnson & Johnson’s (NYSE: JNJ) unit Janssen Pharmaceutical has announced results from Phase 3 ACIS study, evaluating the efficacy and safety of Erleada (apalutamide) and Zytiga (abiraterone) plus prednisone (treatment arm) compared to placebo and...
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Veru's COVID-19 Drug Candidate Shows High Relative Reduction In Treatment Failures, Mortality In Mid-Stage Study
Monday, February 8, 2021 - 9:40am | 402Read More...Veru Inc (NASDAQ: VERU) rises sharply after announcing positive efficacy and safety results from a Phase 2 trial evaluating VERU-111 versus placebo in approximately 40 hospitalized patients at high risk for Acute Respiratory Distress Syndrome from SARS-CoV-2. Data...
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Calliditas Starts Dosing In Nefecon Open Label Extension Study In Kidney Disease
Thursday, February 4, 2021 - 9:05am | 317Read More...Calliditas Therapeutics AB (NASDAQ: CALT) has dosed that first patient in the global open-label extension part of Phase 3 study (dubbed as NefIgArd) that will offer a 9-month treatment with Nefecon to all qualifying patients who have completed the NefIgArd study and will...
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Otonomy Rips 90% After Meniere's Disease Drug Achieves Primary Endpoint
Thursday, November 9, 2017 - 11:51am | 460Read More...Otonomy Inc (NASDAQ: OTIC), a biopharmaceutical company that focuses on therapies related to diseases and disorders of the ear, reported its third-quarter results and announced an encouraging update to a phase 2 trial. What You Need To Know Otonomy lost 69 cents in its third quarter on revenue of...
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Rigorous Trial Design, Nice Risk/Reward Keep Analyst Anxious For Avoxant's Phase 3 MINDSET Data
Wednesday, June 14, 2017 - 4:42pm | 285Read More...Axovant Sciences Ltd (NYSE: AXON) reported its fiscal fourth-quarter results on Tuesday, which helped push shares higher by more than 3.5 percent on Wednesday. Investors could potentially be rewarded with another upcoming catalyst in September with topline Phase 3 MINDSET results, analysts at HC...
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Galena Shares Up 50% On Regulatory Pathway For Thrombosis Treatment
Wednesday, December 28, 2016 - 10:56am | 327Read More...Shares of Galena Biopharma Inc (NASDAQ: GALE), a nano-cap biopharmaceutical company that focuses on hematology and oncology therapeutics for the treatment of unmet medical needs, gained more than 20 percent ahead of Wednesday's market open. Galena is currently evaluating its GALE-401 therapy for...
