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MacroGenics’ metastatic HER2-positive breast cancer treatment margetuximab continues to show promise following a second pre-planned interim overall survival analysis of its Phase III SOPHIA trial.
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CareJourney Announces Hellmut Adolphs as Chief Technology Officer
10/23/2019
Successful entrepreneur and technology executive strengthens CareJourney management team
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AWHONN Announces 2020 President-Elect And Board Of Directors
10/23/2019
Board terms officially begin January 1, 2020 Their term officially begins on January 1, 2020.
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United Therapeutics Corporation to Report Third Quarter 2019 Financial Results Before the Market Opens on Wednesday, October 30, 2019
10/23/2019
United Therapeutics Corporation announced that it will report its third quarter 2019 financial results before the market opens on Wednesday, October 30, 2019.
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Longhorn Vaccines & Diagnostics to Present at The 50th Union World Conference on Lung Health
10/23/2019
The conference is the largest gathering of clinicians and public health workers, health program managers, policymakers, researchers and advocates working to end the suffering caused by lung disease with a focus specifically on the challenges faced by low-and lower-middle income populations.
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Statement from FDA Principal Deputy Commissioner and director of the FDA's Center for Devices and Radiological Health, on the agency's continued efforts to protect women's health and enhance safety info
10/23/2019
FDA recommends including a boxed warning and other elements in breast implant labeling
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Gore and SCHOTT to Showcase Commercial Option for Packaging and Delivery of Silicone-Sensitive Biologics
10/23/2019
W. L. Gore & Associates, Inc., a global materials science company has collaborated with SCHOTT, a pharma packaging specialist to develop a tested and validated option for packaging and delivery of silicone-sensitive biologics.
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More Breakthroughs in Nanotechnology Could Lead to Improvements in Drug Delivery and Medicine
10/23/2019
Researchers have developed a precise and non-toxic nanoscale technology that can deliver oncology drugs directly to cancer cells. The minuscule tubes are called peptoids. -
The decision was based on new analysis run by Biogen in consultation with the FDA of a larger dataset from the trials halted in March.
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The U.S. Food and Drug Administration approved a new cystic fibrosis medication that is expected to provide treatment for 90% of patients with this debilitating and life-shortening condition.
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5 Baby Boomer Biotech Influencers
10/22/2019
Here are some of the top biotech influences of this generation. -
Shares of Assertio Therapeutics plunged more than 28% Monday after the company announced the U.S. Food and Drug Administration rejected an injectable formulation of long-acting cosyntropin.
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ORock Technologies Receives PCI DSS, HIPAA and HITECH Certifications
10/22/2019
ORock® Technologies, Inc. today announced that it achieved Payment Card Industry Data Security Standard (PCI DSS) certification for its ORockCloud hosting environment and underlying network infrastructure.
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FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson's and Alzheimer's disease
10/22/2019
Today, the U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson's and Alzheimer's disease, among other conditions or diseases.
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HighTide Therapeutics Announces Completion of Enrollment in Phase 2a NASH Study of HTD1801
10/22/2019
HighTide Therapeutics Inc. ("HighTide"), a clinical-stage biopharmaceutical company, today announced that the last patient has been enrolled in A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adults With NASH and T2DM.
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BioNovelus, Inc. Announces Patricia Frost to Join Advisory Board
10/22/2019
BioNovelus, Inc. (OTC: ONOV) announces Patricia Frost has joined the Company’s Advisory Board. BioNovelus’ Advisory Board seats individual entrepreneurs and senior cyber security / information technology (IT) executives with business, government and technical expertise useful for assisting in identifying, integrating and growing acquired companies.
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Philips and the U.S. Department of Defense Develop Breakthrough Technology Using AI to Identify Infection More Than 48 Hours Before Observable Symptoms
10/22/2019
Using large data sets & machine learning across biomarkers, innovative tech can speed time to detection, intervention & treatment, while improving outcomes & reducing spread of disease
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The GTMRx Institute Celebrates Six Months, Six Hundred Members Strong
10/22/2019
Momentum builds for personalized, team-based approach to medication management
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The Leapfrog Group Highlights Strengths, Pinpoints Improvements Needed across Outpatient and Ambulatory Surgery Settings in Inaugural Report
10/22/2019
The Leapfrog Group released a report summarizing trends on the safety and quality of care for same-day surgical services nationwide: Same-Day Surgery in the U.S.: Findings of Two Inaugural Leapfrog Surveys.
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FDA grants first-ever modified risk orders to eight smokeless tobacco products
10/22/2019
FDA concludes completely switching from cigarettes to these authorized products lowers certain health risks [22-October-2019] SILVER SPRING, Md. , Oct. 22, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration announced today that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway. The authori