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Help us identify the leading employers in the life science industry! We want to uncover who leads in key areas like diversity, culture, unique benefits and, of course, who are the 2019 Life Sciences Ideal Employers.
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Lawsuits against the FDA are fairly common. However, winning the lawsuit will be a tough road for Catalyst, as other pharma companies that challenged the regulatory agency learned.
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AAHRPP Accredits Three More Research Organizations Including First in Jordan
6/19/2019
The Association for the Accreditation of Human Research Protection Programs today announced that it has accredited three more research organizations, including the first in Jordan.
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dMed Biopharmaceutical, a next generation CRO, announced the opening of its US Regulatory Affairs office in Washington DC to build a bridge for affordable innovative drugs for US patients
6/19/2019
Since the China launch earlier this year of an immuno-oncology drug at one-third the price of Merck's Keytruda, there has been a wave of applications for affordable innovative therapies from China, developed to Western standards of safety and efficacy, to register in the US.
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PBMs Advocate on behalf of Consumers to Reduce Prescription Drug Costs
6/19/2019
Pharmaceutical Care Management Association (PCMA) President and CEO JC Scott released the following statement on the Senate Special Committee on Aging's hearing, "The Complex Web of Prescription Drug Prices, Part III: Examining Agency Efforts to Further Competition and Increase Affordability:"
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HemoShear Therapeutics Names Biopharma Veteran Kathleen M. Metters, PhD, to Board of Directors
6/19/2019
Metters Was Most Recently CEO of Lycera and Previously Led Worldwide Basic Research for Merck
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New Study Finds Increased CT Use for Suspected Urolithiasis
6/19/2019
A new study performed in conjunction with the Harvey L. Neiman Health Policy Institute examines changing characteristics of utilization and potential disparities in US emergency department (ED) patients undergoing CT of the abdomen and pelvis (CTAP) for suspected urolithiasis.
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Trade tensions between Washington, D.C. and Beijing continue, but have not yet impacted the pharmaceutical products traded between the two countries. However, if the punitive tariffs continue and pharma is impacted, a third global player could step in to fill the void in both countries.
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Only Half of Post-Marketing Commitments Get Published in Peer-Reviewed Journals, Study Shows
6/18/2019
Transparency in clinical trials has been a concern and the new study highlights the continued issue. -
Statement from Acting FDA Commissioner Ned Sharpless, M.D., on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs
6/18/2019
The U.S. Food and Drug Administration is committed to helping facilitate American patients' access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs.
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Statement from Susan Mayne, Ph.D., director of the FDA's Center for Food Safety and Applied Nutrition, on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products
6/18/2019
Three years ago, the U.S. Food and Drug Administration announced the most comprehensive reform to the Nutrition Facts label since its introduction in 1993.
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National Scoliosis Center Says Early Detection Of Scoliosis Is Critical To Treatment
6/18/2019
An estimated 7 million Americans have scoliosis*—that's why Luke Stikeleather, National Scoliosis Center (NCS) Founder and President says:
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Fostering the Development of Regenerative Medicine and Chronic Disease Medicines: Thought Leadership & Innovation Foundation Expands Fellowships
6/18/2019
With the help of philanthropic support for regenerative medicine and biomedical research, Dr. Robin Robinson, Ph.D., the first director of the Biomedical Advanced Research and Development Authority (BARDA) and former deputy Assistant Secretary for Preparedness and Response at the Department of Health and Human Services (HHS), was named a Fellow with the Thought Leadership & Innovation Foundation (TLI)
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Breakthrough Device Designation received from the FDA
6/18/2019
Accelerated regulatory pathway for first internal use product
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Vanda Pharmaceuticals to Present at the JMP Securities Life Sciences Conference
6/18/2019
The corporate presentation at the JMP Securities Life Sciences Conference will be available live on Vanda's corporate website, where it also will be archived for 30 days.
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FDA Office of Regulatory Affairs and Salient CRGT Receive 2019 FedHealthIT Innovation Award for the FDA Data Dashboard
6/18/2019
Salient CRGT announced that its client, the FDA Office of Regulatory Affairs, has received a FedHealthIT Innovation Award for the FDA Data Dashboard.
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Reston Hospital Center Medical Staff Announces 2019 Scholarship Winners
6/18/2019
The Medical Staff of Reston Hospital Center awarded scholarships to 17 Fairfax and Loudoun County High School seniors in recognition of their academic excellence and excitement for pursuing a career in healthcare.
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The lawsuit was joined by Merck, Eli Lilly and Amgen. The companies claim the Department of Health and Human Services does not have the legal authority to force the companies to comply with the new rule.
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June is turning out to be a busy month for approvals for the U.S. Food and Drug Administration. The agency has a slate of PDUFA dates this week, including two for Merck alone. Here’s a look.
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Clinical Catch-up for June 10-14
6/17/2019
Last week there were quite a few clinical trials whose data were presented. Many were at the American Diabetes Association 79th Scientific Sessions, while others were presented at separate meetings or independently. Here’s a look.