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Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s diarrhea, migraine headaches and more.
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New Year, fresh start? Could be. WalletHub recently compared more than 180 cities across the U.S., using 30 key indicators to evaluate their job strength. Some of those factors were job opportunities, employment growth, monthly average starting salary and employment outlook.
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The FDA approved Cabometyx based on the Phase III CELESTIAL trial that showed the drug provided a statistically significant and clinically meaningful improvement in median overall survival.
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The partial government shutdown has entered day 24 and the pharma and medtech industry is beginning to feel the impact even more, particularly as the U.S. Food and Drug Administration grows more incapable of reviewing some medications for approval.
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It didn’t take long for the new leadership structure in the U.S. House of Representatives to take on the pharmaceutical industry. On Monday, the House Committee on Oversight and Reform launched an investigation into prescription drug pricing practices.
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Wave Life Sciences is working to get its nucleic acid treatment, suvodirsen, for Duchenne muscular dystrophy (DMD) approved. DMD is a rare muscle-wasting disease that affects mostly boys, about 15,000 in the U.S.
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Your Feedback Matters! Topics in 2019
1/15/2019
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2019. Let us know which topics you want to hear more about. -
Nuo Therapeutics Announces Corporate Update Conference Call
1/15/2019
Nuo Therapeutics, Inc. (OTCQB: AURX) ("Nuo" or the "Company"), today announced plans to conduct a conference call to provide a corporate update and respond to questions, particularly with respect to steps it is taking as a result of its discussions with representatives of the Coverage and Analysis Group (CAG) of the Centers for Medicare & Medicaid Services.
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Three ADA Pathway Grant Awardees' Collaborative Breakthrough: Analysis Describing the Genetic Link Between Beta (β) Cell Function and Type 2 Diabetes Published in Cell Reports
1/15/2019
American Diabetes Association (ADA) Pathway to Stop Diabetes® grant recipients Michael L. Stitzel, PhD, of the Jackson Laboratory, Stephen C.J. Parker, PhD, of the University of Michigan, and Praveen Sethupathy, PhD, of Cornell University, recently embarked on a collaborative research initiative empowered by the ADA Pathway to Stop Diabetes program.
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Hooper, Lundy & Bookman Authors Newest Edition of the Essential Monograph on Stark Law
1/15/2019
Hooper, Lundy & Bookman announces that the firm has authored the sixth edition of The Stark Law: Comprehensive Analysis + Practical Guide, published by the American Health Lawyers Association (AHLA).
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Pharmaceutical Industry Veteran Dr. Kurt R. Nielsen to lead Pharmaceutics International, Inc. (Pii)
1/15/2019
Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the appointment of Kurt R. Nielsen, Ph.D., to the position of President and CEO, effective immediately.
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CEL-SCI Regains Full Listing Compliance with NYSE American
1/15/2019
The Company is now considered in full compliance with the continued listing requirements.
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Dr. Lorraine Beraho Joins BAHP as Expert Advisor
1/15/2019
Lorraine Beraho, MD, MPH, FAAP, a board-certified pediatrician and Fellow of the American Academy of Pediatrics, has joined The Center for Baby and Adult Hygiene (BAHP) as an expert advisor on issues related to baby care, providing crucial insight for mothers and caregivers.
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Popper and Company Adds Diagnostic Industry Leaders as Senior Advisors
1/15/2019
Popper and Co., a strategy consulting and transaction advisory firm guiding medical technology and life sciences companies working on the leading-edge of diagnostics and patient management, announced today the addition of Vincent Linder, PhD and Gene Vivino to its growing team of industry and clinical senior advisors.
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Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies
1/15/2019
The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug (IND) applications.
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CVS Health Announces Walmart Decision to Leave CVS Caremark Commercial and Managed Medicaid Retail Pharmacy Networks
1/15/2019
CVS Health (NYSE: CVS) announced today that Walmart has opted to leave the CVS Caremark pharmacy benefit management (PBM) commercial and Managed Medicaid retail pharmacy networks.
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BrainScope Announces Publication Describing Proprietary Concussion Biomarker to Assess Potential Severity and Predict Prolonged Recovery
1/15/2019
Future Capability Could Aid in Objective Return-to-Activity Decisions
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Because of the government shutdown, which as of Monday, January 14 is into its fourth week, 40 percent of the U.S. FDA employees were furloughed. However, the two approvals described here should still be on track.
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The U.S. Food and Drug Administration (FDA) approved Bridgewater, NJ-based Amneal Pharmaceuticals’ generic version of Novartis’ Exelon Patch (Rivastigmine Transdermal System) for dementia related to Alzheimer’s and Parkinson’s diseases.
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The Orphan Drug Act (ODA) was enacted on January 4, 1983. It was designed to encourage the development of drugs for rare diseases. The law was amended the following year to define rare diseases as ones that affect fewer than 200,000 people in the U.S. But it also included drugs that affect more t...