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It’s a busy week for the U.S. Food and Drug Administration (FDA) with quite a number of pending drug approvals, several of which were delayed for a variety of reasons. Here’s a look.
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The latest financing round will boost the study of KarXT, Karuna’s lead product candidate, which is currently in Phase II development as a potential treatment for acute psychosis in patients with schizophrenia.
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Takeda Receives U.S. FDA Approval to Manufacture FLEXBUMIN® at New Plasma Manufacturing Facility near Covington, Georgia
3/18/2019
FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution is indicated for hypovolemia, hypoalbuminemia, (burns, Adult Respiratory Distress Syndrome (ARDS), and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN). Albumin is not indicated as an intravenous nutrient
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Anika Appoints Robert Richard, Ph.D. as Vice President of Research and Development
3/18/2019
Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid ("HA") technology, today announced the appointment of Robert Richard, Ph.D., to the newly created position of Vice President of Research and Development.
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Bicycle Therapeutics Appoints Pierre Legault as New Director and Board Chairman - March 18, 2019
3/18/2019
Bicycle Therapeutics announced the appointment of Pierre Legault, MBA, CPA, as a Director and Chairman of the Board of Directors.
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Fractyl Expands Management Team as Company Initiates U.S. Clinical Trial in Type 2 Diabetes
3/18/2019
These additions come as Fractyl is preparing for commercialization efforts outside the U.S. and has started the company’s first U.S. clinical trial for its lead product candidate Revita™ DMR for the treatment of type 2 diabetes and fatty liver disease.
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Myomo® Announces New Sales and Service Agreement for Italy
3/18/2019
Progettiamo Autonomia Robotics Expands its Portfolio with MyoPro®
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Boston Heart Diagnostics Publishes Randomized Trial
3/18/2019
Boston Heart Diagnostics announced the publication of a new research study: “Cardiovascular Risk Factor Reduction in First Responders Resulting from and Individualized Lifestyle and Blood Test Program: A Randomized Controlled Trial”.
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Enanta Pharmaceuticals Completes Enrollment in Two Ongoing Phase 2 Studies
3/18/2019
Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced it has completed enrollment in two Phase 2 studies.
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CeQur Appoints Peter B. Luther to Board of Directors
3/18/2019
Former Johnson & Johnson President and Private Equity CEO Brings Extensive Experience in Consumer Health and Diabetes
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Karuna Announces $68 Million Series B Financing
3/18/2019
Proceeds will be used to advance clinical development of lead product candidate, KarXT, for additional indications beyond the ongoing Phase 2 clinical trial in schizophrenia and for expansion of the pipeline
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Bicycle Therapeutics Appoints Pierre Legault as New Director and Board Chairman
3/18/2019
Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide product platform, announced the appointment of Pierre Legault, MBA, CPA, as a Director and Chairman of the Board of Directors.
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Late-breaking Clinical Trial Highlights Positive Safety and Efficacy Data for the LUMINIZE™ RF Balloon Catheter
3/17/2019
New data showcasing performance of recently acquired RF balloon-based, single-shot ablation technology
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Tip That Launched College Bribery Scandal Case Came From Pharma Pump-and-Dump Investigation
3/15/2019
The scandal, dubbed Operation Varsity Blues, revolves around dozens of wealthy parents paying a college consultant to help cheat on entrance exams and falsify student athlete profiles, as well as bribing coaches at a number of prestigious universities. -
BioSpace Movers and Shakers: March 15
3/15/2019
Biotech and pharma companies make changes to their executive leadership teams, with moves at Sandoz, PAREXEL, FSD, Karuna, Precision Bio, and more. -
Exclusive speaker interview with SCHOTT Pharmaceutical Systems released for Pre-Filled Syringes East Coast 2019
3/15/2019
Senior expert from SCHOTT Pharmaceutical Systems is set to present at Pre-Filled Syringes East Coast Conference in just four weeks’ time in Boston, USA.
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Mother Dirt Launches Retail Pop-Up at Showfields, "The Most Interesting Store in the World"
3/15/2019
Mother Dirt, the microbiome company creating skincare products containing a live culture of bacteria, announced today its first-ever pop-up shop at SHOWFIELDS in New York, a retail concept that invites visitors to discover and engage with the brands of tomorrow.
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ArQule Announces Management Team Changes
3/15/2019
ArQule, Inc. announced that Robert Weiskopf, Senior Vice President, Chief Financial Officer and Treasurer, has decided to retire effective March 29 of this year.
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Myomo Makes NYSE American Section 610(b) Public Announcement
3/15/2019
Myomo, Inc. announced that, as previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2018 filed on March 12, 2019 with the Securities and Exchange Commission, the audited financial statements for the year ended December 31, 2018 included in the 10-K contained an audit opinion from its independent registered public accounting firm, which included a going concern emphasis of matter paragraph.
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The Bioinformatics Infrastructure Congress launches in Boston on May 7-9, 2019
3/15/2019
The Bioinformatics Infrastructure Congress is the first bioinformatics conference that is solely focussed on tools and unit set-up, rather than application.