Industry News

LEO Science & Tech Hub, Elektrofi collaborate on dermatological drug delivery

Centerwatch - Wed, 2017-10-11 10:51

LEO Science & Tech Hub, an R&D unit of LEO Pharma dedicated to identifying, developing, and funding innovative solutions that improve the lives of people with skin diseases, announced a collaboration agreement with Elektrofi, a Cambridge-based biotechnology company focused on drug delivery innovations, to explore advanced formulation technology for dermatological drug delivery.  “We are excited […]

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Algorics announce Dr. Malcolm Burgess as new advisory board member

Centerwatch - Tue, 2017-10-10 10:30

Algorics, a provider of clinical analytics solutions and software for the global life sciences industry, announced the appointment of Dr. Malcolm Burgess to the Advisory Board of Algorics. Dr. Burgess will help to continue to shape and guide the Algorics Risk Based Monitoring (RBM) strategy working closely with the leadership team. Dr. Burgess brings more […]

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Malin appoints Dr. Andrew von Eschenbach as Chief Medical Adviser

Centerwatch - Tue, 2017-10-10 10:29

Malin, an Irish-based global life sciences company, announced the appointment of Dr. Andrew von Eschenbach as Chief Medical Adviser, effective immediately. Dr. von Eschenbach previously served as an advisory partner to Malin. Dr. von Eschenbach is currently the president of Samaritan Health Initiatives Inc, and serves as an adjunct professor at Houston’s University of Texas […]

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Children’s Hospital Los Angeles to study “Bubble Boy” syndrome

Centerwatch - Tue, 2017-10-10 10:26

Michael Pulsipher, M.D., of the Children’s Center for Cancer and Blood Diseases at Children’s Hospital Los Angeles, along with co-principal investigator, Sung-Yun Pai, M.D., of Boston Children’s Hospital, has been awarded nearly $9 million from the National Institute of Allergy and Infectious Diseases of the NIH to study a new treatment approach for babies born […]

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CHLA receives Magnet Recognition for Clinical Excellence for the third time

Centerwatch - Tue, 2017-10-10 10:19

For the third consecutive time, the American Nurses Credentialing Center (ANCC) has bestowed Magnet recognition for clinical excellence to Children’s Hospital Los Angeles (CHLA). “Receiving Magnet Recognition for the third time in Children’s Hospital Los Angeles’ history affirms our commitment to providing the best in patient care,” said CHLA President and CEO Paul S. Viviano. “My sincerest gratitude […]

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NIH Director’s high-risk research awards announced for 2017

Centerwatch - Tue, 2017-10-10 10:05

The NIH’s High-Risk, High-Reward Research program, part of the NIH Common Fund, funded 86 awards to exceptionally creative scientists proposing to use highly innovative approaches to tackle major challenges in biomedical research. The program supports high-risk ideas with high-impact potential, such as recording the history of an individual cell in its DNA for future playback; understanding […]

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Anthem, HealthCore and Boehringer Ingelheim initiate pragmatic clinical trial

Centerwatch - Tue, 2017-10-10 10:03

The first patients have now enrolled in AIRWISE, a pragmatic clinical trial in chronic obstructive pulmonary disease (COPD) to study how commonly prescribed medicines may reduce the occurrence of exacerbations of COPD. This landmark research is a collaboration between Anthem, its outcomes research subsidiary, HealthCore, and Boehringer Ingelheim, a pharmaceutical company with a long history […]

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CEL-SCI updates ongoing arbitration against former CRO

Centerwatch - Tue, 2017-10-10 09:59

CEL-SCI announced that as it nears the conclusion of its arbitration with its former CRO, the company has restructured its agreement with the litigation funding firm Lake Whillans to further incentivize the law firm representing CEL-SCI in the arbitration. Geert Kersten, CEO of CEL-SCI said, “We are finally near the end of this arbitration. Both […]

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NIH to fund seven research centers in minority institutions

Centerwatch - Tue, 2017-10-10 09:56

The National Institute on Minority Health and Health Disparities (NIMHD), part of the NIH, will fund seven new awards to support the Research Centers in Minority Institutions (RCMI) Specialized Centers program. RCMI is designed to support institutional research capacity and foster the career development of new and early career investigators conducting minority health and health […]

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NIH to fund Centers of Excellence on Minority Health and Health Disparities

Centerwatch - Tue, 2017-10-10 09:54

Twelve specialized research centers designed to conduct multidisciplinary research, research training and community engagement activities focused on improving minority health and reducing health disparities will launch. The centers, to be funded by the National Institute on Minority Health and Health Disparities (NIMHD), part of the NIH, will share approximately $82 million over five years, pending the […]

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PPD wins Best CRO at World ADC Awards for advancing cancer research

Centerwatch - Tue, 2017-10-10 09:51

Pharmaceutical Product Development (PPD), a global CRO, was named Best CRO Provider at the World ADC Awards. This recognition acknowledges the excellence and dedication of PPD Laboratories professionals in supporting clients’ antibody-drug conjugate (ADC) research to develop new anticancer therapies. ADCs are complex biotherapeutic molecules, combining monoclonal antibodies with an attached payload of highly potent […]

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FDA to modernize digital health software regulatory framework

Centerwatch - Tue, 2017-10-10 08:00

The FDA has named nine companies selected to participate in a first-of-its-kind pilot program designed to revolutionize digital health regulation in the U.S. The importance of this pilot program is vast and the driving force behind why the FDA is launching it. According to the FDA, “The FDA’s Pre-Cert Pilot Program is intended to inform […]

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There’s a lot of ways to leave a good impression

Centerwatch - Tue, 2017-10-10 08:00

There is no better learning opportunity than to observe an experienced individual correctly complete a process that you are trying to understand/implement outside of a classroom in a real-world environment. It lends depth to the sometimes-lifeless instruction of written curriculum. The demonstration tames the daunting unknown, creating confidence in an ability where there may have […]

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FDA Adverse Events Reporting System (FAERS) Public Dashboard

FDA News - Fri, 2017-09-29 18:19
Four FAERS summary statistics reports updated with data through December 31, 2013.
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FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files

FDA News - Fri, 2017-09-29 11:08
FDA Adverse Event Reporting System (FAERS) - Quarterly Data Extract (QDE): The Quarterly Data Extract files, contain raw data extracted from the FAERS database for the indicated time ranges (not cumulative), in ASCII or SGML formats.
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Generic Drug Development

FDA News - Thu, 2017-09-28 14:03
News and Announcements updated
Categories: Industry News

Newly Added Guidance Documents

FDA News - Thu, 2017-09-28 11:45
Categories: Industry News

Drugs@FDA Data Files

FDA News - Tue, 2017-09-26 14:56
Data files updated through September 26, 2017.
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Drugs@FDA Download File (new structure)

FDA News - Tue, 2017-09-26 14:55
Data files updated through September 26, 2017.
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