United States

FDA approves Sanofi, Regeneron’s Praluent (alirocumab) Injection

Monday, July 27, 2015 12:36 PM

The FDA has approved Sanofi and Regeneron Pharmaceuticals’ Praluent (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein (LDL) cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.

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ICER launches New Drug Assessment Program with $5.2M award

Friday, July 24, 2015 09:15 AM

With drug prices for cancer and many other conditions soaring to new highs amid questions about their true value to patients, the Institute for Clinical and Economic Review (ICER) has launched a program to transform the way new drugs are evaluated and priced in the U.S.

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Covance opens fit-for-purpose Dallas clinical research unit, to add 45 jobs

Friday, July 24, 2015 08:31 AM

Covance Drug Development has relocated its clinical research unit (CRU) in Dallas to a new, fit-for-purpose clinical research facility. The new unit, which opened earlier this month, has expanded from 72 to 100 medical beds and is located in the same building as the prior unit. In addition, a LabCorp patient service center will be co-located in the CRU, at which patients will have an opportunity to learn more about volunteering and participating in early-stage clinical trials.

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Eli Lilly to expand San Diego Biotechnology Center, add 130 jobs

Friday, July 24, 2015 08:26 AM

Eli Lilly plans to expand the Lilly Biotechnology Center located in San Diego. The expansion will effectively double Eli Lilly’s research presence in San Diego as the company seeks to develop new collaborations in one of the world’s leading regions for drug research and development.  

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NIH joins public-private partnership to fund research on autism biomarkers

Wednesday, July 22, 2015 01:43 PM

The NIH, the Foundation for the NIH (FNIH), the Simons Foundation Autism Research Initiative (SFARI) and others will fund a multiyear project to develop and improve clinical research tools for studying autism spectrum disorder (ASD).

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Eisai to transfer Research Triangle Park campus to Biogen

Friday, July 17, 2015 11:51 AM

Eisai has entered into a definitive agreement to transfer ownership of its Research Triangle Park (RTP) manufacturing campus to Biogen. This arrangement expands upon the capacity-sharing manufacturing alliance Eisai and Biogen have had in place at the RTP facility since early 2013.

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U.S. House passes 21st Century Cures Act

Wednesday, July 15, 2015 12:03 PM

The U.S. House of Representatives has approved H.R. 6, the 21st Century Cures Act, by a vote of 344-77 and now goes to the U.S. Senate for consideration. This legislation would reauthorize the National Institutes of Health, focus efforts to increase strategic investments and medical research at the NIH and modernize the approval and regulatory process for new drugs, biologics and medical devices at the FDA.  On May 21, 2015, the bill passed the House Energy and Commerce Committee by a vote of 51–0. 

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NIH-funded vaccine for West Nile virus enters human clinical trials

Wednesday, July 8, 2015 11:18 AM

A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The experimental vaccine was discovered and developed by scientists at the Oregon National Primate Research Center at Oregon Health & Science University (OHSU) in Portland. The scientists were funded with a $7.2 million grant from NIAID, awarded in 2009. The new vaccine is being tested in a phase I clinical trial at Duke University in Durham, North Carolina, one of NIAID’s Vaccine and Treatment Evaluation Units (VTEUs).

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Social media bill introduced for pharma product information

Monday, July 6, 2015 09:24 AM

U.S. Representative Billy Long has introduced legislation to update regulations guiding how drug manufacturers communicate product information.

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Schulman Associates IRB acquires Absolute Research to expand its research capabilities

Monday, July 6, 2015 08:00 AM

Looking to bolster its clinical research regulatory services for its institutional clients and gain eConsent technology for small to mid-size biopharmaceutical customers, Schulman Associates IRB has acquired Absolute Research, whose research and technology capabilities will be expanded.

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CWWeekly

July 27

AB Science warned about putting study volunteers in danger

FDA, Google unite to detect search-data adverse events

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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