United States

Charles River Laboratories International to pay $1.8M to settle False Claims Act allegations

Friday, March 24, 2017

Charles River Laboratories International has agreed to pay the U.S. government $1.8 million to settle claims that it violated the False Claims Act by improperly charging for labor and other associated costs that were not actually provided on certain NIH contracts, the Justice Department announced. Charles River is a for-profit corporation headquartered in Wilmington, Massachusetts. 

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FDA grants Breakthrough designation for Rituxan (Rituximab) in pemphigus vulgaris

Friday, March 24, 2017

Genentech, a member of the Roche Group, has announced that the FDA granted Breakthrough Therapy Designation status to Rituxan (rituximab) for pemphigus vulgaris, a rare, serious and life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. FDA Breakthrough Therapy Designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible. Genentech is currently enrolling a phase III study in pemphigus vulgaris (PEMPHIX, NCT02383589), a disease for which there are limited treatment options. 

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Western IRB establishes single-IRB solution

Tuesday, March 21, 2017

Western Institutional Review Board (WIRB), a provider of ethical review of clinical research, announced the launch of its WIRB NIH Single Review Solution (SRS) for NIH-funded multi-site research. WIRB has an extensive background in reviewing clinical trials funded by NIH. Building upon status as the IRB of record for the majority of institutions that conduct clinical research in the U.S., WIRB NIH Single Review Solution will provide participating institutions the gold standard of research review.   

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BioSig Technologies, Mayo Clinic partner

Friday, March 17, 2017

BioSig Technologies, a medical device company developing the PURE EP System, a proprietary platform designed to address an unmet technology need for the $4 billion electrophysiology (EP) marketplace, has signed a 10-year strategic agreement with Mayo Clinic and Mayo Clinic Ventures. This new, expanded collaboration with Mayo builds upon the work realized under the Advanced Clinical Research Program that was signed with Mayo Clinic in March 2016.

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PTC Therapeutics to acquire Emflaza for Duchenne muscular dystrophy

Thursday, March 16, 2017

PTC Therapeutics has entered into an asset purchase agreement with Marathon Pharmaceuticals to acquire all rights to Emflaza (deflazacort). Emflaza is the first treatment approved in the U.S. for all Duchenne muscular dystrophy (DMD) patients five years and older, regardless of their genetic mutation. DMD is a rare and fatal genetic disorder that results in progressive muscle weakness from early childhood and leads to premature death due to heart and respiratory failure. Emflaza aligns with PTC’s mission to bring therapies to patients who have rare diseases with limited or no treatment options.

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FDA grants Orphan designation to Boehringer Ingelheim’s BI 836858 for myelodysplastic syndromes

Thursday, March 9, 2017

Boehringer Ingelheim has announced that the FDA has granted Orphan Drug designation to its anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic syndromes (MDS). Orphan Drug designation is granted by the FDA to investigational compounds intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people.

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FDA, EU drug inspectors ink Mutual Recognition Agreement

Monday, March 6, 2017

The U.S. and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.

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