FDA Revises Interpretation of 5-year NCE Exclusivity

By: Stanley Chalvire In an effort to incentivize the development of certain fixed-combination drug products, the Food and Drug Administration (FDA) recently issued draft guidance revising its interpretation of the 5-year New Chemical Entity exclusivity provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act). Sections 505(c)(3)(E) and 505(j)(5)(F) of the FD&C Act provide the holder …

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FDA to Partner with Industry to Help Expedite Medical Device Development

By David A. Fazzolare The FDA issued a press release December 3, 2012 announcing its role in a new public-private partnership aimed at expediting medical device review and approval by improving the regulatory science underlying medical device development, assessment and review. In particular, the biomedical science trade association LifeScience Alley (LSA) created the Medical Device …

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FDA Clears MindChild Medical’s Fetal Monitor

In February we reported that MBBP client MindChild Medical Inc. had filed for a Pre-Marketing Notification Application (510(k)) with the U.S. Food and Drug Administration for its non-invasive fetal heart rate monitor, MERIDIAN™.  On September 25, MindChild announced that the FDA has cleared MERIDIAN™ and anticipates it entering the U.S. markets in the near future. Bill Edelman, CEO of …

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FDA Releases Long-Awaited Draft Guidance on Biosimilars

By: David Fazzolare The long-awaited guidance on biosimilar product development has finally been released by FDA. On Thursday, February 9th, FDA released three guidance documents on biosimilar product development which reflect the agency’s current thinking on important scientific and regulatory considerations pertinent to submitting biosimilar applications. The first guidance document, entitled “Scientific Considerations in Demonstrating Biosimilarity …

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MindChild Medical Looks for FDA Approval

MBBP client MindChild Medical Inc. recently announced it has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the U.S. Food and Drug Administration for Meridian, a non-invasive fetal heart rate monitor. MindChild Medical expects the FDA to provide feedback on the 510(k) application in the next quarter, and also plans to begin marketing Meridian, …

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FDA to Meet on December 16 to Discuss Proposed User Fee Program for Biosimilar and Interchangeable Biologic Product Applications

By David Fazzolare The FDA recently announced a notice of public meeting and request for comments in the Federal Register regarding proposed recommendations for a user fee program for biosimilar biological products for fiscal years 2013 through 2017. The Federal Register notice describes the FDA’s proposed user fee program, as well as FDA’s proposed performance …

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FDA Approves Pluromed Surgical Gel

MBBP client Pluromed, Inc. recently announced that the United States Food and Drug Administration (FDA) has approved their surgical gel, LeGoo® Internal Vessel Occluder. LeGoo is a water-soluble temperature-sensitive medical device that allows doctors to temporarily stop blog flow during surgery without using clamps or elastic loops. Pluromed plans to start commercializing LeGoo at select medical …

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MBBP Client Valeritas Receives FDA 510(k) Clearance for Insulin Delivery Device

MBBP client Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, has gained clearance from the U.S. Food and Drug Administration on the company's V-Go Disposable Insulin Delivery Device for use with Novo Nordisk's NovoLog® for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing …

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European Commission Approves Shire’s Gaucher Drug

MBBP client Shire Human Genetic Therapies was recently featured in a Boston Business Journal article. Shire's Gaucher disease treatment VPRIV  was approved by the European Commission, thereby allowing VPRIV to be marketed in thirty European countries. VPRIV approval by the U.S. Food and Drug Administration in March 2010 was fast-tracked due to the shortage of Genzyme Corporation's Gaucher drug Cerezyme. For more …

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Patient Data Shows Safe Switch from Genzyme to Shire Drug

Due to the temporary closing of Genzyme's Allston plant last summer, MBBP client Shire's new Gaucher Disease treatment VPRIV was fast-tracked and approved by the FDA. Shire is now reporting data from a Phase 3 study which showed that when patients switched from Genzyme's Cerezyme to Shire's VPRIV, in the same dosage, several key health …

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