GTCbio recently announced that it will be holding the 4th Annual CNS Diseases World Summit from September 18-19, 2014 in San Francisco, California. The summit consists of two individual conferences that will run in parallel: (1) the 7th CNS Partnering & Deal-Making conference; and (2) …
By James E. Valentine – On June 11, 2014, a panel before the House Energy and Commerce Committee’s Subcommittee on Health hosted its second hearing on the 21st Century Cures Initiative. The Subcommittee sought input on whether current economic and regulatory incentives are sufficient to encourage …
By Alexander J. Varond – On May 29, FDA issued its final guidance on “Expedited Programs for Serious Conditions – Drugs and Biologics.” We blogged previously on the draft guidance and each of FDA’s four expedited programs (fast track designation, accelerated approval, priority review, and breakthrough …
By James C. Shehan & David B. Clissold – Good brand names have been important to drug marketers as far back as Biblical times – the Book of Ecclesiastes tells us that “a good name is better than precious ointment.” In a new draft guidance applicable …
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
By Alexander J. Varond & James E. Valentine – On May 20, 2014, Hyman, Phelps & McNamara, P.C.’s Frank J. Sasinowski appeared on a panel before the House Energy and Commerce’s Subcommittee on Health to present testimony at the first hearing on the 21st Century Cures …
By Kurt R. Karst – In moves that may displease both brand-name and generic drug manufacturers, and that could lead to litigation from both sides, FDA has with one hand proposed to giveth New Chemical Entity (“NCE”) exclusivity to certain Fixed-Dose Combination Drugs (“FDCs”) and has …
By Alexander J. Varond – Purdue Pharma recently submitted a citizen petition challenging FDA’s decision to require labeling revisions and postmarket study requirements for extended-release and long acting opioid analgesic products but not immediate-release products. We discussed these revisions here. Purdue’s citizen petition, dated February 11, 2014, …
By James C. Shehan – Vermont law has banned manufacturers of prescription drug, device, and biologics products from providing most gifts to physicians and other healthcare professionals since 2009 and has required these manufacturers to report permitted gifts and payments to Vermont HCPs since 2002 (summarized …
By Kurt R. Karst – Last Friday, BioMarin Pharmaceutical Inc. (“BioMarin”) and FDA announced (here and here) the approval of a BLA for a new biological product for patients with Mucopolysaccharidosis type IVA, also known a “Morquio A syndrome”: VIMIZIM (elosulfase alfa) Injection. The approval of …
By Kurt R. Karst – In a new paper published by The Petrie-Flom Center for Health Law Policy, BioTechnology, and BioEthics at Harvard Law School, and presented at a February 3, 2014 Health Law Workshop, Kevin Outterson, a Professor of Law at Boston University and member …
By Kurt R. Karst – On December 12th, a group of bipartisan lawmakers led by Representatives Phil Gingrey (R-GA) and Gene Green (D-TX) introduced H.R. 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013 (“ADAPT Act”). If enacted, the ADAPT Act would, among other …
By Allyson B. Mullen – For many individuals, a diagnosis, be it life threatening or chronic, is scary. However, the trial and error process that can follow the diagnosis in order to find a therapy (e.g., drug, device and/or biologic) that works best for the patient …
An article published in the current edition of Regulatory Focus, the flagship publication of the Regulatory Affairs Professionals Society (RAPS), and authored by Hyman, Phelps & McNamara, P.C.’s Alexander J. Varond discusses the recent trends and developments in personalized medicine, including FDA’s current thinking and …
By Kurt R. Karst – We’ve previously noted the resurgence of interest in (and controversy over) brand-side exclusivity. There’s the QI Program Supplemental Funding Act of 2008 (Pub. L. No. 110-379), which gave new life to “old” antibiotics. FDC Act § 505(u), titled “Certain Drugs …
