Media Results

The Hill: Medicare negotiating with pharma is not the answer by Joseph Gulfo

The concept of Medicare negotiating drug prices directly with manufacturers has been raised throughout 2015 by the Senate and the president, but never more vocally than over the last month by presidential candidates Hillary Clinton and Sen. Bernie Sanders (I-Vt.) following Turing Pharmaceuticals’ attempted 55-fold increase in the price of Daraprim and Valeant Pharmaceuticals’ receipt…

Read More →

Los Angeles Times: California vintner John Jordan wants to shape politics — on his terms by Seema Mehta

John Jordan got his first taste of politics when he ran for vice president of his fifth-grade class. He wasn’t the most popular kid in class. He wasn’t even aware of the cliques that favored his rivals. He lost. “I was two votes short, out of 27,” said Jordan, in an interview at Jordan Winery’s…

Read More →

Wall Street Journal: Actress Mitzi Gaynor’s Former Home Lists for $11.5 Million by Candace Taylor

Developer Nick Sinatra renovated the Beverly Hills property with the wishes of the ‘South Pacific’ star in mind A developer is selling the longtime Beverly Hills home of Mitzi Gaynor—after a renovation approved by the “South Pacific” actress—for $11.5 million. Ms. Gaynor, now in her 80s, sold her home to developer Nick Sinatra last year…

Read More →

Los Angeles Times Home of the Day: A modern home with rural notes in Venice by Neal Leitereg

This whitewashed two-story in Venice riffs contemporary and farmhouse styles with a twin-gable roofline, vertical siding and a small front porch set off the front entrance to the home. A chef’s kitchen complete with pendant lighting and Carrara marble countertops anchors the open-area floor plan. On the second floor, a private balcony set off the…

Read More →

Crain’s Chicago Business: The best is yet to come in Chicago for this New York real estate firm by Ally Marotti

A New York real estate company is entering the Chicago market by way of a 272-unit apartment complex in Aurora. Sinatra & Co. Real Estate bought Orchard Village Apartments for $34.5 million in a deal that closed yesterday, said president Nick Sinatra. Chicago-based residential property management and acquisitions firm Stadt Group partnered with Sinatra on…

Read More →

The Hill: How the FDA can settle the off-label use vs. off-label promotion conflict by Joseph Gulfo

Both the U.S. Court of Appeals for the Second Circuit and district courts have ruled against the Food and Drug Administration (FDA) in two widely publicized cases involving the agency’s enforcement of misbranding policies to prohibit off-label drug promotion, the intention (encouragement of physicians and advertising) of a drug manufacturer to have its drug used…

Read More →

The Buffalo News: EXPO, upscale downtown food hall, announces lineup by Andrew Z. Galarneau

A lineup of up-and-coming Buffalo restaurants are signed as tenants of an upscale Main Street food hall downtown. Its name will be EXPO and, if all goes well, it might be opening in November, according to developer Nick Sinatra, who owns the space. Newbury Street, Crush Juicery, Osteria 166, Agave and Sun Restaurant will all…

Read More →

Forbes.com: Patients Are Tired Of Waiting On The FDA by Joseph Gulfo

The Food and Drug Administration (FDA) regulates 25% of the U.S. economy. For fiscal year 2016, the FDA’s budget is $4.9 billion, with $2.2 billion (or 45%) generated from user fees, payments collected by the FDA from companies submitting new drug, biologics and medical device applications for review. They were authorized under the Prescription Drug User Fee Act (PDUFA, 1992) and Medical Devices User Fee Act…

Read More →

The Hill: Different approach to FDA user fee reauthorizations needed by Joseph Gulfo

Initially passed in 1992 and 2002, respectively, PDUFA (Prescription Drug User Fee Amendments) and MDUFA (Medical Device User Fee Amendments) require reauthorization every five years. Hearings for the 2017 reauthorization are being scheduled to take place throughout 2016. Forty-five percent, or $2.2 billion, of the Food and Drug Administration’s (FDA) $4.9 billion fiscal 2016 budget…

Read More →

The Hill: Fixing the FDA’s broken combination products policies by Joseph Gulfo

One of the most fertile areas of medical innovation today is the combination of devices and drugs. These products, also known as combination products, are comprised of two or more regulated components, i.e., drug and/or device and/or biologic, and don’t fit nicely into existing regulatory pathways, yet comprise roughly one-third of all products in development…

Read More →

Back to Top