Report: FDA hearing to discuss biosimilar regulations
WASHINGTON The Food and Drug Administration is looking for input on regulations concerning knock-off versions of biotech drugs, according to published reports.
The Hill, a newspaper in Washington, reported Monday that the FDA would have a hearing on Nov. 2 and 3 concerning follow-on biologics, based on a draft document distributed to healthcare lobbyists.
According to the report, the hearing would focus on such issues as interchangeability and definitions of such terms as “biological product.”
Price Chopper expands Diabetes AdvantEdge program with free offerings
SCHENECTADY, N.Y. Insulin-dependent diabetics will be eligible to receive free syringes and pen needles from Price Chopper, the Northeast supermarket chain said.
Price Chopper said the expansion of its Diabetes AdvantEdge program meant that it could serve 100% of the population that manages diabetes with increased access to medication, supplies, support and information, as well as education on food, nutrition and diabetes management.
“Diabetes AdvantEdge has been so well-received by those managing diabetes, as well as members of the healthcare community, that several chain drug stores have attempted to follow suit,” Price Chopper VP pharmacy Vincent Mainella said. “As a supermarket, however, we differentiate ourselves by providing a wide variety of fresh and packaged foods coupled with open access to our health professionals, registered dietitians and nutrition specialists.”
Prestige Brands to acquire Blacksmith Brands for $190 million
IRVINGTON, N.Y. Prestige Brands on Monday announced that it has entered into a definitive agreement to acquire 100% of the stock of Blacksmith Brands for $190 million in cash. Blacksmith manages five over-the-counter brands, including Efferdent, Effergrip, PediaCare, Luden’s and NasalCrom.
With the addition of these five brands, OTC products in the Prestige portfolio now account for 75% of revenues and an even greater percentage of brand contribution.
“Strategic acquisitions in the OTC market are core to our shareholder value creation strategy,” stated Matthew Mannelly, Prestige CEO. "We are strengthening Prestige’s position in key categories with the additions of Efferdent, PediaCare and Luden’s. These three scale brands compete in attractive categories we know well.”
The transaction is subject to customary closing conditions, including clearance under the Hart-Scott Rodino Antitrust Improvements Act of 1976, and is expected to close during fourth quarter 2010.
In June, Blacksmith Brands had voluntarily recalled all lots of its four children’s products in the PediaCare line, which were being manufactured for Blacksmith Brands by McNeil Consumer Healthcare at McNeil’s now-closed Fort Washington, Pa., plant. That recall was not initiated as a result of any consumer reports of adverse events, and no consumer complaints have been received about the safety or purity of the products, the company stated at the time.
In line with the announcement of the Blacksmith transaction, Prestige also announced the divestiture of its Cutex line of nail polish removers, the largest remaining product in its personal care segment. The sale to Arch Equity Partners of St. Louis was effective Sept. 1.