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Kellogg’s completes Pringles acquisition

BY Allison Cerra

BATTLE CREEK, Mich. — Kellogg’s announced that it has completed its acquisition of Procter & Gamble’s Pringles business, a deal valued at nearly $2.7 billion.

The transaction, which was first announced in mid-February, further strengthens Kellogg’s competitive position in global snacks as it nearly triples the size of the company’s international snacks business, with Pringles sales totaling $1.5 billion across more than 140 countries.

As previously reported, P&G initially inked an agreement with Diamond Foods through which Diamond Foods would acquire Pringles for $2.35 billion. The deal was delayed "to allow Diamond Foods to complete an accounting investigation." After the deal fell through, the P&G-Kellogg’s deal was announced.

"In Pringles, Kellogg has acquired a terrific business, with exceptional employees, world-class manufacturing facilities, iconic brand awareness, and a tremendous platform for growth," Kellogg’s president and CEO John Bryant said. "The addition of Pringles to our portfolio significantly advances the company’s strategic goal of building a global snacks business on par with our global cereal business, and expanding our global footprint."

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House passes PDUFA bill 387 to 5

BY Michael Johnsen

WASHINGTON — The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.

The bill, a version of which already passed through the Senate, now heads to committee where the House and Senate versions of the bill can be reconciled before Oct. 1 and submitted to the president. According to published reports, the Senate version would require more scrutiny for some new devices.

The House’s FDA Reform Act of 2012 (H.R. 5651) includes reforms to the FDA’s current evaluation and approval processes for prescription drugs and medical devices that makes the process more efficient, transparent and consistent, noted bill sponsor Fred Upton, R-Mich. Under current law, U.S. companies have been put at a competitive disadvantage with overseas manufacturers, who already benefit from a more streamlined approval process, Upton noted in a statement released Wednesday.

Upton expected a final bill to reach the president’s desk by early summer.

H.R. 5651 reauthorizes for five years the Prescription Drug User Fee Act and the Medical Device User Fee Act. Under these user fee agreements, the FDA collects fees directly from medical manufacturers to fund the agency’s drug and device approval processes. The legislation also establishes new user fee programs for generic drugs and biosimilars, and encourages the development of treatment options for children with rare diseases.

Lawmakers must reconcile differences in the bills, such as dates for the FDA to comply with certain provisions and language in the Senate’s version that would require more scrutiny for some new devices.

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Janssen seeks FDA approval for canagliflozin as Type 2 diabetes treatment

BY Allison Cerra

RARITAN, N.J. — A Johnson & Johnson subsidiary is seeking approval for a Type 2 diabetes treatment.

Janssen Research and Development has submitted a new drug application to the Food and Drug Administration for the approval of canagliflozin — an investigational oral, once-daily, selective sodium glucose co-transporter 2 inhibitor — for use in adult patients. Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels, the company said.

The filing was supported by a comprehensive global phase-3 clinical development program, which included nine multicenter, randomized clinical studies that enrolled approximately 10,300 patients. The late-stage clinical trial evaluated the safety and efficacy of canagliflozin across the spectrum of Type 2 diabetes and included placebo- and active comparator-controlled studies. The program also included a dedicated cardiovascular study conducted in patients who have or are at high risk for developing cardiovascular disease.

Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma. Janssen Pharmaceuticals has marketing rights in North America, South America, Europe, Middle East, Africa, Australia, New Zealand and parts of Asia.


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C.Morton says:
Jan-10-2013 02:15 pm

According to this article, http://www.rxwiki.com/news-article/canagliflozin-type-2-diabetes-closer-approval-may-have-safety-issues Researchers found that the drug was able to lower blood sugar levels but may increase the risk of heart, kidney and bone-related problems. But how do you decide if it's worth the risk?

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