PHARMACY

CVS-Longs antitrust regulation waiting period expires

BY Antoinette Alexander

WOONSOCKET, R.I. CVS Caremark and Longs Drug Stores announced on Monday that the regulatory waiting period under the Hart-Scott-Rodino Antitrust Improvement Act has expired, satisfying a condition to the closing of the deal.

The waiting period expired Sept. 5.

As previously reported by Drug Store News, CVS Caremark plans to buy for $2.9 billion, including debt, Longs Drug Stores’ 521 retail locations in California, Hawaii, Nevada and Arizona, as well as its PBM services.

CVS Caremark’s planned acquisition of Longs Drug Stores opens the door for CVS Caremark to become a major player on the West Coast and transforms the self-proclaimed pharmacy health care service company into one that will fill or manage more than 1.2 billion prescriptions per year and will operate approximately 6,800 drugstores in 41 states and the District of Columbia.

As part of the deal, which is for $71.50 per share in cash, CVS Caremark will bolster its already strong PBM business by acquiring Longs’ Rx America subsidiary, which offers prescription benefits management services to more than 8 million members and prescription drug plan benefits to approximately 450,000 Medicare beneficiaries. Management plans to integrate Rx America with Caremark over time.

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FDA increases drug warnings for TNF blockers

BY Alaric DeArment

WASHINGTON A risk of fungal infection has prompted the Food and Drug Administration to call on four drug makers to strengthen warnings on some of their products.

Johnson & Johnson’s Remicade (infliximab), Abbott Laboratories’ Humira (adalimumab), Amgen’s and Wyeth’s Enbrel (etanercept) and UCB’s Cimzia (certolizumab pegol) are the drugs affected after the FDA reviewed 240 reports of the respiratory fungal disease histoplasmosis in patients using the drugs. Of the 240 patients, 45 died from the disease, whose symptoms resemble those of the flu.

The drugs belong to a class of drugs that block tumor necrosis factor, which normally helps the body fight cancer but is sometimes overproduced, leading to diseases such as arthritis and Crohn’s disease.

“Amgen and Wyeth are committed to the safety of patients,” the companies said in a jointly released statement Friday. “Both companies maintain ongoing safety surveillance programs worldwide to analyze and evaluate safety reports from controlled and open-label clinical trials and patient registries, as well as reports received from health care professionals and patients. Both companies work with regulatory agencies to update the label periodically as appropriate based on emerging information.”

Amgen, they stated, will work with the FDA to finalize and communicate revised product labeling for Enbrel to both physicians and patients.

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FDA posts first quarterly drug safety report

BY Alaric DeArment

WASHINGTON The Food and Drug Administration has posted its first quarterly report on drugs under review for possible safety issues, the agency announced Friday.

The drugs are identified based on a review of reports in the FDA’s Adverse Event Reporting System and are listed under the Food and Drug Administration Amendments Act of 2007, which requires the FDA to inform the public of new safety information or potential signals of serious risk, based on reviews of AERS.

But, the FDA cautioned, a drug’s appearance on the list doesn’t mean it definitely carries the risk only because the FDA has identified a potential safety issue.

“My message to patients is this: Don’t stop taking your medicine,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.”

Please click here to view the full list of drugs.

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