FDA rejects approval application from Bristol-Myers Squibb, ImClone Systems
NEW YORK The Food and Drug Administration has rejected an approval application from Bristol-Myers Squibb and Eli Lilly & Co. subsidiary ImClone Systems for an additional use of a cancer drug, the two companies announced Monday.
In its letter, the FDA requested an additional study to confirm the comparability of Erbitux (cetuximab) used as a first-line treatment for squamous cell carcinoma of the head and neck in the rejected approval application as compared to Erbitux marketed in the United States. The companies used supplies of Erbitux provided by German drug maker Merck KGaA, which markets Erbitux outside of North America.
Bristol and ImClone recently withdrew an application seeking approval for Erbitux as a treatment for advanced non-small cell lung cancer, also because the FDA needed a comparability study. The FDA’s decisions do not affect Erbitux already marketed in the U.S.
United Drugs and Associated Pharmacies merger to combine strengths
Behind the decision by United Drugs and Associated Pharmacies to merge is one overriding theme: a national, integrated cooperative of more than 2,000 pharmacies all rowing in roughly the same direction is a force to be reckoned with.
In today’s economic maelstrom, it may also mean the difference between success and failure for many of the independent pharmacy operators operating under the combined United-Associated umbrella.
This economy — which is chewing up many smaller businesses, drying up demand for all manner of goods and services, and throwing hundreds of thousands of workers a week off corporate payrolls — leaves little room for error. And the financial meltdown makes operating an independent drug store — not an easy proposition in the best of times — a daunting prospect. Any combination of buying and marketing co-ops that can boost efficiencies and/or beef up the menu of services or purchasing clout of their members has to be a topic of serious consideration.
What’s more, merging the memberships of United and API creates one of the nation’s largest independent pharmacy networks, on a par with McKesson Corp.’s Health Mart franchise operation, Cardinal Health’s Leader umbrella program for independents and its Medicine Shoppe franchise pharmacy brand, or AmerisourceBergen’s Good Neighbor Pharmacy store-service and branding program. Only a handful of drug, supermarket or mass merchandise chains field as big a store network.
But many questions remain, even assuming the merger is approved. Among them: how will the combined programs squeeze new operating efficiencies and a stronger service program for their members out of their marriage? What additional steps need to be taken in this kind of unforgiving market to unite the 2,000 pharmacies under a stronger marketing, advertising and branding umbrella? Will there be a unified national advertising and pricing strategy? And, finally, will the members of both groups embrace the combination as a long-term benefit to their business?
Carmel Pharma designates April National Safe Handling Awareness Month
COLUMBUS, Ohio Carmel Pharma has designated April as National Safe Handling Awareness Month, and April 20 as National Safe Handling Awareness Day.
The company said the purpose of the month was to educate healthcare workers about safe handling of drugs and protect them from hazardous drug exposure. According to an alert published by the National Institute for Occupational Safety and Health, exposure to hazardous drugs can lead to skin rashes, infertility, miscarriages, birth defects and possibly cancer.
Carmel Pharma will sponsor a free webcast April 20 from 1 p.m. to 2 p.m. EST, followed by a live “ask the experts” session. The webcast will be part of a month of regional and national continuing education activities.