PHARMACY

Dey Pharma settles DoJ suit

BY Allison Cerra

BASKING RIDGE, N.J. — A Mylan subsidiary has settled a lawsuit brought on by the Department of Justice four years ago.

Dey Pharma — which was involved in the suit prior to begin acquired by Mylan from Merck KGaA in 2007 — said that it agreed to pay $280 million to the DoJ in exchange for a release of claims, which dealt with Medicare and Medicaid reimbursements paid by the federal government to pharmacists and other healthcare providers. Dey added that Merck KGaA is responsible for paying the full amount of this settlement, as well as all costs and other expenses associated with pending and future-related lawsuits.

The settlement agreement confirmed that the resolution of the case does not constitute an admission, finding or evidence of fault, liability or wrongdoing by Dey, the drug maker said.

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FDA releases annual ‘Generic Drug Roundup’

BY Alaric DeArment

SILVER SPRING, Md. — Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

The roundup is an annual highlighting of what the agency considers the most significant generic drug approvals.

One of the most important was enoxaparin sodium injection, approved in July. The drug, a generic version of Sanofi-Aventis’ anti-clotting drug, Lovenox, is marketed by Sandoz, the generics arm of Swiss drug maker Novartis. While the FDA approved Lovenox as a pharmaceutical, its chemical complexity and production process place it in league with biologics, and many analysts said the special circumstances under which the agency approved it could influence regulations governing biosimilars in the future. Lovenox had sales of $2.7 billion in 2009, according to Sanofi-Aventis financial data.

June saw the approval of Roxane Labs’ anastrozole tablets, a generic version of AstraZeneca’s breast cancer treatment Arimidex, which had sales of $916.8 million, according to IMS Health. Roxane, based in Columbus, Ohio, is the generics arm of German drug maker Boehringer Ingelheim.

Also in June, the FDA approved Teva’s venlafaxine hydrochloride extended-release capsules, a generic version of Wyeth’s major depressive disorder treatment Effexor XR, which has annual sales of around $2.75 billion, according to IMS.

In October, the FDA approved Actavis’ losartan potassium tablets, a generic version of Merck’s Cozaar, used to treat hypertension. Losartan potassium tablets had sales of around $940 million for the 12-month period ended in June, according to IMS.

In July, the agency approved APP Pharmaceuticals’ injected drug aztreonam, a generic version of Bristol-Myers Squibb’s antibiotic Azactam, which had sales of around $86 million in 2009, according to IMS.

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PwC report discusses what’s next for healthcare industry

BY Alaric DeArment

NEW YORK — The healthcare industry could see an “extreme makeover” next year, according to a new report by PwC.

The research firm’s "Top Health Industry Issues of 2011" report, based on a nationwide survey of 1,000 adults in the United States, identified six major issues facing health organizations:

  1. Record spending on health information technology will drive demand for skilled professionals in this area, increased roles for chief information officers and industry consolidation.

  2. Insurers adapting to new medical loss ratios are expected to make “significant” changes to benefit plan design and pricing, and despite the recent court ruling on the individual mandate, states will still have to develop health insurance exchanges.

  3. Shifts in focus from fee-for-service to measurements of performance, outcomes and savings in accountable care organizations will create new opportunities and risks.

  4. Cost shifting may have reached its limit, and decreased utilization by price-sensitive consumers may create a trickle-down effect among health organizations, starting with physicians and drug companies as consumers reduce doctor visits and spending on drugs, followed by reduced sales of other products and fewer diagnostics.

  5. Health organizations may seek to share administrative burdens and information technology investments, gain market share and fill strategic gaps through increased merger and acquisition activity.

  6. Drug companies may see more opportunities to increase their visibility to consumers, influence health outcomes and reduce costs, and the use of mobile health and wireless technologies by health organizations is expected to continue increasing.

“Health organizations are placing their bets on the future direction of health care and making decisions that will position their businesses for competitive advantage,” said Daniel Garrett, PwC principal of health industries technology practice. “Some organizations will undergo an extreme makeover while others will stay the course or refine existing strategies. Whichever path they take, all health organizations will be under pressure to deliver greater value for less, and they will face new risks and realities as business models and market players emerge.”

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