Branded

The Supreme Court usually has a lot on its plate in any given year, but this year's term included a pretty big case for the pharmaceutical industry: the Federal Trade Commission v. Actavis, which concerned legal settlements between branded and generic drug makers that often occur when the latter attempts to market a generic drug before the former's patents have expired.

WOODCLIFF LAKE, N.J. — Eisai Inc., announced today that the U.S. Food and Drug Administration has granted orphan drug designation to its investigational compound (E7777) for cutaneous T-cell lymphoma. E7777 is designed to have an improved purity profile and manufacturing process. It is currently in a pivotal trial intended to support its submission for approval.

The world is turning generic. That's the takeaway from the latest trends in the drug industry, according to IMS Health. In 2012, according to the healthcare industry analytics firm, dollar sales of drugs fell by 1% to $325.7 billion, but prescriptions grew by 1.2% as generic drugs' share of total drugs dispensed grew to nearly 83%.

Of all the policies to come out of the Obama administration, few have caused more controversy and greater uncertainty than healthcare reform.

Passed and signed into law in 2010, the Patient Protection and Affordable Care Act is designed to address the tens of millions of Americans who lack healthcare coverage, and it is expected to add more than 30 million new patients when it takes full effect. Following a legal challenge to the law, the U.S. Supreme Court ruled last year that one of its key elements, the individual mandate, did not violate the Constitution.

NEW YORK — Keryx Biopharmaceuticals, Inc., today announced the submission of a new drug application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

The urgency behind Diplomat's launch of its Retail Specialty Network isn't hard to fathom. As the growth momentum in pharmaceuticals shifts from traditionally developed drugs to more complex and expensive specialty and biotech products, traditional pharmacies without access to these specialized medicines — and the patients who depend on them — find themselves stranded in a receding market like boats at low tide.

Results of a recent federal survey of Medicare Part D claims is again roiling the sometimes strained relationship between independent and smaller-chain community pharmacies and managed care, and could herald a growing threat to those pharmacies as health plan payers and pharmacy benefit managers abandon open pharmacy provider networks and shift more business to exclusive preferred pharmacy groups.

PARSIPPANY, N.J. — Actavis has acquired global rights to a drug made by a Spanish company for fungal infections of the vagina, the companies said Tuesday.

Actavis and Palau Pharma announced that Actavis Specialty Brands had acquired right's to albaconazole, an orally administered antifungal for vulvo-vaginal candidiasis, onychomycosis and others. The drug, which Palau discovered, is currently in phase-2 clinical trials, and Actavis foresees a potential U.S. commercial launch of the drug in 2017.