Specialty Pharmacy

NEW YORK — A privately owned drug maker in New York is offering $6.5 billion for Irish drug maker Elan, but hasn't heard back from it, according to published reports.

The Associated Press reported that Royalty Pharma's $11-per-share offer for Elan represented a 4% premium over its closing price Friday. Royalty buys royalty interests in drug products that are in late-stage development or have already entered the market, but doesn't develop or market drugs of its own, the AP reported.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the digestive system, the agency said Monday.

The FDA announced the approval of Stivarga (regorafenib) for gastrointestinal stromal tumors that could not be removed through surgery or had spread to other parts of the body and were no longer responding to treatment with Novartis' Gleevec (imatinib) or Pfizer's Sutent (sunitinib).

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

Amneal announced Monday the approval of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, a generic version of Reckitt Benckiser Healthcare's Suboxone.

Suboxone had sales of $1.5 billion in 2012, according to IMS Health.

FLINT, Mich. — A clinical technology manager at Diplomat Specialty Pharmacy has received an award from a state pharmacy association.

Diplomat said Monday that Michael Crowe had received the Fellow of Michigan Pharmacists Association award, announced over the weekend at the MPA's annual convention and exposition in Detroit. According to the MPA, the award "recognizes achievements and dedication to the practice of pharmacy, the community and MPA. The distinction signifies the recipient's actions well beyond the regular practice toward the advancement of pharmacy."

NEW YORK — One of the Food and Drug Administration's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered Friday morning by FDA commissioner Margaret Hamburg at the Generic Pharmaceutical Association's annual meeting.

In the address, viewed via webcast, Hamburg addressed issues ranging from quality to drug shortages to follow-on biologics, praising the generics industry's role in contributing more than $1 trillion in savings to the healthcare system over the past decade.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said Friday.

The FDA announced the approval of Genentech's Kadcyla (ado-trastuzumab emtansine) for HER2-positive breast cancer that has spread to other parts of the body. HER2 is a protein involved in the growth of normal cells but found in increased amounts in some kinds of cancer cells, which contributes to cancer cell growth and survival. Genentech is the U.S. subsidiary of Swiss drug maker Roche.

WOODCLIFF LAKE, N.J. — Valeant Pharmaceuticals has bought rights to a drug used to treat skin cancer from Eisai, the companies said Thursday.

Valeant has bought the rights to Targretin (bexarotene) capsules and gel from Eisai for $65 million upfront, plus additional payments based on certain milestones. Under the deal, Eisai has transferred its regulatory approval application to Valeant, which will assume responsibilities for all regulatory obligations associated with the product in the United States. Eisai will retain rights to the drug outside the United States.

KING OF PRUSSIA, Pa. — The Food and Drug Administration has approved a new vial size for a drug made by CSL Behring to treat a bleeding disorder and an immune disorder, the company said Thursday.