Branded

SILVER SPRING, Md. — An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.

SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.


One of the main plotlines of the big story called the drug industry over the past several years has been the patent cliff, the steady loss of patent protection on blockbuster primary care drugs and subsequent generic competition that has forced many drug companies to find new revenue streams. Much of this has taken place in the form of a gradual shift to specialty drugs for such conditions as cancers and autoimmune disorders, but recent developments have shown that primary care drugs may still have some steam left in them.


LONDON — The global market for celiac disease is expected to grow substantially over the decade as more people are diagnosed with the condition, according to a new report.

The report, by British market research firm GlobalData, found that the global celiac disease therapeutics market would be worth more than $512 million by 2017 and $664.4 million by 2019.

MELVILLE, N.Y. — Fougera Pharmaceuticals has promoted Walt Kaczmarek to serve as the company's SVP commercial operations, the drug maker announced.

Kaczmarek, who joined the company in 2004, has been managing national accounts for Fougera’s three marketing divisions, including Fougera, PharmaDerm, and Savage Labs, for the past eight years. He recently began managing accounts for the managed care markets of Fougera's branded division PharmaDerm, Fougera said.

PHOENIX — Managed care and prescription plans are working to switch patients to generic versions of Pfizer's Lipitor despite the drug maker's efforts to reduce costs for the branded version, a new study suggested.

According to a report released Wednesday by Wolters Kluwer Pharma Solutions' inThought research group, while Lipitor (atorvastatin) has 41% of the market share of all dispensed prescriptions of atorvastatin, it has 35% of the payer approval volume.

PITTSBURGH — Mylan is changing the name of its branded specialty pharmaceutical business, the company said Wednesday.

The drug maker announced that it would change the name of Dey Pharma to Mylan Specialty. Dey makes treatments for respiratory diseases, psychiatric disorders and severe allergic reactions, including the EpiPen (epinephrine).

NEW YORK — Bristol-Myers Squibb has completed its acquisition of a developer of hepatitis C treatments.

Bristol said it successfully completed its tender offer for all of the outstanding shares of common stock of Alpharetta, Ga.-based Inhibitex, at a purchase price of $26 per share via a “short form merger” in which all such shares were converted into the right to receive the aforementioned share price in cash and without interest, less any applicable withholding taxes.