Specialty Pharmacy

SAN DIEGO — Drug maker Amylin Pharmaceuticals has submitted the first of a series of sections of a regulatory approval application for a biotech drug to treat patients with a rare lipid disorder.

BURLINGTON, Mass. — An investigational treatment for irritable bowel syndrome could become a blockbuster by the end of the decade, according to a report by Decision Resources.

The report, which the healthcare market research firm said it would publish later this month, found that linaclotide — made by Ironwood Pharmaceuticals, Forest Labs, Almirall and Astellas Pharma — would emerge as the market leader for IBS and achieve sales of $1.1 billion in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan by 2019.

SILVER SPRING, Md. — Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a revised dosage for a drug combination, which includes a Johnson & Johnson drug, in HIV patients who have received treatment but whose virus has not become immune to the J&J drug.

LAKE MARY, Fla. — The Accreditation Commission for Health Care has accredited specialty pharmacy provider Axium Healthcare Pharmacy, Axium said Tuesday.

PARSIPPANY, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a pain drug made by Pacira Pharmaceuticals, Pacira said Tuesday.

The drug maker submitted its application for the long-acting painkiller Exparel (bupivacaine) in September.

The drug is a topical medication for managing pain following surgery. The FDA expects to finish reviewing the application in July 2011.

CAMBRIDGE, Mass. — Biotech company Genzyme still is saying “no thanks” to French drug maker Sanofi-Aventis’ tender offer of $18.5 billion, or $69 per share, to acquire it, saying the offer “substantially undervalues” the company.

The offer has been extended until Jan. 11, Genzyme said.

Sanofi has sought to buy Genzyme since August. Genzyme, based in Cambridge, Mass., specializes in treatments for rare genetic disorders, such as Fabry disease and Gaucher disease.

BURLINGTON, Mass. — Biotech drugs will help drive the markets for acute and chronic gout through 2019, according to a new report by market research firm Decision Resources.

The report, titled “Acute and Chronic Gout — New Agents Target Refractory Patients and Tap Market Opportunity,” found that the acute gout drug market would triple in size to $117 million, while the chronic gout market would reach $1.83 billion.