Branded

VALENCIA, Calif. — It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

The Food and Drug Administration on Thursday issued a complete response letter to the drug maker regarding Afrezza (insulin human [rDNA origin]) inhalation powder. The regulatory agency requested that the company conduct two clinical trials, one in patients with Type 1 diabetes and one in patients with Type 2 diabetes, with its next-generation inhaler, to assure it works as effectively as MedTone, its predecessor.

BOSTON — Finalizing an acquisition of biotech company Genzyme by French drug maker Sanofi-Aventis “will take some time,” media reports quoted Genzyme’s chief executive as saying.

The Boston Globe quoted Genzyme CEO Henri Termeer as saying it would be a long process to understand the company’s full value, in particular because of an investigational multiple sclerosis drug, Campath (alemtuzumab), which could achieve blockbuster sales and thus raise the company’s value and acquisition price if it wins approval.

CAMBRIDGE, Mass. — The Food and Drug Administration and Health Canada have granted priority review to a drug for treating hepatitis C.

Vertex Pharmaceuticals announced Thursday that the two agencies had given the designation to telaprevir for treating patients with chronic infections.

ATLANTA — British drug maker ProStrakan Group will partner with two U.S. companies to administer its risk evaluation and mitigation strategy for a cancer pain drug.

ProStrakan said it would use RelayHealth Pharmacy Solutions’ and McKesson Specialty Care Solutions’ services to administer the REMS for Abstral (fentanyl citrate), a drug that patients can place under the tongue to treat breakthrough pain associated with cancer when they already have received and become tolerant of opioid painkillers.

SOUTH SAN FRANCISCO, Calif. — Patients taking an investigational drug made by Genentech for advanced skin cancer fared better than those receiving standard treatments, according to results of a late-stage clinical trial announced Wednesday.

The company, part of Swiss drug maker Roche, said patients with advanced melanoma containing a mutated version of a protein called BRAF lived longer when receiving the orally administered personalized investigational medicine RG7204 than those receiving the injected chemotherapy drug dacarbazine.

CRAWLEY, England — An insulin pen for children made by Novo Nordisk has won a design award, the company said Wednesday.

The Danish drug maker won the 2010 Good Design Award from the Chicago Athenaeum Museum of Architecture and Design and the European Centre for Architecture, Art, Design and Urban Studies for its NovoPen Echo, used to treat Type 1 diabetes. The annual award, which the two organizations have given since 1950, are the oldest and among the most coveted for design and innovation, Novo Nordisk said.

THOUSAND OAKS, Calif. — German drug maker Boehringer Ingelheim will purchase a manufacturing plant from U.S. biotech company Amgen, the two said.

The plant, located in Fremont, Calif., is 100,000 sq. ft. and employs around 360 people. BI has been a contract manufacturer for Amgen for more than 10 years. Financial terms of the deal were not disclosed, though BI said it would purchase “substantially all” of the assets at the plant.

NEW YORK — Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.

The San Francisco Business Times reported Tuesday that Genentech, part of Swiss drug maker Roche, is appealing the FDA’s plan to revoke approval for the drug Avastin (bevacizumab) as a first-line treatment for advanced HER2-negative breast cancer in combination with paclitaxel chemotherapy.