Branded

SILVER SPRING, Md. — The Food and Drug Administration has approved two drugs made by GlaxoSmithKline for use together in patients with advanced melanoma that can't be removed by surgery or has spread to other parts of the body, the agency said Friday.

The FDA announced the new approval for Mekinist (trametinib) and Tafinlar (dabrafenib). The agency originally approved the two drugs for use as single agents for the same indication in May 2013.

WHITEHOUSE STATION, N.J. — The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

Merck announced the approval of Isentress (raltegravir) for oral suspension, aimed at small children with HIV. The drug may be used by patients as young as four weeks, and the full line of formulations of Isentress now includes the orlal suspension, as well as chewable tablets and film--coated tablets. The company plans to launch the oral suspension in the third quarter of this year.

NEW YORK — Forest Labs will buy privately owned drug maker Aptalis for $2.9 billion, Forest said Thursday.

Aptalis specializes in making drugs for gastrointestinal disorders and cystic fibrosis, with sales of $688 million in fiscal year 2013. More than 60% of its sales come from the ulcer treatment Carafate (sucralfate), the inflammatory bowel disease treatment Canasa (melamine) and the cystic fibrosis drug Zenpep (pancrelipase).

JERUSALEM — Teva Pharmaceutical Industries has appointed Erez Vigodman as president and CEO, the Israeli drug maker said Thursday.

Vigodman will replace acting president and CEO Eyal Desheh, who will return to his previous position as group EVP and CFO. Desheh took the interim position after the departure of former president and CEO Jeremy Levin in October 2013.

ALEXANDRIA, Va. —Vulnerable patients, including seniors and cancer patients, suffer from lack of access to needed painkillers as efforts to combat diversion and misuse of controlled substances often result in drugs not getting into the hands of those who need them, according to a new pharmacist survey by the National Community Pharmacists Association. 

OSAKA, Japan — Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

Takeda announced the start of two phase-3 trials of MLN0002 (vedolizumab) in patients with severe ulcerative colitis and Crohn's disease. The trials are designed to find out the efficacy, safety and effects on the body of the drug, particularly to see if patients show a response after 10 weeks of treatment and disease remission after 60 weeks.

PARSIPPANY, N.J. — Japanese drug maker Daiichi Sankyo is seeking Food and Drug Administration approval for a once-daily tablet to reduce the risk of stroke in patients with atrial fibrillation and treatment of other conditions.

Daiichi Sankyo announced the submission of a new drug application for Savaysa (edoxaban). The company also is hoping to get the FDA's approval for the pill as a treatment for deep vein thrombosis and pulmonary embolism, as well as preventing the recurrence of symptomatic venous thromboembolism.

SOLON, Ohio — Efficient Collaborative Retail Marketing on Wednesday unveiled the ECRM Data web site, ECRMData.com. ECRM Data is an industry solution that offers turnkey solutions for promotional tracking and analysis functions.