Bristol-Myers Squibb Co. said that U.S. regulators expanded approval of its HIV drug Sustiva to children as young as three months old and as light as 7.7 pounds. The capsule-based drug was first approved in 1998 to treat HIV-infected children who are age three and older and weigh at least 22 pounds.
Gilead reported its first-quarter results and new trial data for two of its experimental hepatitis C drugs. Gilead said its net income climbed on lower costs and greater sales of its new HIV drugs Complera and Stribild. Sales of its heart drug Letairis and angina treatment Ranexa also improved.
Drug developer Arena Pharmaceuticals Inc. announced that it is withdrawing its application for approval of the weight loss drug Belviq in Europe. The San Diego company also said that it is still waiting for a U.S. decision on the status of the drug.
Generic drugmaker Actavis Inc. took a loss in the first quarter on costs related to acquisitions. Actavis combined with Watson Pharmaceuticals in October, and in January the company acquired Belgian drug developer Uteron Pharma to expand its women's health business.
Teva Pharmaceutical Industries Ltd.'s first-quarter earnings fell 27%, as generic competition, a weaker Japanese yen and other factors dragged down revenue for one of the world's largest generic drugmakers. The company's U.S. sales of Provigil plunged 92% in the quarter.
French drug maker Sanofi said its net profit was slashed in the first quarter from a year earlier as falling sales and patent losses on key drugs combined to hammer earnings. Sanofi's net profit was $1.3 billion in the January-March quarter, down 45% from a year earlier.
Pharmacyclics Inc. had a bigger loss in the first quarter as its costs increased. Pharmacyclics said costs increased with the timing of stock option grants, growth in its share price, and hiring employees. The company is developing the cancer drug ibrutinib with a unit of Johnson & Johnson.
Companion diagnostic tools allow companies to increase their chances of drug approval by targeting the right patients early. Developing the strategy, timing, and resources necessary for companion diagnostics success begins with understanding the mechanisms that successful companies use to build their programs.
Allergan executives announced that are delaying late-stage testing of an experimental eye treatment by one to two years. Allergan was previously expected to launch a study of DARP-in, an experimental drug for macular degeneration, by late 2013.
Hospira Inc. took a loss in the first quarter after it decided to take some of its older infusion pumps and devices off the market. Hospira will retire older products like its Symbiq infusion device, GemStar pumps, and some of its Plum and PCA pumps.
Moody's Investors Service said that it's reviewing its ratings for drugmaker Merck & Co.'s and may downgrade them. Moody's cited Merck's plan to buy back about $7.5 billion worth of its shares over the next 12 months. Those repurchases are part of a new $15 billion share repurchase program approved by Merck's board.
Actavis has acquired a bacterial vaginosis gel developed by Valeant Pharmaceuticals. Actavis said it agreed to pay Valeant $55 million for its metronidazole gel product, which has not yet received marketing approval. The total includes both an upfront payment and payments related to sales targets.
Perosphere and Daiichi Sankyo have entered into a clinical trial agreement under which Daiichi Sankyo will support and co-sponsor a Phase 1 clinical trial testing the safety, tolerability, and effectiveness of PER977 to reverse the anticoagulant activity of Daiichi Sankyo’s edoxaban.
Merck & Co. reported lower first-quarter results and cut its 2013 profit forecast by 15 cents a share. Merck tried to reassure investors by announcing a huge share buyback, up to $15 billion worth of its stock, but its share price dropped nearly 3% in premarket trading after its revenue missed expectations.
There’s hope for patients with myotonic dystrophy. A new small-molecule has been shown to break up the protein-RNA clusters that cause the disease in living human cells, an important first step toward developing a pharmaceutical treatment for the as-yet untreatable disease.