Endo Health Solutions Inc. said the U.S. Food and Drug Administration wants more information about its long-acting testosterone injection Aveed before it will approve the drug. Endo said the FDA is concerned about risks and severe complications related to post-injection reactions.
A Wedbush analyst has upgraded Ironwood Pharmaceuticals Inc.'s stock, saying growth in prescriptions for the company's bowel drug Linzess has been better than he expected. He is now projecting about $229 million in sales over the four quarters ending March 31, up from $152 million.
The next blockbuster drug revenue streams are likely to come from a class of targeted therapies geared towards the treatment and management of chronic human disease states—especially cancer—and involve the use of monoclonal antibodies linked to small-molecule drugs.
A detailed look at two cases of a deadly new respiratory virus called MERS suggests people who have the disease should be isolated for at least 12 days to avoid spreading it. The new germ was first seen in the Middle East and so far has sickened more than 40 people worldwide, killing about half of them.
Researchers have found that a naturally occurring protein secreted only in discrete areas of the mammalian brain may act as a Valium-like brake on certain types of epileptic seizures. The protein is known as diazepam binding inhibitor, or DBI.
GlaxoSmithKline PLC will buy Okairos AG for about $323 million, gaining the Swiss vaccine developer's products. GlaxoSmithKline said Okairos is studying vaccine technology that could be used in shots that can both prevent and cure infections or diseases.
Perrigo Co. said it is seeking approval for a generic version of Eli Lilly and Co.'s Axiron testosterone product, and is being sued by Lilly. Axiron is an underarm gel that rolls on like deodorant, and Perrigo said the product has about $229 million in annual sales.
Drug developer Pozen Inc. said that the U.S. Food and Drug Administration is now reviewing an experimental cardiovascular drug it developed. Pozen said the FDA will conduct a standard review and should make a decision on its application by Jan. 24.
Astellas Pharma Inc. said it will form a joint venture with Amgen Inc. to develop and market drugs in Japan.The new company will start business operations in October to develop five drugs, including for gastric cancer and osteoporosis, under a plan to launch drug sales in 2016.
Bayer AG has received antitrust clearance from the Federal Trade Commission for its approximately $1.1 billion acquisition of Conceptus. The company makes Essure, an irreversible birth control method in which small metal and polyester coils are inserted to block a woman's fallopian tubes.
A group of Jefferies & Co. analysts said that drug companies are putting more emphasis on restructuring and spinning off parts of their business. Investors are likely to push some companies towards restructuring and separations as a path to better stock performance.
While tailor-made drugs have not yet materialized on a broader scale, the tools and technologies that emerged during or subsequent to the ground-breaking Human Genome Project are having a growing impact on the development of novel diagnostic tests.
AstraZeneca plans to spend about $260 million on Omthera Pharmaceuticals, a specialty drug developer with a potential treatment for patients who have high levels of triglycerides in their blood. Omthera expects to submit Epanova for approval by the middle of this year.
An FDA-approved epilepsy drug shows promise in a mouse model at preventing tinnitus from developing after exposure to loud noise. Researchers found that mice that were treated with retigabine immediately after noise exposure did not develop tinnitus.
Valeant Pharmaceuticals will buy eye-health company Bausch + Lomb for $8.7 billion in cash in a massive expansion of its ophthalmology business. Valeant says the deal will help it capitalize on an aging population, growing demand in emerging markets, and increasing rates of diabetes.