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.
The Delaware Supreme Court has upheld a finding that SIGA Technologies is liable for breaching contractual obligations to negotiate in good faith with rival biodefense company PharmAthene. But the court also remanded the case back to the Delaware Court of the Chancery to reconsider the damages it awarded.
ISTA Pharmaceuticals has pleaded guilty in a federal case involving its eye drug Xibrom, admitting it promoted the drug for unapproved uses and agreeing to pay $33.5 million in fines and fees. ISTA also pleaded guilty to violating anti-kickback laws by sponsoring outings intended to persuade doctors to prescribe the drug.
Actavis Inc. said a federal appeals court granted an injection that blocks it from selling a generic version of AstraZeneca PLC's asthma treatment Pulmicort Respules. The injunction bars Actavis from selling its generic until the litigation with AstraZeneca is resolved.
An initial review of data from three separate Phase 3 trials did not provide evidence of efficacy for preladenant compared with placebo. Based on these results, Merck is taking steps to discontinue the extension phases of these studies and no longer plans to pursue regulatory filings for preladenant.
Forest Laboratories Inc. announced that Howard Solomon, its CEO for the last 36 years, will retire at the end of 2013. Solomon, 85, will step down as president and CEO on Dec. 31, and will resign as chairman at the time of the company's annual shareholder meeting in 2014.
Alkermes said that it was profitable in its fiscal fourth quarter as it received bigger royalty payments and more revenue for drug manufacturing. The Irish company said revenue from manufacturing and royalty payments climbed 33% during the quarter, and its total revenue rose 25%.