We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The Senate HELP Committee unanimously passed a bill that would allow drugs to be sold before the Drug Enforcement Agency permanently assigns them to a controlled substance schedule to help extend their marketing exclusivity. Read More
The House Energy & Commerce Committee is once again demanding information on the status of all patients in NIH clinical trials affected by the shutdown of the agency’s drug compounding facility, despite receiving a letter from NIH saying there were no negative impacts on affected patients. Read More
The European Medicines Agency has nominated Guido Rasi as its executive director, nearly one year after he was forced to resign from the position due to a procedural issue. Read More
Baxter Healthcare is recalling 139,104 bags of 0.9 percent sodium chloride injection produced at the company’s maligned Jayuya, Puerto Rico, facility following complaints of mold on the interior surface of the overpouch — the firm’s ninth recall since December 2013. Read More
The FDA has cleared Bristol-Myers Squibb’s new mixed-drug regimen for the treatment of advanced melanoma, in a first-ever approval of an immune-oncology combination. Read More
Teva is expanding its footprint in emerging markets with the $2.3 billion purchase of Mexico-based Representaciones e Investigaciones Medicas, or Rimsa, a specialty drugmaker with a portfolio of products and patents across Latin America. Read More
United Therapeutics has agreed to grant Sandoz a nonexclusive license to manufacture and sell a generic version of its hypertension drug Remodulin beginning in 2018, putting an end to ongoing patent litigation. Read More
Eli Lilly and Incyte’s new once-daily rheumatoid arthritis drug baricitinib outperformed the standard care in a Phase 3 clinical trial, putting the drugmakers on track for a regulatory filing this year. Read More
With a growing number of biologics set to lose patent protection in coming years, a leading industry group is calling for regulatory reforms to encourage the development and approval of biosimilars. Read More
New Hampshire’s attorney general is investigating whether some opioid manufacturers knowingly misled doctors and patients about their drugs’ safety and benefits, causing the state to pay for potentially dangerous and unnecessary opioid prescriptions. Read More