Industry News

Conatus Pharmaceuticals Inc announced that top-line results from the company’s ENCORE-LF clinical trial of emricasan did not meet its primary endpoint and the company is discontinuing further treatment of patients enrolled in the ENCORE-LF clinical trial.  Also, results from the 24-week extension in the company’s ENCORE-PH clinical trial of emricasan were consistent with results from the initial 24-week treatment period and did not meet predefined objectives. Conatus will continue to work with its partner Novartis on ensuring that all remaining obligations related to the emricasan program are fulfilled.

The latest Annual Report to the Nation on the Status of Cancer finds that, for all cancer sites combined, cancer death rates continued to decline in men, women, and children in the United States from 1999 to 2016. Overall cancer incidence rates, or rates of new cancers, decreased in men from 2008 to 2015, after increasing from 1999 to 2008, and were stable in women from 1999 to 2015. In a special section of the report, researchers looked at cancer rates and trends in adults ages 20 to 49.

The European Commission has approved Dupixent® (dupilumab) for use in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroid (ICS) plus another medicinal product for maintenance treatment.

AbbVie announced that it has resolved U.S. HUMIRA (adalimumab) litigation with Boehringer Ingelheim (BI). Under the terms of the resolution, AbbVie will grant BI a non-exclusive license to its HUMIRA-related intellectual property in the United States.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today announced awards to establish four Cooperative Research Centers (CRCs) focused on developing vaccines to prevent sexually transmitted infections (STIs). The grants, totaling $41.6 million over five years, will support collaborative, multidisciplinary research on the bacteria that cause syphilis, gonorrhea and chlamydia. At the end of the program, each center is expected to identify at least one candidate vaccine ready for testing in clinical trials.

U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the same active moiety, tafamidis, but they are not substitutable on a milligram to milligram basis and their recommended doses differ.

The U.S. Food and Drug Administration  approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. This is the first FDA approval of a treatment specifically for pediatric patients with LEMS. The only other treatment approved for LEMS is only approved for use in adults.

The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.

There has been a growing discussion in recent months around the safety of certain breast implants, with regulatory agencies around the world weighing the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). It’s an issue that has been a priority for us at the U.S. Food and Drug Administration since 2011 when we warned women that the available information at the time indicated that there is a risk for women with breast implants, especially those with textured implants, for developing this disease.