With the recognition by the US Food and Drug Administration (FDA)of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories.
According to the report by Transparency Market Research, the global active pharmaceutical ingredients market is projected to worth approximately US$257.5 bn by the end of 2026. It is noticeable that the market valued nearly US$160.0 bn during 2017. This means that the market is expected to witness the growth with staggering 5.4% CAGR from 2018 to 2026.
C4X Discovery Holdings plc a pioneering drug discovery company, entered into a collaboration with PhoreMost, a UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets. The collaboration, focused initially in Parkinson’s Disease, will combine both company’s technology platforms.
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.
Connecticut Attorney General William Tong is leading a 44-state coalition in an antitrust lawsuit against 20 makers of generic drugs and 15 individuals, claiming the companies conspired to fix prices for 114 medications.
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.