Stent manufacturers and importers in India were asked by the National Pharmaceutical Pricing Authority to submit feedback on the issue of coronary stent pricing by Dec. 31. The regulator is expected to revisit its order fixing ceiling prices of the stents in the first two months of next year.
7 keys: Put real-world evidence into action Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
Boehringer Ingelheim's Cyltezo, or adalimumab, a biosimilar version of AbbVie's Humira, was granted European approval to treat inflammatory diseases including Crohn's disease, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis. A comprehensive data package comprising analytical, pharmacological, nonclinical and clinical data supported the biosimilarity of Cyltezo to Humira.
Novartis unit Sandoz reported that its biosimilar version of adalimumab had safety and efficacy profiles similar to those of AbbVie's Humira, and its rituximab matched the safety and efficacy of Roche and Biogen's Rituxan.
The US FDA issued a warning letter to Lupin for repeatedly ignoring tests demonstrating that pills produced at two of its facilities didn't meet quality standards. The agency found that in 2015 and 2016, Lupin ignored results 134 times that showed its pills or active ingredients failed initial tests, and at another plant, the company deleted failing sample results and retested to get a passing result.
A distribution deal has been completed between Sysmex Asia Pacific and Genedrive for marketing rights to the latter's HCV ID kit and PCR platform for the Asia Pacific region. The partners plan to pursue regulatory approvals in a number of Asian countries for the assay.
The number of confirmed cases of dengue in India has reached 8,063, with 4,188 of those located in Delhi. Indian health officials also reported that the number of recorded cases of malaria as of Saturday stands at 1,106, while the number of chikungunya cases has reached 855.
Medical devices are essential to our modern society. But the companies who make them face strict regulatory, quality and safety standards. To succeed, they must constantly innovate, drive down costs and navigate complex regulatory pathways. Read the Viewpoint.
At LiveWorx, our use case harnessed the power of PTC's ThingWorx Analytics platform to analyze rich multimedia data — not just text or numbers — to improve cancer detection in medical images. Smart-connected medical imaging equipment sends images to the cloud for deep learning analysis, comparing them to hundreds of thousands of others to look for the tell-tale signs of cancer. Watch the Use Case.
The FDA approved a formulation of Otsuka Pharmaceutical's mental health drug Abilify that contains a tracking device developed by Proteus Digital Health. The device is activated by stomach juices and sends a signal to a wearable patch, which transmits data to a smartphone application, in an effort to help with medication regimen compliance.
The US is one of 22 countries engaged in the elimination of the hepatitis C virus, but only nine nations are making progressive headway toward total elimination by 2030, according to the Polaris Observatory, which provides data on hepatitis B and C elimination. Australia, Egypt, France, Georgia, Germany, Iceland, Japan, the Netherlands and Qatar are slated to eliminate HCV by 2030, the target date set by the World Health Organization.
Seasonal malaria chemoprevention, an older process that involves providing patients with a monthly combination dose of antimalarial drugs during the rainy season, was found to reduce the prevalence of malaria in West African children by up to 84%, according to data reported at a meeting of the American Society of Tropical Medicine and Hygiene. Seasonal malaria chemoprevention involves combining three drugs, sulphadoxine, pyrimethamine and amodiaquine, which will not negate the efficacy of the malaria drug artemisinin once that is taken.
Get the information you need to ensure your pharmacovigilance programs are built on a foundation supported by strong strategic planning and practical decision-making. Expand your knowledge of all new regulations, regulatory pathways, data sources, technologies and cutting-edge therapeutic products, and discover how to adapt your pharmacovigilance and risk management strategies to remain effective while keeping pace with change. Attend DIA’s Pharmacovigilance and Risk Management Strategies Conference, Jan. 22-24, in Washington, D.C.
A summary that ran Nov. 14 incorrectly identified the company that developed the multiple sclerosis drug Mavenclad. The company should have been listed as Merck KGaA, Darmstadt, Germany. SmartBrief regrets the error.