The Orphan Drug Act of 1983 was created to encourage pharmaceutical companies to develop drugs for so-called rare or ultra-rare diseases. The National Institutes of Health (NIH) defines rare diseases as afflicting as fewer than 200,000 individuals. Generally speaking, it has worked. Many companies are willing to inv...
Find MoreNICE Rejects Gilead Sciences’ Yescarta on Cost Concerns The United Kingdom’s government-funded health service isn’t being so nice to Gilead Sciences’ CAR-T blood cancer treatment Yescarta. The country’s National Institute for Health and Care Excellence (NICE) said the therapy is too expensive for th...
Find MoreUse of Placebo is Necessary Only in Certain Types of Oncology Trials: USFDA In a new draft guidance released, the USFDA is questioning whether or not the use of a placebo in a double-blind, randomized clinical trial is always necessary. The FDA said sometimes the use of a placebo can present practical or ethical co...
Find MoreAbbVie Receives USFDA Approval for Imbruvica Plus Rituximab as First Chemotherapy-Free Combination Treatment for Waldenström's Macroglobulinemia Adults AbbVie announced that the USFDA approved Imbruvica (ibrutinib) plus rituximab (Rituxan) for the treatment of adult patients with Waldenström's macroglobulinemia (W...
Find MoreA digital pill is a tablet or capsule with embedded indigestible sensors that communicate about data outcomes related to when the medication is taken to a mobile application for access by the patient and treating their physicians. The novel digital pill system is designed to facili...
Find MoreFor all-in-one dialysis system, Outset Medical captures USD 132 Million to extend U.S. expansion Outset Medical bagged USD132 Million in series D capital. This ensued in encouraging the production capabilities and accelerating the commercial expansion for all-in-one dialysis system. The FDA cleared the Tablo Hemodia...
Find MoreNational health authorities, U.K.'s NICE determines Gilead's cancer cell therapy exorbitant The National Institute for Health and Care Excellence (NICE) found Gilead's cancer cell therapy, Yescarta to be clinically efficacious for treating a type of lymphoma, but no ample evidence is present to estimate the benefit...
Find MoreNovartis sends out orphan disease drug to LifeMax Labs LifeMax Laboratories, biotech based in San Francisco is given an authorization of a treatment by Novartis for Netherton syndrome, an orphan genetic disorder. Focus of treatment is on managing symptoms and avoiding skin infections and other complications. Life...
Find MoreAs part of its “Made in China 2025” industrial plan, China hopes to reinvent its pharmaceutical industry. President Xi Jinping has identified his country’s reliance on foreign drug imports as a critical concern. China’s enormous population, coupled with the rise of disease and illness, make the country a prime marke...
Find MoreHepato Cellular Carcinoma (HCC) Not all deadly battles are lost. Some are won too.It is without the slightest doubt that the ones won are the typical examples of smart management, involving implementation of prudent steps, guided by the knowledge of every nook and corner. Undoubtedly, these examples not only serve ...
Find MoreThe American Society of Clinical Oncology (ASCO) is one of the largest and most respected conferences in the field of oncology. Held annually, this conference brings together researchers, physicians, and other healthcare professionals from around the world to discuss the latest advances in cancer research, diagnosis, and treatment.