The draft Diagnostic Accuracy and Innovation Act "could result in an anti-competitive system that favors the few laboratories with sufficient resources to comply with FDA requirements that were developed for manufacturers, thereby creating a situation wherein testing costs could rise," according to the American Association for Clinical Chemistry. The association contends that high-risk laboratory-developed tests should be jointly regulated by the FDA and the CMS, while moderate and low-risk LDTs should be exclusively regulated under the Clinical Laboratory Improvement Amendments.
The FDA has approved Portola Pharmaceuticals' drug BevyxXa, or betrixaban, the first oral medication developed to inhibit blood coagulation in patients who are hospitalized for long periods, such as those with pulmonary disease and heart failure or who have suffered a stroke.
South Carolina health officials said mosquito samples captured in Beaufort County tested positive for West Nile virus. Insecticide spraying has begun in areas with the most mosquito activity.
Early clinical trial data of a gene therapy candidate for beta-thalassemia from bluebird bio suggest a manufacturing change may be associated with higher production of hemoglobin A, but the first patient to be dosed achieved better results than the next two. The company also said that tests showed a French teenager treated with a gene therapy candidate for sickle cell disease was producing normal red blood cells at a rate of 50%, while two patients treated later had not produced normal functioning red blood cells at rates above 30%.
Sweden has begun an initiative to establish a national Center for Advanced Medical Products in partnership with Xintela, a regenerative medicine firm. The research center will work with the country's research institutes, universities and pharmaceutical firms.
A new formulation of Roche Holding's blockbuster cancer drug Rituxan called Rituxan Hycela can now be given as a subcutaneous injection within a five- to seven-minute period, unlike previous versions of the drug, which require infusion. Rituxan Hycela was approved for the treatment of follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia, and will be available to US patients in one to two weeks, according to Roche.
The American Society of Hematology is working on clinical practice guidelines for the management of sickle cell disease. Five panels will consider topics including blood transfusion therapy and stem cell transplantation, and publication is expected in 2019.
Yellow fever vaccine in Canada is in short supply, and provincial health centers are splitting some doses among multiple patients. Full doses are being prioritized for certain populations, including travelers to nations where the virus is spreading.
An additional cell-culture manufacturing facility in Vacaville, Calif., will produce Genentech's Rituxan SC formulation for the treatment of B-cell non-Hodgkin lymphoma. The plant is part of an almost $300 million expansion project that will double production capacity.
The State Intellectual Property Office of China will award Intellia Therapeutics a patent for its CRISPR-Cas9 single-guide gene editing technology.
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