Janssen's Stelara, or ustekinumab, has been approved by the FDA as a treatment for moderately to severely active Crohn's disease after assessment of data from three pivotal late-stage studies. The drug is indicated for adults with the condition who previously failed to respond or are intolerant to tumor necrosis factor inhibitors, or those who are intolerant or did not respond to immunomodulators or corticosteroids but have never failed treatment with a TNF inhibitor.
The FDA will give priority review to dupilumab, a new injectable atopic eczema drug by Sanofi and Regeneron Pharmaceuticals, according to the companies. They are also developing the drug as a treatment for severe asthma.
The FDA has granted Bethesda, Md.-based BrainScope clearance to market its Ahead 300, a wearable medical device intended for diagnosing traumatic brain injury. The device analyzes the brain's electronic activity using electrodes and transmits data to a reconfigured Android smartphone for injury assessment.
The Medicare Part B proposal, part of the CMS' plan to fix the drug reimbursement system, would cause "devastating, unintended consequences" for cancer patients due to a lack of monitoring provisions, quality protections and safeguards to protect clinical trial participants, write Daniel Hayes and Clifford Hudis of the American Society of Clinical Oncology. The ASCO is working with the CMS and Congress to develop a more comprehensive payment reform plan that is better than the Part B demo, they write.
Adaptimmune Therapeutics entered into a multiyear strategic partnership with the University of Texas MD Anderson Cancer Center to develop specific peptide-enhanced affinity receptor T-cell immunotherapies to combat solid and hematologic cancers. The financial terms of the deal were not disclosed.
Scientists from DuPont Pioneer have discovered a non-Bacillus thuringiensis gene that kills rootworms, a corn plant pest that has become resistant to Bt genes in biotech corn, according to a study published in the journal Science. Also, Monsanto is using RNA interference to produce a type of RNA that would be poisonous to the pest.
An accelerator called five.eight has been launched by GE Healthcare to provide 10 global health care startups with financial assistance worth up to $5 million each to commercially scale technologies for improving health care accessibility and quality in emerging economies. The first company to receive funding is Tricog, which seeks to use cloud-connected ECG devices to lower the average time from symptoms to treatment and improve heart attack survival rates in India.
Labs can gain some benefits from using nontraditional matrix types such as dried blood spots, hair and nails to detect direct ethanol biomarkers, which show evidence of alcohol exposure. These matrix types provide ease of collection and longer detection windows but require high-sensitivity instruments, don't provide pharmacokinetic information and bring an increased risk of receiving an insufficient amount of a specimen.
Summit Therapeutics' investigational Duchenne muscular dystrophy treatment ezutromid has received a fast-track designation from the FDA. The drug is in a midstage study, with results expected by the second half of 2017.
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