The Senate Finance Committee sent a letter to HHS and CMS requesting reform of direct and indirect remuneration fees concerning pharmacies under the Medicare part D program. "This letter reflects the strong bipartisan recognition that pharmacy DIR fees must be stopped to prevent harm to patients and to the pharmacies that serve them," pharmacy groups said in a joint statement.
Takeda issued an immediate recall for all lots of its Natpara parathyroid hormone in the US. The company said there is a potential danger of rubber fragments detaching into the pen cartridge during administration.
An expanded indication for GlaxoSmithKline's Nucala, or mepolizumab, gained the FDA's approval as a treatment for pediatric patients with severe eosinophilic asthma between the ages of 6 to 11. The subcutaneous injection received FDA approval in 2015 as a supplementary maintenance therapy for patients with severe asthma aged 12 years or older.
The FDA has approved Ardelyx's Ibsrela, or tenapanor, to treat adult irritable bowel syndrome with constipation, to be taken twice daily in 50-mg doses. Patients who have or are suspected of having mechanical gastrointestinal obstruction are not advised to take Ibsrela.
VBI Vaccines has partnered with GlaxoSmithKline to assess it vaccine candidate VBI-1901 in a Phase I/IIa study in patients with recurrent glioblastoma. An additional arm will be added to evaluate VBI-1901 in combination with Glaxo's AS01B adjuvant, a component of its Shingrix shingles vaccine.
People with cancer who took broad-spectrum antibiotics in the month before receiving immunotherapy drugs had significantly shorter survival, regardless of cancer type, compared with those who weren't given antibiotics, UK researchers reported in JAMA Oncology. However, the study was small and no effect was seen among those given antibiotics during immunotherapy.
Experts say ransomware, cryptojacking, device hacking, data theft, phishing and insider breaches will remain the primary cyberthreats in health care next year, and health care organizations should patch and update critical systems regularly, train employees and avoid common mistakes like using out-of-office autoreplies. Cybersecurity should be a priority at the board and executive levels, and organizations that cannot afford to hire experts full-time should form partnerships, says Fairwarning CEO Kurt Long.
The Healthcare and Public Health Sector Coordinating Council recently issued guidance for sharing information on cyberthreats, risks and responses in the health care sector. The guidance is meant to help health care organizations understand the importance of cybersecurity information sharing, provide resources to start participating in threat sharing and help organizations establish an appropriate information management structure.