Denise Myshko

The company is transferring manufacturing of the final product to its own site in Austria.

Despite an advisory committee recommendation for approval, the FDA did not approve what would have been the first disease-modifying therapy for type 1 diabetes.

This approval comes days after Merck announced it would withdraw indication for third-line gastric cancer.

New, extended-release therapy for post-operative pain reduces the need for opioid pain relief.

Merck will withdraw Keytruda's advanced gastric indication after an FDA panel vote, a drug with supply problems gets a new indication, NDAs for an HIV therapy, and other news.

Coverage now includes 85% of commercial lives.

Formulary adoption is a key step in achieving sales pull through starting in 2022, company officials said.

The therapy, a recombinant version, was developed to address supply and manufacturing issues.

Patients are being offered $500 to make the switch.

A recent study finds that the approval of a biosimilar was associated with a change in the trajectory of net prices.

Data from a phase 2/3 study will be presented in July.

The label for the type 2 diabetes treatment has been updated to include the risk of ketoacidosis and damage to the kidney.

But there is no benefit for patients receiving chemotherapy.

Kite plans to submit a supplemental BLA based on these findings.

Regulatory actions for drugs for children, a combination cancer therapy, launches of two generic therapies for COPD, and cancer and Alzheimer’s therapies receive Breakthrough Designation round out this week’s FDA news.

Implementation of value-based approaches requires measurement of value, authors said.

The anticancer therapy is now available in 21-count bottles to help accommodate dispensing.

The two organizations have created a fellowship program to help improve patient outcomes and reduce costs.

Positive findings for Tepmetko and Tabrecta reported at ASCO.

The therapy would be used to help prevent and treat blood clots in pediatric patients.

Understanding medication utilization patterns is important for future evaluations of clinical outcomes, investigators say.

A longstanding four times per day testing requirement will cease, and patients using inhaled insulin now qualify for continuous glucose monitoring.

A new indication, a nonprescription switch, a recall, and new guidances round out this week’s FDA news.

Regardless of political affiliation, the public supports congressional action to allow the federal government to negotiate prices.

Although Lorbrena can improve health outcomes, it is not as cost-effective an option compared with Xalkori.

The therapy is a modified poliovirus vaccine that not only kills cancer cells but also can trigger long-term immune memory.

The Supreme Court’s dismissal of the latest challenge means patients will have access to lower-cost therapies, an advocacy group says.

The COX-2 inhibitor Anjeso, a faster-acting injectable formulation of meloxicam, reduces opioid use after surgery.

Chances of left ventricular ejection fraction almost disappeared when patient took the ACE-inhibitor lisinopril during treatment with trastuzumab/anthracycline, according to research presented at ASCO.

Immune-related AEs can occur one to two years after treatment, are more common in combination treatments, and can be difficult to manage.