Denise Myshko

Merck has submitted the data from the study KEYNOTE-522 to the FDA for review.

Committee members raised safety concerns about FibroGen/AstraZeneca’s oral therapy roxadustat.

After generic entry, Zytiga’s market share fell to about 14% and monthly net sales across the entire market fell 85%.

New analysis suggests that even with rebates, the new Alzheimer’s therapy could have implications for Medicaid drug spending.

A permanent code is expected in the third quarter of 2021.

The therapy for opioid-induced constipation has no restrictions on an unidentified national formulary that serves these Blues plans.

Jardiance lowered risk of hospitalization from acute kidney injury but increased risk of hospitalized from diabetic ketoacidosis compared with a DPP4 inhibitor in one interim analysis.

Commercial insurers are beginning to provide coverage information on Biogen’s controversial therapy.

Keytruda loses one indication but gains another, Biogen narrows use of Aduhelm, Padcev gets regular approval and expanded indication, Amgen submits application for asthma biologic, agency issues complete response letter for diabetes prevention therapy teplizumab, Novartis resubmits NDA for inclisiran.

This is the eighth generic version of the drug to treat insomnia.

Orally dissolving film formulation of riluzole is now available for patients who have difficulty swallowing.

The prescribing information for Aduhelm now specifies its use in patients with a mild form of the disease.

The agency also granted tezepelumab priority review with a PDUFA date sometime in the first quarter of 2022.

The single-dose antibiotic with a one-hour infusion is approved to treat MRSA and other skin infections.

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.