Mike Hidock, Director of Quality and Compliance Services at IQVIA, analyzes key considerations for preparing quality management systems (QMS) for fast tracked COVID-19 treatment approvals.

The head of the U.S. Food and Drug Administration is willing to fast-track a Covid-19 vaccine as quickly as possible, the Financial Times reported him as saying in a published interview.

Novartis was granted fast-track reviews of its cell therapy Kymriah for blood cancers in the United States and Europe.

Eli Lilly reported an increase of 8 percent in second-quarter 2017 revenue, but the real shake-up is what the company plans to do with its pipeline.

AstraZeneca canceled its combination of PD-L1 durvalumab and CTLA-4 medication tremelimumab in pancreatic ductal carcinoma.

Shares of Novavax plummeted more than 82 percent after the company released data that its Phase III trial for its RSV F Vaccine for older adults did not meet its goals, failing to demonstrate “vaccine efficacy.”

Portola Pharmaceuticals announced that the U.S. Food and Drug Administration rejected its AndexXa to treat life-threatening or uncontrolled bleeding.

Roche Holding AG said on Monday the U.S. Food and Drug Administration has granted priority review for atezolizumab for treating people with a specific type of lung cancer.   The designation covers treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 as determined by an […]

PHOENIX – After its stock dropped nearly 20 percent, Insys Therapeutics defended its practices from allegations it falsified data in order to sell more of its painkiller, the fentanyl-based Subsys. The Arizona-based company said it is committed to patient safety and has complied with all law, including those related to adverse event reporting.   In […]

LONDON – Looking to strengthen its cardiovascular and metabolic offerings, London-based AstraZeneca (AZN) is snapping up Bay Area-based ZS Pharma (ZSPH) in a deal worth $2.7 billion in hopes of leveraging that company’s ion-trap technology treatments for hyperkalemia into a blockbuster drug. The deal, which will see AstraZeneca spend $90 per share for ZS Pharma, […]