MannKind FDA meeting delayed; Pluristem updates Phase I results;

 @FierceBiotech: Exelixis spurs takeover rumors with Goldman ploy. News | Follow @FierceBiotech

 @JohnCFierce: Novartis gets expert panel support for its blockbuster Afinitor as a treatment for pancreatic cancer. Report | Follow @JohnCFierce

> MannKind's end-of-review meeting with the FDA has been postponed until May 4. The decision was made when the agency was preparing for a possible government shutdown. MannKind release

> Pluristem's PLX-PAD placenta-derived cell therapy produced positive three- and six-month follow-up results in a Phase I study of critical limb ischemia. The drug reduced the amputation rate from critical limb ischemia by 75 percent, to 3.7 percent. Report

> Access Pharmaceuticals reached a deal with an undisclosed "major pharmaceutical company" to use its CobaCyte and CobOral RNAi therapeutic delivery technology. No details of the deal were released, except that any formulations discovered will be jointly owned by both companies. Access release

> In many ways, biomarkers are only as effective as the biosensors available to detect and monitor them. FDA and the Defense Advanced Research Projects Agency (DARPA), which funds high-risk technology, are getting together to accelerate development and approval of devices that can continuously monitor biomarkers in people. News

> Glioblastoma multiforme, a malignant brain tumor, is frustratingly elusive because it can appear in many forms. A team of researchers from the University of Cincinnati hope to shine a light on the brain tumor's multiple personalities by sequencing individual glioblastoma genomes and tracking abnormalities through the bloodstream, the university announced in a release. Story

> Researchers had a gut feeling that gastrointestinal bacteria are harmed by stress, which then weakens the entire immune system, but it took two biomarkers to help them prove it. Article

> The San Diego Union-Tribune tells us about a large, $40 million, five-year study to find elusive biomarkers for Parkinson's disease. Report

Drug Delivery News

> Report: Monoclonal antibodies set to drive drug-delivery growth. News

> Modified herpes simplex virus delivers anti-pain gene therapy. Story

> Study: Most kids do not use inhalers properly. Article

> Nano-capsules may solve solubility problem of anti-cancer drug. Report

> Taming photosensitive chemicals to deliver drugs. Item

Medical Device News

> Biomet announces Q3 results. News

> Mirador closes $1.5M Series B funding round. Article

> Lanx launches Durango, Concero systems. Item

> Shuren to appear on Capitol Hill to discuss FDA approvals. Report

> ReGen files for Chapter 11 bankruptcy protection. Story

And Finally... Two genes have been identified that appear to be responsible for the amount of caffeine an individual drinks. Report

Suggested Articles

Xcovery's ALK inhibitor shrank tumors in 75% of lung cancer patients, compared to 67% for Pfizer's Xalkori, the first FDA-approved drug of that class.

The FDA accepted the regulatory filing for Biogen's once-failed Alzheimer's drug, aducanumab, with plans to decide its fate by March 7, 2021.

Alexion named a chief diversity officer, while COVID-19 vaccine player has two new members of its C-suite.