The Centers for Medicare & Medicaid Services (CMS) waded into the growing debate over the use of value-based pricing of prescription drugs by proposing to test a new model to deliver Medicare Part B drugs – infused cancer therapies, injectable antibiotics, eye care treatments and other treatments administered in a physician's office or hospital outpatient setting. Read More

LONDON – Building on recent advances in understanding of the disease pathology, the EMA has for the first time formulated guidelines for companies developing treatments for autism, providing advice on inclusion criteria, trial design and choosing endpoints in this extremely heterogeneous disorder. Read More

DUBLIN – Aprea AB raised €46 million (US$50.7 million) in a series B round that will fund a phase IIb trial in ovarian cancer of its first-in-class p53 reactivator APR-246, as well as a series of exploratory trials in several other oncology indications in which p53 mutations are implicated. The compound works by stabilizing the conformation of p53 proteins with point mutations in the DNA binding domain and has already generated promising clinical data as monotherapy and in combination with chemotherapy. Read More

LONDON – A three-day meeting of drugs, vaccines and diagnostics experts convened by the World Health Organization (WHO) in Geneva this week has set out the key R&D priorities for developing products to combat the escalating Zika virus epidemic. Read More

Scientists have discovered that triple-negative breast cancer (TNBC) that are driven by overexpression of the oncogene Myc have changes to their metabolism that can be targeted with inhibitors of fatty acid oxidation. Read More

A Senate committee met to mark up legislation responding to the House 21st Century Cures bill passed last year, but Sen. Elizabeth Warren (D-Mass.) advised the GOP committee members that the legislation has little chance of passage on the Senate floor without mandatory funding for the NIH. Read More

Two major medical centers chasing some of the multi-faceted rewards of genomic sequencing – better informed prescribing decisions and potentially lower medical costs – are making slow but steady strides in rolling out nascent infrastructures for the project, according to key players in the initiatives who spoke at the Molecular Medicine Tri-Con meeting this week. Read More

Stemcells Inc., of Newark, Calif., said it priced an underwritten public offering of common stock, series A warrants and series B warrants with an offering price of $0.30 for one share, a series A warrant to purchase 0.50 of a share of common stock and a series B warrant to purchase 0.75 of a share of common stock. Read More

Marathon Pharmaceuticals LLC, of Northbrook, Ill., said that it is expanding patient access to deflazacort, its investigational medicine for Duchenne muscular dystrophy (DMD) by making it available to qualified patients, at no cost, through a growing network of medical research centers across the country. Read More

Helix Biopharma Corp., of Aurora, Ontario, said Polish regulators approved an amendment to the phase I/II study (LDOS002) defining the dose and dosing regimen for the phase II portion. Read More