China's Ministry of Human Resources and Social Security is adding 36 drugs to those covered by basic insurance plans after pharma companies said they would provide an average 44% decrease -- and up to 70% -- from last year's prices. Additions include Celgene's Revlimid; Johnson & Johnson's Zytiga; Roche Holding's Herceptin, Avastin and MabThera; Novartis' Afinitor; Brilinta, from AstraZeneca; and Victoza, from Novo Nordisk.
European Ombudsman Emily O'Reilly will investigate whether the meetings of drug companies with officials of the European Medicines Agency before formal submissions influence approval decisions. O'Reilly said such meetings, although valuable, may create "at least some perception of bias" with the public.
T2 Biosystems' T2Bacteria Panel has been granted CE mark approval by European regulators. The panel, which will be released in Europe in the third quarter as part of the company's T2Sepsis Solution, operates on the company's T2Dx instrument and takes about 3.5 hours to deliver species-specific results of targeted bacterial infections using whole blood.
The first European patient in a study of Intact Vascular's Tack endovascular system, designed for arterial dissection repair, has been enrolled at Austria's Medical University of Graz. The 232-patient, 50-site trial seeks to assess the efficacy and safety of the device in combination with standard balloon angioplasty for the treatment of below-knee critical limb ischemia.
The Indian pharmaceutical sector must increase its R&D investments to meet the challenges of a changing international marketplace, including regulatory oversight by the US FDA, according to a report from S&P Global Ratings. Pricing pressures will encourage a shift to specialty drugs but will also promote the use of generics, the report predicted.
Gilead Sciences' single-tablet Vosevi, or sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg, has been approved by the FDA as a treatment for adult patients with chronic hepatitis C virus with genotypes 1 through 6 who had prior treatment with a regimen containing an NS5A inhibitor. The drug is also approved for HCV patients with genotype 1a or 3 who were previously treated with a regimen containing sofosbuvir without an NS5A inhibitor.
The FDA intends to issue an internal manual of policies and procedures this year to improve the process for reviewing generic-drug applications and increase competition, according to FDA Commissioner Dr. Scott Gottlieb. The FDA also plans to issue guidance for submitting abbreviated new drug applications suggesting ways to avoid common problems.
Tokyo-based PeptiDream agreed to work with Kleo Pharmaceuticals on the development of immuno-oncology drugs for multiple indications using PeptiDream's Peptide Discovery Platform System technology to identify peptides against targets selected by Kleo. Under the deal, Kleo will get an upfront payment and retain rights to develop and market products resulting from the agreement, while PeptiDream will receive a tiered portion of the proceeds.