Reuters - Health Report

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Tuesday, December 12, 2017

FDA proposes new fast path to market for certain medical devices

(Reuters) - The U.S. Food and Drug Administration on Monday proposed creating a new fast track to market for certain medical devices and a potential reduction in the amount of safety data required for approval.

'Ground-breaking' new drug gives hope in Huntington's disease

LONDON (Reuters) - Scientists have for the first time fixed a protein defect that causes Huntington's disease by injecting a drug from Ionis Pharmaceuticals into the spine, offering new hope for patients with the devastating genetic disease.

U.S. FDA accepts application for Indivior's new schizophrenia drug

(Reuters) - U.S. Food and Drug Administration (FDA) accepted Indivior's application for its new schizophrenia treatment, the British drugmaker said on Tuesday, boosting hopes of marketing the drug in the country.

Promising responses seen with Agios leukemia drug in study

(Reuters) - Nearly a third of patients with an advanced form of a fast-progressing leukemia who carry a specific genetic mutation experienced a complete or near complete response to an experimental Agios Pharmaceuticals drug, according to data from an early stage trial released on Monday.

Medical lab trade group sues over U.S. reimbursement cuts

(Reuters) - A U.S. trade association representing medical laboratories filed a lawsuit on Monday challenging a new reimbursement system used by the federal government that it said would reduce how much Medicare pays for labs by about $670 million in 2018.

Amgen's Kyprolis improves overall survival in blood cancer patients

(Reuters) - Amgen Inc said on Monday a final analysis of late-stage trial data showed that its Kyprolis combined with two other drugs helped blood cancer patients live longer.

Austria to drop impending smoking ban, bucking Western trend

VIENNA (Reuters) - While much of the West has barred smoking in restaurants and bars, Austria's impending ban is set to be stubbed out.

FDA OKs Sanofi's follow-on biologic of Lilly's diabetes drug Humalog

(Reuters) - The U.S. Food and Drug Administration said on Monday it approved Sanofi SA's Admelog as the first follow-on biologic version of Eli Lilly and Co's fast-acting insulin, Humalog.

NZ's Fisher & Paykel sues Resmed in Australia over patent dispute

(Reuters) - New Zealand's Fisher & Paykel Healthcare filed a lawsuit in Australia on Tuesday against Resmed Inc alleging the medical device manufacturer's respiratory treatment products violate four Fisher & Paykel patents.

Air pollution fine particles linked to poor sperm quality

(Reuters Health) - Exposure to fine particles in air pollution may be another factor that affects men’s sperm quality and their fertility, suggest researchers in Taiwan.