Edition:
United States

Toni Clarke

U.S. panel deals blow to Philip Morris tobacco device

Jan 25 2018

WASHINGTON Philip Morris International Inc should not be allowed to claim its iQOS electronic tobacco product is less risky than cigarettes, U.S. health advisers said on Thursday, dealing a blow to the company as it seeks to strengthen its portfolio of alternative nicotine devices. | Video

Philip Morris sees six million U.S. smokers switching to iQOS device if cleared

Jan 25 2018

WASHINGTON Philip Morris International Inc told a U.S. advisory panel on Wednesday that it expects around 6 million smokers to switch completely to its iQOS electronic tobacco device if the company is allowed to claim it is less risky than cigarettes.

U.S. health advisers weigh risks of novel Philip Morris tobacco device

Jan 24 2018

WASHINGTON, Jan 24 U.S. health advisers on Wednesday began to consider whether Philip Morris International Inc should be allowed to claim its novel electronic tobacco product is less harmful than cigarettes, potentially making it the first such device to carry a reduced risk claim.

FDA's tobacco stance faces test with Philip Morris iQOS device

Jan 22 2018

WASHINGTON In a decision expected to test the Trump administration's approach to tobacco regulation, U.S. health advisers will vote this week on whether to allow Philip Morris International Inc to claim its novel iQOS tobacco device is less harmful than cigarettes.

U.S. government to shield health workers under 'religious freedom'

Jan 19 2018

WASHINGTON The U.S. government is seeking to further protect the "conscience and religious freedom" of health workers whose beliefs prevent them from carrying out abortions and other procedures, in an effort likely to please conservative Christian activists and other supporters of President Donald Trump. | Video

FDA approves expanded use of AstraZeneca cancer drug

Jan 12 2018

The U.S. Food and Drug Administration said on Friday it has approved expanded use of AstraZeneca Plc's cancer drug Lynparza to include patients with metastatic breast cancer whose disease is associated with a mutation of the BRCA gene.

Spark to charge $850,000 per patient for blindness gene therapy

Jan 03 2018

Spark Therapeutics Inc said on Wednesday it will charge $850,000 per patient for its breakthrough gene therapy to treat a rare form of blindness, a lower than expected price that the company said reflects patient and insurer concerns about access and cost.

FDA medical device proposal may skirt the law: legal experts

Dec 19 2017

A proposal by the U.S. Food and Drug Administration to create a new fast-track path to market for medical devices may exceed its authority and require some creative reasoning to justify, legal experts said.

U.S. approves first gene therapy for inherited disease

Dec 19 2017

The U.S. Food and Drug Administration on Tuesday approved Spark Therapeutics Inc's treatment for a rare form of blindness, marking the first time the agency has approved a gene therapy for an inherited disease.

FDA proposes new fast path to market for certain medical devices

Dec 12 2017

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.

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