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802 Total results for product and free and sample content found

HBW Insight

With High Profile At FDA, Gottlieb Headed Ambitious Consumer Health Initiatives

By Malcolm Spicer 07 Mar 2019

Scott Gottlieb claimed higher profile than most previous FDA commissioners with frequent Twitter posts and by including his remarks in many agency communications to industries and consumers. In his nearly two years in post, he also had more central role in FDA initiatives in areas such as keeping unsafe products labeled as supplements off the market and explaining why hemp and CBD are available and supplements even though FDA considers the products noncompliant as dietary ingredients.

Topic FDA

Medtech Insight

Drug-Coating Safety Risk Acknowledged At Cardiology Gathering, But Cause Remains Elusive

By Elizabeth Orr 07 Mar 2019

Physicians and researchers in an all-day session at the Cardiovascular Research Technologies conference in Washington, DC, on March 5 largely backed the recent finding that paclitaxel-coated balloons and stents may be tied to a higher patient mortality rate. But the specific mechanism underlying the deaths remains unknown.

Topic Medtech

Scrip

Bayer Bosses Beg Risk-Averse Europe To Rethink

By Kevin Grogan 07 Mar 2019

The German group believes it is going to be at the forefront of development in the cell and gene therapy space but is worried that Europe is failing to recognize the value that the pharma industry and its new technologies can create for society.

Topic Cell and gene therapy

Scrip

Asia Deal Watch: Bharat Expands Its Vaccine Holdings By Buying GSKs Chiron Behring

By Anju Ghangurde 07 Mar 2019

Bharat hopes to expand international reach of Chiron Behring’s rabies vaccine. WuXi and Biolingus partner on sublingual delivery.

Topic Drug approval Business strategies

HBW Insight

Targeted Omega-3 Supplementation Could Save Up To €64.5bn In Healthcare Costs, Food Supplements Europe Claims

By David Ridley 07 Mar 2019

A new position paper by Food Supplements Europe calculates the potential savings that targeted supplementation with omega-3, calcium, phytosterols and vitamins D and B9 could bring for cash-strapped European governments.

Topic Drug development landscape Drug review

Medtech Insight

4C Medical Plans First Early Feasibility Study For An Implantable In Japan

By Elizabeth Orr 07 Mar 2019

4C Medical plans to conduct both an early feasibility study and the pivotal trial for its mitral regurgitation treatment device simultaneously in Japan, the US and Canada. The company says the study is the first early feasibility study in Japan for an implantable device.

Topic Medtech

Generics Bulletin

Two New Categories Join GGB Awards In 2019

By David Wallace 07 Mar 2019

Two new categories – Value Added Medicine Of The Year and Legal Strategy Of The Year – have been added to the Global Generics & Biosimilars Awards in 2019, which will take place on 5 November in Frankfurt, Germany.

Topic BioPharmaceutical Biosimilars

Generics Bulletin

US Bill Aims To Increase Transparency On Biologics

By David Wallace 07 Mar 2019

Several US senators have lent their backing to the draft Biologic Patent Transparency Act, as part of efforts to address “patent thickets” around brand biologics.

Topic BioPharmaceutical Drug approval Drug review

HBW Insight

E-Cigarettes' Appeal For Smoking Cessation Cooled By Risk Questions

By Eileen Francis 27 Feb 2019

E-cigarette use among people with cancer increased from 8.5% in 2014 to 10.7% in 2017, with the greatest increase among people younger than 50, according to a JAMA Oncology study. A recently NEJM study also questions safety of growing dependence on e-cigarettes by people trying to quit smoking.

Topic Cancer

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