Why It s Time to Get Smarter about Content Management and Document Production

In other industries with complex information and document needs, such as aerospace engineering, creating smarter documents populated with pre-approved information components is accepted practice. Yet up to now structured authoring is an approach that has eluded life sciences, limiting firms a Powered by WPeMatico Continue reading Why It s Time to Get Smarter about Content Management and Document Production

Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With

After months of expectations and repeated delays, President Donald Trump formally announced his strategy for making prescription medicines more affordable and accessible in the U.S. Trump promised to take on the tangled web of special interests that drive up drug prices, noting the high amount Powered by WPeMatico Continue reading Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With

Mega Budget Bill Boosts Funding for Biomedical Research, FDA programs

After months of delay, Congress finally passed a $1.3 trillion omnibus budget bill March 22, 2018, just in time to avoid another government shut-down. The measure increases federal support for biomedical research and health programs for fiscal year 2018, which began months ago. A m Powered by WPeMatico Continue reading Mega Budget Bill Boosts Funding for Biomedical Research, FDA programs

Growth in the Time of Brexit: James Burt, Accord Healthcare

Accord Healthcare, which acquired Actavis UK and Ireland in 2017, is one of the fastest-growing generic pharmaceutical companies in the UK. It aims to become a Top 5 pan-EMENA (Europe, Middle East and North Africa) generics company by 2021 and has developed a specialty products commercialization Powered by WPeMatico Continue reading Growth in the Time of Brexit: James Burt, Accord Healthcare

FDA s Gottlieb Hits Innovators, Insurers for Blocking Biosimilar Uptake

Pernicious rebating and contracting schemes and Kabuki drug-pricing constructs expose consumers to high out-of-pocket costs for biosimilars and actively discourage competition from these more affordable alternatives, says FDA commissioner Scott Gottlieb. As part of FDA initiatives to reward Powered by WPeMatico Continue reading FDA s Gottlieb Hits Innovators, Insurers for Blocking Biosimilar Uptake

Why a Data Health Check May Be the Best Medicine for Pharmaceutical Regulatory Compliance

Darren Cooper The way medicines are discovered and developed is changing, and regulatory organizations around the world, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are working on alignment schemes to create Identification of Medicinal Pr Powered by WPeMatico Continue reading Why a Data Health Check May Be the Best Medicine for Pharmaceutical Regulatory Compliance

Why a Data Heath Check May Be the Best Medicine for Pharmaceutical Regulatory Compliance

Darren Cooper The way medicines are discovered and developed is changing, and regulatory organizations around the world, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are working on alignment schemes to create Identification of Medicinal Pr Powered by WPeMatico Continue reading Why a Data Heath Check May Be the Best Medicine for Pharmaceutical Regulatory Compliance

Trump Budget Boosts FDA, Squeezes Resources for NIH & Healthcare

FDA advocates on all sides applauded the request to increase funding significantly for FDA under the Trump administration s budget for fiscal year 2019, which seeks more than $400 million in additional outlays for oversight of drugs, biologics and medical devices. The Alliance for a Stronger FDA Powered by WPeMatico Continue reading Trump Budget Boosts FDA, Squeezes Resources for NIH & Healthcare

Gottlieb To Promote Biosimilars, Safer Opioid Packaging

In highlighting key FDA priorities for the coming months, commissioner Scott Gottlieb told agency advocates in Washington D.C. that he will continue to seek ways to curb rampant opioid addiction, to promote competition that curbs high drug prices, and to advise on right-to-try legislation that h Powered by WPeMatico Continue reading Gottlieb To Promote Biosimilars, Safer Opioid Packaging