Regulatory

Republican control of Washington promises overhaul of healthcare and medical product regulation.

Significant uncertainty surrounds the future of drug pricing reform, causing industry observers to take a closer look at the policy views of the president-elect, state and Congressional lawmakers, and the general public.

Congress took a major step yesterday towards shoring up FDA operations and biomedical research supported by the National Institutes of Health with House passage of the 21st Century Cures bill.

The FDA’s Dr. John Whyte offers his perspectives on patient centricity and the issues that FDA and industry are facing.

Biosimilars are gaining more support among payers and physicians, but more needs to be done to explain their benefits as well as their safety and efficacy profiles, writes Barbara Testa.

The European Medicine Association is determined keep open all options on the future of drug approvals in advance of a crucial meeting in December, writes Peter O'Donnell.

Biopharma companies should no longer consider FDA an obstacle to innovation and in need of major reform, according to Jim Greenwood, President of BIO.

The surprise victory of Donald Trump opens the door to new strategies for providing healthcare to Americans, including coverage and oversight of prescription drugs.

FDA officials agree that large comparative clinical trials defeat the purpose of the abbreviated development program for biosimilars.

Policymakers, payers and pharma companies weigh strategies for rationalizing drug prices . Jill Wechsler reports.

The FDA approved Sarepta’s Exondys for Duchenne muscular dystrophy despite little evidence of efficacy, leading many to regard the decision as not being a model for future drug development.

FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.

When lobbying tips the scales: a path to drug approval.

Highlighting the seven key trends in global pharma that drove discussion at this year's CPhI Worldwide event in Spain.

Despite notable deficiencies in the frameworks for assessing the value of prescription drugs, these initiatives are expected to have a major impact on drug utilization and reimbursement.

The EpiPen eruption plus the emergence of more cutting-edge therapies with drug and biotech components has put combination products under the spotlight. Jill Wechsler reports.

ISPOR's Value Assessment Stakeholder Conference showed its Special Task Force still reaching for clarification around the subject, writes Ansis Helmanis.

PDUFA VI to enhance FDA staffing, revise fees and expand evidence for drug development.

The UK is moving closer to aligning its two approaches to regulating drug pricing - the voluntary PPRS and statutory price cuts - but the headaches are likely to continue, writes Leela Barham.

The campaign to achieve greater transparency in clinical research activity regulated or funded by the federal government, including the results of those studies, is moving forward after months of debate.

Concerns have emerged that continued growth in biosimilars could be limited by mounting pressure to push down on prescription drug outlays. Jill Wechsler reports.

Traditional sales and pricing practices face legal challenges and political backlash.

$7.5 billion in pharma “transfers of value” made in 2015 has caught the attention of the DoJ and federal and state prosecutors investigating fraud. Jill Weschler reports.

The outrage over Mylan’s price hikes for its EpiPen auto-injector illustrates the many factors that keep drug pricing immune from normal economic pressures, writes Jill Wechsler.

Traditional sales and pricing practices face legal challenges and political backlash, writes Jill Wechsler.

Reflector outlines the obstacles ahead for Europe's revamped Innovative Medicines Initiative.

Analysts examine investment and business factors that shape supply disruptions.

Zika vaccine development is hindered by technical challenges and funding shortfalls, writes Jill Wechsler.

Could the new Vermont Drug Transparency law “lead the US Pharmaceutical industry to an awful end”? Tom Norton reports.

Having lobbied hard to have Inter Partes Review proceedings (IPRs) enacted, the tech industry may now be regretting what it wished for, write Traci Medford-Rosow and Peter C. Richardson.