Eli Lilly's lung-cancer antibody, necitumumab, has incremental benefits, according to an FDA advisory panel.
Last year's increase in CME support from manufacturers came after six straight years of declining budgets.
Three panelists from the FDA's advisory panel offered their views on the panel's decision to recommend approval of Sprout Pharmaceuticals' flibanserin
Dr. Stephen Ostroff took over as the FDA's acting commissioner when Dr. Margaret Hamburg stepped down in March.
Rep. Billy Long introduced legislation that is meant to push the FDA to implement clearer guidelines for regulating drug product information on social media.
Amgen's PSCK9 inhibitor gets a position opinion in the EU; the FDA plans to study how spouses influence perception of DTC ads; Botox may relieve depression
Drugmakers engage early with insurers; patients push for implant to be pulled from the market; about one-third of new drugs qualify for special approval pathways
Novartis reported highest drug sales in 2014; state Medicaid programs spent $1.33 billion on hepatitis-C drugs; former FDA commissioner argues against shortening regulatory review times
FDA's application programming interfaces, or openFDA, reached 6,000 users less than a year after its launch.
FDA posted a revised draft guidance document on its brief summary and adequate directions for use concerning risk information in DTC print ads to reflect "recent social science research."
FDA has named Kathleen Uhl as permanent director of the Office of Generic Drugs.
Sandoz received FDA biosimilar nod; new technique yields 25 antibiotics; Novartis sends two COPD drugs for FDA review.
GSK opts to hold onto $1.6 billion portfolio of older drugs; Sanofi upheavals continue with exit of US diabetes sales exec; Takeda gains breakthrough status on AL amyloidosis therapy.
Jakafi becomes the first drug approved for treating polycythemia vera.
Despite drugmaker discount, VA still can't afford Sovaldi without additional funds; Ousted Sanofi CEO Viehbacher faces lawsuit for an alleged kickback scheme; GSK slims sales and R&D workforce.
Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.
The agency sent a Warning Letter to three marketers over their use of metatags in search engine marketing tactics.
An advisory panel voted against adding warnings to steroid injection labels.
AstraZeneca and Ranbaxy pay-for-delay case marches on; FDA extends Novartis multiple myeloma Priority Review timeline; Endo pays $25 for testosterone nasal gel.
The Center for Drug Evaluation and Research's director says there is a need for new opioids and cuts off dosing comparisons between extended-release and immediate-release opioids.
The reason: coordination and effectiveness.
The north-of-the-border solution comes amid climbing heroin abuse in the US.
BioMarin to acquire Dutch biotech Prosensa; Woodcock says significant efficacy key to Breakthrough Therapy designation; Stryker considers $16 billion bid for UK devicemaker Smith and Nephew.
EMA revises its conflict of interest policy; AbbVie all-oral HCV combo drug receives positive EU recommendation; Merck may help NewLink Genetics scale production of its Ebola vaccine.
The first approved hydrocodone formulated to discourage misuse raises a challenge to controversial Zohydro.
CRS asks if high prices are a tool to offset CMS rebates, the FDA adds another DTC study to its lineup, and the NIH proposes making more clinical trial data public.
As generic drug use soars, the agency intends to "create parity" in label-change rules for brands and generics.
A US Senate bill would also make treatments for the disease eligible for priority review vouchers.
The drugmaker is offering Scotland's NHS a money-back guarantee for Olysio patients.
Salix-Cosmo tax-inversion deal quashed, chronic heart failure market set to expand, rising generic drug prices get lawmakers' attention, NICE gives leukemia drug a thumbs-down, FDA has a good rep
Specialty medicines continue to be a hot category, one in which spending has surged behind products that treat medicine's most complex diseases. This eBook lays out the needs and hurdles along the specialty drug pathway, explaining how stakeholders are working to get meds into patients' hands and ease their experience. Click here to download.