Lilly Necitumumab Survival Results In Line With Previous FDA Approvals, Appear To Satisfy FDA Advisory Committee

Indivior, Adapt Nasal Naloxone NDAs Pending; FDA Holds Two-Day Meeting To Display Action on Overdose Treatment

House Committee Has Questions For FDA On Opioid Labeling And REMS: Possible Themes For PDUFA Renewal Legislation

Lilly Necitumumab: FDA Committee Will Highlight Risks, But Survival Benefit In Lung Cancer Likely To Carry Drug To Approval

FDA Qualifies Plasma Fibrinogen as COPD Biomarker; Should Simplify Trials For Exacerbation/Mortality Claims

“Cures” Bill Ready For House Vote: New Pay-Fors Include Authorized Generic Change, Lower Cap On Antibiotic Incentives

Medicaid Demonstrations Hearing Takes Aim At ACA Expansion Waivers

Purdue OxyContin Label Change To Reflect Impact On Abuse Withdrawn; FDA Likely To Cancel July 7-8 Meeting

House Neonatal Opioid Bill Calls for Prevention, Treatment; Hearing Witness Suggests Removal of MAT Boxed Warning

OxyContin Abuse Deterrence Review By FDA Committee In July May Preview Route For Other Applications In September

Medicare Higher Payment Rates for Antibiotics Compare Well To Other Mechanisms Under Consideration

King v. Burwell Clears A Path for Cures, Signals Higher Bar Moving Forward

OIG Recommends CMS Expand Drug Utilization Review Programs In Part D, Statutory “Lock-In” Authority

Cures Gets $101 Bil. CBO Hurdle On Path To Full House Action: New Orphan Indications Add $869 Mil. To Federal Programs

Alliance for Aging Research Moves Ahead With FDA Qualification, CMS Code for Novel Sarcopenia Endpoint

Pharmaceutical Compounding Committee Kicks Off “Difficult to Compound” List Process With New Criteria; Long Road Ahead

Pharmacy Compounding Committee Pushes Back On One FDA Ingredient Recommendation; Sign Of Things To Come?

FDA Risk Communication Committee Against Boxed Warning on Neonatal Opioid Withdrawal Syndrome for Addiction Drugs

Alpha-1 Antitrypsin Deficiency Patient Meeting September 29; CBER Meeting With Familiar, Experienced Patient Advocacy

“Terrible Twos”: FDA Braces For Tough GDUFA Reauthorization; Promises “Progress” On Communication In Coming Months

340B Pricing Rule: No Surprises On Discount Calculation, Civil Money Penalty Tied To Each “Order”; Does Exclusion Apply?

Patient-Focused Drug Development: Next Steps Include Earlier Involvement, Expanding Efforts Beyond FDA

FDA Finalizes Guidance On Early Stage Cell/Gene Therapy Trials; Agency Moving Quickly Amid Renewed Biopharma Activity

“Cures” NIH Funding: “Accelerated Advancement Program” Is One Area For Rx Companies To Watch

ACO Final Rule Builds On Survival Theme But Little Change For Biopharma; Part D Still Excluded