Weekly Highlights: July 3-July 7

EEGs, Epileptic Events Used As Biomarker, Endpoint in Tuberous Sclerosis/LAM Rx Development Says Rare Disease Director Goldsmith

Weekly Highlights: June 26-30, 2017

Orphan Designation Plan: Collaboration and Delegation to Eliminate the Backlog, Respond Faster to Requests

Rx Pricing Pledges: Pros and Cons Debated at BIO

Executive Order on Drug Costs: Thinking Through The Implications For Biopharma

Gene Therapies Are Coming – As Are Reimbursement Challenges; Why Hemophilia May Be Easier Initial Case Than Blindness

FDA’s Generic Competition Actions: List Sets Targets, MAPP Details Priority ANDA Review Process; Where’s Acthar?

FDA Advisory Committee Tracker: Will ODAC Undefeated Streak Continue In July?

Executive Action On 340B: Contract Pharmacy, Penny Pricing Policies Could Be Curbed –But Enforcement May Be Tricky

Pfizer Uses Patient-Focused Drug Development Meeting To Reach Out To Friedreich’s Ataxia Patients For Suggestions On Wearable Monitors

Weekly Highlights: June 19-23

FDA Hatch-Waxman Meeting To Focus On Competition For Re-Pricing Targets, REMS-Blocking and Shared Systems

Novo Victoza CV Benefit Gets 17-2 Approval Vote After Tough Day: Committee Focuses on FDA Subgroup Analysis Showing Less Effect in US

Orphan Drug Request Backlog To Be Cleared In 90 Days; New Rare Disease Subset Guidance Coming Within Six Months

White House Opioid Commission Holds First Meeting: Access To Drug Therapy, Payor Coverage “Parity” Suggested

Weekly Highlights: June 12-16

Biomarker Assay Validation Document Moving Closer to Completion, Will Help Inform Future FDA Guidance

Novo Victoza Cardiovascular Risk Reduction Claim Looks Good at FDA; Ancillary Safety Data From LEADER Likely To Dominate June 20 Meeting

Opioid Funding, ACA Repeal Take Center Stage At Senate Appropriations HHS Budget Hearing; Drug Prices Not Discussed

FDA Digital Health Plan Will Use Third-Party Certification, RWE For Improvements; Innovation Plans Coming To Other Centers

Senate HELP Drug Costs Hearing Is Short On Policy Solutions; PBM Rebate Reform, Value-Based Contracting Stand Out

Drug Pricing: Wyden SPIKE Act Targets High Percentage Increases and Large Medicare/Medicaid Spending Line Items

Senate HELP Drug Costs Hearing Is Short On Policy Solutions; PBM Rebate Reform, Value-Based Contracting Stand Out

Opioids and Real World Abuse: FDA Workshop On Impact Of Abuse-Deterrent Formulations Will Have Broad Implications