Bay Area's PellePharm Wins FDA Breakthrough Tag for Genetic Rare Disease Drug
PellePharm is aiming to launch Phase III trials of the topical hedgehog inhibitor in early 2018. Source: BioSpace
Store Club Card Not a Valid Drugmaking Tool, FDA Warns Compounder
A worker at an Idaho compounding pharmacy used “a worn plastic store club card” to scoop a powdered drug into empty gelatin capsules, in violation of federal regulations, the FDA…
Insurance Broker Claims Lilly Trained Nurse Educators to Push Its Drugs
A newly unsealed lawsuit filed this summer alleged Eli Lilly ran an illegal kickback operation with two healthcare marketing firms. Source: Drug Industry Daily
Judge Denies Compounder’s Motion to Dismiss Allergan’s False Advertising Complaint
A federal judge refused to dismiss a false advertising lawsuit filed by Allergan against drug compounder Imprimis Pharmaceuticals concerning its dry-eye drug Klarity, meant to compete with Allergan’s Restasis. Source:…
EMA Publishes Q&A on Periodic Safety Update Reports, Previews Possible GVP Update
The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Source: Drug Industry Daily
CMS Proposes to Cut Costs for Medicare Drugs, Rein in Opioids
Medicare Part D beneficiaries could shop for drugs at more pharmacies and take advantage of cheaper new generics sooner under revised rules proposed by the Centers for Medicare and Medicaid…
Why Gilead Should Keep an Eye on Juno's New CAR-T Strategy
CAR-T is a hot new area and there are companies hot on Gilead's tail, namely Juno, in a partnership with Celgene, and Novartis. Source: BioSpace
Pfizer Wins Expanded FDA Nod for Cancer Drug Sutent
The approval was based on results from a trial that demonstrated a significant reduction in the risk of a disease-free survival (DFS) event for patients at high risk of RCC…
Takeda CEO Actively Hunts for Deals, Looks to Shed Non-Core Businesses
Bloomberg noted that Takeda's CEO is looking at making Takeda a nimble company, but one with a deeply entrenched R&D focus. Source: BioSpace
Eli Lilly Insulin Drug Price Tripled While Trump's HHS Nominee Was President of the U.S. Unit
Azar, the new HHS nominee, is being pitched as someone who will help lower the price of prescription drugs. Source: BioSpace
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