Quicksand Pharma/Biotech Weekly News: Recent Episodes
Robert Cormack
A weekly audio digest of the most important news in drug development affecting the pharmaceutical and biotech industry
Guidance on FDA meetings; Best practices for IND sponsor communications; Good ANDA submission practices; Spark’s priciest medicine; France’s biosimilar target
NME approvals; Top five selling drugs; Orphan drug designation for pediatric drugs; FDA guidance on waivers for BA/BE studies; FDA guidance on CMC changes to biologics
FDA guidance on genetic mutations; ANDA deficiency review letters; Refuse to file guidance document; Teva layoffs; Vertex’s gene editing blood disorder studies
Pfizer’s generic Viagra; FDA toxicology roadmap; Rare pediatric disease guidance; Denali Therapeutics IPO; ICH Assembly updates
Herceptin biosimilar approval; Generic abuse-deterrent opioid guidance; Patent submission dates in Orange Book; EMA/EC guideline on Brexit; MedDRA update
EMA moves to Amsterdam; FDA’s approval of GSK’s Juluca; Pfizer’s fight with states over execution drugs; Opioid lawsuits against Purdue Pharma; EudaVigilance update
Suffixes for biologics and biosimilars; Regenerative medicine policy; Record generic drug application reviews; Hemlibra approval; Bill Gates’ Alzheimer’s disease investment
Effects of drugs on driving guidance; Cold sore antiviral drugs guidance; ICH toxicity testing guideline; IQVIA; Marketing authorizations based on single studies
Expanded access; Dispute resolution guidance; EMA RSV guidelines; TGA autologous cell and tissue products; ICH statistical principles
Insys federal charges; DDI guidance documents; Brexit-EMA cuts; ISO IDMP; China-approved Ebola vaccine