https://quicksandnews.podbean.com A weekly audio digest of the most important news in drug development affecting the pharmaceutical and biotech industry Mon, 08 Jan 2018 06:00:00 -0800 https://podbean.com/?v=3.2 en Copyright 2018. All rights reserved. Science & Medicine:Medicine 1440 episodic Pharma/Biotech Weekly News A weekly audio digest of the most important news in drug development affecting the pharmaceutical and biotech industry. Robert Cormack Robert Cormack robert.cormack@outlook.com No Clean http://quicksandnews.podbean.com/feed/ http://deow9bq0xqvbj.cloudfront.net/image-logo/2147035/ituneslogo.png https://quicksandnews.podbean.com 144 144 http://quicksandnews.podbean.com/e/quicksand-episode-12/ http://quicksandnews.podbean.com/e/quicksand-episode-12/#comments Mon, 08 Jan 2018 06:00:00 -0800 quicksandnews Uncategorized quicksandnews.podbean.com/quicksand-episode-12-24b00f90dd1700f333f1ee8f1a4eedd1 Guidance on FDA meetings; Best practices for IND sponsor communications; Good ANDA submission practices; Spark’s priciest medicine; France’s biosimilar target

]]> Guidance on FDA meetings; Best practices for IND sponsor communications; Good ANDA submission practices; Spark's priciest medicine; France's biosimilar target

]]> Guidance on FDA meetings; Best practices for IND sponsor communications; Good ANDA submission practices; Spark's priciest medicine; France's biosimilar target Robert Cormack Clean No 00:08:47 12 full http://quicksandnews.podbean.com/e/quicksand-episode-11/ http://quicksandnews.podbean.com/e/quicksand-episode-11/#comments Mon, 25 Dec 2017 06:00:00 -0800 quicksandnews Uncategorized quicksandnews.podbean.com/quicksand-episode-11-24b00f90dd1700f333f1ee8f1a4eedd1 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

]]> 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

]]> 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 ... Robert Cormack Clean No 00:08:08 11 full http://quicksandnews.podbean.com/e/quicksand-episode-10/ http://quicksandnews.podbean.com/e/quicksand-episode-10/#comments Mon, 18 Dec 2017 06:00:00 -0800 quicksandnews Uncategorized quicksandnews.podbean.com/quicksand-episode-10-24b00f90dd1700f333f1ee8f1a4eedd1 FDA guidance on genetic mutations; ANDA deficiency review letters; Refuse to file guidance document; Teva layoffs; Vertex’s gene editing blood disorder studies

]]> FDA guidance on genetic mutations; ANDA deficiency review letters; Refuse to file guidance document; Teva layoffs; Vertex's gene editing blood disorder studies

]]> FDA guidance on genetic mutations; ANDA deficiency review letters; Refuse to file guidance document; Teva layoffs; Vertex's gene editing blood disorder studies Robert Cormack Clean No 00:08:13 10 full http://quicksandnews.podbean.com/e/quicksand-episode-9/ http://quicksandnews.podbean.com/e/quicksand-episode-9/#comments Mon, 11 Dec 2017 06:00:00 -0800 quicksandnews Uncategorized quicksandnews.podbean.com/quicksand-episode-9-24b00f90dd1700f333f1ee8f1a4eedd1 Pfizer’s generic Viagra; FDA toxicology roadmap; Rare pediatric disease guidance; Denali Therapeutics IPO; ICH Assembly updates

]]> Pfizer's generic Viagra; FDA toxicology roadmap; Rare pediatric disease guidance; Denali Therapeutics IPO; ICH Assembly updates

]]> Pfizer's generic Viagra; FDA toxicology roadmap; Rare pediatric disease guidance; Denali Therapeutics IPO; ICH Assembly updates Robert Cormack Clean No 00:08:16 9 full http://quicksandnews.podbean.com/e/quicksand-episode-8/ http://quicksandnews.podbean.com/e/quicksand-episode-8/#comments Mon, 04 Dec 2017 06:00:00 -0800 quicksandnews Uncategorized quicksandnews.podbean.com/quicksand-episode-8-24b00f90dd1700f333f1ee8f1a4eedd1 Herceptin biosimilar approval; Generic abuse-deterrent opioid guidance; Patent submission dates in Orange Book; EMA/EC guideline on Brexit; MedDRA update

]]> Herceptin biosimilar approval; Generic abuse-deterrent opioid guidance; Patent submission dates in Orange Book; EMA/EC guideline on Brexit; MedDRA update

]]> Herceptin biosimilar approval; Generic abuse-deterrent opioid guidance; Patent submission dates in Orange Book; EMA/EC guideline on Brexit; MedDRA update Robert Cormack Clean No 00:07:52 8 full http://quicksandnews.podbean.com/e/quicksand-episode-7/ http://quicksandnews.podbean.com/e/quicksand-episode-7/#comments Mon, 27 Nov 2017 06:00:00 -0800 quicksandnews Uncategorized quicksandnews.podbean.com/quicksand-episode-7-24b00f90dd1700f333f1ee8f1a4eedd1 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

]]> 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

]]> 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 Robert Cormack Clean No 00:09:00 7 full http://quicksandnews.podbean.com/e/quicksand-episode-6/ http://quicksandnews.podbean.com/e/quicksand-episode-6/#comments Mon, 20 Nov 2017 06:00:00 -0800 quicksandnews Uncategorized quicksandnews.podbean.com/quicksand-episode-6-24b00f90dd1700f333f1ee8f1a4eedd1 Suffixes for biologics and biosimilars; Regenerative medicine policy; Record generic drug application reviews; Hemlibra approval; Bill Gates’ Alzheimer’s disease investment

]]> Suffixes for biologics and biosimilars; Regenerative medicine policy; Record generic drug application reviews; Hemlibra approval; Bill Gates' Alzheimer's disease investment

]]> Suffixes for biologics and biosimilars; Regenerative medicine policy; Record generic drug application reviews; Hemlibra approval; Bill Gates' Alzheimer's disease investment Robert Cormack Clean No 00:09:26 6 full http://quicksandnews.podbean.com/e/quicksand-episode-5/ http://quicksandnews.podbean.com/e/quicksand-episode-5/#comments Mon, 13 Nov 2017 06:00:00 -0800 quicksandnews Uncategorized quicksandnews.podbean.com/quicksand-episode-5-24b00f90dd1700f333f1ee8f1a4eedd1 Effects of drugs on driving guidance; Cold sore antiviral drugs guidance; ICH toxicity testing guideline; IQVIA; Marketing authorizations based on single studies

]]> Effects of drugs on driving guidance; Cold sore antiviral drugs guidance; ICH toxicity testing guideline; IQVIA; Marketing authorizations based on single studies

]]> Effects of drugs on driving guidance; Cold sore antiviral drugs guidance; ICH toxicity testing guideline; IQVIA; Marketing authorizations based on single studies Robert Cormack Clean No 00:08:23 5 full http://quicksandnews.podbean.com/e/quicksand-episode-4/ http://quicksandnews.podbean.com/e/quicksand-episode-4/#comments Mon, 06 Nov 2017 06:00:00 -0800 quicksandnews Uncategorized quicksandnews.podbean.com/quicksand-episode-4-24b00f90dd1700f333f1ee8f1a4eedd1 Expanded access; Dispute resolution guidance; EMA RSV guidelines; TGA autologous cell and tissue products; ICH statistical principles

]]> Expanded access; Dispute resolution guidance; EMA RSV guidelines; TGA autologous cell and tissue products; ICH statistical principles

]]> Expanded access; Dispute resolution guidance; EMA RSV guidelines; TGA autologous cell and tissue products; ICH statistical principles Robert Cormack Clean No 00:08:22 4 full http://quicksandnews.podbean.com/e/quicksand-episode-3/ http://quicksandnews.podbean.com/e/quicksand-episode-3/#comments Mon, 30 Oct 2017 06:00:00 -0800 quicksandnews Uncategorized quicksandnews.podbean.com/quicksand-episode-3-24b00f90dd1700f333f1ee8f1a4eedd1 Insys federal charges; DDI guidance documents; Brexit-EMA cuts; ISO IDMP; China-approved Ebola vaccine

]]> Insys federal charges; DDI guidance documents; Brexit-EMA cuts; ISO IDMP; China-approved Ebola vaccine

]]> Insys federal charges; DDI guidance documents; Brexit-EMA cuts; ISO IDMP; China-approved Ebola vaccine Robert Cormack Clean No 00:08:14 3 full http://quicksandnews.podbean.com/e/quicksand-episode-2/ http://quicksandnews.podbean.com/e/quicksand-episode-2/#comments Mon, 23 Oct 2017 06:00:00 -0800 quicksandnews Uncategorized quicksandnews.podbean.com/quicksand-episode-2-24b00f90dd1700f333f1ee8f1a4eedd1 Yescarta; Restasis; Shingrix; FDA guidances; WHO biosimilars

]]> Yescarta; Restasis; Shingrix; FDA guidances; WHO biosimilars

]]> Yescarta; Restasis; Shingrix; FDA guidances; WHO biosimilars Robert Cormack Clean No 00:06:59 2 full http://quicksandnews.podbean.com/e/quicksand-episode-1/ http://quicksandnews.podbean.com/e/quicksand-episode-1/#comments Tue, 17 Oct 2017 07:18:56 -0800 quicksandnews Uncategorized quicksandnews.podbean.com/quicksand-episode-1-24b00f90dd1700f333f1ee8f1a4eedd1 Luxturna; DTC advertising; PDUFA VI; California price law; China regulations

]]> Luxturna; DTC advertising; PDUFA VI; California price law; China regulations

]]> Luxturna; DTC advertising; PDUFA VI; California price law; China regulations Robert Cormack Clean No 00:08:14 1 full