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Quicksand Pharma/Biotech Weekly News

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Location:

United States

Language:

English


Episodes

Quicksand | Episode 18

2/19/2018
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Purdue Pharma to stop promoting opioids; FDA releases seven guidance documents; Final FDA guidance on co-crystals; Charles River acquires MPI Research; India releases draft drug clinical trial rules

Duration:00:08:16

Quicksand | Episode 17

2/12/2018
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External stakeholder meetings with FDA: FDA releases batch of product-specific guidances; Elemental impurity data in ANDAs; GSK bribery scandal; EMA advice on obesity effects on PK/PD

Duration:00:08:29

Quicksand | Episode 16

2/5/2018
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Turmoil at Apotex; Takeda’s Zika virus vaccine; FDA guidance on QIDP designation; EMA updated advice on ATMPs; TGA biosimilar naming

Duration:00:08:43

Quicksand | Episode 15

1/29/2018
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Celgene acquires Juno Therapeutics; Sanofi acquires Bioverativ; Amgen pediatric exclusivity case; CBER plans to publish guidance on gene therapy; FDA guidance on two-drug combinations for hypertension

Duration:00:08:05

Quicksand | Episode 14

1/22/2018
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EPO revokes Broad Institutes’s gene editing patent; Priority review vouchers; FDA pilot project to release clinical study reports; Guidance on Highlights section of drug labeling; EMA orphan drug designation assessment

Duration:00:07:46

Quicksand | Episode 13

1/15/2018
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Celgene acquires Impact; INC and InVentiv Health become Syneos Health; EMA guideline on rheumatoid arthritis; Shelf life of drugs in multi-dose containers; Swissmedic updates biosimilar guidance

Duration:00:07:28

Quicksand | Episode 12

1/8/2018
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Guidance on FDA meetings; Best practices for IND sponsor communications; Good ANDA submission practices; Spark’s priciest medicine; France’s biosimilar target

Duration:00:08:47

Quicksand | Episode 11

12/25/2017
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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

Duration:00:08:08

Quicksand | Episode 10

12/18/2017
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FDA guidance on genetic mutations; ANDA deficiency review letters; Refuse to file guidance document; Teva layoffs; Vertex’s gene editing blood disorder studies

Duration:00:08:13

Quicksand | Episode 9

12/11/2017
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Pfizer’s generic Viagra; FDA toxicology roadmap; Rare pediatric disease guidance; Denali Therapeutics IPO; ICH Assembly updates

Duration:00:08:16

Quicksand | Episode 8

12/4/2017
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Herceptin biosimilar approval; Generic abuse-deterrent opioid guidance; Patent submission dates in Orange Book; EMA/EC guideline on Brexit; MedDRA update

Duration:00:07:52

Quicksand | Episode 7

11/27/2017
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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

Duration:00:09:00

Quicksand | Episode 6

11/20/2017
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Suffixes for biologics and biosimilars; Regenerative medicine policy; Record generic drug application reviews; Hemlibra approval; Bill Gates’ Alzheimer’s disease investment

Duration:00:09:26

Quicksand | Episode 5

11/13/2017
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Effects of drugs on driving guidance; Cold sore antiviral drugs guidance; ICH toxicity testing guideline; IQVIA; Marketing authorizations based on single studies

Duration:00:08:23

Quicksand | Episode 4

11/6/2017
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Expanded access; Dispute resolution guidance; EMA RSV guidelines; TGA autologous cell and tissue products; ICH statistical principles

Duration:00:08:22

Quicksand | Episode 3

10/30/2017
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Insys federal charges; DDI guidance documents; Brexit-EMA cuts; ISO IDMP; China-approved Ebola vaccine

Duration:00:08:14

Quicksand | Episode 2

10/23/2017
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Yescarta; Restasis; Shingrix; FDA guidances; WHO biosimilars

Duration:00:06:58

Quicksand | Episode 1

10/17/2017
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Luxturna; DTC advertising; PDUFA VI; California price law; China regulations

Duration:00:08:14