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Episodes

Quicksand | Episode 31

5/21/2018
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FDA approves novel treatment to prevent migraines; FDA names firms accused of stifling generic competitors; FDA proposes amending classification rules for combination products; FDA finalizes guidance on IRB written procedures; EMA adopts ICH guideline on nonclinical evaluation of anticancer drugs

Duration:00:07:06

Quicksand | Episode 30

5/14/2018
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FDA seeks to stop procedures at unregulated stem cell clinics; FDA advisory committee backs volanesorsen in split vote; New PIC/S guidance on GMP inspections; EMA report on two years of PRIME experience; Health Canada proposes mandatory erquirements for eCTD requirements

Duration:00:08:47

Quicksand | Episode 29

5/7/2018
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Gene editing innovator cofounds Beam Therapeutics; Fresenius terminated Akorn acquisition due to alleged fraud; EMA proposes changes to vaccine clinical trial guideline; European Commission launches public consultation on fairness of fee system; ICH Q&A on nonclinical evaluation of cancer drugs

Duration:00:08:20

Quicksand | Episode 28

4/30/2018
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Takeda reaches a $64 billion deal to acquire Shire; FDA finalizes guidance on clinical imaging standards; FDA draft guidance on nonclinical development of drugs for chronic hematologic disorders; FDA extends deadline of eCTD implementation for Type III DMFs; UK reassures adoption of EU clinical trial regulation despite Brexit

Duration:00:07:18

Quicksand | Episode 27

4/23/2018
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FDA panel unanimously votes for GW Pharma’s cannabis-based drug: FDA director takes senior role at AstraZeneca; FDA draft guidance on depot buprenorphine products; FDA guidance study datasets in vaccine trials; TGA proposes changes to biologics regulations

Duration:00:07:55

Quicksand | Episode 26

4/16/2018
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Novartis acquires AveXis for $8.7 billion; FDA finalizes guidance on special protocol assessments; FDA issues new ICH addendum on pediatric drug development; Rigel Pharmaceuticals website snafu falsely claiming drug approval; EMA redistributes UK portfolio ahead of Brexit

Duration:00:08:13

Quicksand | Episode 25

4/9/2018
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FDA draft guidance on pregnant women in clinical trials; FDA finalized guidance on liposome drugs; USP monographs for new biologics; EC’s concern regarding MAHs’ approaches to upcoming Brexit; Health Canada adopts ICH guidelines on drug substance manufacturing

Duration:00:08:11

Quicksand | Episode 24

4/2/2018
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GSK buys out Novartis’ joint venture in consumer healthcare for $13 billion; FDA finalizes guidance on questionnaire for COPD trials; FDA publishes public meeting on alopecia drug development; Leading CROs to co-develop open technology standards; EMA to raise fees by 1.7% in April

Duration:00:07:37

Quicksand | Episode 23

3/26/2018
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FDA guidance on drug compounding; Patient-focused drug development guidance; Heron Therapeutics’ long-acting local anesthetic phase 3 study results; Novo Nordisk’s successful semaglutide obesity trial; Novartis strikes deal with Canadian company to distribute medical marijuana products

Duration:00:08:35

Quicksand | Episode 22

3/19/2018
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SEC charges Theranos with fraud; FDA finalizes ICH guidance on carcinogens; MHRA new guidance on data integrity; China plans reorganization of CFDA; TGA releases new clinical trial handbook

Duration:00:08:01

Quicksand | Episode 21

3/12/2018
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Esperion releases data from pivotal study for cholesterol-lowering drug; Pfizer ends research pact with CytomX; EU: UK unliklely staying in EMA after Brexit; EMA suspends AbbVie/Biogen MS drug after urgent safety review; Aurobindo’s regulatory problems

Duration:00:08:43

Quicksand | Episode 19

2/26/2018
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Judge rules in favor of Gilead in hep C patent dispute; Novartis’ Greece bribery scandal intensifies; FDA finalizes ICH guideline on drug substance manufacturing; Marketing application approvals comparison across agencies; Top-level shakeup at India’s drug regulator

Duration:00:08:05

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 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

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