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Episodes

Quicksand | Episode 42

8/13/2018
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FDA drafts guidance on seamless clinical trials for oncology drugs; FDA drafts guidance on endpoints for opioid use disorder; FDA finalizes guidance on dissolution testing and acceptance criteria; FDA calls for industry input on expanding National Drug Code; EC drafts GCP guideline for advanced therapy medicinal products

Duration:00:07:58

Quicksand | Episode 41

8/6/2018
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FDA seeks feedback on clinical outcome assessments; FDA drafts guidance on nonclinical testing of nicotine products; FDA and EMA to hold workshop on early access approaches; More staff than anticipated quit EMA ahead of Brexit relocation; UK to reschedule cannabis-derived medicinal products

Duration:00:07:25

Quicksand | Episode 40

7/30/2018
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FDA closes pediatric study loophole in new guidance; FDA publishes surrogate endpoints list for drug approvals; FDA releases draft guidance on single enzyme defects; FDA releases draft guidance on diet in clinical trials; EMA revises guidelines for Crohn’s disease and ulcerative colitis

Duration:00:08:08

Quicksand | Episode 39

7/23/2018
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FDA announces details of major reorganization of CDER; FDA adopts ICH guideline on multiregional clinical trials; FDA issues draft guidance on field alert report submissions; UK votes to remain in EMA after Brexit; EMA finalizes gene therapy guideline

Duration:00:08:28

Quicksand | Episode 38

7/16/2018
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FDA releases new draft guidances on gene therapy; FDA updates guidance on development of smallpox antivirals; FDA issues draft guidance on hypertension drug development; EMA releases concept paper on drugs to prevent and treat acute kidney injury; Health Canada issues guidance on compliance with notifications of foreign regulatory actions

Duration:00:08:45

Quicksand | Episode 37

7/2/2018
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GW Pharma wins historic FDA approval for cannabis-based drug; FDA strengthens its workforce using authorities from Cures Act; FDA issues draft guidance on radiopharmaceuticals for cancer; FDA unveils two new programs on quality metrics; ICH adds new members and advances guidance documents

Duration:00:08:38

Quicksand | Episode 36

6/25/2018
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FDA withdraws guidance document on analytical studies for biosimilars; CBER launches new program for early meetings with developers of biologics; FDA updates guidance on major depressive disorder; FDA updates guidance on user fee waivers, reductions, and refunds for drugs and biologics; EMA updates guidances for industry on Brexit

Duration:00:07:48

Quicksand | Episode 35

6/18/2018
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FDA issues new guidance on antibiotics for limited patient populations; FDA issues guidance on gathering patient input during drug development; FDA updates inter-center consult request manual for combination products; FDA proposes alternative mechanisms to comply with GMP for combination products; EMA to launch online portal for orphan drug designation filings

Duration:00:07:52

Quicksand | Episode 34

6/11/2018
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CDER unveils plans to modernize Office of New Drugs; CDER moves dispute resolution program; FDA releases updated draft guidance on meetings for sponsors of biosimilars; FDA revises draft guidance on fee waivers for qualifying HIV treatments; EMA’s management board provides updates on Brexit and clinical trial portal

Duration:00:08:04

Quicksand | Episode 33

6/4/2018
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FDA prepares for implementation of “Right-to-Try” law; First U.S. clinical trial of gene editing technology placed on clinical hold; FDA issues draft guidance on including adolescents in adult oncology trials; FDA release two new draft guidance on REMS; FDA adopts ICH guideline on managing post-approval CMC changes

Duration:00:08:04

Quicksand | Episode 32

5/28/2018
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FDA finalizes anthrax treatment guidance; FDA issues guidance on maximal usage trials for OTC drugs; FDA seeks input on pH-dependent drug-drug interactions; EMA draft guideline for handling and shipping investigational medicines; EC seeks consultation on duplicate Marketing Authorisations

Duration:00:07:56

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 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