최고 Off Script Podcast 팟캐스트 (2024)

1
FDA grants Regenxbio accelerated path for Duchenne, Neurogene reports death in Rett trial, Halozyme drops Evotec bid [The good, the bad, the ugly] 3:19

4d ago3:19

3:19

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA grants Regenxbio accelerated approval pathway for Duchenne gene therapy The bad — Neurogene reports patient death in Rett syndrome gene therapy trial The ugly — Halozyme withdraws acquisition pro…

1
PTC secures FDA nod, Kronos Bio halts CDK9 development, Marinus slashes 45% of workforce amid setbacks [The good, the bad, the ugly] 3:13

9d ago3:13

3:13

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — PTC secures FDA nod for brain-targeted gene therapy The bad — Kronos Bio halts CDK9 development The ugly — Marinus slashes 45% of workforce amid setbacks…

1
Ascendis, Novo ink partnership, Court blocks Sun Pharma launch, FDA moves to delist phenylephrine [The good, the bad, the ugly] 3:35

16d ago3:35

3:35

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Ascendis, Novo ink partnership The bad — Court blocks Sun Pharma launch The ugly — FDA moves to delist phenylephrine저자 Pharma Manufacturing

1
MilliporeSigma expands ADC manufacturing, EU fines Teva, AZ exec under investigation in China [The good, the bad, the ugly] 2:57

25d ago2:57

2:57

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — MilliporeSigma expands ADC manufacturing The bad — EU fines Teva The ugly — AZ exec under investigation저자 Pharma Manufacturing

1
[Extended Release] Antibiotic resistance crisis and the global efforts against superbugs 14:59

1M ago14:59

14:59

Join senior editor Andrea Corona and Emily Wheeler, Director of Infectious Disease Policy at the Biotechnology Innovation Organization (BIO), as they discuss the urgency of tackling antimicrobial resistance and the coordinated global efforts needed to save the struggling market of antibiotics. Extended Release is an Off Script series to revisit con…

1
Nucleus RadioPharma expands production with new sites, FDA issues CRL to Camurus' hormone disorder drug, NHS rejects Eli Lilly's Alzheimer's drug over cost [The good, the bad, the ugly] 3:10

1M ago3:10

3:10

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Nucleus RadioPharma expands production with new sites The bad — FDA issues CRL to Camurus' hormone disorder drug The ugly — NHS rejects Alzheimer's drug over cost concerns…

1
FDA approves AbbVie 24-hour Parkinson’s treatment, Sage Therapeutics axes workforce, FDA halts Novavax's COVID-flu vax trials [The good, the bad, the ugly] 2:50

1M ago2:50

2:50

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA approves AbbVie 24-hour Parkinson’s treatment The bad — Sage Therapeutics axes workforce The ugly — FDA halts Novavax's COVID-flu vaccine trials저자 Pharma Manufacturing

1
Roche gets FDA nod for breast cancer combo, Kezar’s lupus drug trial on hold, Zealand Pharma’s hypoglycemia drug rejected over manufacturing [The good, the bad, the ugly] 2:58

2M ago2:58

2:58

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Roche snags breast cancer FDA nod The bad — FDA places clinical hold on Kezar lupus nephritis drug trial The ugly — FDA rejects Zealand Pharma hypoglycemia drug over manufacturing reinspection…

1
Gilead inks deal with generics manufacturers to expand HIV drug access, J&J announces layoffs, Amgen sued for hiding $10.7B tax bill [The good, the bad, the ugly] 4:00

2M ago4:00

4:00

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Gilead inks deal with generics manufacturers to expand HIV drug access The bad — J&J announces layoffs at New Brunswick headquarters The ugly — Amgen sued for hiding $10.7B tax bill…

1
FDA approves BMS schizophrenia drug, bluebird bio announces layoffs, J&J talc subsidiary files for bankruptcy [The good, the bad, the ugly] 3:37

2M ago3:37

3:37

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good —FDA approves BMS schizophrenia drug The bad — bluebird bio announces layoffs The ugly —J&J talc subsidiary files for bankruptcy저자 Pharma Manufacturing

1
[Extended Release] Schizophrenia treatment barriers, KarXT, and the future of neuroscience 17:28

2M ago17:28

17:28

Join senior editor Andrea Corona and Sam Clark, CEO and founder of Terran Biosciences, for a discussion on KarXT's landmark approval, schizophrenia treatment barriers, prodrugs, and more. Extended Release is an Off Script series that allows us to revisit conversations with our sources to explore new developments, gain deeper insights, and provide u…

1
Novo Nordisk shares phase 2a obesity trial data, Achilles Therapeutics ends TIL-based therapy, Express Scripts sues FTC [The good, the bad, the ugly] 3:24

2M ago3:24

3:24

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Novo Nordisk shares phase 2a trial data for obesity treatment The bad — Achilles Therapeutics to discontinue TIL-based therapy The ugly — Express Scripts files lawsuit against FTC…

1
[Solutions Spotlight] Optimizing contamination control in pharma facilities 12:32

2M ago12:32

12:32

Drugmakers face stringent regulations to ensure that products remain free from contaminants that could compromise safety and efficacy. Effective contamination control requires meticulous monitoring of environmental conditions, rigorous testing of products, and implementation of robust cleaning and sterilization procedures. To better understand thes…

1
Roche wins FDA approval for subcutaneous cancer immunotherapy, Moderna to cut $1.1B in R&D expenses, Teva settles $80M opioid case with Baltimore [The good, the bad, the ugly] 3:34

3M ago3:34

3:34

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Roche snags FDA nod for subcutaneous cancer immunotherapy The bad — Moderna to cut R&D expenses by $1.1B The ugly — Teva reaches $80M opioid settlement with Baltimore…

1
Pfizer, Valneva share phase 2 Lyme vax data, IN8bio axes workforce, AstraZeneca employees detained in China [The good, the bad, the ugly] 4:12

3M ago4:12

4:12

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Pfizer, Valneva share phase 2 positive Lyme vax data The bad — IN8bio axes workforce, halts trial The ugly — AstraZeneca employees detained in China저자 Pharma Manufacturing

1
FDA approves Illumina cancer biomarker test, BioMarin reveals more layoffs, FDA hits API maker Global Calcium with 483 [The good, the bad, the ugly] 3:30

3M ago3:30

3:30

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA approves Illumina cancer biomarker test The bad — BioMarin reveals more layoffs The ugly — FDA hits API maker Global Calcium with 483저자 Pharma Manufacturing

1
Pharma’s new age of longevity 4:15

3M ago4:15

4:15

The concept of healthspan has recently gained new attention in the pharma industry and rightfully so, given the surprisingly large chasm in the U.S. between average years lived (77.5) and average years lived in good health (63.9). Facing a growing demographic of unhealthy seniors, a handful of innovative biotechs are reframing the longevity discuss…

1
Emergent donates 50k doses of mpox vaccine to Africa, FDA rejects Regeneron blood cancer bispecific antibody, China indicts Astellas exec for espionage [The good, the bad, the ugly] 3:41

3M ago3:41

3:41

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Emergent donates 50,000 doses of mpox vaccine to Africa The bad — FDA rejects Regeneron blood cancer bispecific antibody The ugly — China indicts Astellas exec for espionage…

1
FDA approves Ascendis drug, Lykos PTSD treatment rejected, Novartis bid blocked [The good, the bad, the ugly] 3:21

3M ago3:21

3:21

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA approves Ascendis hypoparathyroidism drug The bad — FDA rejects Lykos MDMA PTSD drug The ugly — Judge blocks Novartis bid to stop generic blockbuster heart drug…

1
Amneal's Parkinson's pill approved, Novo Nordisk withdraws Wegovy approval expansion bid, FDA delays BeiGene Tevimbra decision [The good, the bad, the ugly] 2:59

4M ago2:59

2:59

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Amneal gets FDA nod for Parkinson’s pill The bad — Novo Nordisk withdraws bid for Wegovy label expansion in heart failure The ugly — FDA delays decision on BeiGene Tevimbra as a first-line therapy…

1
FDA approves Adaptimmune therapy, halts vTv diabetes program; Sanofi sues Sarepta over Duchenne patents [The good, the bad, the ugly] 3:58

4M ago3:58

3:58

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA approves Adaptimmune engineered cell therapy The bad — FDA puts clinical hold on vTv Therapeutics diabetes program The ugly — Sanofi sues Sarepta over manufacturing patents for Duchenne gene ther…

1
FDA approves Sun Pharma hair loss drug, FDA issues warning letter to Brassica, EMA rejects Eisai-Biogen Alzheimer's drug [The good, the bad, the ugly] 3:46

4M ago3:46

3:46

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA approves Sun Pharma hair loss drug The bad — FDA issues harsh warning letter to Indian CDMO Brassica The ugly — EMA issues negative opinion on Eisai-Biogen Alzheimer's drug…

1
Genentech's oral weight loss drug shows promise; FDA denies accelerated approval for Agenus' cancer drug; Orexo's opioid overdose drug rejected again [The good, the bad, the ugly] 3:35

4M ago3:35

3:35

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Genentech's oral weight loss drug shows promise The bad — FDA denies accelerated approval for Agenus' cancer drug The ugly — Orexo's opioid overdose drug rejected again…

1
Pfizer advances obesity pill, FDA rejects Novo insulin, FTC releases PBM report [The good, the bad, the ugly] 3:28

5M ago3:28

3:28

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Pfizer advances once-daily obesity pill The bad — FDA rejects Novo Nordisk once-weekly insulin The ugly — FTC releases long-awaited report on PBMs저자 Pharma Manufacturing

1
Lilly Alzheimer’s drug gets full approval, Rocket gene therapy rejected, Eisai, BMS end ADC partnership [The good, the bad, the ugly] 3:44

5M ago3:44

3:44

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA grants Eli Lilly Alzheimer’s drug full approval The bad — FDA rejects Rocket gene therapy The ugly — Eisai, BMS end ADC partnership저자 Pharma Manufacturing

1
[Solutions Spotlight] Streamlining oral dose packaging design 31:57

5M ago31:57

31:57

By integrating a Quality by Design (QbD) approach, developers can design robust packaging from the outset, drastically reducing development time and costs. Understanding how moisture affects a product is key, allowing developers to use industry-accepted and validated models to predict and address potential stability issues early in the design phase…

1
Verona wins COPD nod, FDA rejects Merck-Daiichi ADC, Glenmark recalls potassium chloride capsules [The good, the bad, the ugly] 3:42

5M ago3:42

3:42

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Verona wins FDA nod for COPD The bad — FDA issues CRL to Merck-Daiichi lung cancer ADC The ugly — Glenmark recalls 114 batches of potassium chloride capsules…

1
Gilead HIV shot delivers zero infections, Takeda epilepsy drug misses endpoints, Lilly goes after counterfeiters [The good, the bad, the ugly] 3:36

5M ago3:36

3:36

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Gilead twice-yearly HIV shot delivers zero infections in trial The bad — Takeda epilepsy drug misses endpoints in trials The ugly — Eli Lilly goes after counterfeiters…

1
FDA backs Lilly Alzheimer’s drug; Pfizer Duchenne gene therapy fails; Talc plaintiffs seek J&J bankruptcy restraining order [The good, the bad, the ugly] 4:25

6M ago4:25

4:25

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA AdComm backs Eli Lilly Alzheimer’s drug The bad — Pfizer gene therapy fails phase 3 Duchenne trial The ugly — Talc plaintiffs seek restraining order on J&J bankruptcy tactic…

1
AZ's Tagrisso shines in phase 3 trial, BMS layoffs, FDA violations at Jiangsu Hengrui site [The good, the bad, the ugly] 3:44

6M ago3:44

3:44

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — AstraZeneca’s Tagrisso delivers 84% progression-free survival in trial The bad — BMS to let go of 863 employees at NJ site The ugly — FDA inspection uncovers multiple violations at Jiangsu Hengrui Ph…

1
J&J depression drug aces trial, Takeda plans layoffs, FDA delays review of Sanofi-Regeneron's Dupixent [The good, the bad, the ugly] 3:24

6M ago3:24

3:24

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — J&J depression drug aces late-stage trial The bad — Takeda plans layoffs at Massachusetts sites The ugly — FDA delays review of Sanofi-Regeneron's Dupixent in COPD…

1
Mining pharma's reshoring rush 4:27

6M ago4:27

4:27

When the pandemic hit and Americans found themselves looking to China for critical medical supplies, the idea of reshoring — a concept that had drifted along the currents of the manufacturing sector for over a decade — embedded itself into pharma discourse with renewed luster. During this podcast, Chief Content Director Karen Langhauser will share …

1
FDA approves biosim to Regeneron Eylea, Evotec exits gene therapy, J&J reports deaths in radioligand trial [The good, the bad, the ugly] 3:30

6M ago3:30

3:30

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA approves first interchangeable biosims to Regeneron Eylea The bad — Evotec exits gene therapy The ugly — J&J reports deaths in early-stage radioligand trial…

1
FDA approves Amgen's T-cell engager for lung cancer, BioMarin announces layoffs, FDA delays Ascendis drug review [The good, the bad, the ugly] 3:49

6M ago3:49

3:49

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA approves Amgen T-cell engager for small cell lung cancer The bad — BioMarin announces 170 layoffs The ugly — FDA delays review of Ascendis hypoparathyroidism drug…

1
Vertex submits NDA for CF drug, MacroGenics reports ADC prostate cancer trial patient deaths, FTC extends review of Novo-Catalent deal [The good, the bad, the ugly] 4:14

7M ago4:14

4:14

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Vertex submits NDA for CF drug The bad — MacroGenics reports patient deaths in prostate cancer ADC trial The ugly — FTC extends review of Novo-Catalent deal…

1
Neurocrine wins FDA nod for 'sprinkle' Ingrezza, Moderna-Metagenomi deal ends, Emergent's layoffs [The good, the bad, the ugly] 3:37

7M ago3:37

3:37

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Neurocrine wins FDA nod for 'sprinkle' Ingrezza formulation The bad — Moderna, Metagenomi end gene editing collab The ugly — Emergent announces layoffs, closes sites…

1
Novartis wins rare cancer pediatric indication, BMS layoffs, McKinsey under fire [The good, the bad, the ugly] 4:26

7M ago4:26

4:26

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Novartis wins rare cancer pediatric indication for Lutathera The bad — BMS unveils cost-saving initiative, layoffs The ugly — McKinsey under fire for alleged role in opioid crisis…

1
GSK antibiotic hits phase 3 goals, Genentech-Adaptimmune collab ends, Par Pharma recall [The good, the bad, the ugly] 4:10

7M ago4:10

4:10

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — GSK antibiotic hits phase 3 goals in gonorrhea The bad — Genentech ends $3B Adaptimmune T-cell collab The ugly — Par Pharmaceutical recalls Treprostinil injection for potential contamination…

1
BMS schizophrenia drug shines, Novartis axes jobs, Lilly compounding suit dismissed [The good, the bad, the ugly] 5:01

7M ago5:01

5:01

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — BMS schizophrenia drug shines in phase 3 trial The bad — Novartis to axe 680 jobs The ugly — Lilly compounding suit dismissed저자 Pharma Manufacturing

1
2024 election's impact on manufacturing 32:57

8M ago32:57

32:57

Politics, whether we like them or not, weigh heavy on manufacturing’s future. In case you haven’t heard, it is an election year! Which means, global trade, regulations, immigration, national security and taxation will all be part of the national discourse, and all of those topics touch on manufacturing in one way or another. During this podcast, we…

1
Basilea grabs FDA nod, Verve halts gene editing trial, Amylyx pulls ALS drug [The good, the bad, the ugly] 3:47

8M ago3:47

3:47

Editor's Review: Week of April 1 Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Basilea Pharmaceutica receives FDA approval for its IV antibiotic The bad — Verve Therapeutics halts gene editing trial, again The ugly — Amylyx removes ALS treatment…

1
[The good, the bad, the ugly] Editor's Review week of March 25 3:45

8M ago3:45

3:45

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — FDA approves Akebia Therapeutics' Vafseo anemia drug The bad — Bristol Myers Squibb's Crohn's disease drug disappoints The ugly — FDA rejects Regeneron Pharmaceuticals lymphoma treatment…

1
[The good, the bad, the ugly] Editor's Review week of March 18 5:31

8M ago5:31

5:31

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Orchard gene therapy wins first FDA nod for rare pediatric disease The bad — Abiomed recalls heart pump instructions due to perforation risks The ugly — J&J files lawsuit against a former employee fo…

1
[The good, the bad, the ugly] Editor's Review week of March 11 3:54

9M ago3:54

3:54

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Madrigal wins first FDA nod for NASH The bad — Acadia abandons plans to expand pimavanserin indications The ugly — BIO backs BIOSECURE Act, boots WuXi…

1
[The good, the bad, the ugly] Editor's Review week of March 4 4:16

9M ago4:16

4:16

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Boehringer Ingelheim to cap out-of-pocket inhaler prices The bad — Amylyx ALS drug falls short in phase 3 trial The ugly — FDA delays Eli Lilly Alzheimer's drug decision with last-minute AdComm…

1
[The good, the bad, the ugly] Editor's Review week of February 29 3:07

9M ago3:07

3:07

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Iovance has launches Amtagvi The bad — FDA rejected Theratechnologies HIV instramuscular injection The ugly — BioMarin receives a subpoena from the DOJ…

1
[The good, the bad, the ugly] Editor's Review week of February 23 3:55

9M ago3:55

3:55

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week: The good — Amtagvi approval The bad — Rapt clinical hold The ugly — Novavax and Gavi settlement저자 Pharma Manufacturing

1
Raising a modern CDMO 8:52

9M ago8:52

8:52

Across the board, the pharma industry is facing sky-high pressures to bring drugs to market quickly, safely and affordably. Facing this daunting landscape, pharma companies are enlisting the help of focused contract manufacturers to shape their therapies from the ground up. CDMOs, who so often go unnamed and unsung, have now become integral to forg…

1
[Solutions Spotlight] Meeting today’s container closure integrity requirements 16:36

1y ago16:36

16:36

In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Derek Duncan Product Line Director, at Lighthouse Instruments to discuss the significance of CCI and the evolving landscape of CCI testing, regulatory guidance, and the unique considerations posed by innovative therapies with extreme storage and transpo…

1
[Solutions Spotlight] Ensuring quality during a syringe surge 13:15

1+ y ago13:15

13:15

In this latest episode of Off Script: A Pharma Manufacturing Podcast, Karen Langhauser is joined by Veronica Ghidotti Product Manager, Visual Inspection Systems at Stevanato Group, to discuss how pharma markets have shifted towards drugs that require syringes and vials — which are historically difficult to inspect — and how new automatic inspection…

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