A(z) Off Script Podcast csatorna legjobb podcastjai (2025)

1
Editor’s (re)View: It matters if Big Pharma is fudging its US investment numbers 4:00

11d ago4:00

4:00

Large biopharma companies in recent months have pledged billions of dollars in capital expenditures for U.S. manufacturing and R&D facilities. What if it’s not accurate?Greg Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/editors-review/article/55314470/editors-review-it-matters-if-big-pharma-is-fudging-its-us-investment-numbe…

1
Can CDMOs keep up with the increasing demand for GLP-1 medications? 5:45

16d ago5:45

5:45

The wildly popular drugs, prescribed for weight loss and type 2 diabetes, are putting a strain on the capabilities of contract development and manufacturing organizations.Greg Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/sector/contract-manufacturing/article/55314756/can-cdmos-keep-up-with-the-increasing-demand-for-glp-1-me…

1
FDA’s program to speed up US manufacturing buildouts is short on detail 5:49

1M ago5:49

5:49

While the agency’s PreCheck regulatory framework is a good first step, it remains to be seen whether the program boosts U.S. drug manufacturing, says former FDA official.Greg Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/all-articles/article/55309136/fdas-program-to-speed-up-us-manufacturing-buildouts-is-short-on-detail…

1
New Jersey remains hot life sciences hub despite macroeconomic, funding headwinds 5:25

1M ago5:25

5:25

The Garden State, called the “medicine chest” to the world, continues to show robust activity with life sciences firms accounting for nearly 30% of all Q2 leasing activity.Greg Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/all-articles/article/55308250/new-jersey-remains-hot-life-sciences-hub-despite-macroeconomic-funding-he…

1
Critical Timing: Hikma’s Billion-Dollar U.S. Investment 6:44

2M ago6:44

6:44

Generics, which make up approximately 90% of prescription volume in the U.S., are produced primarily in India as Hikma looks to onshore production of these critical drugs.Greg Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/all-articles/article/55302441/hikmas-planned-1b-us-investment-comes-at-critical-time-for-generic-medicin…

1
Editor’s (re)View: Is the biopharma industry’s glass half empty or half full? 4:47

3M ago4:47

4:47

While macroeconomic uncertainty weighs on the sector, there are glimmers of hope in some areas of pharmaceutical outsourcing and services.Greg Slabodkin Read by Brittany Duncan Read Article Here: https://www.pharmamanufacturing.com/editors-review/article/55299879/editors-review-is-the-biopharma-industrys-glass-half-empty-or-half-full…

1
Life sciences manufacturers overwhelmingly embrace smart tech: global survey 5:00

3M ago5:00

5:00

Smart manufacturing is “nearly universal” with 95% of manufacturers saying they are using or evaluating smart technology, according to a new survey from Rockwell Automation. Greg Slabodkin Read by Brittany DuncanPharma Manufacturing által

1
Flow state: The evolving shape of continuous manufacturing 15:11

3M ago15:11

15:11

While the pharmaceutical industry has been slow to adopt continuous manufacturing, it appears to be gaining momentum.Greg Slabodkin Read by Brittany Duncan Enjoy the article Here: https://www.pharmamanufacturing.com/all-articles/article/55295669/flow-state-the-evolving-shape-of-continuous-manufacturing…

1
[Solutions Spotlight] Hydrogenation: Bridging the gap between nitration and phosgenation 18:15

5M ago18:15

18:15

Hydrogenation can serve as a critical link in chemical synthesis, particularly between nitration and phosgenation. When integrated strategically, it helps enable safer, more efficient production processes. To better understand this connection, we spoke with Dr. Luca Mantilli, R&D Chemist at Valsynthese, the fine chemicals division of Société Suisse…

1
Editor’s (re)View: BMS, Merck, Roche see manufacturing flexibility as key to dealing with tariffs 4:26

5M ago4:26

4:26

The three Big Pharma companies on their earnings calls this week tried to reassure investors that they have the global footprints to mitigate the effects of tariffs.Pharma Manufacturing által

1
Thermo Fisher opens cell therapy center, FDA cites Aurobindo site, Trump probes pharma imports ahead of tariffs [The good, the bad, the ugly] 4:13

5M ago4:13

4:13

The good — Thermo Fisher opens center to boost cell therapy development The bad — FDA cites Aurobindo plant after Raleigh inspection The ugly — Trump probes pharma imports as tariff threat loomsPharma Manufacturing által

1
Novartis to invest $23B in US sites, US urged to invest $15B in biotech counter to China, Trump warns of major pharma tariffs [The good, the bad, the ugly] 4:10

6M 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 — Novartis to invest $23B in U.S. manufacturing and R&D, including seven new sites The bad — U.S. urged to invest $15B to counter China’s biotech rise The ugly — Trump signals ‘major’ tariffs on pharm…

1
Cellares, Cabaletta validate automated CAR T production, FDA warns Aspen over sterility issues, rejects Hengrui, Elevar cancer combo again [The good, the bad, the ugly] 3:18

6M ago3:18

3:18

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 — Cellares, Cabaletta validate automated CAR T production The bad — FDA warns Aspen over sterility issues The ugly — FDA rejects Hengrui, Elevar cancer combo again…

1
Axplora expands ADC capacity, Merck KGaA CDMO business slump, FDA issues a warning letter to Granules India [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 — Axplora expands its antibody-drug conjugate (ADC) manufacturing capacity to support growing demand. The bad — Merck KGaA’s CDMO business reports a decline The ugly — The FDA issues a warning letter …

1
Eli Lilly expands manufacturing to boost supply, FDA blocks imports from two Indian API makers, ICU Medical recalls potassium chloride injection bags over labeling error [The good, the bad, the ugly] 3:54

7M 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 — Eli Lilly expands manufacturing to boost supply The bad — FDA blocks imports from two Indian API makers over manufacturing violations The ugly — ICU Medical recalls potassium chloride injection bags…

1
Novartis boosts Slovenia investment to $3.6B, Trump tariffs could unsettle biopharma FDI, FDA warns Global Calcium, blocks US imports [The good, the bad, the ugly] 4:24

7M ago4:24

4:24

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 — Novartis boosts Slovenia investment to $3.6B The bad — Trump tariffs unsettle biopharma FDI The ugly — FDA warns Global Calcium, blocks US importsPharma Manufacturing által

1
FDA approves Opdivo subcutaneous version, Marinus Pharmaceuticals sells operations, Novo Nordisk pushes back against compounding pharmacies [The good, the bad, the ugly] 3:19

9M 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 approves Opdivo subcutaneous version The bad — Marinus Pharmaceuticals sells operations The ugly — Novo Nordisk pushes back against compounding pharmacies…

1
EU approves Novo-Catalent acquisition, CDMO National Resilience announces layoffs, FDA investigates blood cancer reports in gene therapy patients [The good, the bad, the ugly] 2:58

10M 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 — EU approves Novo-Catalent acquisition The bad — CDMO National Resilience announces layoffs The ugly — FDA investigates blood cancer reports in gene therapy patients…

1
FDA approves Imkeldi oral solution, Alector axes workforce, Novartis announcnes layoffs [The good, the bad, the ugly] 3:12

10M ago3:12

3:12

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 — FDA approves Imkeldi oral solution The bad — Alector axes workforce The ugly — Novartis announcnes layoffsPharma Manufacturing által

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

10M 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

10M 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

11M 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 phenylephrinePharma Manufacturing által

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

11M 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 investigationPharma Manufacturing által

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

11M 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

11M 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

11M 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 trialsPharma Manufacturing által

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

12M 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

12M 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

12M 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 bankruptcyPharma Manufacturing által

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

1y 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

1y 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

1y 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

1y 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

1y 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 ChinaPharma Manufacturing által

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

1y 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 483Pharma Manufacturing által

1
Pharma’s new age of longevity 4:15

1y 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

1y 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

1y 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

1y 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

1y 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

1y 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

1y 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

1y 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 PBMsPharma Manufacturing által

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

1y 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 partnershipPharma Manufacturing által

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

1y 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

1y 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

1+ y 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

1+ y 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

1+ y 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

1+ y 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…

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