Off Script: A Pharma Manufacturing Podcast - podcast cover

Off Script: A Pharma Manufacturing Podcast

Pharma Manufacturingpharmamanu.podbean.com
The Off Script podcast offers in-depth interviews and discussions with industry experts about hot-button topics in pharma, and goes behind the scenes of Pharma Manufacturing’s print and online coverage, which follows the industry’s biggest issues surrounding scale-up, technology innovations, regulations and more!
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Episodes

Pharma’s new age of longevity

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 discussion: Rather than treat the symptoms of aging one disease at a time, what if we could instead focus on the root causes, enabling treatment of multiple ...

Aug 28, 20244 minEp. 55

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]

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

Aug 26, 20244 minEp. 54

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

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

Aug 12, 20243 minEp. 52

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

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 therapy

Aug 05, 20244 minEp. 51

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]

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

Jul 29, 20244 minEp. 50

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]

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

Jul 22, 20244 minEp. 49

[Solutions Spotlight] Streamlining oral dose packaging design

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, thereby reducing the need for prolonged probe stability testing and potential reformulations or packaging redesign. To understand more about the iss...

Jul 03, 202432 minEp. 44

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]

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

Jun 18, 20244 minEp. 43

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

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 Pharmaceuticals site

Jun 10, 20244 minEp. 42

Mining pharma's reshoring rush

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 a summary of our most recent cover story, Mining pharma's reshoring rush, and discuss where the industry stands amid the U.S. movement to bring the ma...

May 29, 20244 minEp. 40

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]

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

May 13, 20244 minEp. 37

2024 election's impact on manufacturing

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 will share a discussion courtesy of our sister brand, IndustryWeek, as part of their livestream program, Production Pulse. The broadcast features ins...

Apr 12, 202433 minEp. 32

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

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 from market

Apr 08, 20244 minEp. 31

[The good, the bad, the ugly] Editor's Review week of March 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 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

Apr 01, 20244 minEp. 30

[The good, the bad, the ugly] Editor's Review week of March 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 — 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 for allegedly taking over 1,000 files to Pfizer

Mar 25, 20246 minEp. 29

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

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

Mar 18, 20244 minEp. 28

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

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

Mar 11, 20244 minEp. 27

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

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

Mar 05, 20243 minEp. 26
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