Off Script: A Pharma Manufacturing Podcast

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 

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 

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 

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 

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 

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 

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 PBMs 

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 partnership 

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 issues at hand, senior editor Andrea Corona recently spoke with Adrian Possumato, president and Chris Gilmor, director of sales, at Sanner of America.

Learn more about Sanner of America: https://www.sanner-group.com/

 

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