Off Script: A Pharma Manufacturing Podcast

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

[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 

[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

[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

[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

[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

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

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 settlement 

Raising a modern CDMO

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 forging the future of pharma.

During this podcast, Chief Content Director Karen Langhauser will introduce you to the four promising CDMOs we’ve chosen to profile in our March issue — ten23 health, Cellares, INCOG BioPharma Services and Matica Biotechnology.

Launching a new company into a crowded contracting space isn’t for the faint of heart — it demands expertise, ingenuity and a willingness to embrace risk. Fortunately, a new generation of CDMOs are boldly positioning themselves to become pillars of pharmaceutical progress.

[Solutions Spotlight] Meeting today’s container closure integrity requirements

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 transport requirements. 

Read the transcript: https://www.pharmamanufacturing.com/home/article/33011904/solutions-spotlight

Learn more about Lighthouse instruments: https://lighthouseinstruments.com/

[Solutions Spotlight] Ensuring quality during a syringe surge

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 solutions can help. 

Read the transcript: https://pharmamanufacturing.com/33009598

Learn more about Stevanato Group: https://www.stevanatogroup.com/en/