Off Script: A Pharma Manufacturing Podcast

By Pharma ManufacturingNews Business News

Off Script: A Pharma Manufacturing Podcast episodes

April 08, 2024 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
4 min
April 01, 2024 [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
4 min
March 25, 2024 [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
6 min
March 18, 2024 [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
4 min
March 11, 2024 [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
5 min
March 05, 2024 [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
4 min
March 01, 2024 [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
4 min
February 27, 2024 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.
9 min
September 21, 2023 [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/
17 min
August 09, 2023 [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/
14 min

About Off Script: A Pharma Manufacturing Podcast

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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…