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...

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 

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 drugThe bad — Pfizer gene therapy fails phase 3 Duchenne trialThe ugly — Talc plaintiffs seek restraining order on J&J bankruptcy tactic

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 trialThe bad — BMS to let go of 863 employees at NJ site The ugly — FDA inspection uncovers multiple violations at Jiangsu Hengrui Pharmaceuticals site

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 trialThe bad — Takeda plans layoffs at Massachusetts sitesThe ugly —  FDA delays review of Sanofi-Regeneron's Dupixent in COPD

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...

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 first interchangeable biosims to Regeneron Eylea The bad — Evotec exits gene therapyThe ugly —  J&J reports deaths in early-stage radioligand trial

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 Amgen T-cell engager for small cell lung cancer The bad — BioMarin announces 170 layoffs The ugly — FDA delays review of Ascendis hypoparathyroidism 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 —  Vertex submits NDA for CF drugThe bad — MacroGenics reports patient deaths in prostate cancer ADC trial The ugly — FTC extends review of Novo-Catalent deal

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 — Neurocrine wins FDA nod for 'sprinkle' Ingrezza formulation The bad — Moderna, Metagenomi end gene editing collabThe ugly — Emergent announces layoffs, closes sites 

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 wins rare cancer pediatric indication for LutatheraThe bad — BMS unveils cost-saving initiative, layoffsThe ugly — McKinsey under fire for alleged role in opioid crisis  

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 — GSK antibiotic hits phase 3 goals in gonorrheaThe bad — Genentech ends $3B Adaptimmune T-cell collabThe ugly — Par Pharmaceutical recalls Treprostinil injection for potential contamination

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 — BMS schizophrenia drug shines in phase 3 trialThe bad — Novartis to axe 680 jobsThe ugly — Lilly compounding suit dismissed

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...

Editor's Review: Week of April 1Join 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 antibioticThe bad — Verve Therapeutics halts gene editing trial, againThe ugly — Amylyx removes ALS treatment from market

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 drugThe bad — Bristol Myers Squibb's Crohn's disease drug disappoints The ugly — FDA rejects Regeneron Pharmaceuticals lymphoma treatment 

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 diseaseThe 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

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 NASHThe bad — Acadia abandons plans to expand pimavanserin indications The ugly — BIO backs BIOSECURE Act, boots WuXi

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 pricesThe bad — Amylyx ALS drug falls short in phase 3 trialThe ugly — FDA delays Eli Lilly Alzheimer's drug decision with last-minute AdComm

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 AmtagviThe bad — FDA rejected Theratechnologies HIV instramuscular injectionThe ugly — BioMarin receives a subpoena from the DOJ

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 approvalThe bad — Rapt clinical holdThe ugly — Novavax and Gavi settlement 

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...

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...