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 Illumina cancer biomarker test 

The bad — BioMarin reveals more layoffs 

The ugly — FDA hits API maker Global Calcium with 483 

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 chronic diseases simultaneously? 

During this podcast, Chief Content Director Karen Langhauser will share a summary of our most recent cover story, discussing the compelling new research and novel genetic medicines that may help close the gap between healthspan and lifespan.

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 

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 drug The bad — Pfizer gene therapy fails phase 3 Duchenne trial The 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 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

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 trial The bad — Takeda plans layoffs at Massachusetts sites The 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 manufacturing of generic drugs, APIs and ingredients home.

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 therapy The 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 drug The 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 — 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 — Neurocrine wins FDA nod for 'sprinkle' Ingrezza formulation  The bad — Moderna, Metagenomi end gene editing collab The 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 Lutathera The bad — BMS unveils cost-saving initiative, layoffs The 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 gonorrhea The bad — Genentech ends $3B Adaptimmune T-cell collab The 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 trial The bad — Novartis to axe 680 jobs The 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 insights from Pharma Manufacturing’s chief content director Karen Langhauser as well as from editors on Machine Design and Food Processing.

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

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 

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

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

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

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 — Iovance has launches Amtagvi The bad — FDA rejected Theratechnologies HIV instramuscular injection The 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 approval The bad — Rapt clinical hold The 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 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.

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/

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/

In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Daniel Price, director and head of excipients, solid applications at MilliporeSigma, to discuss his work driving innovation in the fields of 3d printing of oral solid dosage forms, next generation pharmaceutical manufacturing, oral delivery of novel modalities and predictive formulation, and how these innovations can help overcome today's drug formulation challenges.  

Read the transcript: https://pharmamanufacturing.com/21438233

For those in the pharmaceutical industry, the recent challenge has been in figuring out how to extend the digital capability of our everyday lives into pharma asset management. How do you bring all of a plant's activities and the data behind them into one place? Furthermore, if you could do that, what benefits would it bring to asset management? Karen Langhauser is joined by Ethan Smith, general manager of Life Sciences for Nuvolo, to get a better understanding of how pharma can bring its asset management into the digital age.

Learn more about Nuvolo: https://www.nuvolo.com/

Read the transcript: https://pharmamanufacturing.com/21436830 

Ophthalmic drug formulation and manufacturing brings with it unique challenges and regulatory requirements. To discuss methods to overcome these challenges, Pharma Manufacturing Senior Editor Andrea Corona speaks with Smita Rajput, field marketing manager at MilliporeSigma. 

Learn more about MilliporeSigma: https://www.emdmillipore.com/US/en 

Read the transcript: https://pharmamanufacturing.com/21436478 

The digitalization journey for pharmaceutical manufacturing can reap many benefits and there are many choices to be made in terms of these technologies and how to deploy them. In this episode, Andrea Corona talks about how digitalization is delivering a competitive advantage and assembly and inspection with Veronica Ghidotti and Fabio Bertacchini from Stevanato Group.

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

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/how-digitalization-can-provide-a-competitive-advantage 

Predictive maintenance can help pharma companies can capture enormous value. Digital solutions can help eliminate downtime, reduce maintenance costs and maximize productivity, ultimately unlocking the capacity that is necessary to get the highest quality product to patients who need them most. Senior editor Andrea Corona discusses this with Zach Gilulah, pharma machine health lead at Augury

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/stop-the-stall-the-time-is-now-for-predictive-maintenance-in-pharma 

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 

Endotoxin testing serves a vital function in pharma quality control by ensuring that products are safe for patients. But the traditional approach to Bacterial Endotoxins Testing (BET) is an area ripe for disruption and improvements. Now, the Sievers Eclipse BET platform by Suez offers new levels of automation, compliance and sustainability, ushering in the next generation of BET.

Learn more about Suez: https://www.suezwatertechnologies.com/ 

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-a-groundbreaking-approach-to-bet-testing

In pharma, the use of gas analysis in fermentation bioreactors is critical for monitoring the health of a culture, and measuring small changes to oxygen and carbon dioxide concentrations at key phases of the process. Whether using continuous or batch fermentation for bacterial, microbial or mammalian cell culture expression, Thermo Fischer Scientific's gas analysis mass spectrometry product range provides precise off-gas analysis through every stage of fermentation. To learn more about the Prima BT and Prima PRO models, senior editor Meagan Parrish chats with Daniel Merriman, strategic marketing manager, Thermo Fischer.

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-gas-analysis-mass-spectrometer-applications-in-fermentation-and-cell-culture-process

RNA-based vaccines have played a starring role in the ongoing COVID-19 pandemic and there is great potential for RNA to be applied to further indications. But nucleic acids are highly negatively charged and fragile and the right delivery systems are needed to protect RNA from degradation. One technology — lipid nanoparticles — has proven to enable the drug delivery of RNA-based therapeutics. Karen Langhauser and MilliporeSigma’s Dr. Estelle Beguin discuss lipid nanoparticles and the role they will play in the success of emerging therapies and vaccines.

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-special-delivery-lipid-nanoparticles-usher-in-new-treatments 

Poor ergonomics have been linked to a host of physical problems and can have an impact on workplace efficiency. Improving posture and physical habits has been linked to increased worker productivity and reduced errors. A reduction in injuries also saves money for companies, and helps businesses retain healthier and happier employees. However, many companies might overlook this aspect of workplace safety and this is where artificial intelligence can come to the rescue. Meagan Parrish and Blake McGowan, Director of Ergonomics Research for VelocityEHS, discuss.

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-harnessing-ai-to-improve-workplace-ergonomics 

Many inside and outside of the pharma industry think so. Now, one group is putting pressure on the FDA and Congress to move pharma away from animal modeling in drug development.

Learn more about the White Coast Waste Project: https://www.whitecoatwaste.org/

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/is-it-time-to-call-the-dogs-off-drug-testing

When doctors administer treatments to patients, some amount of drug is often left behind in the vial. What happens next? It gets tossed. Now, Congress is taking a closer look at this issue and considering new policies aimed at reducing this kind of medical waste.

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/drugs-down-the-drain 

The importance of quality in pharma manufacturing can't be overstated. Fortunately, the industry has stepped up drug quality. While much of this can be attributed to better science and clearer guidance, technology improvements — like the application of AI to visual inspection equipment — have potential. Chief content director Karen Langhauser and Giacomo Girotto, vision inspection project manager for Stevanato Group discuss.

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

Read the full transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solution-spotlight-elevating-quality-inspection-with-ai 

If Biogen’s controversial aducanumab is approved, it could become the best-selling drug of all time — and it’s a drug that has only shown modest efficacy. Here’s more on why the Alzheimer’s pipeline is primed for such a remarkable situation.

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/inside-the-fdas-fateful-alzheimers-decision 

The complex development and manufacturing processes needed to bring biologic drugs to market almost always translates into exorbitant prices, even after the drugs go off patent. Consequently, many areas of the world simply do not have access to the accepted standard of care. Chief content director Karen Langhauser sat down with the founders of Phylloceuticals to discuss how they plan to change this.

Learn more about Phylloceuticals at http://phylloceuticals.com.

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/growing-the-biologic-drug-supply/

What has allowed the government to — for once — move at the speed of industry to help curb the pandemic? And will the FDA be able to maintain this pace once the pandemic winds down?

We caught up a long-time regulatory expert to find out.

Read the transcript.

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 

Pharma stepped up to the plate this year to deliver vaccines in record time and desperately needed therapeutics. Will these historic achievements change the industry's reputation in the eyes of the public? Chief Content Director, Karen Langhauser, and Senior Editor, Meagan Parrish, take a look back at pharma's accomplishments — and stumbles — during the pandemic.

Read the transcript .

Audio clips used:

CNBC: "How pharmaceutical companies are responding to the coronavirus outbreak"

CNA: "Pharmaceutical companies scramble to produce coronavirus vaccine"

CNBC: "The Race To Develop A Coronavirus Vaccine"

CBS News: "Trump to meet with pharmaceutical CEOs amid growing coronavirus outbreak"

CNBC: "Trump meets with big pharma to tackle coronavirus"

CBNC: "Moderna CEO Stephane Bancel on executive stock sales"

The threat of superbugs hasn’t gone away and in many ways the pandemic has made this problem loom even larger. But a new organization called the AMR Action Fund is working to infuse needed dollars and resources into the dwindling pipeline for needed antibiotics.

Read the full transcript

As several late-stage trials edge towards the finish line, skepticism surrounding vaccines continues to spread at a rate faster than the coronavirus itself — and drugmakers and health officials are scrambling to restore public trust. Pharma Manufacturing editors Karen Langhauser and Meagan Parrish discuss.

Read the transcript here: https://bit.ly/34PEeb6

Chief Content Director Karen Langhauser is joined by Richard Wood, Executive Director of Technical Solutions at Softbox Systems.

Read the full transcript: https://bit.ly/2JaQOsQ Learn more: https://bit.ly/2G8oWo3