Claim OwnershipOff 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 coverage, which follows the industry’s biggest issues surrounding scale-up, technology innovations, regulations and more.
90 Episodes
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Large biopharma companies in recent months have pledged billions of dollars in capital expenditures for U.S. manufacturing and R&D facilities. What if it’s not accurate?
Greg Slabodkin
Read by Brittany Duncan
https://www.pharmamanufacturing.com/editors-review/article/55314470/editors-review-it-matters-if-big-pharma-is-fudging-its-us-investment-numbers
The wildly popular drugs, prescribed for weight loss and type 2 diabetes, are putting a strain on the capabilities of contract development and manufacturing organizations.
Greg Slabodkin
Read by Brittany Duncan
https://www.pharmamanufacturing.com/sector/contract-manufacturing/article/55314756/can-cdmos-keep-up-with-the-increasing-demand-for-glp-1-medications
While the agency’s PreCheck regulatory framework is a good first step, it remains to be seen whether the program boosts U.S. drug manufacturing, says former FDA official.
Greg Slabodkin
Read by Brittany Duncan
https://www.pharmamanufacturing.com/all-articles/article/55309136/fdas-program-to-speed-up-us-manufacturing-buildouts-is-short-on-detail
The Garden State, called the “medicine chest” to the world, continues to show robust activity with life sciences firms accounting for nearly 30% of all Q2 leasing activity.
Greg Slabodkin
Read by Brittany Duncan
https://www.pharmamanufacturing.com/all-articles/article/55308250/new-jersey-remains-hot-life-sciences-hub-despite-macroeconomic-funding-headwinds
Generics, which make up approximately 90% of prescription volume in the U.S., are produced primarily in India as Hikma looks to onshore production of these critical drugs.
Greg Slabodkin
Read by Brittany Duncan
https://www.pharmamanufacturing.com/all-articles/article/55302441/hikmas-planned-1b-us-investment-comes-at-critical-time-for-generic-medicines-supply
While macroeconomic uncertainty weighs on the sector, there are glimmers of hope in some areas of pharmaceutical outsourcing and services.
Greg Slabodkin
Read by Brittany Duncan
Read Article Here: https://www.pharmamanufacturing.com/editors-review/article/55299879/editors-review-is-the-biopharma-industrys-glass-half-empty-or-half-full
Smart manufacturing is “nearly universal” with 95% of manufacturers saying they are using or evaluating smart technology, according to a new survey from Rockwell Automation.
Greg Slabodkin
Read by Brittany Duncan
While the pharmaceutical industry has been slow to adopt continuous manufacturing, it appears to be gaining momentum.
Greg Slabodkin
Read by Brittany Duncan
Enjoy the article Here: https://www.pharmamanufacturing.com/all-articles/article/55295669/flow-state-the-evolving-shape-of-continuous-manufacturing
Hydrogenation can serve as a critical link in chemical synthesis, particularly between nitration and phosgenation. When integrated strategically, it helps enable safer, more efficient production processes.
To better understand this connection, we spoke with Dr. Luca Mantilli, R&D Chemist at Valsynthese, the fine chemicals division of Société Suisse des Explosifs Holding (SSE). Dr. Mantilli discussed how hydrogenation was implemented to bridge the gap between two of the company’s core hazardous chemistries: nitration and phosgenation.
Learn more about Valsynthese: https://www.valsynthese.ch/
The three Big Pharma companies on their earnings calls this week tried to reassure investors that they have the global footprints to mitigate the effects of tariffs.
The good — Thermo Fisher opens center to boost cell therapy development
The bad — FDA cites Aurobindo plant after Raleigh inspection
The ugly — Trump probes pharma imports as tariff threat looms
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 to invest $23B in U.S. manufacturing and R&D, including seven new sites
The bad — U.S. urged to invest $15B to counter China’s biotech rise
The ugly — Trump signals ‘major’ tariffs on pharma, urging manufacturing shift back to U.S.
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 — Cellares, Cabaletta validate automated CAR T production
The bad — FDA warns Aspen over sterility issues
The ugly — FDA rejects Hengrui, Elevar cancer combo 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 — Axplora expands its antibody-drug conjugate (ADC) manufacturing capacity to support growing demand.
The bad — Merck KGaA’s CDMO business reports a decline
The ugly — The FDA issues a warning letter to Granules India over manufacturing violations
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 — Eli Lilly expands manufacturing to boost supply
The bad — FDA blocks imports from two Indian API makers over manufacturing violations
The ugly — ICU Medical recalls potassium chloride injection bags over labeling error
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 boosts Slovenia investment to $3.6B
The bad — Trump tariffs unsettle biopharma FDI
The ugly — FDA warns Global Calcium, blocks US imports
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 Opdivo subcutaneous version
The bad — Marinus Pharmaceuticals sells operations
The ugly — Novo Nordisk pushes back against compounding pharmacies
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 — EU approves Novo-Catalent acquisition
The bad — CDMO National Resilience announces layoffs
The ugly — FDA investigates blood cancer reports in gene therapy patients
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 Imkeldi oral solution
The bad — Alector axes workforce
The ugly — Novartis announcnes layoffs
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 Regenxbio accelerated approval pathway for Duchenne gene therapy
The bad — Neurogene reports patient death in Rett syndrome gene therapy trial
The ugly — Halozyme withdraws acquisition proposal for Evotec
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