Off Script: A Pharma Manufacturing Podcast

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 

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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