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The post Safety Stands Out in Arcellx Cell Therapys ASH Data, But Dont Overlook Manufacturing Advantages appeared first on MedCity News. Arcellx is developing its CAR T-treatment under a partnership with Gilead Sciences.
Separately, the pharma giant said all regulatory conditions have been met for Novo Holdings acquisition of Catalent, which will bring to Novo Nordisk three manufacturing sites for GLP-1 medications. The post Novo Nordisk Adds to Manufacturing Capacity, Pumping Billions Into New Rare Disease Site appeared first on MedCity News.
From the executive boardrooms of pharma companies to academic research centers, one fact is becoming unmistakably clear: making radiopharmaceuticals is an inherently complex, high-stakes endeavor, and the industry is racing to manage the risks of these perishable therapies before the clock runs out The post Radiopharmaceutical Manufacturing: A High-Stakes (..)
Shortly after a similarly sized venture from Pfizer, French pharma juggernaut Sanofi has unveiled a major manufacturing outlay in China, marking its biggest investment in the country to date. The new manufacturing site, which will become Sanofi’s fourth in China, is being designed to beef up local end-to-end insulin production.
A dedicated Case Manager provides end-to-end supply chain management and 24/7 oversight and support to help ensure the seamless manufacturing and distribution of each therapy dose to every patient.
s Chancellor of the Exchequer, Rachel Reeves, the country is debuting a new capital grants vehicle known as the Life Sciences Innovative Manufacturing Fund. The fund will dispense up to 520 million pounds sterling (about $675 million) in capital grants that will be used for investments in manufacturing for drugs and medical technologies.
Amid a multi-year, multibillion-dollar spending spree to scale its global manufacturing capacity, Novo Nordisk is laying down fresh foundations at its old stomping grounds in Denmark to bolster a c | Novo will invest 2.9
Lilly Medicine Foundry will research new ways to manufacture medicines. Eli Lilly says in addition to supporting the manufacturing of drugs for clinical trials, manufacturing innovations from the site will be transferred to the company’s other facilities for use in full-scale drug production. The post Eli Lilly Plans $4.5B
When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial.
The Singapore manufacturing site will be AstraZeneca’s first facility capable of handling all steps of antibody drug conjugate production. Manufacturing Site for Global Production of ADC Cancer Drugs appeared first on MedCity News. AstraZeneca aims to open the facility in 2029. The post AstraZeneca Plans $1.5B
Cell therapy offers a treatment option for some advanced blood cancers, but the manufacturing process is lengthy and complex. The biopharmaceutical industry is working on various technologies that could make manufacturing faster and more efficient, or perhaps supplant the current process altogether.
By doing this, CybergenX is seeking to accelerate the potential of engineering biology in drug manufacturing. The post This Chip Seeks to Transform Drug Manufacturing by Learning More About Intracellular Dynamics appeared first on MedCity News.
The post Medical Device Recycling Programs Are Manufacturer Money-Grabs Disguised as Sustainability Initiatives appeared first on MedCity News. Hospitals would be much better served by focusing on reuse and reprocessing programs. So why isn’t that happening and what can be done about it?
With the right data available, BioPharma companies can best implement advanced analytics tools for timely interventions in manufacturing deficiencies and optimize processes. The post Ensuring Data Integrity in BioPharmaceutical Manufacturing: The Need for Contextualization and Cloud-based Integration appeared first on MedCity News.
The German manufacturing site is the latest capital infrastructure move for Eli Lilly, which has already made $11 billion in investments in its global manufacturing capabilities in the past three years. The new site will help Lilly meet strong demand for its diabetes and obesity drugs.
Halozyme views its drug delivery technology for biologic medicines as complementary to Evotec’s biologic drug manufacturing capabilities. But according to Halozyme, Evotec was unwilling to engage in any merger discussions. The post Halozyme Pulls €2B Acquisition Bid as Evotec Commits to Standalone Strategy appeared first on MedCity News.
Filters and membranes from this business segment are used globally in applications such as biopharmaceutical manufacturing. Thermo Fisher Scientific agreed to acquire the Purification and Filtration business of 3M spinoff Solventum.
It had a plan to become a COVID vaccine powerhouse, with enough manufacturing capacity to supply the U.S. | As Novavax presented its quarterly earnings, finance chief Jim Kelly said the company was “actively exploring” the sale of its manufacturing facility in the Czech Republic.
The drug was rejected earlier this year thanks to observations raised during the agency's inspection of a third-party manufacturing facility. . | Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.2
After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production plant, the parties have been engaged in settlem | After a former human resources officer blew the whistle on alleged manufacturing shortfalls at Eli Lilly’s massive Branchburg, New Jersey, production (..)
Aspen Neuroscience, underway with Parkinson's cell therapy trial, bolsters manufacturing with new San Diego facility fkansteiner Wed, 10/02/2024 - 07:31
Creating adequate capacity for any therapeutic can be challenging, and the specialized technologies for manufacturing complex biologics require flexibility and agility in production processes. The post Evolving Capacity to Meet Advanced Biologics Therapies appeared first on MedCity News.
. | Amgen is growing its decade-old collaboration with Amazon Web Services—a widely used cloud platform—to create generative artificial intelligence that the companies aim to use to increase the manufacturing throughput of pharmaceuticals.
The days of booming COVID-19 vaccine sales, which sent Moderna into the ranks of pharma's top companies, have | The company is focusing on scaling back its manufacturing efforts to cope with the lack of COVID-19 vaccine demand.
From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. Earlier this month, Granules was slapped with a Form 483 following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept.
Moderna is laying off employees within its manufacturing unit, with the move tied to a resizing of its COVID production work. | Moderna is laying off some employees within its manufacturing unit after shaving COVID production costs. The company previously disclosed plans to rightsize its COVID vaccine production footprint.
Texas has accused Pfizer and manufacturer Tris Pharma of knowingly providing compromised ADHD medicine to a state Medicaid program for children of low-income families. | In its lawsuit, Texas says the companies knew that deficient manufacturing processes compromised the effectiveness of Quillivant XR.
Pfizer announced Tuesday that it has invested 150 million Australian dollars (about $98 million) to build a new manufacturing facility at its Australian site in Melbourne, where the company will help produce new antimicrobial treatments aimed at addressing the rising tide of antimicrobial resistance.
Demand fluctuations have spurred Thermo Fisher Scientific to downsize at the plasmid DNA manufacturing facility the company opened a little less than three years ago, putting jobs on the chopping b | Demand fluctuations have spurred Thermo Fisher Scientific to downsize at the plasmid DNA manufacturing facility the company opened a little less than (..)
As Galderma attempts to round out its injectable aesthetics portfolio with approvals to resolve crow’s feet and frown lines, the FDA spotted a few manufacturing wrinkles in its RelabotulinumtoxinA | The agency spotted issues relating to chemistry, manufacturing and controls (CMC) processes in the company's application for its liquid botulinum (..)
When it comes to manufacturing cell therapies, it's often said that the "process is the product." The company says it's working to address the situation.
Eli Lilly’s beleaguered manufacturing site in Branchburg, New Jersey, is back in the U.S. The observations run the gamut from problems in tracking manufacturing processes and quality controls to equipment calibration lapses and poor facility maintenance. Food and Drug Administration’s crosshairs, Reuters first reported.
Right now, manufacturers are thriving. Hospitals are failing. And patients are suffering. We must stop this trend in its tracks by becoming better stewards of hospital resources and supply chains.
Awaiting a potential acquisition by Novo Holdings, Catalent is giving its contract manufacturing compatriot a boost as Ardena plots its U.S. Catalent is selling its oral solids facility in Somerset, New Jersey, to Belgium’s Ardena for an undisclosed sum. The site also doubles as Catalent's current corporate headquarters.
Drug manufacturers can’t wave a magic wand and streamline government drug discount programs. Nonetheless, there are actions manufacturers can take to mitigate the impact of noncompliant rebates
Greater collaboration among healthcare providers, medical device manufacturers, and lawmakers and regulators will lead to predictability and consistency in cybersecurity management. Together, we can make even greater strides toward patient safety and a more secure and sustainable healthcare system.
The war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patent | Novo Nordisk has asked the FDA to prevent compounders from manufacturing copycat versions of its juggernaut diabetes and obesity treatments Ozempic and (..)
History is coming full circle as induced pluripotent stem (iPS) cell-derived cell therapy maker Shinobi Therapeutics links up with Panasonic and Japan’s Kyoto University, where the first mouse iPS | Shinobi Therapeutics has entered an accord with electronics powerhouse Panasonic and Kyoto University in a bid to develop a new closed-system manufacturing (..)
A challenging year for the biotech industry has taken a heavy toll on Chinese manufacturer WuXi Biologics, sending the company’s stock plummeting nearly 24% Monday. WuXi Biologics expects to miss its original sales target for the year by around $400 million, thanks to reductions across its development and manufacturing services.
Already with a manufacturing site in Chiba, Japan, AGC Biologics is doubling down on its presence in the country with a new facility in Yokohama. Already with a manufacturing site in Chiba, Japan, AGC Biologics is doubling down on its presence in the country with a new facility in Yokohama.
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