Manufacturing
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Obesity drugsZepbound, Mounjaro shortages are resolved, FDA confirms
The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.
By Ned Pagliarulo • Dec. 19, 2024 -
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Novo Holdings’ purchase of Catalent set to close after regulators’ green light
The $16.5 billion take-private deal can now be completed, along with Novo Nordisk’s related acquisition of three Catalent drug manufacturing plants.
By Ned Pagliarulo • Dec. 16, 2024 -
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Lilly adds to obesity drug production push with $3B investment
The expansion of a newly acquired facility in Wisconsin is Lilly’s largest U.S. manufacturing investment outside of Indiana and will help make more injectable drugs like fast-selling Zepbound.
By Jonathan Gardner • Dec. 6, 2024 -
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What might a Trump administration mean for the Biosecure Act?
Analysts see Trump’s victory raising the high-profile legislation’s chances of becoming law. But the realities of a lame duck Congress may cause its timeline for passage to slip back.
By Amy Baxter • Nov. 20, 2024 -
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Obesity drugsNovo sees Wegovy sales rise as supply constraints ease
Third quarter sales of Novo’s in-demand obesity drug totaled $2.5 billion, roughly 81% higher than the same period in 2023 and nearly doubling the total for Lilly’s Zepbound.
By Jonathan Gardner • Nov. 6, 2024 -
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Obesity drugsNovo takes big step toward ending Ozempic, Wegovy shortages
All doses of the two drugs are now listed as available in the U.S., per an FDA database, although the company cautioned patients may still experience "variability" filling their prescriptions.
By Ned Pagliarulo • Updated Oct. 30, 2024 -
Permission granted by MilliporeSigma
Sponsored by MilliporeSigmaAn effective analytical testing strategy for viral vectors should include these 7 steps
Producing safe, effective, high-quality viral vector therapeutics depends on a robust and tailored analytical testing strategy.
Oct. 7, 2024 -
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FDA makes end of Zepbound, Mounjaro shortage official
Removal of Lilly’s in-demand drugs from the FDA’s shortage list ramps up pressure on the companies selling compounded counterparts.
By Kristin Jensen • Oct. 3, 2024 -
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Lilly plans $4.5B ‘foundry’ for advanced drug manufacturing
With its latest investment, Lilly is looking toward medicines of the future and new methods to produce them.
By Kristin Jensen • Oct. 2, 2024 -
Permission granted by AstraZeneca
Sanofi readies to meet US demand for RSV antibody
With a new production line, Sanofi aims to keep it and partner AstraZeneca’s drug Beyfortus in full supply this RSV season.
By Delilah Alvarado • Sept. 16, 2024 -
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As Biosecure bill advances, drugmakers prepare for prospect of China pivot
While companies’ exposure to the Biosecure Act varies, drugmakers are bracing for the knock-on effects that its passage could create in the market for contract services.
By Amy Baxter • Sept. 16, 2024 -
Permission granted by Novartis
Novartis builds out radiopharma production with expansion, new factory
A planned facility in California will boost Novartis’ West Coast supply chain as new uses for the company’s radioligand therapies grow.
By Kristin Jensen • Sept. 4, 2024 -
Regeneron confirms FDA won’t approve myeloma drug over manufacturing issues
Company executives had warned investors that a delay was likely due to issues at a facility run by a third-party manufacturer.
By Kristin Jensen • Aug. 21, 2024 -
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Novo plans new plant as it races to meet drug demand
The new factory, which Novo is committing some $220 million to build, will supply raw materials for the company’s chronic disease medicines.
By Ned Pagliarulo • Aug. 19, 2024 -
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Evotec, citing research spending slowdown, cuts jobs and exits gene therapy
New CEO Christian Wojczewski announced layoffs that will affect about 7% of the company’s workforce.
By Kristin Jensen • Aug. 14, 2024 -
jetcityimage via Getty Images
Zepbound, Mounjaro back in supply as Lilly resolves shortage
All doses of the in-demand GLP-1 medicines are now available in the U.S., Lilly said ahead of reporting second quarter earnings later this week.
By Ned Pagliarulo • Aug. 5, 2024 -
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Novo to spend $4B on US plant, adding to obesity drug production push
The planned facility in North Carolina is Novo’s latest multibillion-dollar investment in the manufacturing of weight loss drugs, demand for which continues to outstrip supply.
By Jonathan Gardner • June 25, 2024 -
Permission granted by MilliporeSigma
Sponsored by MilliporeSigmaBalancing phase-appropriate needs with commercial readiness in viral vector manufacturing
The MilliporeSigma viral vector team has unlocked unique insights and workflows that can guide innovators through steps they might not even realize they needed to take.
June 10, 2024 -
Scott Olson via Getty Images
Lilly to pour $5B more into expanding Zepbound, Mounjaro production
The planned spending on new facilities in Lebanon, Indiana, brings its total commitment to the site to $9 billion, the largest single manufactuing investment in company history.
By Ned Pagliarulo • May 24, 2024 -
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As drug shortages reach record highs, regulators weigh next steps
With many chemotherapy and ADHD drugs stuck in stubbornly short supply, several agencies are looking for new solutions.
By Kelly Bilodeau • May 6, 2024 -
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Lilly counts on manufacturing scale-up to unstick obesity drug supply
Increasing the production capacity for Zepbound and Mounjaro is “the most ambitious expansion plan in our company’s history,” said CEO David Ricks.
By Jonathan Gardner • April 30, 2024 -
Permission granted by Asymchem
Sponsored by AsymchemSustainability in pharmaceutical manufacturing: a CDMO’s contribution
Consideration of sustainability early in process development, throughout the entire development cycle, and across the entire supply chain must also become common practice.
By Mark McLaws, Ph.D. – Vice President CMC & Development, Asymchem • April 29, 2024 -
Scott Olson via Getty Images
Lilly to buy injectable drug plant in manufacturing ramp-up
The acquisition of a Nexus Pharmaceuticals facility in Wisconsin could help Lilly better meet demand for injectable medicines, like those it makes for diabetes and obesity.
By Delilah Alvarado • April 22, 2024 -
Meletios Verras via Getty Images
Bristol Myers taps startup to boost cell therapy production
A partnership with Cellares, worth up to $380 million, is meant to help Bristol Myers speed and scale manufacture of CAR-T treatments for cancer.
By Ned Pagliarulo • April 22, 2024 -
Permission granted by PHC Corporation of North America
Sponsored by PHC Corporation of North America (PHCNA)Keeping cleanrooms clean: Choosing the right laboratory equipment is key
Because live cell and tissue products are sensitive to contamination from microorganisms, viral particles or other impurities, research and manufacturing involving these materials needs to be conducted in a cleanroom environment.
April 15, 2024
