Manufacturing: Page 12
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Permission granted by Gilead Sciences
Gilead working to quickly boost production of experimental coronavirus drug
CEO Daniel O'Day said Gilead would provide at no charge its current supply of remdesivir, enough to treat some 140,000 patients with severe COVID-19.
By Ned Pagliarulo • April 6, 2020 -
"200323-Z-IB607-0016" by New Jersey National Guard is licensed under CC BY-ND 2.0
DOJ allows medical suppliers to collaborate on manufacturing and distribution
Five major medial suppliers wrote to the agency seeking a reprieve from antitrust enforcement in the context of the COVID-19 pandemic.
By Emma Cosgrove • April 6, 2020 -
Emergent to produce Novavax's flu vaccine under CDMO deal
Recent late-stage results showed Novavax's candidate the equal of Sanofi's Fluzone, setting the stage for the Maryland drugmaker to file for FDA approval.
By Kristin Jensen • April 2, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
J&J picks top coronavirus vaccine candidate; human tests to start in September
Together with BARDA, the pharma has agreed to spend $1 billion co-funding vaccine research, development and testing.
By Jacob Bell • March 30, 2020 -
China halts import of Bristol Myers cancer drug after inspection at US plant
Chinese drugmaker Beigene, which sells Bristol Myers' Abraxane in China, said it's bracing for a disruption in supply of the chemotherapy.
By Kristin Jensen • March 25, 2020 -
Drugmakers boost production of malaria pill touted by Trump as coronavirus treatment
Chloroquine, a decades-old generic therapy, has drawn attention as a potential therapy for COVID-19, although the evidence supporting its promise is thin.
By Ned Pagliarulo • Updated March 20, 2020 -
US automakers study medical manufacturing as coronavirus squeezes capacity
Switching to produce medical equipment will require new supply lines running to manufacturing facilities that are capable of delivering needed components.
By Matt Leonard • March 19, 2020 -
Courtesy of Centers for Disease Control and Prevention
How an 'overwhelmed' Buffalo lab facing coronavirus supply shortage signals nationwide struggles
Labs like the one in western New York face insufficient stocks of swabs and reagents as they attempt to gauge the outbreak's spread.
By Greg Slabodkin • March 18, 2020 -
Regeneron expects its antibody cocktail for coronavirus to enter human testing in early summer
The biotech is prepping manufacturing facilities so that, once the top antibody contenders are selected, clinical production can quickly begin. By the end of the summer, the aim is to make hundreds of thousands of doses per month.
By Jacob Bell • March 17, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49565158908/in/album-72157713108522106/.
Vir, signaling its commitment, taps Biogen to make coronavirus treatment
For smaller biotechs like Vir, manufacturing is a likely roadblock to advancing any promising drug candidate that might emerge from initial testing.
By Kristin Jensen • March 12, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Coronavirus spread prompts FDA to postpone nearly all overseas inspections
The agency's decision was based on U.S. government travel restrictions, but it said "alternative tools and methods" will help it maintain oversight.
By Jonathan Gardner • March 10, 2020 -
Hospitals dipping into emergency stocks to combat coronavirus
Community spread of COVID-19 has hospitals bracing for a rush of patients and payers waiving fees for telemedicine consults and extra drug supplies.
By Shannon Muchmore • March 10, 2020 -
After waffling, Qiagen agrees to $11.5B buyout by Thermo Fisher
The instruments maker will pay a 23% premium to take out Qiagen, adding to the diagnostics side of its business after investments in its contract drug offerings.
By Maria Rachal • March 3, 2020 -
FDA reports first drug shortage due to coronavirus impact
Supplies of the drug, which the FDA did not identify, ran short as a result of issues at a site that produces the active ingredient. Other options are available, the agency said.
By Ned Pagliarulo • Updated March 2, 2020 -
As shortages draw spotlight, Sanofi to spin out drug ingredient business
The new company will launch with significant size, employing 3,100 and drawing from a network of six factories across Europe.
By Ned Pagliarulo • Feb. 24, 2020 -
With supply tight, Novartis readies gene therapy plant for production
Bringing the facility in Durham, North Carolina, online is a critical step for the Swiss pharma's plans to expand the market for Zolgensma, its gene therapy for spinal muscular atrophy.
By Ned Pagliarulo • Feb. 21, 2020 -
WuXi Vaccines inks $3B manufacturing deal with 'global vaccine leader'
Set to last 20 years, the contract between Wuxi and an unidentified vaccine maker calls for the Chinese CDMO to build a dedicated production plant.
By Kristin Jensen • Updated Feb. 21, 2020 -
Audentes to spend $110M on new gene therapy plant in North Carolina
The biotech, which was bought last year by Astellas, joins Pfizer, Bluebird bio and AveXis in choosing to locate gene therapy manufacturing in the state.
By Ned Pagliarulo • Feb. 18, 2020 -
Jacob Bell/BioPharma Dive
FDA monitoring impact of coronavirus outbreak on medical product supply
The agency postponed drug and device inspections in China that were scheduled for February, limiting its oversight of a key country in the medical supply chain.
By Nick Paul Taylor • Feb. 18, 2020 -
In turnaround bid, Teva tries to wring more savings out of manufacturing
The generic maker's push to reduce manufacturing costs follows a restructuring that's saved $3 billion but resulted in layoffs for thousands of employees.
By Kristin Jensen • Feb. 13, 2020 -
Lonza resuming production as coronavirus spread threatens manufacturers
The Swiss contractor briefly extended holiday plant closures in China in response to the outbreak, which has also disrupted Airbus and Hyundai.
By Kristin Jensen • Feb. 6, 2020 -
Catalent, expecting a boom in cell therapy, bids for Masthercell
With biologics driving growth, the contract manufacturer is looking to diversify with a $315 million purchase that hands it a slate of production sites.
By Jacob Bell • Feb. 3, 2020 -
Amgen, Pfizer biosimilar sales pressure top drugs
Competition is heating up for copycats to Roche's top-selling cancer drugs, as the U.S. biosimilar market shows some modest signs of shifting.
By Jonathan Gardner • Jan. 31, 2020 -
German Merck continues manufacturing buildout with $275M investment
The money will go toward a 15,700-square-meter facility, to be called the Biotech Development Center, that's set to be fully operational by 2022.
By Jacob Bell • Jan. 30, 2020 -
AstraZeneca pledges to go 'carbon negative' by 2030
Matching a recent commitment from Microsoft, AstraZeneca says it's stepping up its climate efforts. Recent numbers show the pharma has a ways to go.
By Ned Pagliarulo • Jan. 23, 2020
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