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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.
Flush with new business, Philadelphia-based CDMO PCI Pharma Services is blueprinting multiple manufacturing outlays on both sides of the Atlantic. | Altogether, PCI’s manufacturing projects represent an investment of more than $365 million.
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.
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.
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.
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.
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
The adoption of technology and data by biopharma is driving a digital transformation in manufacturing, accelerating the process of bringing molecules from benchside to bedside. I am the Strategic Business Unit Head and Global Head of Mergers and Acquisitions for Life Sciences at Cognizant. |
. | 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.
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.
After inking and expanding a biosimilar production partnership with Pfizer this summer, Korea’s Samsung Biologics is boosting yet another Big Pharmamanufacturing agreement. The partners have already been working together on antibody manufacturing and have expanded their relationship over time.
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.
Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control. Let’s also remember that pharma is going to make a LOT of money on these vaccines. The post How did pharma develop a vaccine so quickly?
Royalty Pharma, a company known for ponying up chunks of cash in exchange for long-term drug royalties, has hopped on board with Ascendis Pharma's long-acting growth hormone Skytrofa. Ascendis hopes to bring its second TransCon product to the market and overcome manufacturing issues.
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.
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.
No large pharma company has traversed this decade's ups and downs quite like Pfizer. | No large pharma company has traversed this decade's ups and downs quite like Pfizer. As the company rolls ahead with a large restructuring campaign, some staffers in Ireland will soon feel the effects.
Sanofi is jumping on the artificial intelligence boat with a new app and a pledge to become “the first pharma company powered by artificial intelligence at scale.” | Sanofi's new app, plai, provides teams with a “360° view" to aid decision-making.
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.
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.
Eton Pharmaceuticals’ dehydrated alcohol injection didn’t pass muster with the FDA, instead receiving a complete response letter (CRL) raising flags the company believes are “addressable.” | The dehydrated alcohol injection was turned down due to problems with its chemistry manufacturing and controls, issues which the company believes are addressable, (..)
Three large pharma companies plan to expand their manufacturing footprints. Three large pharma companies plan to expand their manufacturing footprints. Kyowa Kirin’s $4.25 million gene therapy set a new world pricing record. Kyowa Kirin’s $4.25 million gene therapy set a new world pricing record.
After Takeda’s unsuccessful attempt to sell an Austrian manufacturing and development site, the Japan-based company is calling it quits on much of the operations at the facility.
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.
After a manufacturing-related complete response letter held up the U.S. | UCB had previously expected an FDA decision during the first half of the year after suffering a prior rejection on its medicine. But now the company warned a decision will likely be delayed past the third quarter.
Kyowa Kirin is planning “a significant reduction” in its small molecule drug discovery research activities and will trim certain manufacturing roles. Like many other biopharma companies, Kyowa Kirin is in restructuring mode. The company is also divesting its Chinese operations as part of a larger restructuring in the Asia-Pacific region.
Though gene therapy manufacturing specialist Ascend Advanced Therapies just launched a little more than a year ago, the CDMO is already on the hunt to expand. Ascend, which bills itself as a “total solutions gene therapy development partner,” has picked up the manufacturing team and site of Beacon Therapeutics in Alachua, Florida.
Efforts from regulators and manufacturers have brought the U.S. While there's certainly more work to do, the U.S. supply of cisplatin back to nearly 100% of pre-shortage levels, according to the White House. The moves are “greatly alleviating the shortages of carboplatin,” too, the White House said.
UCB has been “eagerly awaiting” an FDA approval for its psoriasis therapy Bimzelx (bimekizumab) after manufacturing problems resulted in a rejection last May. The FDA rejected the drug last May after conducting an inspection at UCB's Belgian manufacturing plant. Now, the wait is over. |
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
. | Roche may not receive the FDA's decision on a subcutaneous version of its cancer immunotherapy Tecentriq on time thanks to the agency's requirement for changes to the drug's manufacturing process.
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