Fierce Pharma

SEPTEMBER 18, 2023

After inking and expanding a biosimilar production partnership with Pfizer this summer, Korea’s Samsung Biologics is boosting yet another Big Pharma manufacturing agreement. The partners have already been working together on antibody manufacturing and have expanded their relationship over time.

Manufacturing 286

Manufacturing Pharma 286

Fierce Pharma

APRIL 3, 2024

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 (..)

Manufacturing 263

Manufacturing 263

Fierce Pharma

APRIL 18, 2024

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 (..)

Electronics 303

Electronics Manufacturing 303

Fierce Pharma

APRIL 9, 2024

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.

Manufacturing 289

Manufacturing 289

Fierce Pharma

SEPTEMBER 6, 2023

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.

Manufacturing 286

Manufacturing Pharma FDA Marketing 286

European Pharmaceutical Review

MARCH 1, 2024

Although pharma companies are working steadily to leverage the power of data and become more agile and resilient, there is still room for improvement. The post 2024 Pharmaceutical industry trends – discover the latest pharma quality and manufacturing trends appeared first on European Pharmaceutical Review.

Manufacturing 90

Manufacturing Pharma Pharmaceutical 90

Fierce Pharma

JUNE 28, 2023

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, (..)

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Manufacturing FDA Pharma Pharmaceutical 246

Fierce Pharma

JANUARY 22, 2024

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.

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Manufacturing Food FDA 317

Fierce Pharma

JANUARY 4, 2024

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.

Manufacturing 289

Manufacturing 289

Fierce Pharma

MARCH 13, 2024

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.

Manufacturing 298

Manufacturing 298

Fierce Pharma

DECEMBER 7, 2022

Cognizant’s Gaurav Marya talks M&A and Pharma Manufacturing. Wed, 12/07/2022 - 14:18.

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Manufacturing Pharma 130

Fierce Pharma

DECEMBER 7, 2023

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.

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Manufacturing FDA 328

Fierce Pharma

SEPTEMBER 29, 2023

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 (..)

Manufacturing 321

Manufacturing 321

Fierce Pharma

JANUARY 9, 2024

But the Japanese company will have to clear up manufacturing issues first. The FDA has sent a complete response letter to Astellas, rejecting zolbetuximab because of unresolved deficiencies identified in a pre-license inspection of a third-party manufacturing facility.

Manufacturing 297

Manufacturing FDA 297

Fierce Pharma

OCTOBER 3, 2023

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 (..)

Manufacturing 317

Manufacturing FDA 317

Fierce Pharma

FEBRUARY 14, 2024

FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic fkansteiner Wed, 02/14/2024 - 05:10

Manufacturing 306

Manufacturing Sales FDA 306

European Pharmaceutical Review

NOVEMBER 29, 2023

This step is important as these countries are key markets for pharmaceuticals manufacturing. GSK propels its progress to Net Zero Renewable energy in the pharma supply chain The SMI Health Systems Task Force is a public-private partnership launched at COP26.

Manufacturing 88

Manufacturing Marketing Pharma Pharmaceutical manufacturing 88

Fierce Pharma

FEBRUARY 22, 2024

To get a pulse on Moderna following its “year of transition” in 2023, look no further than the company’s manufacturing operations. | To get a pulse on Moderna following its “year of transition” in 2023, look no further than the company’s manufacturing operations.

Manufacturing 277

Manufacturing 277

Fierce Pharma

DECEMBER 4, 2023

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.

Manufacturing 298

Manufacturing Sales 298

Fierce Pharma

NOVEMBER 29, 2023

. | 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.

Manufacturing 340

Manufacturing Medicine Pharmaceutical 340

Fierce Pharma

AUGUST 24, 2023

Royalty Pharma has built a niche by finding innovative products pre- and post-approval from companies that need an infusion of cash in exchange for future royalties. Royalty Pharma has signed a deal with Ferring Pharmaceuticals to collect royalties on bladder cancer drug Adstiladrin. New York City-based Royalty will receive 5.1%

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Pharma Manufacturing Sales Pharmaceutical 246

European Pharmaceutical Review

NOVEMBER 16, 2022

As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. That is because of the relative expense of emerging therapies and the pressure on pricing for continuing product lines.

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Manufacturing Pharma Biopharma Management 116

Fierce Pharma

MARCH 4, 2024

Following an inspection of Eugia's injectables facility in Telangana, India, the FDA issued a formal rebuke laying out seven manufacturing observations, parent company Aurobindo said in a recent filing. Aurobindo said the observations are “procedural in nature” and that it plans to respond to the FDA.

Manufacturing 276

Manufacturing FDA 276

Fierce Pharma

OCTOBER 18, 2023

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. |

Manufacturing 288

Manufacturing FDA 288

pharmaphorum

DECEMBER 29, 2022

The turbulence of the last three years can make it seem as though pharma manufacturers have been operating in an atmosphere of non-stop crisis. The net effect has been to stimulate change in every aspect of the pharma industry – an industry not exactly known for its embrace of manufacturing innovation.

Manufacturing 97

Manufacturing Pharma Medicine Engineering 97

Fierce Pharma

SEPTEMBER 8, 2023

Three Japanese pharma companies lead our news stories from Asia this week. And Takeda is ordered to pay AbbVie nearly $480 million because of a manufacturing hiccup. Astellas has abandoned its challenge against the Inflation Reduction Act. Astellas has abandoned its challenge against the Inflation Reduction Act.

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Pharma Manufacturing Leads 259

PharmaTech

MAY 2, 2023

Digital transformation to the Pharma 4.0 paradigm moves forward in process development and clinical and commercial manufacturing.

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Manufacturing Pharma 69

Fierce Pharma

AUGUST 22, 2023

Problems with quality management, data integrity, expired raw materials and more have prompted the European Medicines Agency (EMA) to put the kibosh on manufacturing at Serra Pamies’ Reus, Spain, f | Problems with quality management, data integrity, expired raw materials and more have prompted the European Medicines Agency to put the kibosh on manufacturing (..)

Manufacturing 246

Manufacturing Medicine Management 246

Fierce Pharma

MARCH 28, 2024

[Yangzhou, China - March 26, 2024] - Aurisco Pharmaceutical, a leading global pharmaceutical company, is excited to announce the completion of its investment in cGMP peptide manufacturing capacity | Aurisco Pharmaceutical Launches State-of-the-Art Manufacturing Facility for GLP-1 Peptides

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Manufacturing Pharmaceutical Leads 147

Fierce Pharma

NOVEMBER 2, 2023

As strong demand continues to push Mounjaro sales to new highs, Eli Lilly CEO David Ricks said the company is "not done with" manufacturing expansions. But strong demand continues to push sales of the GLP-1/GIP agonist to new highs ahead of an FDA decision on weight loss. |

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Manufacturing Sales FDA 290

European Pharmaceutical Review

JANUARY 24, 2024

The first in our inaugural Pharma Horizons report series is dedicated to exploring the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control. The post Pharma Horizons: Artificial Intelligence appeared first on European Pharmaceutical Review.

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Pharma Pharmaceutical manufacturing Manufacturing Pharmaceutical 129

Fierce Pharma

OCTOBER 9, 2023

Dorothy Gemmel, the Chief Commercial Officer for manufacturer solutions business within GoodRx, identifies two exciting opportunities in pharma marketing today: personalization and partnerships.

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Marketing Pharma Patients Manufacturing 130

Fierce Pharma

JANUARY 4, 2024

As bankers predict a rise in private equity exits this year, one of 2024’s M&A moves could come from the drug manufacturing realm. billion), Bloomberg reported Wednesday, citing people close to the talks.

Manufacturing 278

Manufacturing Sales Pharmaceutical 278

Pharmaceutical Technology

JUNE 7, 2023

The manufacturing site will be completed in three phases and will produce anti-bacterial medicines and anti-malarial drugs. Fosun Pharma chairman Wu Yifang stated: “We are glad to be supported by IFC to localise pharmaceutical manufacturing and distribution in Africa.

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Manufacturing Pharma Distribution Pharmaceutical products 96

Fierce Pharma

SEPTEMBER 20, 2023

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.

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Manufacturing FDA Medicine 306

Fierce Pharma

JANUARY 16, 2024

As British pharma giant AstraZeneca looks abroad to build new factories, GSK is sticking close to home, where it plans to plug hundreds of millions of pounds into the United Kingdom over the next t | As other British drugmakers like AstraZeneca look abroad to build new factories, GSK is sticking close to home, where it plans to plug hundreds of millions (..)

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Networking Manufacturing Pharma 290

Fierce Pharma

SEPTEMBER 28, 2023

As bluebird bio’s pricey gene therapy launches take flight, the company is boosting manufacturing capacity with Swiss CDMO Lonza. Under the updated deal, Lonza has agreed to increase manufacturing capacity for bluebird’s therapies Zynteglo and Skysona, according to a SEC filing published Wednesday.

Manufacturing 277

Manufacturing 277