Fierce Pharma

SEPTEMBER 11, 2023

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. |

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Manufacturing Biopharma Pharma 196

Fierce Pharma

OCTOBER 30, 2024

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.

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Manufacturing Biopharma Medical 248

Fierce Pharma

OCTOBER 2, 2024

Aspen Neuroscience, underway with Parkinson's cell therapy trial, bolsters manufacturing with new San Diego facility fkansteiner Wed, 10/02/2024 - 07:31

Manufacturing 322

Manufacturing 322

PharmaTech

SEPTEMBER 18, 2024

The drug manufacturing ecosystem Pharma 4.0, a term coined in 2017 by the International Society for Pharmaceutical Engineers, promises a revolution across drug discovery, manufacturing, and supply chain logistics, ensuring drugs are delivered precisely when needed, and improving overall patient care.

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Manufacturing Pharma Engineering Pharmaceutical 52

Fierce Pharma

OCTOBER 1, 2024

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.

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Manufacturing Pharma 264

Fierce Pharma

OCTOBER 14, 2024

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.

Manufacturing 253

Manufacturing 253

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.

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Manufacturing Pharma 239

Fierce Pharma

OCTOBER 14, 2024

Today, manufacturing biomolecules presents unique challenges, like cost pressure and market uncertainty. The need to develop proprietary processes to differentiate from competitors is higher than ever before.

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Manufacturing Marketing 181

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.

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Manufacturing Marketing Pharma Pharmaceutical manufacturing 107

Fierce Pharma

AUGUST 8, 2024

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.

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Manufacturing Sales Government 279

Fierce Pharma

MARCH 1, 2024

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.

Manufacturing 306

Manufacturing 306

Fierce Pharma

SEPTEMBER 19, 2024

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.

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Manufacturing FDA 286

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

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.

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Manufacturing Pharma FDA Marketing 240

Fierce Pharma

NOVEMBER 4, 2024

The deal is expected to extend Nektar's cash runway into 2026 and help the company hone its development of novel immunology drugs.

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Manufacturing Sales 184

Fierce Pharma

MARCH 21, 2024

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.

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Pharma Manufacturing FDA 218

European Pharmaceutical Review

MAY 1, 2024

By providing pharma companies with a real-life replicable model of a cloud-first manufacturing facility, we will drive forward the digital capability of pharma manufacturers” A new digital collaboration is set to take advantage of a manufacturing facility model featuring innovative technologies, accelerating how fast new medicines are made.

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Medicine Manufacturing Pharma Government 105

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.

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Manufacturing Pharmaceutical Pharma 98

Fierce Pharma

OCTOBER 3, 2024

After unlocking commercial supply and enlisting a manufacturing partner earlier this year, Ferring Pharmaceuticals has reached a new turning point on its quest to satisfy current and future demand | Ferring on Thursday opened a new global manufacturing hub in Kuopio, Finland, to help produce drug substance for Adstiladrin, which was approved by the (..)

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Manufacturing FDA Pharmaceutical Patients 241

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 232

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 119

Fierce Pharma

AUGUST 6, 2024

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.

Manufacturing 322

Manufacturing 322

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 (..)

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Manufacturing 316

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 260

Manufacturing 260

pharmaphorum

SEPTEMBER 13, 2024

Eli Lilly has added $1 billion to its investment plan for a new manufacturing facility in Ireland that will be used to produce its Alzheimer's therapy donanemab.The facility at a business park in Raheen, Limerick, was first announced in 2022 and this is the second time that Lilly has opted to double its investment in the site, taking the total above (..)

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Manufacturing Pharma 99

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 (..)

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Manufacturing FDA 293

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.

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Manufacturing Pharma Medicine Engineering 103

Fierce Pharma

AUGUST 1, 2024

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.

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Manufacturing Biopharma 270

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 309

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.

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Manufacturing Medicine Pharmaceutical 337

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 303

Fierce Pharma

JULY 11, 2024

regulator made "requests related to the manufacturing process and the type 1 diabetes indication," which the company said it does not expect to remedy by the end of this year. . | The FDA has slowed the roll for Novo Nordisk, rejecting its once-a-week insulin icodec for patients with Type 1 and Type 2 diabetes.

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Manufacturing FDA Marketing Patients 233

PM360

SEPTEMBER 30, 2024

Sustainable Tech’s Positive Effect on Pharma Funding Recent innovations, including rapid advancements in AI-powered technologies and GLP-1s, have significantly impacted the investment climate and consolidated funding to a smaller number of organizations in the last eight months.

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Manufacturing Pharma Pharmaceutical Competition 52

Fierce Pharma

SEPTEMBER 3, 2024

Reddy’s has been cut off from China’s bulk-buy drug procurement program after an inspection turned up “serious defects” in the company’s manufacturing operations.

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Manufacturing Sales Medical 244

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

JUNE 6, 2024

to establish a manufacturing plant as it progresses on its radiopharma journey. Amid a nuclear medicine boom, France’s Orano Med has chosen the U.S. Orano Med—which is working on targeted alpha therapies for cancer—on Thursday inaugurated its first Alpha Therapy Laboratory (ATLab) in Brownsburg near Indianapolis, Indiana.

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Manufacturing Medicine Leads 221

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 265

Manufacturing 265