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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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.

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Manufacturing 325

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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Fierce Pharma

JUNE 6, 2024

When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. |

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Manufacturing FDA 298

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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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 261

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

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

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Manufacturing 328

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 317

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.

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Manufacturing FDA 296

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 321

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.

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Manufacturing 289

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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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

DECEMBER 4, 2024

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

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Manufacturing 289

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 320

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.

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Manufacturing 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.

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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

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Manufacturing Sales FDA 306

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.

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Manufacturing 331

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

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 264

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.

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Manufacturing 275

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 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.

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Manufacturing 298

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 (..)

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Electronics Manufacturing 306

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. |

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Manufacturing FDA 288

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.

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Manufacturing 289

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.

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Manufacturing Sales 298

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 (..)

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Manufacturing 263

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 200

Fierce Pharma

MAY 20, 2024

Riding high on its Daiichi Sankyo-partnered antibody drug conjugate (ADC) Enhertu—and banking on an approval for its next ADC contender datopotamab durextecan this winter—AstraZeneca is placing a b | Riding high on its Daiichi Sankyo-partnered antibody drug conjugate (ADC) Enhertu—and banking on an approval for its next ADC contender datopotamab durextecan (..)

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Manufacturing 288

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

MAY 10, 2023

Sandoz taps Evotec in long-term biosimilar development and manufacturing deal fkansteiner Wed, 05/10/2023 - 08:39

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Manufacturing 286

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.

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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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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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