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 301

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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Fierce Pharma

NOVEMBER 2, 2023

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.

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Fierce Pharma

DECEMBER 2, 2024

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.

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Fierce Pharma

NOVEMBER 21, 2023

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.

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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 273

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 307

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 247

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 288

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 251

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 247

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

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 249

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 257

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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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 238

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 261

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 260

Fierce Pharma

JANUARY 4, 2023

Moderna makes its first-ever acquisition, buying Japanese DNA manufacturer OriCiro for $85M. Wed, 01/04/2023 - 06:37.

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Manufacturing 264

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 248

Fierce Pharma

MARCH 21, 2023

Biopharma industry lobbies for tax breaks related to US-based manufacturing kdunleavy Tue, 03/21/2023 - 11:14

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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 262

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 254

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 241

Fierce Pharma

SEPTEMBER 14, 2023

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.

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Manufacturing FDA 257

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 233

Fierce Pharma

SEPTEMBER 25, 2023

GSK manufacturing review prompts Scynexis to pull Brexafemme, halt trials over contamination concerns esagonowsky Mon, 09/25/2023 - 12:26

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Manufacturing 251

Fierce Pharma

SEPTEMBER 7, 2023

. | 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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Manufacturing FDA 262

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 251

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

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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Fierce Pharma

SEPTEMBER 13, 2023

While the FDA and the Centers for Disease Control and Prevention (CDC) have signed off on updated COVID vaccines for this season, Moderna is already reportedly preparing for lower demand for its sh | Moderna is speaking with its manufacturing partners to scale back production of its mRNA COVID vaccine to adapt to the endemic phase of the disease, Moderna’s (..)

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Manufacturing FDA 264

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 (..)

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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 203

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 221

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 221