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 278

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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Manufacturing Sales Pharma 300

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.

Manufacturing 283

Manufacturing FDA 283

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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Manufacturing Medicine Pharma 283

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 287

Manufacturing 287

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 238

Manufacturing 238

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 254

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 229

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 269

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 267

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 238

Manufacturing 238

Fierce Pharma

JANUARY 4, 2023

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

Manufacturing 260

Manufacturing 260

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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Manufacturing Pharma 232

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 209

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 242

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 240

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 230

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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Biopharma Manufacturing 232

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 227

Manufacturing 227

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 243

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 234

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 223

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.

Manufacturing 238

Manufacturing FDA 238

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 215

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.

Manufacturing 243

Manufacturing FDA 243

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 230

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 221

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

Manufacturing 232

Manufacturing 232

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 232

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 206

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 193

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 (..)

Manufacturing 244

Manufacturing FDA 244

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 206

Manufacturing Pharma 206

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 (..)

Manufacturing 205

Manufacturing 205

Fierce Pharma

MAY 10, 2023

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

Manufacturing 206

Manufacturing 206

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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Manufacturing Medicine Management 189