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

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

AUGUST 1, 2024

Additionally, Regeneron reported that its FDA decision date on its application for approval of multiple myeloma therapy linvoseltamab is likely to be delayed because of a manufacturing issue. The target date is August 22.

Manufacturing 265

Manufacturing Sales FDA 265

Fierce Pharma

JUNE 6, 2024

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

Manufacturing 289

Manufacturing FDA 289

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.

Manufacturing 238

Manufacturing Medicine Leads 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 (..)

Manufacturing 311

Manufacturing FDA 311

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.

Manufacturing 315

Manufacturing Food FDA 315

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.

Manufacturing 324

Manufacturing FDA 324

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

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.

Manufacturing 330

Manufacturing Medicine Pharma 330

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 284

Manufacturing 284

Fierce Pharma

JULY 30, 2024

District Court in Delaware claiming that in producing groundbreaking Duchenne muscular dystrophy treatment Elevidys, Sarepta encroaches on two of its patents involving the manufacture of viral vectors.

Manufacturing 233

Manufacturing 233

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.

Manufacturing 328

Manufacturing Sales Pharma 328

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

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 295

Manufacturing Sales 295

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 282

Manufacturing FDA 282

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 300

Electronics Manufacturing 300

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 282

Manufacturing 282

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 276

Manufacturing FDA 276

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 258

Manufacturing 258

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 242

Manufacturing 242

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 289

Manufacturing 289

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 243

Manufacturing Medicine Management 243

European Pharmaceutical Review

JUNE 13, 2024

What are the top three challenges associated with gene therapy manufacturing? Manufacturing of AAV vectors for gene therapy presents several significant challenges, such as: Scalability : AAV production often involves complex biological processes that are difficult to scale without compromising quality and yield.

Manufacturing 145

Manufacturing Food and Drug Administration Safety Engineering 145

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. |

Manufacturing 286

Manufacturing Sales FDA 286

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 266

Manufacturing Pharma 266

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.

Manufacturing 300

Manufacturing FDA Medicine 300

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.

Medicine 105

Medicine Manufacturing Pharma Government 105

Fierce Pharma

JULY 12, 2024

Rentschler this week revealed that the production line at its site in Milford, Massachusetts (formerly known as the Rentschler Biopharma Manufacturing Center), is now fully operational. The company already has one “major project” underway utilizing the new production tech, plus several additional projects in the pipeline.

Manufacturing 230

Manufacturing Biopharma 230

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 278

Manufacturing FDA 278

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 259

Manufacturing FDA 259

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 264

Manufacturing 264

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 269

Manufacturing Sales Pharmaceutical 269

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

Manufacturing 147

Manufacturing Pharmaceutical Leads 147

European Pharmaceutical Review

JUNE 10, 2024

The first industrial-scale pharmaceutical manufacturing facility for production of lead-212-based radioligand therapies has been inaugurated. During the earlier announcement for its French facility, Orano Med highlighted one key challenge of developing lead-212 based radioligand therapies is manufacturing then on an industrial scale.

Manufacturing 98

Manufacturing Distribution Pharmaceutical manufacturing Leads 98

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 277

Manufacturing 277