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 291

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

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 327

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 315

Manufacturing FDA 315

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.

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Manufacturing FDA 269

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

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 298

Manufacturing Sales 298

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 331

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 284

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 340

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 134

Electronics Manufacturing 134

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 328

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 246

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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Manufacturing Sales Pharmaceutical 275

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 277

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

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Manufacturing Pharmaceutical Leads 147

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 289

Fierce Pharma

FEBRUARY 28, 2024

. | EuroAPI's four-year restructuring campaign will include streamlining the company’s active pharmaceutical ingredients portfolio, becoming a more “focused” contract development and manufacturing organization, developing a “rationalized” industrial footprint and transforming into a “leaner organization."

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Manufacturing Pharmaceutical 229

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 272

Manufacturing 272

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 304

Manufacturing FDA Medicine 304

Fierce Pharma

NOVEMBER 7, 2023

WuXi's bioconjugation spinoff is set to break free onto the Hong Kong Stock Exchange this month, with plans to funnel hundreds of millions of dollars in proceeds back into its Asian manufacturing n | WuXi's bioconjugation spinoff is set to break free onto the Hong Kong Stock Exchange this month, with plans to funnel hundreds of millions of (..)

Manufacturing 241

Manufacturing Networking 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.

Manufacturing 278

Manufacturing FDA 278

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 290

Manufacturing FDA 290

Fierce Pharma

JULY 12, 2023

. | Following an inspection of Lupin’s Pithampur Unit-2 manufacturing facility in Madhya Pradesh, India, from March 21 to March 29, the FDA handed the company an inspection with a classification of Voluntary Action Indicated.

Manufacturing 241

Manufacturing FDA 241

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 278

Manufacturing 278

Fierce Pharma

OCTOBER 18, 2023

After launch limitations, Johnson & Johnson exec touts manufacturing progress on CAR-T drug Carvykti fkansteiner Wed, 10/18/2023 - 14:44

Manufacturing 272

Manufacturing 272

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 298

Manufacturing FDA 298

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

European Pharmaceutical Review

MARCH 20, 2024

Lonza has agreed to acquire one of the world’s largest biologics manufacturing sites (by volume), for a total of $1.2 The acquisition of the manufacturing facility will significantly increase Lonza’s capacity of the manufacture of large-scale biologics, to meet demand for commercial mammalian contract manufacturing.

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Manufacturing Medicine Networking Pharmaceutical 100

European Pharmaceutical Review

APRIL 15, 2024

billion to expand the planned FUJIFILM Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina, US. The expansion means identical large-scale production facilities can be built in US and Europe to support integration drug manufacturing production “regardless of location”, FUJIFILM explained.

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Manufacturing Biopharma Networking Pharmaceutical 89

European Pharmaceutical Review

APRIL 11, 2024

The pharmaceutical industry is becoming increasingly conscious of emissions and the importance of sustainable manufacturing. 1 Every major pharmaceutical manufacturer in the UK and Ireland is investing in making their operations and supply chains more environmentally friendly.

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Manufacturing Pharmaceutical Engineering Pharmaceutical manufacturing 100

Pharmaceutical Commerce

MARCH 29, 2024

In this Pharmaceutical Commerce video interview, Barry Heavey, Life Sciences Supply Chain Lead, Accenture, discusses the specific factors contributing to rising manufacturing costs.

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Manufacturing Biopharma Leads Pharmaceutical 104

Fierce Pharma

SEPTEMBER 6, 2023

Ascendis hopes to bring its second TransCon product to the market and overcome manufacturing issues. 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.

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Manufacturing Pharma FDA Marketing 278

Fierce Pharma

NOVEMBER 3, 2023

Olivia Gannon, Associate Director of Global MES and Digital Execution Systems, Life Sciences Manufacturing, Cognizant, explores how a digitalization strategy harnessing the latest innovatio | Olivia Gannon, Global MES Service Line Lead at Cognizant, explores how a digitalization strategy harnessing the latest innovations in MES technologies can help (..)

Manufacturing 147

Manufacturing Leads 147

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 277