Fierce Pharma

MARCH 30, 2023

Fierce Pharma Asia—Takeda's manufacturing expansion; Leqembi's sales prospects; GSK's PrEP generics aliu Thu, 03/30/2023 - 16:18

Prospecting 174

Prospecting Manufacturing Sales Pharma 174

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

Manufacturing 293

Manufacturing 293

Fierce Pharma

SEPTEMBER 20, 2024

Fierce Pharma Asia—Merck's collabs with Daiichi, Eisai deliver readouts; Granules hit with FDA manufacturing observations aliu Fri, 09/20/2024 - 09:21

Manufacturing 169

Manufacturing Pharma FDA 169

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. |

Manufacturing 200

Manufacturing Biopharma Pharma 200

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 311

Manufacturing Medicine Pharmaceutical 311

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 278

Manufacturing Sales FDA 278

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

JUNE 8, 2023

Fierce Pharma Asia—Eisai and Biogen's Leqembi progress; AZ and Daiichi's Enhertu data; Samsung Biologics' manufacturing deal zbecker Thu, 06/08/2023 - 19:34

Manufacturing 178

Manufacturing Pharma 178

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

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 (..)

Manufacturing 254

Manufacturing FDA 254

Fierce Pharma

JUNE 6, 2024

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

Manufacturing 229

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.

Manufacturing 269

Manufacturing FDA 269

World of DTC Marketing

DECEMBER 29, 2020

Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control. Let’s also remember that pharma is going to make a LOT of money on these vaccines. The post How did pharma develop a vaccine so quickly?

Pharma 307

Pharma Food and Drug Administration Media Food 307

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.

Manufacturing 207

Manufacturing Pharma FDA Marketing 207

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 267

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

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.

Manufacturing 227

Manufacturing Pharma 227

Fierce Pharma

JUNE 14, 2023

Sanofi is jumping on the artificial intelligence boat with a new app and a pledge to become “the first pharma company powered by artificial intelligence at scale.” | Sanofi's new app, plai, provides teams with a “360° view" to aid decision-making.

Manufacturing 281

Manufacturing Pharma 281

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.

Manufacturing 209

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 (..)

Electronics 242

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.

Manufacturing 240

Manufacturing Sales 240

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, (..)

Manufacturing 190

Manufacturing FDA Pharma Pharmaceutical 190

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.

Pharma 182

Pharma Manufacturing FDA 182

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 230

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

Biopharma 232

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.

Manufacturing 243

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.

Manufacturing 234

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.

Manufacturing 223

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. |

Manufacturing 215

Manufacturing FDA 215

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

Manufacturing 230

Manufacturing 230

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

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