Fierce Pharma

JULY 12, 2023

Lupin is no stranger to FDA rebukes, though its latest write-up from the U.S. 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. .

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Manufacturing FDA 213

Fierce Pharma

AUGUST 2, 2023

FDA reads like a checklist of what not to do when the regulator pays a visit to your manufacturing facility. | The FDA handed Intas a five-observation write up after inspecting the company’s Sanand, India, production plant from November 22 to December 2, 2022. Intas Pharmaceuticals’ new warning letter from the U.S.

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Fierce Pharma

JANUARY 22, 2024

Eli Lilly’s beleaguered manufacturing site in Branchburg, New Jersey, is back in the U.S. Following a July inspection, the FDA has uncovered eight new production deficiencies at Eli Lilly's Branchburg production plant. Food and Drug Administration’s crosshairs, Reuters first reported.

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Fierce Pharma

MARCH 4, 2024

Aurobindo subsidiary Eugia is back in hot water with the FDA after a recent plant inspection yielded yet another Form 483—this time in India. Aurobindo said the observations are “procedural in nature” and that it plans to respond to the FDA.

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Manufacturing FDA 224

Fierce Pharma

APRIL 10, 2024

FDA chided Kilitch Healthcare India for “poor practices” tied to written procedures around microbial contamination, shoddy lab records, behaviors that could have caused contamination and quality control lapses. In a four-observation warning letter issued this week, the U.S.

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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, (..)

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Fierce Pharma

MAY 16, 2023

FDA orders Sun to hire manufacturing consultant for troubled plant as export pause persists fkansteiner Tue, 05/16/2023 - 09:33

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Consulting Manufacturing FDA 229

Fierce Pharma

AUGUST 30, 2023

Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases.

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Fierce Pharma

NOVEMBER 2, 2023

But strong demand continues to push sales of the GLP-1/GIP agonist to new highs ahead of an FDA decision on weight loss. | 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.

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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 260

Fierce Pharma

FEBRUARY 12, 2024

When it comes to what not to do during an FDA inspection of your drug ingredient manufacturing facility, having the plant’s quality control chief intentionally give investigators the runaround by f | When it comes to what not to do during an FDA inspection of your drug ingredient manufacturing facility, having the plant’s quality control chief intentionally (..)

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FDA Manufacturing 247

Fierce Pharma

JUNE 27, 2023

Despite Regeneron’s impressive high-dose Eylea data, its high-stakes launch is delayed thanks to an unexpected FDA rejection. | In a surprise decision, the FDA issued powerhouse Eylea's high-dose version a complete response letter. But the company said it has nothing to do with the drug's efficacy or safety.

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FDA Manufacturing Safety 238

Fierce Pharma

JULY 7, 2023

After a pandemic-fueled lull the past few years, FDA inspections are back in full force. The FDA has issued a trio of Form 483s after inspecting three Indian drug plants. This week, a pair of Indian drugmakers have found themselves in the agency’s crosshairs. |

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FDA Manufacturing Pharmaceutical 223

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 268

Fierce Pharma

SEPTEMBER 19, 2023

Novo Nordisk’s shares continued to trend downward Tuesday after reports surfaced that the FDA had recently flagged manufacturing shortfalls at the Danish drugmaker’s Clayton, North Carolina product | After inspecting Novo’s Clayton, North Carolina, facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality (..)

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Fierce Pharma

JULY 24, 2023

After Teva’s Alvotech-partnered Humira biosimilar suffered its second FDA rejection, the generics giant is stepping up its role in their long-term collaboration with increased manufacturing involve | After Teva and Alvotech's proposed Humira biosimilar suffered a second FDA rejection because of issues at Alvotech's manufacturing plant, Teva (..)

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Fierce Pharma

OCTOBER 12, 2023

After the FDA passed on an approval for mirikizumab in ulcerative colitis earlier this year because of manufacturing shortfalls, the Eli Lilly drug is gaining new momentum with a win in a phase 3 C | A majority of Crohn's disease patients experienced a clinical response and clinical remission after treatment with mirikizumab, the company said.

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FDA Manufacturing Patients 237

Fierce Pharma

OCTOBER 12, 2023

Even as Teva Pharmaceuticals’ Icelandic counterpart Alvotech works to get its Reykjavik manufacturing facility back up to snuff, lingering problems at the plant—which derailed approval of the partn | The FDA shot down Alvotech and Teva's biosimilar candidate to Johnson & Johnson's Stelara over “certain deficiencies” uncovered by the FDA (..)

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FDA Manufacturing Pharmaceutical 275

Fierce Pharma

OCTOBER 11, 2023

With observations ranging from dirty packing rooms to incomplete lab control records, Spectrum Laboratory Products’ new FDA manufacturing write-up reads like a guide on what not to do when producin | With observations ranging from dirty packing rooms to incomplete lab control records, Spectrum Laboratory Products’ new FDA manufacturing write-up reads (..)

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FDA Manufacturing 225

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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Fierce Pharma

MARCH 15, 2024

Takeda will shut down a gene therapy manufacturing and R&D facility in Austria. The FDA questioned whether Carvykti should be approved in an earlier line of multiple myeloma after noticing an early detriment to patient survival in a clinical trial. | WuXi AppTec left BIO amid alleged biosecurity concerns and as U.S.

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European Pharmaceutical Review

JUNE 11, 2023

The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. The site is a “critical component” of BMS’ expanding global cell therapy manufacturing footprint, the company said. “The

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Fierce Pharma

NOVEMBER 30, 2023

It’s critical to keep your workplace equipment clean and calibrated—especially in the realm of pharmaceutical manufacturing. Now, Dr. | It’s critical to keep your workplace equipment clean and calibrated—especially in the realm of pharmaceutical manufacturing.

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Pharmaceutical manufacturing FDA Manufacturing Pharmaceutical 199

Fierce Pharma

OCTOBER 2, 2023

The FDA has rejected Lilly’s investigational atopic dermatitis treatment lebrikizumab over findings uncovered during the inspection of a third-party contract manufacturing organization. After laying out a goal to launch four new drugs in 2023, Eli Lilly has run into yet another regulatory snag. |

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Fierce Pharma

OCTOBER 20, 2023

Late this week, the FDA dished up a pair of manufacturing write-ups, with one going to high-flying Samsung Biologics and the other to India’s Nectar Lifesciences.

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PharmaTech

MAY 4, 2024

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

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Manufacturing FDA Engineering Medicine 52

pharmaphorum

JANUARY 9, 2024

Manufacturing problems have scuppered Astellas’ chances of approval in the US this month for zolbetuximab, currently leading the field among Claudin 18.2-targeted targeted drug candidates for cancer.

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Fierce Pharma

APRIL 10, 2024

In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients in clinical trials of its blockbuster Kis | In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients (..)

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Recruitment FDA Manufacturing Patients 236

European Pharmaceutical Review

JANUARY 9, 2024

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392.

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

Fierce Pharma

JULY 24, 2023

FDA are picking up the pieces after a violent tornado devastated the drugmaker’s massive North Carolina injectables plant last week. Pfizer on Friday said it kicked off “immediate efforts” to provide relief and repair to the damage caused to its manufacturing facility in Rocky Mount, North Carolina. Pfizer and the U.S.

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FDA Manufacturing Medicine 203

Fierce Pharma

NOVEMBER 2, 2023

Ever since Novo Nordisk won FDA approval for its GLP-1 weight-loss med Wegovy more than 2 years ago, analysts and investors have been keeping a close eye on the blockbuster drug launch.

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Manufacturing FDA Sales 241

Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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PharmExec

SEPTEMBER 10, 2022

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

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Manufacturing Marketing FDA 130

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. BeiGene’s PD-1 inhibitor finally crossed the FDA finish line after a 20-month delay. Kyowa Kirin’s $4.25 million gene therapy set a new world pricing record. Kyowa Kirin’s $4.25

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Pharma Manufacturing FDA 211

European Pharmaceutical Review

FEBRUARY 27, 2024

It is the company ’s most advanced manufacturing facility to date. Additionally, in partnership with Columbus State Community College, Amgen declared that it hosting an 18-month manufacturing apprenticeship at the new facility. Amgen has opened a new biomanufacturing plant in Central Ohio, US.

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European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US.

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FDA Food and Drug Administration Manufacturing Pharmaceutical manufacturing 91

PharmaTech

SEPTEMBER 19, 2023

FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency. Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S.

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Manufacturing FDA 52