European Pharmaceutical Review

APRIL 16, 2024

Pre-specified interim analysis results from the Phase III APPLAUSE-IgAN clinical trial were presented at the 2024 World Congress of Nephrology (WCN). In December 2023, the US Food and Drug Administration (FDA) approved the treatment for adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH).

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Food and Drug Administration Food Safety Medicine 79

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). We do not expect entry of Stelara biosimilars in the United States during 2024,” Joseph Wolk CFO, Johnson & Johnson, stated during the company’s Q3 earnings call on 18 October.

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Food and Drug Administration FDA Side effects Safety 88

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. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co.

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FDA Food and Drug Administration Manufacturing Pharmaceutical manufacturing 89

European Pharmaceutical Review

FEBRUARY 8, 2024

RIDGELINE 105, evaluated the safety and efficacy of the vanza triple in children with cystic fibrosis between six and 11 years old with at least one mutation responsive to triple combination CFTRm. Vertex confirmed that full data set from these studies will be presented at medical meetings later in 2024.

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Food and Drug Administration Medicine Medical Consulting 88

European Pharmaceutical Review

FEBRUARY 2, 2024

ADUHELM was the “groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the [Alzheimer’s] field,” commented Christopher Viehbacher, President and Chief Executive Officer of Biogen. On 9 January 2024, Eisai confirmed that LEQEMBI was approved in China to treat Alzheimer’s.

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Food and Drug Administration FDA Food Marketing 75

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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European Pharmaceutical Review

MARCH 5, 2024

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. This was communicated in a Letter to Industry (medical devices) published by the agency on 20 February 2024.

Medical 81

Medical Manufacturing Food and Drug Administration Safety 81

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The prescription drug user fee act (PDUFA) date is expected to be set as January 2024.

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Food and Drug Administration FDA Prescription Food 59

European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs. The device may be reassessed to ensure the performance and safety of the device is negatively impacted.

Medical 90

Medical Food and Drug Administration Manufacturing Safety 90

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). We are eager to confirm our preclinical data in the clinic and expect to begin enrolling patients in Phase I during the second quarter of 2024.”

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Food and Drug Administration FDA Food Safety 59

European Pharmaceutical Review

SEPTEMBER 29, 2023

The US Food and Drug Administration (FDA) has approved Exxua (gepirone hydrochloride extended-release tablets) for adults with major depressive disorder ( MDD ). The major depressive disorder treatment is expected to be available for patients in early 2024.

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FDA Food and Drug Administration Medicine Food 91

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. It will be offered to patients in prefilled syringe and autoinjector administration options.

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Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

APRIL 24, 2023

Validated through the access consortium work-sharing initiative, the marketing applications are currently under review, with approval decisions expected in the first half of 2024. In February 2023, Syfovre (pegcetacoplan injection) received the US Food and Drug Administration’s approval for the same indication.

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Pharmaceutical Technology

JUNE 16, 2023

This includes the company’s upcoming Phase IIIb trial, but also another Phase III study and a long-term safety trial, said ANeuroTech CEO Eric Buntinx in an interview with Pharmaceutical Technology. While the drug is marketed in other countries, it is not registered in the US.

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Food and Drug Administration Side effects Safety Recruitment 52

European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. The safety profile of SYFOVRE is well-demonstrated following ~12,000 injections.

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FDA Food and Drug Administration Food Leads 85

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

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Food and Drug Administration Side effects Leads Patients 93

European Pharmaceutical Review

SEPTEMBER 25, 2023

Moreover, the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. The FDA’s target action date is the second half of 2024. months for chemotherapy.

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Food and Drug Administration Manufacturing Safety Medicine 88

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

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Food and Drug Administration Side effects Leads Patients 93

Pharmaceutical Technology

SEPTEMBER 22, 2022

Carisma develops chimeric antigen receptor macrophage (CAR-M) therapies and is said to be the only firm developing such therapies with proof of mechanism and safety findings shown in clinical trials. . They will also be used for funding operating expenses and capital expenditure needs up to 2024. .

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Food and Drug Administration Engineering Food Leads 52

Nixon Gwilt Law

APRIL 22, 2024

The rule aims to regulate and enhance the transparency, effectiveness, and safety of predictive DSIs used in healthcare settings, ensuring that these technologies are developed and managed responsibly. This oversight is crucial in minimizing errors that could compromise patient safety.

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European Pharmaceutical Review

DECEMBER 28, 2023

We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval. We have now already treated the first patients and are expecting the first results from this study in the first half of 2024. 

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Food and Drug Administration Patients Safety Medical science 84

European Pharmaceutical Review

MARCH 28, 2024

FDA is expected to provide initial feedback on the data submitted by July 2024, with further data to be collected and analysed over the next two years. The DVA assesses the progression and severity of Duchenne muscular dystrophy using video assessments as a primary endpoint.

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Food and Drug Administration FDA Patients Insurance 52

European Pharmaceutical Review

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. Conversely, in the US, it has always been clear and regulated as a drug.

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Food and Drug Administration Manufacturing Medicine Pharma 98

Pharmaceutical Technology

JULY 29, 2022

On 25 June, Pfizer and BioNTech (Mainz, Germany) reported pivotal Phase II/III data demonstrating the safety, tolerability and immunogenicity of two Omicron-adapted vaccine candidates. Australia’s Therapeutic Goods Administration (TGA) granted a provisional determination in April to Moderna’s Omicron jab, and in July to Pfizer’s Omicron jab.

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European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

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FDA Food and Drug Administration Safety Manufacturing 88

European Pharmaceutical Review

JANUARY 5, 2024

The Phase III STARLYNG-1 clinical study is designed to bridge to the previously established safety and efficacy of immediate-release Risperdal for schizophrenia and bipolar disorder as agreed with the US Food and Drug Administration. Based on the results, the clinical trial was stopped early. “We

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Food and Drug Administration Medical Safety Medicine 97

European Pharmaceutical Review

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Valneva SE’s IXCHIQ ® , the first chikungunya vaccine to be authorised in the world. In October 2023, Valneva submitted a marketing application for the chikungunya vaccine to the European Medicines Agency (EMA), which included initial safety data from the trial.

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Food and Drug Administration FDA Medicine Food 52

European Pharmaceutical Review

JANUARY 5, 2023

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in all infants. MELODY clinical trials evaluating nirsevimab.

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Food and Drug Administration FDA Safety Prescription 59

Pharmaceutical Technology

JANUARY 6, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca ’s nirsevimab biologics licence application (BLA) for review to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in children aged up to 24 months. Nirsevimab showed a 74.5%

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Food and Drug Administration FDA Prescription Food 59

Legacy MEDSearch

SEPTEMBER 29, 2023

Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. ReGelTec, Inc. announced that the U.S.

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