European Pharmaceutical Review

DECEMBER 20, 2023

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental Biologics License Application for Xolair ® (omalizumab) for treatment of children and adults with food allergies. The FDA is expected to decide on approval of Xolair for patients with food allergies in the first quarter of 2024.

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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.

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Medical Manufacturing Food and Drug Administration Safety 104

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. GA is an advanced form of age-related macular degeneration (AMD).

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European Pharmaceutical Review

APRIL 17, 2024

Roche explained that additional data offered further evidence on the safety profile of OCREVUS SC injection. It was consistent with the safety profile of OCREVUS IV infusion, the findings revealed. No new safety signals were identified for OCREVUS SC.

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European Pharmaceutical Review

JANUARY 29, 2024

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. ng/day, compared to EMA which is 18 ng/day.

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European Pharmaceutical Review

FEBRUARY 2, 2024

Biogen’s decision A strategic review of the company’s R&D work evaluated the time and investment required for the post-marketing confirmatory ENVISION study and the likely advancements in the field by the time of potential ADUHELM FDA traditional approval, Biogen explained.

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European Pharmaceutical Review

MAY 7, 2024

Johnson & Johnson’s Phase I study is assessing the safety and efficacy of TAR-210 as a delivery method for sustained, local release of erdafitinib into the bladder. These data for the drug delivery system for erdafitinib were featured at the 2024 American Urological Association (AUA) Annual Meeting.

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Food and Drug Administration Patients Food Safety 97

European Pharmaceutical Review

DECEMBER 22, 2023

KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024.

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Food and Drug Administration Side effects Safety Food 98

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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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. The safety profile of nirsevimab was similar to placebo.

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European Pharmaceutical Review

NOVEMBER 21, 2024

In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults.

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European Pharmaceutical Review

JUNE 27, 2024

Looking back briefly to 2023, within the cell and gene therapy space, the US Food and Drug Administration (FDA) approved marketing authorisations for seven of these treatments. References [link] [link] The post Drug approval roundup – May/June 2024 appeared first on European Pharmaceutical Review.

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European Pharmaceutical Review

MARCH 18, 2024

He added that the trial results could lead to this specific infusion pump delivery system to be approved by regulatory bodies such as the US Food and Drug Administration (FDA). Espay also stated that two additional subcutaneous delivery systems are also expected to be approved in 2024.

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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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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.

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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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European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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European Pharmaceutical Review

NOVEMBER 25, 2022

GlobalData’s report showed LY03010 is expected to launch in the US in 2024. Thus, LY03010 could be more convenient to administer and improve patient compliance by optimising the initial dosing regimen, while ensuring efficacy and safety. If successful, the drug is forecasted to reach sales of $63.5 million in 2031, representing 0.6

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European Pharmaceutical Review

DECEMBER 8, 2023

The drug has shown promising efficacy and safety in a Phase Ib study for schizophrenia. FDA approves first-in-class antidepressant AbbVie’s recent acquisitions This is the third acquisition announced by AbbVie this quarter. Emraclidine is a positive allosteric modulator (PAM) of the muscarinic M4 receptor.

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Nixon Gwilt Law

JUNE 24, 2024

The Digital Therapeutics Alliance Summit 2024 , held in Washington, D.C., The Importance of FDA Engagement The FDA, particularly through its Center for Digital Health Excellence, plays a pivotal role in supporting DTx developers every step of the way.

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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. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

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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 TEVIMBRA versus 6.3

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PM360

AUGUST 7, 2024

In June 2024, the FDA extended a Cooperative Research and Development Agreement (CRADA) to assess data quality in multicenter clinical trials using statistical modeling and ML. This can make it difficult to identify those which are likely to represent a real issue for participant safety or data integrity.

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PM360

FEBRUARY 8, 2024

It’s open-source design meets FDA requirements for safety and protection. Saatchi & Saatchi Wellness and TOM (Tikkun Olam Makers) The Prescription Paper Pill Bottle An innovative alternative to plastic, the Prescription Paper Pill Bottle is 100% compostable with no artificial glue and no toxic dye.

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European Pharmaceutical Review

OCTOBER 17, 2024

In August 2024, the European Commission approved EURneffy (adrenaline nasal spray) in the EU as the first needle-free emergency option to treat anaphylaxis. This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). Poster Presented at the 2024 AAAAI Annual meeting, DC, US.

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Nixon Gwilt Law

JUNE 24, 2024

The Digital Therapeutics Alliance Summit 2024 , held in Washington, D.C., The Importance of FDA Engagement The FDA, particularly through its Center for Digital Health Excellence, plays a pivotal role in supporting DTx developers every step of the way.

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European Pharmaceutical Review

APRIL 10, 2024

The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the industry and paving the way for advancement and regulatory clearance of additional microbiome products in broader indications.

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pharmaphorum

AUGUST 25, 2022

J&J’s first-mover advantage is likely to translate into a market-leading position unless newer drugs can show a significant advantage in safety or efficacy, according to GlobalData, which says the new drug will probably encroach on some of the CAR-T therapies’ territory.

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Pharmaceutical Technology

JANUARY 8, 2023

Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. Tezspire is being studied in a Phase II COPD study (NCT04039113) that is expected to complete in March 2024. Still, patients require an individual-led approach.

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Pharmacy Times

OCTOBER 28, 2024

Results demonstrating safety and efficacy in those with anemia in non-dialysis dependent chronic kidney disease and anemia in dialysis-dependent chronic kidney disease were presented at the 2024 American Society of Nephrology Kidney Week.

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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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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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Legacy MEDSearch

SEPTEMBER 29, 2023

The HYDR ogel A ugmentation F or I ntervertebral L umbar D iscs (HYDRAFIL-D) Study , is a multicenter, single-blinded, randomized, controlled trial to evaluate the safety and efficacy of the HYDRAFIL System for treatment of chronic low back pain due to degenerative disc disease. Vapotherm (NYSE:VAPO), and National Sleep Technologies.

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European Pharmaceutical Review

DECEMBER 23, 2024

14 This in turn has led to the introduction of safety-based limits, 15 eg, permitted daily exposures (PDEs), etc. ICH Q6A 1 states that specifications should focus on those characteristics found to be useful in ensuring the safety and efficacy of the drug substance and drug product. 2024; 113: 837-855. 25 June 2024.

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Medgadget

SEPTEMBER 29, 2023

We aim to optimize the device’s design for enhanced safety, reliability, and patient comfort and are targeting FDA IND submission and approval in late 2024 to conduct a Phase I first-in-human study in 2025.

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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

Nixon Gwilt Law

JULY 23, 2024

In last year’s 2024 Medicare Physician Fee Schedule Proposed Rule, CMS included a Request for Information on use cases for digital health and digital therapeutics interventions. The Proposed Rule also requires that such FDA clearance occurs under 21 CFR 882.5801, which is limited to substance abuse disorder, insomnia, and depression.

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