European Pharmaceutical Review

OCTOBER 6, 2022

The US Food and Drug Administration (FDA) has approved Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY anti-HER2 (4B5) test), which identifies low HER2 expression in metastatic breast cancer. High levels of HER2 mean patients are HER2-positive and thus are suited to HER2-targeted treatment.

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Pharmaceutical Technology

MAY 22, 2023

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. In March 2022, the US Food and Drug Administration approved the IND application for SM17 to treat asthma.

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European Pharmaceutical Review

OCTOBER 25, 2022

AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) combination therapy has been approved in the US for adult patients with unresectable hepatocellular carcinoma (HCC). Phase III trial results found that three years post-treatment, 31 percent of patients given the drug combination were still alive. p=0.0035).

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Clarivate

JUNE 23, 2022

As part of our Drugs to Watch series, our team of oncology experts pored over thousands of abstracts for presentations at this year’s just-concluded American Society of Clinical Oncology (ASCO) Annual Meeting. It targets mismatch repair deficiency, a biomarker seen in 25-30% of patients with endometrial cancer.

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Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.

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Food and Drug Administration Engineering Patients Food 105

European Pharmaceutical Review

DECEMBER 5, 2022

Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, and JAK2 and activin A receptor type I (ACVR1), which could help myelofibrosis patients with anaemia. Patients were randomised at 2:1 to receive either momelotinib or danazol (n=130 and n=65, respectively).

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European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). 2 With this new indication, more patients will be able to access this innovative treatment.

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Pharmaceutical Technology

MAY 25, 2023

18/072,154, filed on 30 November 2022. The tablet form of metronidazole has been the only approved oral form of the drug available on the US market. ATI-1501 has been designed to enable the wider use of metronidazole in patients who have difficulty swallowing.

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European Pharmaceutical Review

NOVEMBER 16, 2022

The drug will support patients in the worsening opioid crisis in the US, driven by the increased prevalence of synthetic opioids, such as fentanyl. Other drugs in Opiant’s development pipeline include OPNT004, a CB-1 antagonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose (ACO).

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European Pharmaceutical Review

APRIL 12, 2024

There has been a “notable” rise in licensing agreements for innovator drugs incorporating clustered regularly interspaced short palindromic repeats (CRISPR)-based technology for gene therapies over the past five years, according to data and analytics firm GlobalData. Of note, between 2020 to 2022, there was a “remarkable surge” in deal worth.

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Clarivate

JUNE 26, 2023

Obtaining the preferences of patients and their caregivers is not a new concept in healthcare. Increasingly, however, industry guidance documents utilize the term ‘patient preference’ in relation to new drug development and benefit-risk assessment.

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Food and Drug Administration Patients Side effects Medicine 52

Pharmaceutical Technology

APRIL 5, 2023

Shionogi has obtained fast track designation from the US Food and Drug Administration (FDA) for its ensitrelvir fumaric acid, an investigational oral antiviral drug for the treatment of Covid-19. The firm also plans to initiate new studies to further assess the drug. It has not received approval outside Japan.

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Food and Drug Administration FDA Food Safety 52

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults.

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Legacy MEDSearch

DECEMBER 7, 2022

The company hit an important milestone in March 2022 when it received U.S. Food and Drug Administration market clearance for the ArthroFree System. This was followed in September 2022 by another important step as the first surgery using the system was performed by orthopedic surgeon Laith M. Are you hiring?

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European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades.

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Pharmaceutical Technology

APRIL 26, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). We eagerly anticipate enrolling our first Phase II patients for INB-400 later this year.”

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European Pharmaceutical Review

JANUARY 11, 2023

Eisai has submitted a Marketing Authorisation Application (MAA) for lecanemab, for early Alzheimer’s (mild cognitive impairment due to Alzheimer’s (AD) and mild AD dementia) patients in Europe. The submission comes just after lecanemab’s recent accelerated approval by the US Food and Drug Administration (FDA).

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European Pharmaceutical Review

DECEMBER 1, 2023

AbbVie has agreed to acquire ImmunoGen and its first-in-class antibody-drug conjugate (ADC) ELAHERE ® (mirvetuximab soravtansine-gynx), for a total of approximately $10.1 The antibody-drug conjugate is the first to be approved for platinum-resistant ovarian cancer (PROC) and show meaningful survival benefit for this form of the disease.

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European Pharmaceutical Review

JANUARY 3, 2023

A marketing authorisation application (MAA) has been submitted by The Janssen Pharmaceutical Companies of Johnson & Johnson to the European Medicines Agency (EMA) for approval of talquetamab, a bispecific t-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).

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European Pharmaceutical Review

JANUARY 4, 2024

New research from the US indicates that a prophylactic treatment before immunotherapy can significantly reduce the rate of cytokine release syndrome (CRS) in multiple myeloma patients. Immunotherapy drugs like teclistamab can result in potentially fatal side effects, including CRS and immune cell-associated neurotoxicity syndrome (ICANS).

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European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

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Pharmaceutical Technology

SEPTEMBER 13, 2022

Although many patients are diagnosed with early-stage disease, almost a third progress to metastatic disease, with a five-year survival rate of just 30%. Gilead’s Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate (ADC), with a potent topoisomerase I inhibitor payload.

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European Pharmaceutical Review

AUGUST 30, 2022

Based on the results, Pfizer said it intends to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for RSVpreF “in fall 2022”. However, there are currently no prophylactic or therapeutic options for this group of patients. g RSVpreF or placebo in a 1:1 ratio.

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

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Pharmaceutical Technology

MAY 17, 2023

The Inflation Reduction Act, which became US law in August 2022, has invited its fair share of critics and supporters over its drug pricing provisions. While negotiating drug prices is common practice in other major markets, CMS had not previously held the legal authority to do so.

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Food and Drug Administration Pharma Patients Pharmaceutical research 52

Clarivate

SEPTEMBER 11, 2024

Timely and accurate diagnosis is critical to maximize the efficacy of available interventions – but for most individuals, the diagnostic journey remains long, complex and costly (Alzheimer’s Disease International, 2021; Chiari, 2022; Juganavar, 2023). Currently, of the eight drugs approved by the U.S. 2024; Quanterix, 2024).

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Pharmaceutical Technology

JUNE 16, 2023

Avenge Bio has obtained orphan drug designation from the US Food and Drug Administration (FDA) for its AVB-001 to treat mesothelioma patients. 2022 saw approximately 3,000 new cases reported in the US while approximately 2,500 people died from the disease.

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Food and Drug Administration FDA Safety Food 52

European Pharmaceutical Review

JANUARY 23, 2023

The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Evaxion Biotech’s personalised cancer immunotherapy. The FTD is for EVX-01, in combination with Keytruda ® for patients with metastatic melanoma (MM). ”We Moderna, Inc.

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Food and Drug Administration FDA Food Patients 124

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. In patients with severe symptoms, a dosage of 30mg can be considered.

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Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. months , compared to 15.1

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European Pharmaceutical Review

MAY 12, 2023

“There is a large unmet medical need within myelofibrosis, in particular for patients suffering from thrombocytopenia who are inadequately treated by existing medicines. Advancing haematology treatments According to CTI BioPharma, the transaction will diversify Sobi’s portfolio of leading haematology medicines through VONJO.

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Pharmaceutical Technology

JUNE 8, 2023

The use of 4D Molecular Therapeutics’ (4DMT) aerosolised gene therapy 4D-710 has improved the quality-of-life and spirometry-measured outcomes in three cystic fibrosis patients , based on early results from a Phase I/II study presented at this year’s annual meeting of the European Cystic Fibrosis Society (ECFS).

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pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects.

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European Pharmaceutical Review

NOVEMBER 29, 2023

Following the US Food and Drug Administration (FDA)’s approval of Ferring Pharmaceuticals’ gene therapy Adstiladrin ® (nadofaragene firadenovec-vncg) in December 2022, new long-term follow up data has been revealed. percent of patients were cystectomy-free at 36 months. Additionally, 53.8 percent, 36.6

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Pharmaceutical Technology

APRIL 6, 2023

The Singapore Health Sciences Authority (HSA) has accepted Everest Medicines’ new drug application (NDA) for Nefecon to treat adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. Singapore has therefore become the second country to accept the NDA, following mainland China in November 2022.

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Food and Drug Administration Food Medicine Safety 52

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). He added that the approval of Wezlana “could have a meaningful impact for patients managing their disease.” billion in 2022, according to J&J’s financial results.

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