Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. The company plans to submit an MAA to the EMA in H1 this year.

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PM360

AUGUST 9, 2022

The industry has been limited in its ability to implement creative solutions to engage and motivate patients because the FDA has strict guidelines for what pharma companies can communicate with patients. Measuring and monitoring adherence in clinical trials would add valuable information about the effectiveness and safety of drugs.

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Legacy MEDSearch

MARCH 13, 2023

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. The post Vivasure Medical Announces FDA IDE Approval to Initiate U.S.

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European Pharmaceutical Review

NOVEMBER 19, 2024

This new collaboration is set to further improve safety and efficacy of radiopharmaceuticals. The US Food and Drug Administration (FDA) approved Novartis’ Pluvicto (lutetiumlutetium Lu 177 vipivotide tetraxetan) in 2022. “Radioligand therapies hold transformative potential for certain forms of cancer.”

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European Pharmaceutical Review

DECEMBER 21, 2022

But in early 2022, the country’s health minister announced his approval of research into psychedelic therapies and increased funding for mental health research. 3 This notice came on the heels of a January 2022 notice that clarified Health Canada’s desired approach to psilocybin research. Breakthrough therapy designation.

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European Pharmaceutical Review

FEBRUARY 22, 2023

1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. He is currently a CMC consultant with an interest in impurities and safety‑based limits. FDA; 2018 [cited 2023Jan]. Internet] 2022.

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Legacy MEDSearch

AUGUST 15, 2022

“The current version will enable reproducible analysis of patient data which will provide immediate value for our current and future biologics and drug delivery partners as they study volumetric infusion characteristics and longitudinal patient comparisons as part of their safety and pivotal trials. About ClearPoint Neuro. Are you hiring?

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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Pharmaceutical Technology

FEBRUARY 26, 2023

This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times. While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold.

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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

DECEMBER 5, 2022

MOMENTUM was a randomised, double-blind Phase III clinical trial of momelotinib versus danazol in symptomatic and anaemic myelofibrosis patients treated with a US Food and Drug Administration (FDA)-approved JAK inhibitor.

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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. The KM-estimated median duration of HG recurrence-free survival was six months, with a 30.1

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European Pharmaceutical Review

NOVEMBER 7, 2022

has announced its B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb) elranatamab for relapsed or refractory multiple myeloma (RRMM) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). The investigation noted elranatamab delivered a manageable safety profile. Pfizer Inc.

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PM360

OCTOBER 27, 2022

Krystal’s Phase 3 randomized, double-blind, intra-patient placebo-controlled study evaluated the efficacy and safety of B-VEC as a redosable gene therapy in DEB patients aged 6 months and older. Subjects returned to the clinical site 30 days following the last dosing visit for safety evaluation by the trial investigator.

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Pharma Marketing Network

MAY 3, 2023

In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

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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”. Results also indicated the investigational vaccine was well-tolerated, with no safety concerns. “We g RSVpreF or placebo in a 1:1 ratio. percent was observed.

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European Pharmaceutical Review

JANUARY 26, 2023

These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products. The US Food and Drug Administration (FDA) implementation date was 7 November 2022. The draft ICH M10 guideline was published for comments in 2019.

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European Pharmaceutical Review

JANUARY 25, 2023

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively. Costs and profits worldwide are shared with CRISPR Therapeutics.

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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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pharmaphorum

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.

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European Pharmaceutical Review

MAY 8, 2024

Although we have yet to understand the human microbiome and its role in disease fully, the scientific evidence on the efficacy of complex live biotherapeutic products (LBPs) in modulating the microbiome is striking, as evidenced by the approval of the first two commercial donor-derived products, Rebyota and VOWST, in 2022 and 2023, respectively.

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European Pharmaceutical Review

JANUARY 26, 2024

The US Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) as a treatment for children patients aged one to 11 years, weighing at least 15kg with eosinophilic esophagitis (EoE). This new authorisation by the FDA’s expands its initial approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40kg.

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European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). 2022; 10(1). 2022; 24(2): 89 – 97. References 1. Garrido P et al.

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pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease.

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European Pharmaceutical Review

AUGUST 30, 2022

The report, Clinical Trials – The Importance of Diversity in Clinical Trials , examined data from clinical trials initiated between 1 January 2013 and 16 June 2022. Earlier this year the US Food and Drug Administration (FDA) published draft guidance to support companies in enrolling more ethnically diverse trial populations.

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pharmaphorum

NOVEMBER 29, 2022

During the ‘Next-Generation Cytokine Therapy’ session at the Society for Immunotherapy of Cancer’s (SITC) 2022 annual meeting, Dr A Naing (University of Texas MD Anderson Cancer Center) presented the results from two cohorts of patients from the phase 2a clinical trial NIT-110, with relapsed/refractory (r/r) gastrointestinal indications.

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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. g/dL and 45.4%

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pharmaphorum

SEPTEMBER 27, 2022

The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022. Initial phase 1/2a clinical findings for in CLL and multiple myeloma patients showed evidence of anti-tumour activity and an encouraging safety profile, with further readouts due before the end of the year.

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Pharma Marketing Network

MARCH 25, 2022

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. Accessed March 21, 2022. Accessed March 12, 2022. What Can Pharma Do?

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Impetus Digital

JUNE 8, 2022

It used to take years for a drug to progress from laboratory research to FDA approval. The FDA’s recently-launched Real-Time Oncology Review program is a good example of this modernization. The post The Latest Biotech Trends of 2022 appeared first on Impetus Digital. Faster Pharmaceutical Testing and Approvals.

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European Pharmaceutical Review

DECEMBER 6, 2023

The US Food and Drug Administration (FDA) has approved the first oral monotherapy treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH). Over one-third of those patients require blood transfusions at least once per year, according to research published in a 2017 paper in Blood and a 2022 paper in Annals of Hematology.

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Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). The approval of Tzield, a first-in-class therapy, adds an important new treatment option for certain at-risk patients,” says an FDA spokesperson.

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European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent.

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Pharmaceutical Technology

MAY 12, 2023

Editas Medicine will release new efficacy and safety results of its gene therapy EDIT-301 in severe sickle disease as part of an oral presentation at the European Hematology Association’s (EHA) Hybrid Congress. Last month, the US Food and Drug Administration (FDA) granted the treatment an orphan drug designation for sickle cell disease.

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Pharmaceutical Technology

NOVEMBER 9, 2022

A previous October 2020 report concluded that longer-term safety and efficacy were needed to update health-benefit price benchmarks. In August 2020, the agency had rejected an approval application, suggesting the company complete its Phase III Gener8-1 study and include two-year follow-up safety and efficacy data. million ($1.5

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Pharmaceutical Technology

AUGUST 25, 2022

The US Food and Drug Administration (FDA) has gra nted approval for AbbVie and Janssen Biotech’s Imbruvica (ibrutinib) to treat chronic graft versus host disease (cGVHD) in paediatric patients aged one year and above. The post US FDA approves AbbVie-Janssen’s Imbruvica for cGVHD in children appeared first on Pharmaceutical Technology.

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Legacy MEDSearch

SEPTEMBER 26, 2023

Food and Drug Administration (FDA) has approved MRI conditional labeling for the Evoke ® System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy powered by SmartLoop technology. Specific scan conditions and safety information are provided in the Evoke ® SCS System MRI Guidelines manual. Are you hiring?

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