Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. In July 2022, GSK acquired the therapy as part of its $1.9bn acquisition of Sierra Oncology.

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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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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. percent was observed.

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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. Every year 2.3

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Pharmaceutical Technology

DECEMBER 21, 2022

This could spell high-stake consequences for consumers whose privacy and safety could be at risk if AI models are not regulated. Major AI deals in 2022. However, in 2022, other major players have also stepped up. Here are some of the initiatives that have been in the news in 2022. FDA and EMA action.

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European Pharmaceutical Review

DECEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Gilead’s Sunlenca (lenacapavir), a capsid inhibitor for adults living with human immunodeficiency virus type 1 (HIV-1), who cannot be successfully treated with other available treatments. As part of the trial, patients were enrolled into one of two study groups. In this group, 87.5

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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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pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. An oral version of edaravone was cleared this year.

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PM360

SEPTEMBER 15, 2022

In many of the states where abortion is banned, strictly regulated, or soon to be restricted, the procedure is legal only in instances of a life-threatening situation, but no regulations define what such a situation may be, leaving 70% of physicians unclear about when to intervene for maternal safety. Qualio surveyed 2,002 U.S.

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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. The approval provides patients implanted with the Evoke ® System the ability to undergo 1.5 head and extremity and 1.5T

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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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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 NSAA measures functional motor abilities in DMD patients.

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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

DECEMBER 11, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The post US FDA grants Fast Track status for Pfizer-BioNTech’s combination vaccine appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

JUNE 9, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of AstraZeneca’s and Sanofi’s respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) prophylactic nirsevimab for use in newborns and infants entering their first RSV season. However, Dr.

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Legacy MEDSearch

AUGUST 15, 2022

This first-generation anatomical segment analysis tool emerged over 10 years ago from research aimed at detecting subtle volumetric and shape abnormalities in patients with mild traumatic brain injury. More importantly, it provides point-based correspondence longitudinally and across patients. About ClearPoint Neuro.

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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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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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Pharmaceutical Technology

APRIL 18, 2023

Members of the FDA’s Antimicrobial Drugs AdCom voted 12-0 for the drug’s potential approval based on a positive benefit-risk assessment. The agency accepted the drug’s new drug application (NDA) for priority review in November 2022. The application’s PDUFA date was set to 29 May 2023. Entasis is a subsidiary of Innoviva.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

This week, at the European Society of Medical Oncology (ESMO) Congress 2022 researchers presented encouraging updates on immunotherapies in the field of cervical cancer. Positive data with checkpoint inhibitor combinations in particular garnered attention for their potential in broader patient groups. and 30.6%, respectively.

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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. Today, we still can’t easily discern whether a patient took their pill or not and the reason why. Michael Oleksiw.

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Legacy MEDSearch

NOVEMBER 10, 2022

announced consistent and significant blood pressure (“BP”) lowering results across a range of patients with uncontrolled hypertension, including across differences in age, sex, baseline blood pressure, medication level and ethnicity. A favorable safety profile was consistently observed following uRDN treatment across the studies.

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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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PM360

DECEMBER 14, 2022

In its latest venture into the healthcare arena, Amazon is reaching out directly to the consumer via its soon-to-be-launched Amazon Clinic , a virtual health service for patients to see licensed clinicians about common medical issues. So far, the FDA has only granted the interchangeability status to four of the 39 biosimilars it has approved.

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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 percent and 34.2

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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

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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European Pharmaceutical Review

MARCH 4, 2024

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 The emergency use approval from the FDA of lipid nanoparticle- (LNP-) based mRNA vaccines during the COVID-19 pandemic attested the significance of LNPs.

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Clarivate

OCTOBER 10, 2022

Clarivate oncology experts share key takeaways from the 2022 ESMO Congress and their expected impact on the drug treatment landscape and patients. Read on to for insights from our analysts on: Global highlights from ESMO 2022. Key ESMO 2022 highlights from Mainland China. Seven global highlights from ESMO 2022.

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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. Imbruvica is indicated for such patients following failure of one or more lines of systemic therapy.

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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. This ‘quick-approval, quick-withdrawal from the market’ utilised in accelerated approval can benefit both industry and patients alike.

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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). First medicine approved in EU for eosinophilic esophagitis What did the data from the Phase III Dupixent study show?

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pharmaphorum

SEPTEMBER 29, 2022

Sanofi and Regeneron have claimed the first approval in the US for a drug for prurigo nodularis, after the FDA gave a green light to Dupixent as a treatment for adults with the rare skin disease following a priority review. Here is a patient (*written consent obtained) I saw just 2 weeks ago with severe disease. — Brian S.

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PM360

OCTOBER 27, 2022

Patients with DEB experience extensive skin erosions in response to minor injuries or frictions, such as rubbing or scratching. At its root, the missing or mutated gene in DEP patients disrupts the normal functioning of Collagen VII (COL7), a protein that plays a crucial role in adhesion of epidermis to the dermis.

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Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

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Legacy MEDSearch

JULY 21, 2023

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration (FDA) for UroActive. .

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European Pharmaceutical Review

DECEMBER 13, 2022

The following year, the US Congress passed the 1938 Federal Food, Drug and Cosmetic (FD&C) Act, which mandated safety assessments prior to the release of any new drug. There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007. 05 October 2022. 400(10361); 2022; 1395. References.

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