pharmaphorum

NOVEMBER 2, 2022

In many ways, medicine has advanced rapidly and in myriad ways over the last few decades, and yet the opioid epidemic in the US proved that the challenge of helping patients in pain remains a difficult one to address. The study lasted one year and assessed patients with back pain who had received traditional treatments prior to using Jogo-Gx.

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Food and Drug Administration Food Patients FDA 135

pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. The patient centricity movement has been building momentum in recent years. Building relevance.

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Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. dL) for the patients.

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Food and Drug Administration FDA Safety Food 105

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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Pharmaceutical Technology

JUNE 21, 2023

CSL announced the first patient with haemophilia B has been treated with its recently approved gene therapy Hemgenix (etranacogene dezaparvovec). In the study, Hemgenix reduced or eliminated the need for prophylactic treatment in 94% of patients. Hemgenix is the first and only gene therapy approved for haemophilia B.

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Pharmaceutical Technology

JANUARY 16, 2023

In October last year, CARsgen submitted a new drug application (NDA) for CT053 to China’s National Medical Products Administration (NMPA). The US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations to the company’s zevor-cel in 2019.

Medicine 119

Medicine Food and Drug Administration Food Medical 119

European Pharmaceutical Review

AUGUST 1, 2022

The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said. The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team.

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Food and Drug Administration Medical Medicine Engineering 122

pharmaphorum

JANUARY 24, 2023

Drug development has long been an issue for the pharma industry, due to the expense and the high failure rate of potential treatments. Ben Hargreaves finds that the vast amount of genetic data that exists today could help provide a faster, more targeted way of developing new drug candidates.

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Food and Drug Administration Pharma Medicine Healthcare 98

European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. Ultimately, the regulatory body hopes the approach will result in more treatment options and improved patient outcomes.

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European Pharmaceutical Review

AUGUST 11, 2023

Crizanlizumab is a once-a-month, humanised monoclonal antibody infusion, indicated for the prevention of recurrent vaso‑occlusive crises (pain crises) in sickle cell disease patients aged 16 years and above. Adakveo (crizanlizumab) received conditional authorisation by the EC in October 2020.

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Marketing Food and Drug Administration Medicine FDA 98

European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

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Food and Drug Administration Manufacturing Food Medicine 98

European Pharmaceutical Review

SEPTEMBER 2, 2022

An RMP is submitted as part of the dossier of all new drug applications and is evaluated by regulatory authorities before authorisation is given. Jouaville: Most RMM effectiveness studies are formatted as surveys or drug utilisation studies (DUS). How is the efficacy of RMMs assessed? These guidelines have been updated recently.

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Food and Drug Administration Medicine Safety Food 96

European Pharmaceutical Review

JANUARY 29, 2024

In reviewing both the revised ISO standard and FDA study discussed, it is clear robust evaluation of toxicological substances such as extractables and leachables remain a key part of device-drug combination product and medical device safety assessments.

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Food and Drug Administration Medical Safety Food 98

Legacy MEDSearch

FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. These initiatives are core to our transformative approach to MR imaging, making it a reality for a growing number of patients in the fast-evolving diversity of sites of care.” Hyperfine, Inc., Hyperfine, Inc.

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European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. billion by 2030. How has the gene therapy landscape evolved over the last several years?

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Pharmaceutical Food and Drug Administration Medicine Patients 96

European Pharmaceutical Review

JANUARY 19, 2023

The contribution will enable the programme to reach additional physicians and medical students, further expanding the initiative that aims to extend the reach of clinical trials in underserved patient populations in US communities. The Winn Award Program has so far trained 114 early-stage investigator physicians.

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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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PM360

DECEMBER 20, 2024

Clinical trials can offer life saving treatments to patients in need. In 2020, the U.S. Food and Drug Administration reported that 75% of clinical trial subjects were white, while only 6% were Asian, 8% were Black, and 11% were Hispanic. Reference 1. Allison K, Patel D, Kaur R.

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Pharmaceutical Technology

MAY 24, 2023

Inovio has received orphan drug designation for INO-3107 from the European Commission (EC) to treat recurrent respiratory papillomatosis (RRP). In July 2020, the US Food and Drug Administration (FDA) also granted orphan drug designation to INO-3107.

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Food and Drug Administration Medicine Food Marketing 52

Legacy MEDSearch

AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. NaviBot is subsidiary of MicroPort MedBot. About MicroPort MedBot Shanghai MicroPort MedBot (Group) Co.,

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Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

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Pharmaceutical Technology

MARCH 22, 2023

Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. In recent times, suppliers have also chosen other systems that rely on blockchain and sensors to track drug supply and reduce the influx of counterfeit drugs.

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Pharmaceutical Technology

MAY 5, 2023

The European Medicines Agency’s (EMA) committee for medicinal products for human use (CHMP) has recommended full marketing authorisation (MA) for Gilead Sciences ’ Hepcludex (bulevirtide) to treat chronic hepatitis delta virus (HDV) and compensated liver disease in adult patients.

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Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Accord BioPharma is the US specialty division of Intas Pharmaceuticals. Biosimilars are key to making healthcare more affordable and accessible.

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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. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

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European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics.

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European Pharmaceutical Review

JULY 13, 2023

However, even as science advances, there remain patients who still need new treatment options. By re-engineering existing approaches that have already shown clinical promise, there is potential to bring further benefit to the patient community in its fight against cancer.

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Engineering Food and Drug Administration Patients Safety 98

Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. N) = number of approvals.

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Pharmaceutical Technology

DECEMBER 5, 2022

Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN. Key opinion leaders (KOLs) interviewed by GlobalData believe this may have significant impact on patients as the less-invasive route of administration will be preferred by many.

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Pharma Leaders

JUNE 27, 2023

An oral inhibitor of hypoxia-inducible factor prolyl hydroxylase, daprodustat is intended for usage in adult patients who are on chronic maintenance dialysis. The company is developing the therapy as an oral treatment option for CKD patients with anaemia. CKD is characterised by gradual kidney function loss.

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Food and Drug Administration Medicine Food Safety 52

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). Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication?

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Food and Drug Administration Safety Patients Medicine 98

Pharmaceutical Technology

JUNE 27, 2022

Currently, the drug is indicated to treat metastatic or locally advanced epithelioid sarcoma in adults and paediatric patients aged 16 years and above who are not eligible for complete resection and adult patients with relapsed or refractory follicular lymphoma (FL) without any alternative treatment options.

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Food and Drug Administration FDA Food Patients 59

Pharmaceutical Technology

JUNE 19, 2023

In 2020, both companies initially collaborated for Biomm’s distribution and marketing of Bio-Thera’s bevacizumab biosimilar, BAT1706, in Brazil. It has also been approved for the treatment of moderate to severe PsA in patients aged six years or above and adult patients with moderate to severe active Crohn’s disease.

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Pharmaceutical Technology

SEPTEMBER 6, 2022

The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted priority review for InnoCare Pharma ’s orelabrutinib to treat relapsed or refractory marginal zone lymphoma (R/R MZL). The therapy obtained conditional approval from the NMPA for two indications in December 2020.

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Pharmaceutical Technology

MAY 3, 2023

Lupkynis is a new structurally modified calcineurin inhibitor (CNI) indicated for the treatment of active class III, IV and V (including mixed classes III/V and IV/V) lupus nephritis (LN) in adult patients. Lupkynis has also received orphan drug designation in Switzerland. This promotes podocyte stability in the kidneys.

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Pharmaceutical Technology

JANUARY 23, 2023

The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018. Takeda Global Oncology Business Unit president Teresa Bitetti said: “Fruquintinib has the potential to change the treatment landscape for patients with refractory metastatic CRC who are in need of additional treatment options. “We

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Pharmaceutical Technology

APRIL 26, 2023

Patients will receive the digital therapy through their mobile phone applications over a 12-week period, and its efficacy will be evaluated based on the difference in the number of monthly migraine days. Click teamed up with Boehringer Ingelheim in September 2020 to develop and commercialise a digital therapeutic to treat schizophrenia.

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