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).

Marketing 80

Marketing Food and Drug Administration Medicine Food 80

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. .

Food and Drug Administration 80

Food and Drug Administration Medical Patients FDA 80

European Pharmaceutical Review

SEPTEMBER 8, 2023

There were also 54 percent to 88 percent of patients who reached a five percent or greater reduction in body weight. Tirzepatide has been shown… [to lead] to substantial weight loss of, on average, 15 percent over 70 weeks. The US Food and Drug Administration (FDA) first approved tirzepatide for type 2 diabetes in May 2022.

Food and Drug Administration 95

Food and Drug Administration Medicine Food Manufacturing 95

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.

Food and Drug Administration 52

Food and Drug Administration Food Medicine Safety 52

Pharma Marketing Network

MARCH 23, 2023

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. This approval marks a major milestone in the fight against Alzheimer’s, which is the sixth leading cause of death in the United States and affects over 5 million people.

Food and Drug Administration 52

Food and Drug Administration FDA Consulting Food 52

Pharmaceutical Technology

MAY 23, 2023

In 2022, Avrobio’s investigational gene therapy, AVR-RD-04, received a rare paediatric disease designation from the US Food and Drug Administration. The company will also provide knowledge transfer and other related services to support the programme’s transition.

Food and Drug Administration 103

Food and Drug Administration Food Leads Pharmaceutical 103

European Pharmaceutical Review

JULY 13, 2023

1,2 Moreover, except for countries such as Czechia, Denmark and Germany, the cost of these medications is borne by the patient, rather than national insurance or healthcare systems. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside.

Medical 84

Medical Food and Drug Administration Pharmacology Medicine 84

Pharmaceutical Technology

MAY 12, 2023

Last month, the US Food and Drug Administration (FDA) granted the treatment an orphan drug designation for sickle cell disease. In December 2022, the company presented data from the first two patients treated in the Phase I/II RUBY (NCT04853576) trial. At baseline, 77.7% was made up of HbF.

Food and Drug Administration 98

Food and Drug Administration Food Safety Patients 98

PM360

AUGUST 9, 2022

Following the annual American Society of Clinical Oncology (ASCO) conference, oncologists were asked how the data presented would impact their care of patients. Another 17% recommended mandating patient recruitment requirements and 14% would like to see the development of a diverse pool of investigators and staff.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

Pharmaceutical Technology

APRIL 19, 2023

While the Clarksville, US-based company completed a Phase Ia study in healthy participants to eventually develop the drug for Alzheimer’s disease, it is likely that the company will now focus on Parkinson’s disease in its Phase II study first, said Kelleher-Andersson. Similarly, research collaborations are also a consideration.

Food and Drug Administration 52

Food and Drug Administration Recruitment Prospecting Food 52

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. This leads to psychological harm becoming a significant factor in chronic pain, alongside the physical symptoms.

Food and Drug Administration 133

Food and Drug Administration Food FDA Patients 133

Pharmaceutical Technology

JUNE 5, 2023

Led by the investment company Temasek, the round will also be used to improve the company’s commercial readiness as its lead radiopharmaceutical candidate ITM-11 is being studied in Phase III trials in gastroenteropancreatic neuroendocrine tumours (GEP-NETs). Other investors included BlackRock, the Qatar Investment Authority, and Nextech.

Food and Drug Administration 59

Food and Drug Administration Food Manufacturing Patients 59

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).

Food and Drug Administration 52

Food and Drug Administration Patients Safety Recruitment 52

Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Both drugs have generic equivalents available and are PDE5 inhibitors that can take 30 to 60 minutes to kick in.

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52

Pharmaceutical Technology

APRIL 27, 2023

The CHMP used evidence from a Phase III trial ( NCT03729362 ) involving 123 patients with late-onset Pompe Disease (LOPD) to adopt a positive opinion for Opfolda. Sanofi’s Nexviazyme generated €196m ($215m) in global revenues in 2022, while Lumizyme was associated with €958m ($1.05bn) according to the company’s full-year report.

Food and Drug Administration 52

Food and Drug Administration Food Marketing Medicine 52

Legacy MEDSearch

JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive patient remote control. Axonics, Inc.,

FDA 98

FDA Food and Drug Administration Recruitment Medical 98

pharmaphorum

JANUARY 23, 2023

Beijing-based pharma, BeiGene’s Brukinsa (zanubrutinib) has been approved by the US Food and Drug Administration (FDA) for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). of patients and Grade 3 or higher ventricular arrythmias in 0.2% of patients.

FDA 52

FDA Food and Drug Administration Food Patients 52

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.

Food and Drug Administration 84

Food and Drug Administration Manufacturing Food Medicine 84

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

Pharmaceutical 95

Pharmaceutical Food and Drug Administration Medicine FDA 95

European Pharmaceutical Review

JUNE 27, 2023

difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. This followed results from a large metagenomics study published in November 2022, in which gut microbiome was identified as a key part of Parkinson’s pathogenesis.

Food and Drug Administration 97

Food and Drug Administration Manufacturing Medicine Pharma 97

European Pharmaceutical Review

NOVEMBER 4, 2022

Nevertheless, chemotherapy’s disadvantages, including substantial toxicities, combined with inconvenient hospital-based intravenous (IV) administration, impede patients’ ability to stay on treatment and their quality of life. tumour effects. The importance of taxanes in oncology.

Food and Drug Administration 80

Food and Drug Administration FDA Pharmaceutical Patients 80

European Pharmaceutical Review

AUGUST 10, 2022

“We are excited to join in the Tavneos launch and help many more patients with this serious and sometimes life-threatening disease for which there remains significant unmet medical need. ” US sales of Tavneos in the first quarter of 2022 were $5.4

Food and Drug Administration 75

Food and Drug Administration Pharmaceutical Food Medical 75

European Pharmaceutical Review

FEBRUARY 15, 2023

Final analyses of a Phase II trial for resectable non-small cell lung cancer (NSCLC) has concluded that 60 percent of patients treated with neoadjuvant nivolumab remained recurrence-free five years after surgery. In the trial, 20 stage I-III resectable NSCLC patients were treated with two doses of neoadjuvant nivolumab.

Food and Drug Administration 86

Food and Drug Administration Patients Food Networking 86

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?

Food and Drug Administration 90

Food and Drug Administration Safety Patients Medicine 90

Legacy MEDSearch

MARCH 15, 2023

In February 2022, HeartBeam partnered with LIVMOR to build a HeartBeam-branded version of LIVMOR’s FDA-cleared Halo cloud-based software platform to connect physicians and patients. The acquisition extends HeartBeam’s reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product.

Food and Drug Administration 97

Food and Drug Administration FDA Recruitment Physicians 97

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

Food and Drug Administration 77

Food and Drug Administration Manufacturing Safety Transportation 77

Legacy MEDSearch

FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. We are committed to continuous improvement to optimize the clinical utility of the Swoop® system while driving commercial adoption across leading institutions globally. Hyperfine, Inc., Hyperfine, Inc.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

PM360

MARCH 22, 2024

Amor Vegas stated, “T cells have the ability to develop memory and persist in your body for really long periods, which is very different from a chemical drug. Think about patients who need treatment multiple times per day versus you get an infusion and then you’re good to go for multiple years.”

Food and Drug Administration 52

Food and Drug Administration FDA Healthcare Healthcare 52

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

Management 75

Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 75

Pharmaceutical Technology

APRIL 4, 2023

of NSCLC patients with exon 19 and 21 mutations develop resistance mutations at C797S. While Scorpion will lead the development of STX-721, Pierre Fabre will handle STX-241. On April 3, the company said it selected the drug STX-241 as its next development candidate, and that it plans to present related preclinical data in H2 2023.

Food and Drug Administration 52

Food and Drug Administration Biopharma FDA Pharmaceutical 52

Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 52

Nixon Gwilt Law

DECEMBER 16, 2021

What can Healthcare and Life Sciences businesses and investors anticipate for the healthcare industry in 2022? What do you think will be the biggest surprise of 2022? Anything else you'd like to share about 2022 predictions and trends? And now you get the benefit of all that experience as we lay out what to look for in 2022.

Healthcare 52

Healthcare Healthcare Food and Drug Administration Ethics 52

Legacy MEDSearch

JANUARY 18, 2023

Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year. IntelliSep will be available in the United States in the coming weeks.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Physicians 98

Pharmaceutical Technology

MAY 16, 2023

The company plans to announce follow-up data from 26 patients of its US-based Phase I/II study of AMT-130 in Q2 2023, based on a May 9 release. Patients with the condition can suffer from spontaneous and prolonged bleeding, as they lack factor IX that is involved in blood clotting. Haemophilia A affects patients’ factor VIII levels.

Food and Drug Administration 52

Food and Drug Administration Healthcare Healthcare Sales 52

European Pharmaceutical Review

MARCH 2, 2023

This article explores some of the most notable developments of 2022, and areas that are likely to be a growing focus for data-driven transformation in 2023. Improvements were also seen in the drug development process itself. The transition to the new registration system has begun in earnest now.

Food and Drug Administration 83

Food and Drug Administration Government Management Medicine 83

PM360

OCTOBER 25, 2023

Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. 1 Between 2022 and 2023, 47% of Phase III oncology trials involved combination therapies, a number that continues to grow over time (see Figure 1). 3 (2022): e222265. References: 1. Benjamin, Alexander Xu, Mark P.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Marketing Pharmaceutical manufacturing 105

European Pharmaceutical Review

MARCH 7, 2024

Last month, construction began on Europe’s first industrial-scale facility dedicated to the production of lead-212 based radioligand therapies. billion between 2022 to 2027. percent for the gastroenteropancreatic neuroendocrine tumours (GEP-NET) patients who had never received radioligand therapy).

Manufacturing 52

Manufacturing Food and Drug Administration Marketing Management 52