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

European Pharmaceutical Review

MARCH 8, 2024

As for its benefits in pharmacovigilance, the paper explained that GAMP 5 “helps organisations maintain high-quality standards in adverse event reporting and analysis, ensuring the safety of patients and the integrity of data. Therefore, to achieve this, quality by design offers a systematic approach to development, the authors stated.

Pharmaceutical 85

Pharmaceutical Pharma Safety Manufacturing 85

Pharmaceutical Technology

AUGUST 12, 2022

The treatment is indicated for such patients whose tumours have activating HER2 (ERBB2) mutations and previously received systemic therapy. . The latest approval was based on the findings from the Phase II DESTINY-Lung02 clinical trial, which assessed the safety and efficacy of two doses of Enhertu in HER2 mutant metastatic NSCLC patients. .

Food and Drug Administration 105

Food and Drug Administration FDA Safety Engineering 105

Pharmaceutical Technology

JANUARY 27, 2023

The European Union (EU) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (trastuzumab deruxtecan) as monotherapy to treat unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer adult patients.

Engineering 94

Engineering Safety Medicine Patients 94

pharmaphorum

OCTOBER 26, 2022

And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. We try to have a very long-term orientation because we believe that aligns our objectives very well with the objectives of society and the patients we serve, and it makes us a stable business.”.

Patients 68

Patients Pharma Consulting Transportation 68

Pharmaceutical Technology

APRIL 26, 2023

INB-400, an autologous, genetically engineered gamma-delta T cell therapy, is the company’s DeltEx chemotherapy-resistant autologous and allogeneic drug-resistant immunotherapy (DRI) technology. We eagerly anticipate enrolling our first Phase II patients for INB-400 later this year.”

Food and Drug Administration 52

Food and Drug Administration FDA Engineering Food 52

pharmaphorum

OCTOBER 12, 2022

Explore updates to drug device combination product design approaches considering patient preference at the forefront with case studies from big pharma representatives. Eleanor Kimber, Principal Device Engineer, GSK. Markus Hemminger, Principal Medical Device Engineer, Roche. Petra Renne, Senior Expert Engineering, Novartis.

Engineering 52

Engineering Safety Consulting Medical 52

European Pharmaceutical Review

OCTOBER 20, 2022

In recent years there has been significant development within the cell therapy field, as chimeric antigen receptor (CAR) T-cell therapy demonstrated an ability to transform the treatment of patients with haematological malignancies. What are Tregs and how are they applicable to immune-mediated disease?

Engineering 124

Engineering Side effects Manufacturing Patients 124

Pharma Leaders

JUNE 27, 2023

Intended to treat adult patients, fidanacogene elaparvovec is an investigational therapy that comprises a bio-engineered adeno-associated virus (AAV) capsid and a human coagulation Factor IX (FIX) gene variant. Based on the safety and efficacy findings from the Phase III BENEGENE-2 study, the company made these filings.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Engineering 52

European Pharmaceutical Review

DECEMBER 12, 2023

Yannis Morel, Executive Vice President of product portfolio strategy and business development of Innate Pharma SA, offers insight on engineering antibodies to develop antibody-based NK cell therapeutics. A favorable safety profile was also observed. Innate Pharma also developing IPH5201 in collaboration with AstraZeneca. An ORR of 46.4

Pharma 108

Pharma Engineering Safety Patients 108

Pharmaceutical Technology

FEBRUARY 27, 2023

Enhertu has received approval as a monotherapy to treat unresectable or metastatic HER2-positive breast cancer in adult patients who have previously received one or more anti-HER2-based regimens. Being jointly developed and commercialised by the two companies, it is a specifically engineered HER2-directed antibody-drug conjugate (ADC).

Safety 52

Safety Engineering Physicians Patients 52

European Pharmaceutical Review

MARCH 4, 2024

2,3 Biologics, unlike chemically synthesised drugs, are large molecules with complex formulations consisting of proteins and nucleic acids, or their genetically engineered fusion constructs, with a variety of complex molecular moieties from post-transcriptional or translational modification. 2023; 13(3). Drug Deliv. 2021; 12(1):294–305.

Food and Drug Administration 90

Food and Drug Administration Transportation FDA Medical 90

European Pharmaceutical Review

NOVEMBER 20, 2023

Up to 1,000 people, such as engineers, operators and scientists will be employed to leverage state-of-the-art technology. This will ensure that patients have rapid access to new treatment options and make us more independent from fragile supply chains,” commented Professor Dr Karl Lauterbach, Federal Minister of Health.

Manufacturing 85

Manufacturing Medicine Biopharma Engineering 85

Pharmaceutical Technology

JULY 25, 2022

Digitalization is now in full swing as medical care integrates with ICT to take the patient experience to the next level. According to Tom Lenaerts, Head of Global Process Engineering at Datwyler, this transformation will reshape the entire healthcare ecosystem.

Pharmaceutical 114

Pharmaceutical Engineering Healthcare Provider Healthcare 114

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 80

Food and Drug Administration Manufacturing Safety Transportation 80

Healthcare Success

MAY 9, 2022

The QR code allows hospitals and healthcare providers to satisfy this need with immediate physician-patient interaction and engagement – all through smartphones and tablets. . In this blog post, you’ll learn: Why QR codes have made a comeback, When to use them, And, 8 ways to improve the patient experience and drive leads with QR codes. .

Leads 52

Leads Patients Healthcare Provider Healthcare 52

PM360

AUGUST 24, 2023

Accelerating Clinical Trial Timelines Notwithstanding our desire to speed important new medicines to patients in need, the planning, conduct, analysis and synthesis of programs of clinical research is a lengthy process. Increased adoption of patient engagement tools—mainly reliant on smartphone app-based technologies—was a natural response.

Physicians 98

Physicians Patients Engineering Medicine 98

Pharmaceutical Technology

APRIL 28, 2023

Editas had previously announced positive safety and efficacy data with two patients enrolled in the RUBY study, stating that the therapy was well-tolerated and that both patients were successfully engrafted and free of vaso-occlusive events during the follow-up. The first patient had a total haemoglobin level of 16.4

Food and Drug Administration 105

Food and Drug Administration Engineering Patients Food 105

European Pharmaceutical Review

JANUARY 27, 2023

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Clear regulatory expectations and allowing easier product development.

Manufacturing 89

Manufacturing Medicine Consulting Engineering 89

Medgadget

OCTOBER 27, 2022

“Essentially, immune cells of the patient are removed and gene-edited to be cytotoxic for cancer cells, then reintroduced into the patient’s bloodstream. The method allows the researchers to precisely deposit tumor spheroids or other engineered cell constructs into a gel substrate.

Ethics 126

Ethics Engineering Safety Patients 126

Pharmaceutical Technology

JUNE 14, 2023

The therapy comprises liposomes engineered to capture the virulence factors, which are produced by a wide range of Gram-positive and Gram-negative bacteria. The company is currently evaluating CAL02 in a Phase II clinical trial, which is expected to enrol 276 SCABP patients globally.

Food and Drug Administration 52

Food and Drug Administration FDA Engineering Food 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). 4 Amivantamab targets the extracellular portion of the EGFR and MET receptors.

Food and Drug Administration 93

Food and Drug Administration Safety Medicine Patients 93

Penrod

MARCH 25, 2024

The ideal healthcare ecosystem is one where the patient thrives and the hospital functions at peak efficiency. EHR and ERPs: The Foundation of Healthcare Operations EHRs revolutionized healthcare by digitizing patient data and providing a centralized repository for medical histories, conditions, diagnostics, and treatment plans.

Healthcare 52

Healthcare Healthcare CRM Customer Relationship Management 52

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.

Engineering 89

Engineering Food and Drug Administration Safety Patients 89

Pharmaceutical Technology

MAY 3, 2023

BrightPath Biotherapeutics CEO Kenichi Nagai stated: “This collaboration with Artisan provides us with the potential to create highly engineered allogeneic iNKT cellular therapy programmes for a range of indications, including solid tumours. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Engineering 52

Engineering Leads Safety Sales 52

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.

FDA 98

FDA Recruitment Safety Patients 98

Pharmaceutical Technology

APRIL 20, 2023

Antibody-based therapies provide enhanced efficacy and safety whilst reducing the need for frequent administration for autoimmune disease treatment. However, not all patients respond to treatment equally well and the therapies can lead to immunosuppression. As per Maxion, there are more than 80 types of autoimmune conditions.

Engineering 52

Engineering Competition Safety Leads 52

Medgadget

AUGUST 22, 2023

Paulson School of Engineering and Applied Sciences have developed a technique that allows them to 3D print a heart ventricle, that can then go on to beat rhythmically. The technique could unlock more advanced cardiac models for drug testing, and could also permit personalized medicine for cardiac patients.

Medicine 68

Medicine Engineering Safety Patients 68

European Pharmaceutical Review

APRIL 12, 2023

The platform is “designed to cross the blood-brain barrier (BBB) and safely increase exposure of the therapeutic antibody in the brain and potentially lead to improved efficacy and/or safety,” stated Joseph Lewcock, PhD, Chief Scientific Officer of Denali. These include transferrin receptors, which are expressed at the BBB.

Transportation 80

Transportation Engineering Safety Sales 80

Medgadget

SEPTEMBER 29, 2023

This layer of specialized endothelium significantly restricts which drug molecules can enter the brain, normally greatly limiting treatment options for patients with brain-based disease. In addition, it isn’t sustainable to have patients in-hospital for months at a time seeking this type of treatment.

Medicine 106

Medicine Distribution Specialization Medical 106

PM360

JULY 13, 2023

Using this flexible platform, Ambrx is developing engineered precision biologics with site-specific, homogenous, and stable conjugation to overcome limitations of traditional ADC technologies. Cellectis is pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients.

Patients 98

Patients Engineering Side effects Leads 98

pharmaphorum

SEPTEMBER 11, 2022

A personalised cell therapy based on tumour-infiltrating lymphocyte (TIL) cells has been shown to be more effective at improving progression-free survival than Bristol-Myers Squibb’s immunotherapy Yervoy in patients with advanced melanoma.

Side effects 89

Side effects Patients Engineering Management 89

European Pharmaceutical Review

AUGUST 25, 2022

However, patient survival rates remain low, with the standard of care delivering a progression?free the promise of leveraging oncolytic viruses stands out because of their excellent safety profile, minimal predicted side effects and potent ability to kill cancer cells while leaving healthy cells unscathed2. free survival of just 6.9

Side effects 100

Side effects Safety Patients Engineering 100

Legacy MEDSearch

NOVEMBER 29, 2022

engine acts as a second reader to radiological technologists at point-of-care for image quality on every mammogram. generated image quality assessments while the patient is still in the exam room, and supports reduced technical recalls and improved mammography quality. The intelliMammo A.I. ” About Densitas ®. .

Recruitment 98

Recruitment FDA Engineering Management 98

Impetus Digital

NOVEMBER 14, 2022

Waqaas Al-Siddiq, Founder & CEO of Biotricity , sat down with me to discuss his journey from computer engineering to healthcare, innovation in the cardiac monitoring space, the concept of Mobile Cardiac Telemetry (MCT), and more. What was the patient journey like before you ever entered the scene? Book a Consultative Demo.

Doctors 52

Doctors Professional Services Healthcare Healthcare 52

European Pharmaceutical Review

MARCH 12, 2024

If data used to support the safety , efficacy and quality of pharmaceutical products is compromised or unreliable, it can lead to regulatory non-compliance, product recalls, and most importantly, harm to patients who depend on those medications. What is the greatest current challenge in maintaining data integrity?

Government 90

Government Pharma Ethics Training 90

European Pharmaceutical Review

APRIL 18, 2024

While pharmaceutical manufacturing’s overall contribution is small compared to patient use and inappropriate disposal of pharmaceuticals, inadequately managed manufacturing emissions can impact local environments and receiving waters.

Pharmaceutical 78

Pharmaceutical Manufacturing Management Doctors 78