European Pharmaceutical Review

FEBRUARY 13, 2023

Anne Kerber, Senior Vice President, Cell Therapy Development at Bristol Myers Squibb explained the intention behind developing Abecma: “We sought to deliver a personalised therapy that provides durable outcomes with a single infusion to advance the multiple myeloma treatment paradigm for patients.” Ultimately, this goal proved successful.

Food and Drug Administration 114

Food and Drug Administration Engineering Safety Patients 114

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

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

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 77

Patients Pharma Consulting Transportation 77

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

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 88

Manufacturing Medicine Consulting Engineering 88

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

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 92

Food and Drug Administration Safety Medicine Patients 92

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 79

Food and Drug Administration Manufacturing Safety Transportation 79

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.

Food and Drug Administration 90

Food and Drug Administration Transportation FDA Medical 90

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. Our lead indications are HER2-positive metastatic breast cancer (mBC) and metastatic castration-resistant prostate cancer (mCRPC).

Patients 98

Patients Engineering Side effects Leads 98

Pharma Marketing Network

JULY 19, 2023

Content Marketing as a Sales Driver: Unlocking Your Business Potential in the Pharmaceutical Industry Content marketing is a long-term strategy that can help businesses of all sizes generate leads, increase brand awareness, and drive sales.

Marketing 98

Marketing Pharmaceutical Sales Education 98

European Pharmaceutical Review

FEBRUARY 12, 2024

‘From bench to bedside’ is a well-known aphorism that merely hints at the arduous journey drug treatments must undergo from their position as a candidate molecule or soon to be explored pathway, to becoming a tablet, injection, or infusion administered to patients worldwide. How does it do this?

Manufacturing 90

Manufacturing Medicine Leads Media 90

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

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

European Pharmaceutical Review

MAY 8, 2024

Based on the growing evidence of positive outcomes seen with full ecosystem products, mbiomics has developed a proprietary techbio platform that aims to combine the disease-modifying potential of large consortia with the safety and scalable manufacturability of GMP-manufactured non-engineered microbial strains isolated from healthy individuals.

Manufacturing 69

Manufacturing Safety FDA Patients 69

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 79

Transportation Engineering Safety Sales 79

European Pharmaceutical Review

DECEMBER 26, 2023

The increasing adoption of technologies promoting safety, efficacy and reduced production costs has been a persistent trend that will continue to benefit the industry and help to treat a broader patient population. These challenges predominantly surround scalability, stability, regulatory compliance and access to patients.

Manufacturing 86

Manufacturing Safety Patients Competition 86

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 89

Government Pharma Ethics Training 89

Pharmaceutical Technology

MAY 17, 2023

Scribe Therapeutics CEO Benjamin Oakes said: “With the compelling in vivo proof-of-principle data we have generated in multiple disease areas, Scribe has validated our X-Editing technologies for industry-leading editing activity, specificity and deliverability.

Medicine 52

Medicine Engineering Leads Safety 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

pharmaphorum

JANUARY 17, 2023

Angion Biomedica ended 2022 in the midst of a strategic review after its lead drug for kidney diseases flamed out, and it has now charted a path forward – a reverse merger with clinical-stage biotech Elicio Therapeutics. Darrell Irvine. The post Angion stock falls after agreeing Elicio Therapeutics merger appeared first on.

Pharmacology 70

Pharmacology Engineering Consulting Leads 70

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 percent and 14.3

Food and Drug Administration 78

Food and Drug Administration Safety Patients Leads 78

Pharmaceutical Technology

SEPTEMBER 7, 2022

Before drugs are authorised, evidence of their safety and efficacy is limited to results from clinical trials, so it is essential that pharmacovigilance continues after a therapy has been approved. After AEs are recorded, they must be translated and put back out to doctors and scientists for processing.

Safety 52

Safety Engineering Medicine Medical 52

European Pharmaceutical Review

MARCH 24, 2023

In NASH, excess fat in the liver can lead to progressive disease, including inflammation, liver cell injury and fibrosis, which are associated with increased risk for cardiovascular disease and liver morbidity and mortality. Pegozafermin also has a favourable safety and tolerability profile, with few gastrointestinal (GI) side effects.

Medical 85

Medical Side effects Safety Pharmaceutical 85

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 77

Pharmaceutical Manufacturing Management Doctors 77

Legacy MEDSearch

AUGUST 4, 2022

Direct visualization of the neural structures increases efficiency and safety when accessing the disc space, and the robust offering of new, endoscopic-specific discectomy tools included with OptiLIF Endo facilitates efficient endplate preparation under endoscopy to optimize fusion.”. With OptiLIF ® Endo, we will lead that market.”.

Recruitment 52

Recruitment Safety Marketing Engineering 52

European Pharmaceutical Review

DECEMBER 11, 2023

The first approved ASO was designed for injection directly into the eye for the local treatment of cytomegalovirus (CMV) retinitis in immunocompromised AIDS patients. They can be composed of various types of oligonucleotides, including siRNAs and PMOs that can be engineered to modify RNA function in different ways.

Pharmacology 85

Pharmacology Safety Engineering Medical 85

European Pharmaceutical Review

NOVEMBER 16, 2022

Engineering or redesigning facilities without due consideration of what is needed, of what may be superfluous, or of how systems and processes will be validated over time, could lead to costly remedial action and delays in getting important and premium new products to market.

Manufacturing 112

Manufacturing Pharma Biopharma Management 112

Medgadget

OCTOBER 17, 2023

The market’s current leading liquid embolic contains a solvent, dimethyl sulfoxide (DMSO), which can cause pain upon injection, necessitating the use of anesthesia and special compatible catheters. It is a potentially life-saving intervention that can rapidly stabilize a patient and serve as a bridge to definitive surgery for patients.

Medical 69

Medical Specialization Engineering Leads 69

European Pharmaceutical Review

NOVEMBER 10, 2022

Crucially, these insights can be applied across the pipeline to help more complex medicines reach the market, for patient benefit. . With the new modalities used to treat disease and address previously undruggable targets, advanced drug delivery systems are critical to ensure targeted delivery, and to maximise safety and efficacy.

Medicine 97

Medicine Distribution Engineering Electronics 97

Legacy MEDSearch

SEPTEMBER 11, 2023

Zeta’s computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement. ” About Zeta Surgical Zeta Surgical is a digital surgery company focused on improving the accuracy, safety, and accessibility of image guided procedures.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 86

Manufacturing Pharma Food and Drug Administration Safety 86

Legacy MEDSearch

JULY 27, 2022

Rapid Medical , a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER 13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. The ability to tailor each procedure can provide new safety levels for higher-risk thrombectomies.

Medical 52

Medical FDA Recruitment Physicians 52

Evolve Your Success

DECEMBER 19, 2023

Career success in MedTech is not just about climbing the corporate ladder; it’s about relentlessly advocating for patients, embracing change, and, above all, never giving up. with Fred Colen as he shares his transformation from an engineer to a MedTech executive. Do I want to be a medical doctor or an engineer?

Engineering 52

Engineering Patients Medical Sales 52

pharmaphorum

DECEMBER 6, 2022

Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicating data are stuck in the past. This unlocks opportunities for more trial sites and patients to participate in research – and speeds the research process to get critical treatments in the hands of patients sooner.

Electronics 98

Electronics Patients Medical Marketing 98

pharmaphorum

NOVEMBER 3, 2022

We see how digital measures of adherence ensure that sample size calculations hold and drug developers can accurately evaluate the safety and efficacy of new molecules. Other tools enhance patient centricity, inclusivity, generalisability of findings, participant retention, and technical success, while reducing timelines.

Pharma 80

Pharma Medicine Education Recruitment 80