Clarify Health

AUGUST 26, 2020

While many plans did not meet their minimum medical loss ratio (or MLR Target) for 2020, in three steps, payers can better position themselves to meet these targets in 2021. So with 2020 MRL targets slashed for many plans, what can they do to ensure they’re tracking in 2021? But first… What is a Medical Loss Ratio (MLR)?

Insurance 52

Insurance Medical Networking Management 52

European Pharmaceutical Review

OCTOBER 5, 2022

An industry that is among the world’s biggest polluters is caught in a balancing act between satisfying the health and safety demands of industry regulators and meeting the needs of modern eco-conscious consumers. However, when it comes to pharmaceutical products, health and safety remains the primary consideration.

Pharma 98

Pharma Safety Pharmaceutical Manufacturing 98

European Pharmaceutical Review

OCTOBER 22, 2024

It follows a consultation with stakeholders in 2021, which resulted in great support for proposals for a framework focused on point of care and modular manufacturing. Introduction of this framework was originally announced by the MHRA in January 2023. Introduction of this framework was originally announced by the MHRA in January 2023.

Medicine 89

Medicine Manufacturing Safety Consulting 89

Pharma Marketing Network

APRIL 27, 2021

Head of the Discovery Technology Center in Cambridge, Massachusetts, Head of Discovery Research in Ann Arbor, Michigan, and Head of Drug Safety R&D. The post Dr. Rod MacKenzie, 2020-2021 HBA Honorable Mentor appeared first on Pharma Marketing Network. HBA Honorable Mentor 2020-21, Dr. Rod MacKenzie.

Medicine 52

Medicine Networking Safety Marketing 52

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. Donor of stools for MBK-01 were screened for pathogens and viruses to ensure safety. Safety and quality of life of the patients participating in the study were also assessed. 2021; 27 (2): S1-S21.

Safety 111

Safety Patients Side effects Management 111

European Pharmaceutical Review

OCTOBER 9, 2023

A new approach to potassium-channel openers for epilepsy Critically, XEN1101 combines the effectiveness of potassium-channel openers with the safety of more traditional drugs, stated study lead author and neurologist Dr Jacqueline French. It ran between January 2019 and September 2021.

Side effects 110

Side effects Recruitment Safety Medicine 110

European Pharmaceutical Review

JULY 28, 2023

Publication of results of the Phase III SKYLARK study “is a pinnacle moment in treating postpartum depression ( PDD ),” stated Dr Kristina M Deligiannidis, Professor at the Institute of Behavioral Science at the Feinstein Institutes, the trial’s principal investigator, lead author of the paper.

Food and Drug Administration 98

Food and Drug Administration Food Safety Patients 98

Pharmaceutical Technology

NOVEMBER 14, 2022

Such developments, including a 2021 approval of AstraZeneca’s Saphnelo (anifrolumab) , prompted The Lancet Rheumatology to posit that 2022 could be a “banner year” for the condition. Saphnelo is also being studied in a Phase III trial in lupus nephritis, where a person’s immune system targets the kidneys, eventually leading to kidney failure.

Side effects 144

Side effects Patients Manufacturing Safety 144

European Pharmaceutical Review

JANUARY 18, 2023

She shared: “Respiratory diseases are a major public health priority given they… are a leading cause of hospitalisation.” The trial showed the mRNA vaccine was well tolerated with no safety concerns identified. Safety and tolerability will continue to be followed in this ongoing study.

Safety 105

Safety Leads Pharmaceutical 105

European Pharmaceutical Review

MAY 24, 2024

UCB has announced positive results from the first Phase III trials evaluating the efficacy and safety of an IL-17A and IL–17F inhibitor to treat adults with moderate-to-severe hidradenitis suppurativa. This medicine was authorised by the European Commission for plaque psoriasis in August 2021.

Patients 98

Patients Medical Safety Medicine 98

European Pharmaceutical Review

JANUARY 25, 2023

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively. Costs and profits worldwide are shared with CRISPR Therapeutics.

Medicine 111

Medicine Food and Drug Administration FDA Pharmaceutical 111

European Pharmaceutical Review

FEBRUARY 2, 2024

ADUHELM received accelerated approval from the US FDA in June 2021, Biogen confirmed. However, Biogen noted that while the move is not a result of safety or efficacy concerns, a “large portion” of the resources will be diverted in Biogen’s Alzheimer’s disease franchise.

Food and Drug Administration 97

Food and Drug Administration FDA Food Marketing 97

Legacy MEDSearch

DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

Food and Drug Administration 98

Food and Drug Administration Safety Recruitment Medical 98

Pharmaceutical Technology

JUNE 2, 2023

The original contract, signed in May 2021, required the EU to purchase 900 million doses from Pfizer/BioNTech, with an option for an additional 900 million, by the end of 2023. The European Commission (EC) and Pfizer/BioNTech have agreed to amend their current supply contract to deliver Covid-19 vaccines to the EU.

Leads 52

Leads Safety Distribution Marketing 52

European Pharmaceutical Review

NOVEMBER 10, 2022

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. Dr Isabel Peset is Lead Scientist – Advanced Microscopy, Medicines Discovery Catapult. Figure 1 ). About the authors.

Medicine 105

Medicine Distribution Engineering Electronics 105

Legacy MEDSearch

DECEMBER 5, 2022

The FDA clearance follows the CE mark already received by the product in May 2021. The WISE Cortical Strip performances have been successfully validated in a multicentric pre-market clinical study in Europe, the WIN study ( NCT03731455 ), that demonstrated safety, performance and usability of the product.

FDA 98

FDA Recruitment Leads Medical 98

pharmaphorum

JANUARY 27, 2023

The decision comes after Ipsen was forced to withdraw its marketing application for palovarotene in the US in 2021, which delayed regulatory filings elsewhere, although the French pharma company has picked up an approval for the drug in Canada, where it is sold as Sohonos.

FDA 98

FDA Marketing Medicine Prospecting 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.

Pharmacology 93

Pharmacology Engineering Consulting Leads 93

Pharma Marketing Network

APRIL 30, 2021

At this year’s Reuters Pharma Clinical 2021, I joined over 500 global leaders in clinical research as they discussed many of these issues under the theme, “rebuild clinical trials in the image of patient need.”. How do we increase the diversity of clinical trials?

Patients 52

Patients Pharma Recruitment Distribution 52

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. We note the Commission has not conducted an assessment on the impact of removing paper leaflets on patient safety. percent as EU average with some Member States as high as 25 percent).

Healthcare 98

Healthcare Healthcare Safety Electronics 98

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, 5 Why was the data presented at ELCC 2023 on the bispecific monoclonal antibody significant?

Food and Drug Administration 98

Food and Drug Administration Safety Patients Medicine 98

Pharmaceutical Technology

JANUARY 22, 2023

The mutation leads to disordered thyroid hormone transport, which causes patients to experience intellectual and motor disabilities. DMD pathology is caused by a lack of dystrophin protein, leading to the weakening and damage of muscle cells progressively over time. In clinical trials, the drug showed a 3.8-point compared to 38.5%

FDA 126

FDA Safety Pharmaceutical Patients 126

European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent. Through its longer half-life of 12.7

Food and Drug Administration 97

Food and Drug Administration Manufacturing Safety Transportation 97

Medico Reach

OCTOBER 17, 2022

billion in 2021, with a compounded annual growth rate (CAGR) of 3.1% However, this can lead to several issues, such as: Implantation resistance due to reactionary metabolism Allergic reactions to the nickel component found in stainless steel composites Widespread bone destruction due to immunological responses to cobalt particles.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

European Pharmaceutical Review

JULY 13, 2023

A new therapeutic antibody class, bispecific antibodies, was engineered to build on the classic antibody design and bind to two different proteins, demonstrating how incremental changes in protein design can lead to entirely new therapies. 2021; 11(5): 355. 2011; 117(11): 2993–3001. Salvaris R, Ong J, Gregory GP.

Engineering 98

Engineering Food and Drug Administration Patients Safety 98

pharmaphorum

JANUARY 3, 2023

According to the World Federation of Hemophilia, more than 38,000 people worldwide were living with haemophilia B in 2021. during the lead-in pre-treatment period of at least six months. It is almost exclusively found in males. The results of the phase 3 BENEGENE-2 study demonstrated superiority with a mean ABR for all bleeds of 1.3

Medicine 98

Medicine Engineering Safety FDA 98

European Pharmaceutical Review

JULY 13, 2023

While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. This could lead to significant research waste. 2021 Jul;11(4):395-403. References Attwood D, Curley A, Keenan E, Murphy S. Mechoulam R.

Medical 98

Medical Food and Drug Administration Pharmacology Medicine 98

Salesforce

SEPTEMBER 9, 2021

Heading into the 2021 holiday season, retail and consumer goods brands must once again prepare for peak demand. Frustrating out-of-stocks, inaccurate inventory counts, and faulty orders — all leading to upset customers. In 2021, there are 900 million more digital buyers than there were in 2020. The result?

Management 95

Management Retail Sales Distribution 95

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

FDA 115

FDA Side effects Pharmacology Patients 115

European Pharmaceutical Review

FEBRUARY 22, 2023

Although effective, the inconvenience of regular injections can lead to poor patient adherence, with studies showing that persistence and adherence are generally better for oral medications compared with injections. Top companies and drugs by sales in 2021. the enteric coating and the capsule dissolve. References Urquhart L.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Safety Pharmaceutical 105

pharmaphorum

AUGUST 19, 2022

The endorsement of the drug’s efficacy and safety comes at a good time for the Swedish biotech, just a month before the drug, known as Pepaxto in the US, will have its safety reviewed by an FDA advisory committee after being withdrawn from sale there last year.

FDA 52

FDA Safety Sales Marketing 52

European Pharmaceutical Review

DECEMBER 11, 2023

mAbs have well-established safety profiles, high specificity and affinity and long half-lives – they have been used in drug development for more than 30 years. 7 Their safety profiles have also shown to be unfavourable for broad applicability as treatment options for many diseases including chronic diseases.

Safety 98

Safety Pharmacology Engineering Medical 98

Curzon Consulting

NOVEMBER 15, 2021

15th November 2021 1 Minutes. Chetan Trivedi I lead Healthcare at Curzon Consulting. I am deeply passionate about improving health outcomes, safety and quality of life for patients. If hip and knee implant manufacturers want to stay relevant, and “move the needle” on value creation, they need to play big or go home!

Manufacturing 52

Manufacturing Consulting Healthcare Healthcare 52

European Pharmaceutical Review

FEBRUARY 12, 2024

Liam Dunne, MSD Biotech Site Lead, explains that the site operates at the forefront of science and technology with 15,000L-scale, repeatable, robust manufacturing processes to produce highly sensitive monoclonal antibodies (mAbs). The downstream process ensures cell removal, virus safety, and impurity removal. How does it do this?

Manufacturing 98

Manufacturing Medicine Leads Patients 98

pharmaphorum

NOVEMBER 24, 2022

The opportunity is open to academic, government, and industry organisations anywhere in the world, with a lead partner based in the UK. Dr Catherine Kettleborough, lead of the LifeArc Chronic Respiratory Infection Translational Challenge, said: “Repurposing an existing drug or compound is a faster way of getting new treatments to patients.

Government 59

Government Leads Medical Safety 59

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 98

Manufacturing Safety FDA Patients 98

Clarivate

JULY 31, 2023

Following the acquisition of Dialog Solutions as part of the ProQuest M&A in December 2021, Dialog Solutions products and services will be folded into the Clarivate portfolio of offerings for Life Sciences & Healthcare. Today, the Dialog Solutions brand has been integrated into Clarivate.

Healthcare 52

Healthcare Healthcare Safety Competition 52