European Pharmaceutical Review

JULY 15, 2022

In a report supported by the AMR Industry Alliance , One Health Trust described the current climate for antimicrobial innovation, focusing on regulatory challenges and opportunities for the approval of new antibiotics in Brazil, India, and South Africa.

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pharmaphorum

DECEMBER 14, 2020

Armed with new data from a randomised clinical trial, one company is hoping to change that mindset. D aimed at people living with diabetes, which is undergoing clinical testing in the US and India. Bhargav Sri Prakash. Meanwhile, its turning its attention to other apps, notably fooya!D

Communication 109

Communication Immunization Vaccines 109

DiversifyRx

SEPTEMBER 6, 2022

You can reduce your pharmacy’s reliance on PBMs by earning more revenue from clinical services. How is clinical revenue or service-based revenue defined? My definition of clinical revenue has two components: It is revenue that does not flow through a PBM. In the past, I wouldn’t have put this in the easy category.

Independent Pharmacies 98

Independent Pharmacies Packaging Compounding Vaccines 98

ISPE

SEPTEMBER 29, 2023

The site has also a strong waste reduction culture and they are constantly analyzing their recycling program and looking for new reusable opportunities. Their overall goal is to reduce freshwater withdrawal by 90% by 2027 (the equivalent of 600 million liters of freshwater).

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Labelling Patient Care 52

pharmaphorum

JULY 4, 2022

Hughes – currently Vertex’s head of clinical development and translational medicine – will make the move to his new employer on 1 August, less than a year after taking on the role. Eric A Hughes. He will be based out of Teva’s US headquarters in Parsippany, New Jersey.

Generic Medicine 52

Generic Medicine 52

pharmaphorum

AUGUST 3, 2021

The FDA has relaxed a clinical hold on clinical trials of Novartis’ intrathecal formulation of spinal muscular atrophy (SMA) gene therapy Zolgensma, allowing a new phase 3 trial to get underway. They will fall into the category of SMA type 2, a less severe form of the disease.

FDA 104

FDA 104

pharmaphorum

OCTOBER 26, 2022

mjn-SERAS already has a CE mark in Europe and is currently in clinical testing, with results due in 2023. Bringing Neuraxpharm onboard provides an opportunity for mjn-neuro to accelerate the take-up of the wearable device, piggybacking on the 37-year-old drugmaker’s sales channels across Europe.

Communication 62

Communication 62

Roots Analysis

APRIL 28, 2024

Rare kidney diseases are a group of conditions, with at least 150 different disorders falling into this category. They have been described below: Clinical Heterogeneity: This arises due to the insufficient study populations, poor access to genetic testing, and phenotypical differences.

Insurance Coverage 40

Insurance Coverage Insurance FDA 40

pharmaphorum

NOVEMBER 16, 2021

This could form a new commitment in the successor to the voluntary scheme learning from experience from measuring uptake on five highest health gain categories of medicines. For example, it was not defined upfront what the five HHG categories would be and how they would be chosen. That timetable translated to June 2021.

Dosage 96

Dosage 96

Board Vitals - Pharmacist

APRIL 7, 2022

If you’re like most nursing students, your clinical experiences will be either the best or worse (or potentially both) part of nursing school. There are many factors that influence the quality of your clinical experience. Your experience in nursing clinicals hinges heavily on your assigned preceptor (the RN that you will be shadowing).

Patient Care 52

Patient Care Hospitals 52

pharmaphorum

MARCH 29, 2021

Her experience spans many categories including oncology & immunology, rare disease, respiratory, women’s health, diabetes, nutrition and hospitals. Throughout her career she has worked with industry leaders including AstraZeneca, Pfizer, Lilly, Sanofi, GSK, Johnson & Johnson, Janssen, Merck, Genentech, and the Mayo Clinic.

Mayo Clinic 67

Mayo Clinic Pharmaceutical Companies Pharmaceutical Companies Hospitals 67

pharmaphorum

AUGUST 31, 2022

It is actually the control formulation used in clinical development of its original product MED2005, which contained glyceryl trinitrate as an active ingredient. However, “the USA remains the largest market opportunity globally for ED treatments,” said Futura’s chief executive, James Barder.

FDA 52

FDA 52

The FDA Law Blog

JUNE 22, 2023

Though there has been a large number of OTC IVD clearances and decades of experience reviewing OTC IVDs, the bulk of OTC IVD clearances fall in just a few categories, such as pregnancy tests, drugs of abuse tests, and glucose monitoring devices. In the intervening decades, FDA has cleared approximately 1,200 OTC IVDs. lay users).

FDA 59

FDA Labelling Hospitals 59

pharmaphorum

NOVEMBER 3, 2022

The studies involved more than 3,000 female adults and adolescents with uncompleted UTIs and showed that a five-day oral course of gepotidacin was as effective as standard therapy nitrofurantoin at achieving combined clinical and microbiological responses to the infection at 28 days.

FDA 98

FDA 98

pharmaphorum

NOVEMBER 10, 2021

It is competing in the US with rival oral CGRPs, namely AbbVie’s Qulipta (atogepant) which was approved for episodic migraine prevention in September and AbbVie’s Ubrelvy (ubrogepant) in the acute treatment category, as well as several CGRP-targeting antibodies delivered by injection or infusion from Amgen, Eli Lilly, Teva and Lundbeck.

FDA 52

FDA 52

pharmaphorum

APRIL 11, 2022

Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. How can this data be incorporated into clinical trials?”. We believe that VivoSense is ‘the tip of the spear’ in this category.”. Tabakin agrees. “In

Pharmaceutical Companies 109

Pharmaceutical Companies Pharmaceutical Companies Packaging 109

ISPE

JULY 26, 2023

Navigating Emerging Markets: Challenges and Opportunities: Expanding into emerging markets presents unique challenges and opportunities for pharmaceutical companies. The Genentech Clinical Supply Center (CSC) project wins the FOYA 2023 Pharma 4.0™

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

NOVEMBER 2, 2022

Australia’s CSL is the latest vaccines company to buy into the mRNA category, tapping US biotech Arcturus Therapeutics for a wide-ranging alliance targeting COVID-19, influenza and other respiratory pathogens, including those that may cause future pandemics.

Vaccines 52

Vaccines Immunization 52

European Pharmaceutical Review

DECEMBER 22, 2022

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category. Mar 1;23(5):2736.

Vaccines 106

Vaccines Immunization Hospitals 106

pharmaphorum

MARCH 31, 2022

UK startup Sano Genetics has raised $11 million in first-round financing to develop its go-between service, which aims to overcome one of the big challenges in clinical research by connecting patients with trial sponsors. There’s no cost to participants, but study sponsors pay a subscription fee to access the patient database.

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pharmaphorum

AUGUST 2, 2021

UCB is bringing up the rear of the IL-17 inhibitor category with bimekizumab, which will be a latecomer if approved behind drugs like Novartis’ Cosentyx (secukinumab), Eli Lilly’s Taltz (ixekizumab) and Bausch Health’s Siliq/Kyntheum (brodalumab).

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The FDA Law Blog

JULY 24, 2023

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

FDA 52

FDA Patient Care 52

pharmaphorum

AUGUST 25, 2021

The drugmaker has looked close to home for its latest entry into the category, as Lycia’s founder Prof Carolyn Bertozzi has held a seat on its board of directors since 2017 – a position she has now surrendered as a result of the deal. Eli Lilly has bolstered its position the fast-emerging area of protein degrader drugs, agreeing a $1.6

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pharmaphorum

MARCH 22, 2022

A review of clinical studies published in 2015 found response rates of between 24% and 73% with the technique. GDH is designed to influence pain sensation and promote healthier control of digestive tract function by addressing a “miscommunication” between the brain and gut. metaMe’s latest fundraising added to $3.8

FDA 57

FDA 57

pharmaphorum

OCTOBER 7, 2022

When it comes to the horizontal plays, Debong sees two big categories. The other broad category is around data exchange. Because data is still not interoperable, there are a lot of great opportunities for companies to build services around easy data exchange. One is around payment and reimbursement. Making connections.

Documentation 98

Documentation Insurance 98

pharmaphorum

JUNE 25, 2021

Disruption creates opportunity, and what happens with that opportunity is up to us to shape. After COVID, there is an opportunity to reset the playing field for CVD.”. Notably, he says, the world now has a much greater understanding of how access to care has become a major issue. Think about that. That to me is shocking.”.

Communication 98

Communication 98

Impact Pharmaceutical Services

SEPTEMBER 20, 2023

Drug repurposing, also known as drug repositioning paves an alternate path for drug development which involves identifying new therapeutic indications or uses for the existing molecules that could have been initially approved for or have clinically failed in a different indication.

Documentation 59

Documentation Packaging Dosage Pharmaceutical Companies 59

ISPE

OCTOBER 27, 2022

Challenges & Opportunities in Emerging Digital Health Technologies. Challenges & Opportunities in Emerging Digital Health Technologies. DHTTs are electronic technology tools intended for use in clinical investigations (inclusive of clinical trial and post-market settings) or clinical practice. Trudy Patterson.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

pharmaphorum

MARCH 22, 2022

million tied to clinical, regulatory, and commercial milestones as well as royalties on sales if MVA-BN RSV is launched in those markets. The agreement gives Bavarian Nordic a leg-up in the big Chinese market, as it tried to keep pace with heavyweight rivals in the RSV vaccine category closer to home. million, with another $212.5

Vaccines 52

Vaccines FDA 52

pharmaphorum

SEPTEMBER 30, 2021

Data showing that Prevnar 20 can be administered alongside the flu jab could provide more convenience for patients, who would be able to book in for both shots at the same time and avoid two clinic visits. “However, vaccination rates decline when someone needs to make multiple appointments to receive these vaccines,” he added.

Vaccines 52

Vaccines Immunization 52

pharmaphorum

DECEMBER 11, 2022

And although not all categories involve patients directly, Hadjiat says, they all need to start from a place of patient centricity and patient need. “As Hadjiat says the team can build digital tools for clinicians because they have a team that represents both technical and clinical expertise. Conclusion.

Hospitals 137

Hospitals 137

ISPE

OCTOBER 27, 2022

Challenges & Opportunities in Emerging Digital Health Technologies. Challenges & Opportunities in Emerging Digital Health Technologies. Regulatory discretion in the use of virtual patient monitoring and remote clinical outcome assessments for clinical trials during the COVID-19 pandemic 6. Trudy Patterson. Ryan Hoshi.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

pharmaphorum

SEPTEMBER 22, 2020

The Swiss pharma giant is paying €380 million (around $450 million) upfront for Dublin-based Inflazome, getting rights to a portfolio of oral NLRP3-targeting drugs including two candidates at the clinical testing stage, and has also pledged undisclosed milestone payments.

Immunization 57

Immunization FDA 57

pharmaphorum

JANUARY 26, 2021

There is an opportunity to address this at scale with digital tools and techniques, and expand support into just about any therapeutic area through the holistic integration of mental and behavioural health solutions that improve patient care. Clinical trials get more and more digitalised. Aging in place’ becomes more commonplace.

Health and Personal Care Stores 141

Health and Personal Care Stores Medication Guidelines Insurance Communication 141

European Pharmaceutical Review

FEBRUARY 21, 2023

Arthur Wakeley What data can you share about clinical trials for cannabis-based medicines? Early results for pain reduction, sleep and opioid reduction from a live study at a London-based clinic assessing the efficacy of cannabis-based medicines for chronic pain have been hugely encouraging.

Pharmaceutical Companies 129

Pharmaceutical Companies Pharmaceutical Companies Compounding 129

Pharmaceutical Technology

OCTOBER 26, 2022

Experts at the recent webinar presented health equity data, showing the opportunities to achieve significant financial gain whilst reducing health inequity. These principles also aim to allow an acknowledgement of Black and brown mistrust of clinical trials. trillion in savings over the next decade.

Insurance Coverage 64

Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies Insurance 64

PQA

MARCH 28, 2024

The Arine platform develops insights from clinical, socioeconomic, and behavioral data to proactively target at-risk members, generate personalized medication recommendations, and continuously optimize patient outcomes. MedOrion developed a new solution category – Health Behavior Management (HBM).

Specialty Pharmacies 40

Specialty Pharmacies Communication Insurance Pharmaceutical Companies 40