pharmaphorum

MARCH 17, 2022

The uptake of digital health tools during the pandemic has been enormous due to improved access they provide to healthcare. Digital health has a tremendous capacity to transform the healthcare industry, with the ability to provide easy access to a multitude of services and new types of therapies. Whole system approach.

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145

Pharmaceutical Technology

DECEMBER 12, 2022

The development, clinical trial and marketing expenses for the cell therapy will be shared by the companies while co-commercialising the product and equally splitting profits from the US region. Kite will oversee the marketing of the product outside the US while Arcellx is eligible for royalty payments on sales.

Communication 105

Communication 105

Pharmaceutical Technology

JANUARY 5, 2023

Capsida Biotherapeutics CEO Peter Anastasiou said: “Prevail’s expertise in neuroscience, gene therapy R&D, and access to Lilly’s world-class commercialization capabilities complements Capsida’s fully integrated approach, including our next-generation AAV engineering platform.

Communication 95

Communication 95

Pharmaceutical Technology

NOVEMBER 29, 2022

TCR-Ts can detect intracellular targets such as cancer-specific mutations to unlock targets which were not accessible earlier using cell therapies. The takeover will offer AstraZeneca access to TCR-Ts, which possess the potential for fighting solid tumours.

Communication 111

Communication 111

pharmaphorum

NOVEMBER 20, 2020

Gordon joins Prescient with more than 15 years of dedicated oncology experience in market research and competitive intelligence. He has an MBA in market and strategy from Carnegie Mellon University and a BA in biochemistry from the University of Pennsylvania.

Medical Schools 69

Medical Schools 69

Pharmaceutical Technology

JANUARY 11, 2023

AbbVie will get exclusive rights to license and develop and market the programmes. By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

Communication 59

Communication 59

Pharmaceutical Technology

MARCH 1, 2023

The deal offers access to the platforms of Tevard to discover and develop tRNA-based therapies. Tevard Biosciences and Vertex Pharmaceuticals have announced a four-year global research partnership to develop new tRNA-based therapies to treat Duchenne muscular dystrophy (DMD) patients.

Communication 52

Communication 52

Pharmaceutical Technology

JULY 28, 2022

By carefully weighing up a range of factors, businesses can ensure they are choosing a city or region where their company can access the resources needed to scale multinational operations smartly. Domestic market and transportation infrastructure. Locations with access to the sea may also offer a cheaper way of transporting goods.

Research Laboratories 52

Research Laboratories Patient Care 52

Hospital Pharmacy Europe

JULY 7, 2023

The MHRA has granted marketing authorisation for ruxolitinib cream 15mg/g (brand name Opzelura) for treating patients from 12 years of age who have non-segmental vitiligo affecting facial areas. Both included patients aged 12 years or older who had non-segmental vitiligo with depigmentation covering 10% or less of total body-surface area.

Hospitals 52

Hospitals FDA 52

PQA

FEBRUARY 29, 2024

Like all patients, individuals with rare disease want medications that are accessible, safe, effective and help them achieve the best outcomes possible. Clarify unmet market needs, gaps in care, or interventions that can be realized through research, education, and collaboration.

Specialty Pharmacies 45

Specialty Pharmacies Communication Patient Care 45

pharmaphorum

MARCH 30, 2021

When you’re bringing a transformational therapy to market, you have to think quite differently about it. These include perceptions of transformational therapies as ‘unaffordable’ and the often-limited evidence available when ground-breaking treatments come to market sometimes on the basis of phase 2 data alone. “If

Communication 83

Communication Labelling 83

Pharmaceutical Technology

JANUARY 20, 2023

According to the website, Moderna’s mRNA access program intends to “accelerate the creation of new vaccines using mRNA technology in collaboration with global partners”. During the panel, Bancel discussed plans to get mRNA vaccines for the 15 high priority viruses, as identified by the WHO, into the clinic.

Vaccines 98

Vaccines Communication FDA 98

ISPE

JULY 5, 2023

For pharmaceuticals, however, the continuous production volume, and hence runtime, is flexible to meet variable market demand. 13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

NOVEMBER 3, 2022

Challenges of individualized therapies include manufacturing, nonclinical development, clinical development, and product access. Convergence from marketing across high-income countries could help to produce the number of treatments necessary for commercial viability, he suggested. Project ORBIS/ACCESS Consortium)?

Communication 98

Communication FDA Documentation Vaccines 98

ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Accumulus Synergy White Paper.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). Discussion paper. Accessed 14 April 2023. 1 (2021):48. 3 (2022):593–607.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

NOVEMBER 1, 2022

OPQ is engaged in various steps to develop QMM, including a quality rating system; activities such as stakeholder meetings and a white paper released in April on the importance of QMM and an upcoming advisory committee meeting are further steps toward that goal. He predicted this will become a leading indicator.

FDA 98

FDA Insurance Chemotherapy Documentation 98

pharmaphorum

SEPTEMBER 18, 2020

The Transformational Value: Preparing for a Decade of Radical Change white paper from the Adelphi Group sets out the key tenets of the concept and the opportunity for pharma to take a big picture view of ‘transformational value’ and how to respond to it. The post Preparing for a decade of radical change in pharma appeared first on.

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Pharmaceutical Technology

MARCH 10, 2023

The virtual company creation of Cell One Partners helps in removing the barriers to access to senior C-suite leadership by providing virtual management at one-third of the cost of a traditional new start-up company. This allows the asset owners to focus their cash and energies on research and development.

Communication 98

Communication 98

pharmaphorum

JUNE 29, 2022

The prescription medicine market has recovered from the wild swings of the early pandemic with renewed growth. COVID vaccines and treatments have created a substantial market over and above the existing Rx market- IQVIA estimates that the cumulative value of COVID vaccines could be between $185 and 295bn to 2026.

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Vaccines Pharmaceutical Companies Pharmaceutical Companies 58

The Thyroid Pharmacist

OCTOBER 7, 2022

In my past life, I would put three teaspoons of (white, refined) sugar in my tea. I knew from papers that I read in pharmacy school, that artificial sweeteners were toxic. Several stevia products currently on the market are USDA-certified organic.). Accessed September 27, 2022. You need to cut out the sugar.”.

Immunization 92

Immunization Labelling Compounding FDA 92

Pharmaceutical Technology

FEBRUARY 28, 2023

More than 100 treatments are currently on the market, with hundreds more on their way. However, costs need to fall to improve access to these life-saving therapies. To learn more about how the 3M Harvest RC Chromatographic Clarifier is revolutionising biopharma production, download this specially commissioned white paper.

Documentation 94

Documentation Communication 94

pharmaphorum

FEBRUARY 1, 2021

Italy was working up big changes in market access throughout 2020 which will be implemented in 2021. In the latest of a suite of features looking at the biggest markets in Europe, Leela Barham takes stock of what 2021 could bring for market access in Italy. Italy operates two special funds for innovative medicines.

Hospitals 52

Hospitals 52

pharmaphorum

SEPTEMBER 13, 2022

Thanks to the dedicated efforts of doctors, patients, carers, and healthcare professionals, people diagnosed with blood cancer are now living longer, with a steady stream of more effective treatments entering the market each year. 1847 – Virchow links tumours and white blood cells. 1844 – First reported case of multiple myeloma.

Chemotherapy 98

Chemotherapy Immunization FDA Documentation 98

ISPE

MARCH 8, 2023

21 RAs may also have to review the risks of patients taking the contaminated medications, 22 especially for manufacturers with large market shares (such as ZHP), which can impact large numbers of patients globally. 31 Drug Cross-Contamination Eighteen papers 32 , 33 , 34 , 35 , 36 reported cross-contamination with another drug product.

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 52

The FDA Law Blog

JANUARY 5, 2023

CDRH is building an extensive library of similar reports and white papers as it prepares its final guidance for medical device cybersecurity, scheduled to come out next Fall. Post-market, combination products potentially face the same enforcement scrutiny as single-entity medical devices.

FDA 59

FDA Hospitals 59

Pharmaceutical Technology

MARCH 22, 2023

Patients living with cancer and Alzheimer’s are two examples of groups that need access. By increasing productivity, manufacturing costs are reduced, which also offers the opportunity to expand access for biotherapeutics to more patients living with serious and chronic diseases.

Documentation 52

Documentation Communication 52

Pharmaceutical Technology

FEBRUARY 1, 2023

The first RSV vaccine to enter the market will access a first-mover advantage and capture 100% of the market share, says Nancy Jaser, senior infectious disease analyst at GlobalData. Among the many competitors in this space, seven companies are in Phase III trials and some may face regulatory decisions in 2023.

Vaccines 64

Vaccines FDA Pharmaceutical Companies Pharmaceutical Companies 64

pharmaphorum

JANUARY 14, 2021

The promotional environments of major pharmaceutical markets were already divergent in 2019 – some, like Italy and Spain were very high on traditional face to face interactions, others, like the UK, were the complete opposite, and still others, like Japan and the US, had high volumes of both digital and face to face contacts.

Pharmaceutical Companies 71

Pharmaceutical Companies Pharmaceutical Companies Labelling 71

The FDA Law Blog

JANUARY 24, 2024

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. If this vision is achieved, the United States can bring innovative biotechnologies and products to markets faster while building a more robust supply chain ecosystem. drug supply chain.

Documentation 69

Documentation 69

Pharmaceutical Technology

DECEMBER 9, 2022

Brazil is the largest country in Latin America, with a population of over 212 million, and consequently has the biggest pharmaceutical market in the region. Advantages of joining PIC/S include the adoption of codes that should reduce the number of audits required for some products, accelerating their time to market.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Communication 98

Pharmaceutical Technology

MARCH 17, 2023

These agreements have been particularly propelled by the recent rise in inflationary pressures and pharmaceutical market instability, pushing healthcare systems to find new ways to reduce risks associated with new drugs. Thus, a higher risk score reflects a more hostile market access environment and drug launch in a geographical area.

Pharmaceutical Companies 102

Pharmaceutical Companies Pharmaceutical Companies Communication 102

Pharmaceutical Technology

MAY 3, 2023

First generics are the first opportunity manufacturers have to market new generic drug products in the US. In recent years, first generics have improved patient access to essential treatments and offered affordable treatment options for patients with multiple sclerosis, asthma, heart disease, diabetes, and even the flu.

FDA 98

FDA Generic Medicine Communication 98

Pharmaceutical Technology

FEBRUARY 7, 2023

Another tool used as a supportive measure for balancing the incentivisation of pharmaceutical innovation with the containment of drug prices is the health technology assessment (HTA), where the value (in terms of efficacy and costs) of using a pharmaceutical versus alternatives on the market is evaluated.

Packaging 52

Packaging Insurance Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

MARCH 7, 2023

Abacus Medicine Pharma Services (AMPS) and AddMedica are proud to announce the signing of a partnership agreement for the marketing and distribution of Siklos® in Benelux. AddMedica is a European company focused on developing and market medical products for rare diseases and niche markets.

Communication 52

Communication 52