World of DTC Marketing

MARCH 17, 2022

9, 2020, by the Breast Cancer Research and Treatment journal. Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease. The Food and Drug Administration approved them, an analysis JAMA Internal Medicine found.

Food and Drug Administration 255

Food and Drug Administration Medical Ethics Patients 255

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Biosimilars are key to making healthcare more affordable and accessible.

Food and Drug Administration 52

Food and Drug Administration FDA Biopharma Food 52

European Pharmaceutical Review

AUGUST 11, 2023

Adakveo (crizanlizumab) received conditional authorisation by the EC in October 2020. This review started after results of a Phase III study (STAND) did not show a statistically significant difference between crizanlizumab and placebo in rates of pain crises leading to a healthcare visit over the first-year.

Marketing 82

Marketing Food and Drug Administration Medicine FDA 82

Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

Safety 52

Safety Food and Drug Administration Pharmaceutical Marketing 52

pharmaphorum

JANUARY 24, 2023

Drug development has long been an issue for the pharma industry, due to the expense and the high failure rate of potential treatments. Ben Hargreaves finds that the vast amount of genetic data that exists today could help provide a faster, more targeted way of developing new drug candidates.

Food and Drug Administration 82

Food and Drug Administration Pharma Medicine Healthcare 82

Pharma Marketing Network

MARCH 25, 2023

Pharmaceutical advertising is a crucial aspect of promoting and marketing drugs to the public. According to a report by Kantar Media, in 2020, spending on DTC advertising was estimated to be around $7.2 Another example is the “Roche” campaign, which aimed to raise awareness about their drug “Tamiflu” as a treatment option for the flu.

Pharma 52

Pharma Food and Drug Administration Prescription Pharmaceutical 52

pharmaphorum

NOVEMBER 27, 2022

This follows the initial licence for treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in 2020. Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster. It is coordinated by the US Food and Drug Administration (FDA).

Food and Drug Administration 82

Food and Drug Administration Medicine Consulting Patients 82

World of DTC Marketing

MARCH 9, 2022

There’s a lot of blame to go around, including: Trump – When the first American coronavirus infection was confirmed in late January 2020, Trump had already known for two months that an especially nasty pathogen was killing people in Wuhan, China. Our healthcare system failed us all even though vaccines were developed.

Food and Drug Administration 201

Food and Drug Administration Media Government Healthcare 201

Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Pharma 52

Pharmaceutical Technology

DECEMBER 5, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has also since granted the Great Britain marketing authorisation of Lupkynis to treat adults with active LN. Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN.

Food and Drug Administration 59

Food and Drug Administration Physicians Competition FDA 59

PM360

MARCH 22, 2024

Amor Vegas stated, “T cells have the ability to develop memory and persist in your body for really long periods, which is very different from a chemical drug. An analysis of cervical cancer screening rates per 1,000 members between January 2020 and June 2022 shows that the number of women getting screenings has declined each year.

Food and Drug Administration 52

Food and Drug Administration FDA Healthcare Healthcare 52

Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.

Food and Drug Administration 141

Food and Drug Administration Pharmacology Side effects Physicians 141

Pharmaceutical Technology

MAY 16, 2023

UniQure is selling a part of its royalty rights to the haemophilia B gene therapy Hemgenix (etranacogene dezaparvovec) to HealthCare Royalty and Sagard Healthcare for a gross purchase price of up to $400 million dollars. HealthCare Royalty is a royalty acquisition company. HealthCare Royalty is a royalty acquisition company.

Food and Drug Administration 52

Food and Drug Administration Healthcare Healthcare Sales 52

European Pharmaceutical Review

JANUARY 19, 2023

With the skills, experience and networks they will gain… in the Winn Award Program, [the programme participants] will make a significant difference in how healthcare is delivered in the US,” stated Jude Ngang, Executive Director, and leader of the Amgen Representation in Clinical Research (RISE) programme.

Food and Drug Administration 79

Food and Drug Administration Physicians Medicine Food 79

European Pharmaceutical Review

AUGUST 22, 2022

For instance, Lhasa initiated a Nitrites in Excipients database to facilitate risk assessment of drug products, which was recently published. This data provides invaluable insight into the likelihood of nitrites in a drug product formulation. European Directorate for the Quality of Medicines & HealthCare. 25 June 2020.

Food and Drug Administration 59

Food and Drug Administration Prescription Food Medicine 59

European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. In subsequent years, up to 2022, half this number or less were issued.

FDA 82

FDA Food and Drug Administration Media Manufacturing 82

Clarivate

NOVEMBER 14, 2023

Figure 1: Timeline of GLP-1 RA development [9] , [10] Abbreviations: EMA, European Medicines Agency; US FDA, United States Food and Drug Administration. 2020; 41:733-755. [4] 2020; 33(1):44-49. [5] 9] Food and Drug Administration. Drug approvals and databases. What’s next in diabetes?

Food and Drug Administration 52

Food and Drug Administration Medicine Patients Food 52

Pharmaceutical Representative Training

DECEMBER 28, 2021

Before 2020, the landscape of drug marketing involved following drug approvals by the Food and Drug Administration ( FDA ), finding which patient population would benefit from therapy, and visiting specialized doctors in-person to advertise its advantages compared to current guidelines.

Marketing 52

Marketing Food and Drug Administration Pharma Doctors 52

European Pharmaceutical Review

APRIL 13, 2023

As psychedelics diffused into wider society and recreational use increased, some individuals reported…ongoing symptoms after the drugs had left the body” At a time when psychiatry lacked effective medical therapies, the discovery of LSD was of interest.

Medicine 113

Medicine Food and Drug Administration Doctors Government 113

European Pharmaceutical Review

SEPTEMBER 2, 2022

An RMP is submitted as part of the dossier of all new drug applications and is evaluated by regulatory authorities before authorisation is given. Jouaville: Most RMM effectiveness studies are formatted as surveys or drug utilisation studies (DUS). US Food and Drug Administration. Available from: [link].

Food and Drug Administration 73

Food and Drug Administration Medicine Safety Food 73

Pharmaceutical Technology

MARCH 22, 2023

Healthcare providers are under pressure to address the growing issue of substance use disorders. According to GlobalData’s Medical Device Pipeline Analytics, there are 61 products in development for treating substance abuse disorders classed as healthcare IT.

Food and Drug Administration 52

Food and Drug Administration Healthcare Healthcare Medical 52

Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021.

Medicine 98

Medicine Food and Drug Administration FDA Healthcare 98

European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars. Senate Bill 562 (S.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). This important milestone enables the world’s first prescription music platform, and is a remarkable day for our company, for music, for healthcare, and most importantly for stroke survivors.” ” InTandem is anticipated to be available soon in select market segments.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Nixon Gwilt Law

DECEMBER 16, 2021

What can Healthcare and Life Sciences businesses and investors anticipate for the healthcare industry in 2022? We asked our team five direct questions about innovations in healthcare, life sciences, and digital health in the coming year: What healthcare trends or opportunities are you most excited about?

Healthcare 52

Healthcare Healthcare Food and Drug Administration Ethics 52

Clarivate

MAY 21, 2024

Major barriers to the broader adoption of alternative oncology-relevant endpoints in clinical trials include a lack of agreement on their value and the uncertainty among payers that they accurately capture treatment benefits for patients and healthcare systems [4] [6]. PharmacoEconomics, 2020. Am J Cancer Res, 2021. 1121-1131. [2]

Food and Drug Administration 52

Food and Drug Administration Patients Consulting Marketing 52

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

European Pharmaceutical Review

NOVEMBER 4, 2022

Nevertheless, chemotherapy’s disadvantages, including substantial toxicities, combined with inconvenient hospital-based intravenous (IV) administration, impede patients’ ability to stay on treatment and their quality of life. tumour effects. The importance of taxanes in oncology.

Food and Drug Administration 79

Food and Drug Administration FDA Pharmaceutical Patients 79

European Pharmaceutical Review

JUNE 27, 2023

At MaaT Pharma our donor-derived products are made through pooling (ie, mixing multiple donors), thus achieving a higher overall richness and standardisation of the resulting drug product. Conversely, in the US, it has always been clear and regulated as a drug.

Food and Drug Administration 96

Food and Drug Administration Manufacturing Medicine Pharma 96

Legacy MEDSearch

MAY 10, 2023

Food and Drug Administration (FDA) for continuous neonatal and infant monitoring for babies born of any gestational age to infants of 2 years at the International Maternal Newborn Health Conference in Cape Town, South Africa. . Sibel’s partnerships include some of the most respected healthcare organizations worldwide.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors. However, there is still some use of remote patient monitoring technologies.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 52

Legacy MEDSearch

JUNE 22, 2023

Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. The regulatory clearance of the EyeArt v2.2.0

FDA 52

FDA Food and Drug Administration Recruitment Marketing 52

pharmaphorum

SEPTEMBER 28, 2022

“For example, in early 2020, we enrolled somewhere between 3,000 to 3,500 participants each week. In March 2020, when the pandemic hit, we had to pause in-person recruitment. ” There’s a great deal of momentum in the healthcare community, including the pharmaceutical sector, to increase personalised care options using data.

Medicine 81

Medicine Food and Drug Administration Medical FDA 81

Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. Clarify launched its real-world evidence on health disparities in 2021.

Food and Drug Administration 52

Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

European Pharmaceutical Review

NOVEMBER 15, 2022

ISPE GAMP, RDI Good Practice Guide: Data Integrity by Design, ISPE, 2020. Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that. References. FDA, 2022. .

Manufacturing 83

Manufacturing Pharma Food and Drug Administration Safety 83

Clarivate

MARCH 17, 2022

Drug developers often face a Catch-22 regarding clinical trials and pregnancy. How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10

European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

Pharmaceutical 73

Pharmaceutical Food and Drug Administration Medicine Manufacturing 73