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.

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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.

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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.

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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. Consequential FDA and EMA decisions.

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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.

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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.

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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).

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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.” MedRhythms is headquartered in Portland, Maine. Are you hiring?

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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.

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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.

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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. . ” Pediatric medical innovation remains a challenge.

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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. FDA continues to approve the most NASs.

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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.

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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.

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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.

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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. ” This latest FDA clearance for the EyeArt v2.2.0

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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. Citizen Petitions before the FDA. Senate Bill 562 (S.

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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.

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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. Endocrine Reviews.

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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.

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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.

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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.

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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].

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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. The plant is set to be operational before the end of 2023.

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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?

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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].

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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.

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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. However, another study found that 0.1% 2] Figure 1.

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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.

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European Pharmaceutical Review

NOVEMBER 15, 2022

This aligns well with newly-issued FDA draft guidance on Computer Software Assurance, which states: “Because the computer software assurance effort is risk-based, it follows a least-burdensome approach, where the burden of validation is no more than necessary to address the risk.” FDA, 2022. . About the authors.

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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.

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Pharmaceutical Technology

MAY 5, 2023

The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA). In this case, the woman had taken apetamin in the form of cyproheptadine, lysine, and vitamin syrup.

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Pharmaceutical Technology

MARCH 22, 2023

In recent times, suppliers have also chosen other systems that rely on blockchain and sensors to track drug supply and reduce the influx of counterfeit drugs. In recent times, various global administrators have issued regulatory standards. In 2020, Fresenius Kabi introduced their first RFID-enabled medication, Diprivan +RFID.

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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.

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European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry. .” For example, in September 2022, the company Rebiotix, Inc.

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Pharmaceutical Technology

MARCH 31, 2023

On March 30, ViiV Healthcare and Medicines Patent Pool (MPP), announced sublicensing agreements with the pharma manufacturers Aurobindo , Cipla and Viatris to produce generic forms of the long-acting cabotegravir used as pre-exposure prophylaxis (PrEP) for HIV. GSK owns a majority stake in ViiV Healthcare.

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European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. While Zolgensma is also being investigated in the form of an injection, the MOA currently approved by the FDA is a single infusion.

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