Pharma Marketing Network

JULY 3, 2021

Join the Society for Health Care Strategy and Market Development (SHSMD) at their annual conference, SHSMD Connections 2021 this autumn. Safety: Join SHSMD for an exceptional conference filled with quality content and networking opportunities, while following the latest local and CDC guidelines to ensure everyone is safe.

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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)?

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European Pharmaceutical Review

AUGUST 16, 2022

The Phase III RATIONALE 301 study evaluated the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. . In addition, the safety profile for tislelizumab was consistent with previous studies and no new safety signals were reported.

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European Pharmaceutical Review

NOVEMBER 1, 2022

The Phase III open-label, randomised trial ( NCT03682536 ) evaluated the efficacy and safety of Reblozyl versus epoetin alfa. The safety results for the trial were consistent with previous studies. The safety results for the trial were consistent with previous studies. No new safety issues were reported. in November 2021.

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European Pharmaceutical Review

DECEMBER 6, 2022

In July 2021, the French temporary authorisation for use (Autorisation Temporaire d’Utilisation, ATU) programme was the subject of a major reform, initially published within the 2021 healthcare plan on the 14th December 2020 (Article 78 – La Loi de financement de la sécurité sociale , FSSL). 03/11/2021. ✓. 27/10/2021.

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European Pharmaceutical Review

JUNE 29, 2023

Initiating Phase II trials for an AI-generated drug The Phase II study will assess the safety, tolerability, pharmacokinetics and preliminary efficacy of 12-week oral INS018_055 dosage in subjects with the rare lung disease idiopathic pulmonary fibrosis (IPF). Patients will be divided into four parallel cohorts.

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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.

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European Pharmaceutical Review

OCTOBER 20, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) granted a UK licence for the product in 2021. The secondary endpoint for both trials was to evaluate the contraceptive efficacy, bleeding patterns and overall safety of the drug in women of the reproductive years 18-50 and 16-50.

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Pharmaceutical Technology

JANUARY 23, 2023

The management of SLE and LN consists largely of treatment options that are based on highly efficacious steroids or immune-suppressive therapy with an undesirable safety profile, which includes accrued organ damage, infections and cancer.

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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.

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European Pharmaceutical Review

SEPTEMBER 15, 2023

The study for Dercum’s disease evaluated the efficacy and safety of CBL-514 injections in twelve participants. Promisingly, Caliway also shared that according to the Global Dercum’s Disease Market Research Report, the global Dercum’s disease treatment market size in 2021 was $11.3 percent and 54.7

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European Pharmaceutical Review

AUGUST 1, 2023

The MHRA introduced ILAP in early 2021. Use of vepdegestrant in ongoing and planned clinical trials will continue to monitor and evaluate safety and anti-tumour activity of the anti-cancer treatment. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialisation of vepdegestrant.

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Medicine Safety Healthcare Healthcare 98

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.

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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.

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Medicine Manufacturing Safety Consulting 89

Pharma Pathway

SEPTEMBER 12, 2022

Passout years: 2020, 2021, 2022. As part of Covid-19 safety measures, candidates are requested to sanitize their hands at the entrance, Maintain social distance and ware face mask before entering the venue. Greetings From Shodhana Labs!!! Department: Quality Control /Quality Assurance/ Production/ R&D/ AR&D. Aadhar Card Xerox.

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Pharma Marketing Network

MAY 3, 2023

In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation. In conclusion, navigating the regulatory environment of pharmaceutical marketing requires a delicate balance between patient safety and industry innovation.

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Safety Food and Drug Administration Pharmaceutical Marketing 52

European Pharmaceutical Review

OCTOBER 25, 2023

The device may be reassessed to ensure the performance and safety of the device is negatively impacted. The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs.

Medical 105

Medical Food and Drug Administration Manufacturing Safety 105

European Pharmaceutical Review

FEBRUARY 22, 2023

3 Voluntary withdrawals demonstrate industry compliance In 2021, the FDA’s Oncology Center of Excellence requested a meeting with industry as part of its ongoing review of the accelerated approval process, particularly where confirmatory clinical trials did not confirm clinical benefit. 2021; 22(7): 3464. cited 2023Jan]. Fierce Pharma.

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European Pharmaceutical Review

JANUARY 18, 2023

In 2021, Peter Kohut, Director of Drug Safety at Arriello shared with EPR how European medical cannabis market lacks a common regulatory framework. “… there is a lack of standardisation in the manufacturing of medical cannabis products , their ingredients and labelling.”.

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European Pharmaceutical Review

JANUARY 16, 2023

Rykindo ® was approved for marketing in China in 2021 for the treatment of schizophrenia. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder. Clinical trials of the FDA approved Rykindo ®.

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Pharmaceutical Technology

APRIL 3, 2023

Treatment is then conducted as a clinical trial by the National Cancer Center Hospital to confirm its safety and efficacy. Developed using Epizyme’s proprietary product platform, tazemetostat received approval to treat relapsed or refractory EZH2 gene mutation-positive follicular lymphoma in Japan in 2021.

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European Pharmaceutical Review

NOVEMBER 23, 2022

Sponsorship of the clinical trials transitioned to Australian biopharma company CSL after it acquired global rights to commercialise the treatment in May 2021. The safety and effectiveness of Hemgenix was evaluated in two studies of 57 adult males between 18 to 75 years old with severe or moderately severe Haemophilia B.

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European Pharmaceutical Review

MARCH 17, 2023

The clinical trial evaluated the safety and efficacy of efgartigimod in 167 patients. The post First FcRn blocker approved in UK for myasthenia gravis appeared first on European Pharmaceutical Review.

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Medicine Safety Consulting Patients 98

European Pharmaceutical Review

NOVEMBER 22, 2022

The application is supported by results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-centre Phase I/II trial evaluating the safety and preliminary efficacy of epcoritamab in adults with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL). EPCORE NHL-1 Trial of epcoritamab .

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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. The CAR-T therapies for conditions like lupus continue to look promising, but their safety is a concern, says Gilkeson. MSCs and CAR-Ts for lupus.

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European Pharmaceutical Review

JANUARY 18, 2023

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. In August 2021, mRNA-1345 gained Fast Track designation in adults over 60 years old. To date, most solicited adverse reactions were mild or moderate.

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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.

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Food and Drug Administration Safety Recruitment Medical 98

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.

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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?

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European Pharmaceutical Review

JULY 28, 2023

Phase III ROBIN trial In 2021, Phase III results of the ROBIN clinical trial were published in the Journal of the American Medical Association (JAMA) Psychiatry. Based on the results, the safety and efficacy of 50mg of zuranolone was subsequently evaluated in the SKYLARK trial.

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Food and Drug Administration Food Safety Patients 98

pharmaphorum

JULY 19, 2022

The FDA has been paying close attention to the safety of JAK inhibitors, and Opzelura was approved with black box warning that includes JAK class-wide wording for risks such as infections, heart-related events and cancer, despite being used on the skin rather than administered systemically.

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European Pharmaceutical Review

AUGUST 12, 2022

Key secondary endpoints include progression-free survival (PFS), duration of response (DoR) and safety. Analysis data cut-off: 27 August 2021. The safety profile of Tagrisso plus savolitinib was consistent with the known profiles of the combination and each treatment alone. No new safety signals were identified.

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European Pharmaceutical Review

NOVEMBER 1, 2023

The safety profile of the adapted vaccine is expected to be like that of the originally authorised Nuvaxovid, EMA said. Nuvaxovid was first authorised in the European Union in December 2021. 5, it was able to trigger a strong immune response against this strain. Based on these data, the Committee concluded that Nuvaxovid XBB.1.5

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Side effects Medicine Safety Marketing 105

European Pharmaceutical Review

NOVEMBER 15, 2022

“This paper highlights how the revised 2022 WHO Biosimilars Guideline provides Clarity, Consistency and Confidence in state-of-the-art regulatory science for biosimilar medicines based on… experience and over 1 million patient-treatment years of safety data in Europe alone,” explained Julie Maréchal-Jamil, Co-Chair of the Biosimilars Committee. “We

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European Pharmaceutical Review

AUGUST 24, 2023

Almost 6,000 participants were enrolled in the trial, which was conducted between 2021 and 2023. The results from the pharma company ‘s study are in line with findings from the Phase III trials ZOE-50 and ZOE-70 investigating the efficacy and safety of RZV.

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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.

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Patients Medical Safety Medicine 98

European Pharmaceutical Review

OCTOBER 31, 2022

The study evaluated the safety and efficacy of the drug in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL). Data from the dose escalation section of the investigation was published in The Lancet in 2021. The submissions are supported by Phase II trial data.

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