Pharmaceutical Technology

AUGUST 15, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. In addition, no serious safety concerns linked to the vaccine were observed.

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Vaccination Vaccine Immune Response Clinical Trials 214

Pharmaceutical Technology

JUNE 28, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting approval for AstraZeneca and Merck’s (MSD outside the US and Canada) Lynparza (olaparib) as adjuvant therapy for high-risk early breast cancer patients.

Clinical Trials 162

Clinical Trials Clinical Trials Trials Medicine 162

Cloudbyz

APRIL 25, 2023

Pharmacovigilance plays a pivotal role in safeguarding patients from potential adverse effects and ensuring the safety of drugs and medical devices. A vital aspect of pharmacovigilance is regulatory reporting, which facilitates effective communication between pharmaceutical companies, medical device manufacturers, and regulatory authorities.

Compliance 76

Compliance Clinical Trials Clinical Trials Manufacturing 76

Pharmaceutical Technology

AUGUST 5, 2022

In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) recommended approving the treatment in this setting. It analysed the safety and efficacy of Lynparza in breast cancer patients.

FDA Approval 147

FDA Approval DNA Clinical Trials Clinical Trials 147

Sciensano

MARCH 27, 2024

Although several health authorities warned the public against using this medicine outside clinical trials, the medicine was widely used on a major scale in late 2020 and in 2021. In scientific literature, we find reports of serious side effects such as reduced blood pressure, confusion and hallucinations.

Contamination 52

Contamination Bacteria Packaging Packaging 52

Pharmaceutical Technology

DECEMBER 9, 2022

This development comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency provided a positive recommendation in October this year. growth in reported revenue to $27.4bn (JPY3,569bn) during the fiscal year 2021 (FY2021), against $24.6bn (JPY3,197.8bn) in FY2020.

Vaccination 147

Vaccination Vaccine Marketing Trials 147

Drug Discovery World

FEBRUARY 7, 2024

Globally, approximately 573,000 new cases of bladder cancer and 212,000 deaths are reported annually. It is estimated that approximately 25,000 people in Japan are diagnosed with bladder cancer each year and approximately 10,000 deaths were reported in 2022.

Regulation 52

Regulation Containment Genetics Clinical Trials 52

Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

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Bioequivalency Production Branding Contamination 130

FDA Law Blog

FEBRUARY 21, 2024

2, 2024, FDA’s Center for Veterinary Medicine (CVM) announced that it will withdraw its Program Policy and Procedures Manual Guide 1240.3605 (PPM). The PPM has severely limited development of new animal feed ingredients, including ingredients that promote growth, productivity claims, and ingredients with benefits for the environment.

Regulation 52

Regulation Production Development Drugs 52

Cloudbyz

AUGUST 2, 2022

Other regulatory agencies, such as the European Medicines Agency (EMA), use the term post-authorization studies instead of post-marketing studies. . Post-marketing studies concentrate mainly on safety and effectiveness. Post- Authorization Safety Studies (PASS ). Post market research for monitoring drug safety.

Marketing 78

Marketing Research Clinical Trials Clinical Trials 78

Pharmaceutical Technology

SEPTEMBER 26, 2022

In July, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion recommending a grant of marketing authorisation for Ultomiris. A subject-reported scale, MG-ADL evaluates the ability of participants to carry out day-to-day activities.

Medicine 147

Medicine Antibody Production Trials 147

Pharmaceutical Technology

MARCH 23, 2023

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. Between 2017 and 2021, the number of industry-led Phase III trials initiated fell by 48%, as per the report.

Clinical Trials 147

Clinical Trials Clinical Trials Regulation Trials 147

Camargo

JULY 8, 2021

It is exciting to find new uses of drugs with known safety because these drugs can reach new groups of patients in a relatively short timeframe. Researchers at the Broad Center of Regenerative Medicine and Stem Cell Research at UCLA have observed that MAOIs might help the immune system attack cancer. So how did the FDA do?

Development 130

Development Bioequivalency Gene Expression Drugs 130

Cloudbyz

DECEMBER 15, 2023

The aim is to improve the well-being of animals, enhance veterinary medicine, and contribute to public health (e.g., by evaluating food safety or zoonotic diseases). Human Trials: Aim to assess the safety and efficacy of treatments, drugs, or medical devices for human health.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Medicine 64

Pharmaceutical Technology

MAY 25, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) aims to launch a pilot genetic biobank that will gather patient data to associate drug-related adverse events to their genetic makeup. According to the press release, the MHRA will be the first drug safety regulator in the world to pilot such a biobank.

Biobanking 130

Biobanking Genetics Genome Project Genome 130

Pharmaceutical Technology

FEBRUARY 24, 2023

The revision process is reviving old conflicts in the pharma industry over fair and affordable access to medicines versus Europe’s status as a competitive home for pharma innovation. She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation. You can compare timelines.

Regulation 162

Regulation Clinical Trials Clinical Trials Medicine 162

FDA Law Blog

OCTOBER 16, 2023

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

Radiology 119

Radiology Regulation Production Development 119

Drug Discovery World

JULY 26, 2023

A first in human study of a 3D printing drug product, T21, designed to treat moderate to severe ulcerative colitis (UC), has reported positive results. The administration of oral medication is generally regarded as the preferred method for patients with UC due to its safety, pain avoidance and patient compliance.

Drug Delivery 52

Drug Delivery Compliance Medicine Drugs 52

Drug Discovery World

FEBRUARY 28, 2024

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a Type II variation for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of relapsed and refractory multiple myeloma (RRMM).

Medicine 52

Medicine Protein Drugs Production 52

Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Note: Some medicines are in more than one category.

Gene Therapy 155

Gene Therapy Gene Packaging Packaging 155

Drug Discovery World

JULY 13, 2023

The European Medicines Agency (EMA) safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), is reviewing data on the risk of suicidal thoughts and thoughts of self-harm related to GLP-1 receptor agonists. The presence of a signal does not necessarily mean that a medicine caused the adverse event in question.

Drugs 52

Drugs Medicine Production 52

Cloudbyz

AUGUST 2, 2022

Other regulatory agencies, such as the European Medicines Agency (EMA), use the term post-authorization studies instead of post-marketing studies. Post-marketing studies concentrate mainly on safety and effectiveness. Non-FDA mandated postmarketing studies may utilize a wide array of research designs with various objectives.

Marketing 52

Marketing Research Clinical Trials Clinical Trials 52

Pharmaceutical Technology

OCTOBER 13, 2022

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Colonis Pharma’s melatonin oral solution for the treatment of sleep-onset insomnia in children and adolescents with attention-deficit hyperactivity disorder (ADHD). Prescription-only vs OTC.

Drugs 147

Drugs Hormones Sales Medicine 147

Pharmaceutical Technology

SEPTEMBER 8, 2022

The expert services rendered by them help in improving patient outcomes, minimising costs of the healthcare system, improving medicinal adherence and persistency and saving clinicians’ time. The list includes companies that offer various products and services, including but not limited to: · Special handling services.

Pharmacy 113

Pharmacy Containment Manufacturing Business Development 113

Rethinking Clinical Trials

JULY 6, 2023

Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance. Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

Camargo

MARCH 9, 2021

This statistic comes from an FDA investigation and report in the Journal of the American Medical Association Internal Medicine (JAMA). Therefore, it was a bit surprising that the FDA prepared this JAMA report, though it aggregated data so as not to reveal any specific sponsors or drug products. in 2020) Keytruda.

Development 146

Development Manufacturing Drugs Production 146

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. In more serious instances, sponsors might see their products recalled entirely. Working together, the U.S.

Clinical Research 52

Clinical Research Compliance Research Clinical Trials 52

Pfizer

AUGUST 3, 2022

This decision is not based on safety concerns. . Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. REALM-DCM (NCT03439514) is a multinational, Phase 3, placebo-controlled study evaluating the efficacy and safety of PF-07265803 in patients with symptomatic LMNA-related DCM. About REALM-DCM.

Development 101

Development Vaccination Vaccine Production 101

pharmaphorum

NOVEMBER 2, 2020

The tender awarded to Maidenhead, Berkshire-based GenPact UK aims to “ensure that no details from the ADRs…are missed” as the UK prepares to start rolling out COVID-19 vaccines – assuming their safety and efficacy is supported in late-stage trials. The post MHRA looks to AI to hunt for COVID-19 vaccine side effects appeared first on.

Vaccination 145

Vaccination Vaccine Regulation Trials 145

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. Adoption of Lupkynis in the European market will depend largely on pricing as well as reception by physicians.

FDA Approval 147

FDA Approval Compliance Trials Marketing 147

pharmaphorum

NOVEMBER 16, 2022

Novartis has already spun out its eyecare business Alcon, and is now considering the sale of its ophthalmology and respiratory medicines businesses as it continues a narrowing of its focus, according to media reports. Meanwhile, Lucentis sales have been in decline as a result of biosimilar competition, contracting 11% to $1.55

Sales 122

Sales Gene Therapy Allergies Medicine 122

pharmaphorum

NOVEMBER 28, 2022

According to a report by the Office of Health Economics (OHE), commissioned by the Association of the British Pharmaceutical Industry (ABPI), immediate action must be taken by governments, health systems, and companies to secure the era of green pharmaceuticals. The report was released while COP27 was underway in Egypt.

Pharma Companies 105

Pharma Companies Medicine Production Marketing 105

XTalks

NOVEMBER 27, 2023

“FDA approval of Pombiliti and Opfolda is a testament to the power of science, medicine and our passionate determination to improve the lives of people living with Pompe disease. I am just so immensely proud of our team, and so very grateful to everyone who has worked to bring this medicine to this approval.

FDA Approval 104

FDA Approval Clinical Trials Clinical Trials Trials 104

Cloudbyz

JUNE 7, 2023

Real-World Evidence refers to the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from the analysis of Real-World Data (RWD). Post-market Surveillance and Vigilance With RWE, companies can proactively monitor and address safety concerns after the product has entered the market.

Clinical Trials 82

Clinical Trials Clinical Trials Trials Marketing 82

pharmaphorum

AUGUST 17, 2021

Rapid advances in the use of artificial intelligence (AI) in healthcare and medicines development are at risk of outstripping current regulatory frameworks, according to a new report.

Regulation 113

Regulation Medicine Development Clinical Development 113

FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

Medicine 59

Medicine Gene Therapy Gene Production 59

Drug Discovery World

JULY 13, 2022

The study is assessing the safety and clinical use of Mim8 in patients with haemophilia A. Interim results from 32 patients showed that six of seven participants in the lowest dose cohort still reported at least one bleed, whereas at high doses, only two of the 25 patients reported bleeds. Official comments .

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52