European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. Some, 250,000 child deaths per year can be attributed to counterfeit malaria and pneumonia medicines.

Medicine 88

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 88

European Pharmaceutical Review

FEBRUARY 27, 2024

The Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), Dame June Raine, will step down in the Autumn following five years in the role. While she is stepping down from her current role, Dame June shared that she still hopes to contribute “to patient safety and public health in other ways.”

Pharmacology 92

Pharmacology Safety Medicine Education 92

European Pharmaceutical Review

MAY 2, 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a policy paper on its strategic approach to artificial intelligence (AI). It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023.

Safety 95

Safety Medicine Government Medical 95

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 recent years, digital marketing has become an increasingly important tool for pharmaceutical companies to reach patients and healthcare providers.

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Safety Food and Drug Administration Pharmaceutical Marketing 52

Pharmaceutical Technology

JUNE 20, 2023

It was developed in collaboration with the Institute for Protein Design (IPD) at the University of Washington School of Medicine, with funding support from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI).

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Safety Medicine Healthcare Healthcare 145

European Pharmaceutical Review

JUNE 29, 2022

As the healthcare sector grows, there is a clear trend towards the expansion of biologic therapeutic drugs and vaccines like the one developed by Novavax. How does that impact the safety of the biologics? First, we see a global trend of developing more ethical solutions for the safety testing of biologics. PathoQuest.

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Ethics Safety Manufacturing Medicine 81

Pharmaceutical Technology

JULY 7, 2022

But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. It is certainly a pivotal moment for the cell and gene industry, with the next decade of R&D and clinical trials expected to transform the future of medicine.

Medicine 98

Medicine Transportation Manufacturing Biopharma 98

European Pharmaceutical Review

APRIL 17, 2024

Roche multiple sclerosis subcutaneous injection: late-breaking data “Updated results from OCARINA II further underline the potential benefits of subcutaneous OCREVUS for patients with both relapsing and progressive forms of MS,” shared Scott Newsome , DO, lead author, Johns Hopkins University School of Medicine.

Food and Drug Administration 65

Food and Drug Administration Safety Medicine Food 65

Pharmaceutical Technology

NOVEMBER 9, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 1 vaccine as well as the safety results from a clinical trial underway. 5 sub-variants.

Side effects 105

Side effects Safety Medicine Healthcare 105

European Pharmaceutical Review

OCTOBER 25, 2023

Three key medicine regulatory bodies from the UK, US and Canada have collaborated to publish five guiding principles for machine learning-enabled medical devices MLMDs. The device may be reassessed to ensure the performance and safety of the device is negatively impacted.

Medical 88

Medical Food and Drug Administration Manufacturing Safety 88

European Pharmaceutical Review

JANUARY 8, 2024

“With the European Commission approval of rozanolixizumab, alongside their recent approval of zilucoplan, I am very excited that our gMG portfolio is now approved for use by healthcare professionals across Europe,” commented CEO of UCB, Jean-Christophe Tellier. This will allow quick identification of new safety information.

Biopharma 91

Biopharma Medicine Healthcare Healthcare 91

InCrowd

AUGUST 2, 2023

The similarities in healthcare professionals are easy to see. Our field self-selects and reinforces rigid thinking in the name of safety. It was time for a dose of my own medicine. There was solace in support from a wise guide who successfully traversed their own healthcare burnout. Found support. Interested in joining?

Healthcare 52

Healthcare Healthcare Medicine Consulting 52

European Pharmaceutical Review

NOVEMBER 16, 2023

It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia. No significant safety concerns were identified during the trials.

Safety 91

Safety Side effects Medicine Patients 91

Pharmaceutical Technology

MAY 30, 2023

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. The vaccine was also found to have a standard safety and reactogenicity profile when administered as a primary two-dose vaccination.

Distribution 119

Distribution Medicine Safety Marketing 119

PM360

SEPTEMBER 15, 2022

In many of the states where abortion is banned, strictly regulated, or soon to be restricted, the procedure is legal only in instances of a life-threatening situation, but no regulations define what such a situation may be, leaving 70% of physicians unclear about when to intervene for maternal safety. Qualio surveyed 2,002 U.S.

Healthcare 52

Healthcare Healthcare Doctors Physicians 52

European Pharmaceutical Review

NOVEMBER 15, 2022

The International Generic and Biosimilar Medicines Association (IGBA)’s new whitepaper Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline suggests how the guideline provides great opportunity to revaluate how regulatory requirements can better advance biosimilar access. WHO Biosimilar Guideline updates.

Medicine 87

Medicine Safety Healthcare Healthcare 87

pharmaphorum

OCTOBER 12, 2018

Digital technology is transforming the way that healthcare is practiced and delivered, with areas like digital therapeutics forging ahead to complement traditional medical approaches and augment patient care. We’ll be looking at how digital and traditional approaches to medicine are being combined to improve patient outcomes.

Healthcare 52

Healthcare Healthcare Prescription Doctors 52

European Pharmaceutical Review

AUGUST 29, 2023

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. The safety and efficacy profile was consistent with the IV formulation.

Food and Drug Administration 81

Food and Drug Administration Safety Medicine Food 81

European Pharmaceutical Review

OCTOBER 19, 2023

According to the European Medicines Agency (EMA), pre-filled pens falsely labelled as the type 2 diabetes medicine Ozempic ( semaglutide , 1mg, solution for injection) have been identified at wholesalers in the EU and the UK. News of the falsified diabetes pen arrived as there has been heightened demand for the medicine.

Medicine 92

Medicine Electronics Safety Manufacturing 92

European Pharmaceutical Review

DECEMBER 8, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised diabetes medicine, Mounjaro (tirzepatide), for weight loss and weight management in adults aged 18 and over. The medicine must be used together with a reduced-calorie diet and increased physical activity, MHRA said.

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Management Medicine Food Healthcare 82

European Pharmaceutical Review

OCTOBER 13, 2023

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of BRUKINSA ® (zanubrutinib), a Bruton’s tyrosine kinase inhibitor (BTKi), in combination with obinutuzumab. Specifically, it would be the first medicine of this type to be authorised for four indications.

Medicine 93

Medicine Safety Patients Healthcare 93

European Pharmaceutical Review

MAY 29, 2023

A neurosteroid drug was one of two medicines recommended for approval at the Committee for Medicinal Products for Human Use (CHMP) ’s May 2023 meeting. This medicinal product has potential to diagnose this cancer in high risk patients in early stages and for patients with suspected recurrence.

Medicine 88

Medicine Marketing Safety Leads 88

European Pharmaceutical Review

JANUARY 27, 2023

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Clear regulatory expectations and allowing easier product development.

Manufacturing 84

Manufacturing Medicine Consulting Engineering 84

European Pharmaceutical Review

APRIL 11, 2024

Over the past few years, the biosimilar market has expanded “rapidly” due to these medicines offering a cost-effective alternative to the reference product. Key challenges A challenge for the market is the expense of manufacturing biosimilar medicines, the report noted. million by 2032, at 17.6 percent CAGR between 2023 and 2032.

Marketing 91

Marketing Competition Manufacturing Healthcare Provider 91

World of DTC Marketing

JULY 13, 2021

Our healthcare system cannot continue to support marginally effective drugs. The FDA, when approving drugs, doesn’t take into account costs like some healthcare systems in Europe. STAT News reported, “a new study finds that prices for dozens of cancer medicines were substantially higher when introduced into the U.S.

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FDA Medicine Healthcare Healthcare 187

Pharma Marketing Network

NOVEMBER 20, 2020

This year’s 24 th Annual Healthcare Internet Conference , held on November 16-18, speakers gathered (virtually) to share their thoughts and opinions on how technology is changing the patient and physician relationship, how to grow digital engagement, and how patient experiences are shifting with telemedicine during COVID-19.

Healthcare 52

Healthcare Healthcare Healthcare Provider Physicians 52

European Pharmaceutical Review

AUGUST 16, 2022

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s COVID-19 vaccine, Spikevax, that targets two coronavirus variants as a booster. The regulator confirmed that the vaccine meets its standards of safety, quality and effectiveness. 1) and the original 2020 strain.

Safety 99

Safety Side effects Medicine Healthcare 99

Pharmaceutical Technology

APRIL 6, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease. health system may support accelerated clinical adoption in other worldwide healthcare systems.”

Safety 105

Safety Healthcare Healthcare Manufacturing 105

pharmaphorum

JANUARY 3, 2023

The UK healthcare sector is mourning one of the most eminent of its figures in the last few decades – Professor Sir Mike Rawlins – who has passed away at the age of 81. Dillon said in a statement that Rawlins was “an inspirational leader and always loyal and supportive to those around him. .”

Side effects 52

Side effects Medicine Safety Healthcare 52

European Pharmaceutical Review

JANUARY 18, 2023

Celadon Pharmaceuticals’ Midlands site is now registered by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for GMP manufacturing. The firm’s medicinal cannabis product will be supplied in oil form as an API. Navigating the cannabis API market. A new GMP registration is positive news for the sector.

Manufacturing 104

Manufacturing Medical Medicine Pharmaceutical 104

European Pharmaceutical Review

AUGUST 11, 2023

The European Commission has revoked the conditional marketing authorisation (MA) for Novartis’ sickle cell medicine crizanlizumab in the European Union (EU) and EEA. The decision follows a May recommendation from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).

Marketing 81

Marketing Food and Drug Administration Medicine FDA 81

European Pharmaceutical Review

DECEMBER 13, 2023

The European Commission has approved Blueprint Medicines’ Ayvakyt® (avapritinib) for treatment of adult patients with the haematological disorder indolent systemic mastocytosis (ISM). It also follows a positive recommendation by EMA’s Committee for Medicinal Products for Human Use (CHMP) in November.

Medicine 64

Medicine Safety Patients Healthcare 64

pharmaphorum

SEPTEMBER 6, 2022

The decision follows approval by the Medicines and Healthcare products Regulatory Agency (MHRA) last Saturday, which gave the green light for use of the new vaccine in those aged 12 years and above. No new serious safety concerns were observed. Individuals will be invited to book online or by calling 119. 1 (15mg) spike protein.

Side effects 86

Side effects Medicine Safety Healthcare 86

European Pharmaceutical Review

JANUARY 22, 2024

Market growth factors Pharmaceutical extractable and leachable (E&L) testing services The heightened and increasing demand for biopharmaceutical medicines has resulted in greater demand for E&L testing in drug safety , such as when mitigating cross-contamination risks, the report highlighted. percent, the report added.

Marketing 52

Marketing Safety Medicine Pharmaceutical 52

European Pharmaceutical Review

NOVEMBER 7, 2022

The designation is based on six months of follow-up data from a Phase II study ( NCT04649359 ) evaluating the safety and efficacy of a 76mg weekly (QW) dose of elranatamab, which showed overall response rate (ORR) was 61 percent. . The investigation noted elranatamab delivered a manageable safety profile. percent) or Grade 2 (14.2

Food and Drug Administration 92

Food and Drug Administration Medicine Safety FDA 92

European Pharmaceutical Review

AUGUST 29, 2023

Experts at the European Medicines Agency (EMA) have provided a regulatory perspective on risk factors and mitigation strategies for nitrosamine impurities in human drug products. The paper highlighted an Article 31 referral into medicine safety which began in the EU in September 2019. Cioc et al.

Medicine 85

Medicine Manufacturing Safety Healthcare 85

European Pharmaceutical Review

MARCH 17, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for VYVGART ® (efgartigimod alfa-fcab). The clinical trial evaluated the safety and efficacy of efgartigimod in 167 patients. ” VYVGART is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn).

Medicine 89

Medicine Safety Consulting Patients 89