World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. Do patients care? The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012.

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European Pharmaceutical Review

JULY 3, 2023

Data showed 51 percent of patients on 80mg of the small molecule treatment elafibranor achieved a cholestasis response compared with four percent on placebo. The Phase III trial enrolled 161 patients. A significant proportion of PBC patients are unable to benefit from existing therapies. There are 22.27

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Pharma Marketing Network

MAY 3, 2023

However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information. 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.

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European Pharmaceutical Review

NOVEMBER 14, 2022

Four medicines recommended for approval in the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP)’s latest meeting included a biosimilar for osteoporosis and a novel COVID-19 vaccine. Indication extension recommendations for 11 medicines. CHMP’s safety update.

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European Pharmaceutical Review

DECEMBER 15, 2022

The European Commission (EC) has expanded the marketing authorisation for Dupixent ® (dupilumab) in the European Union (EU), to treat adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy, making it the first and only targeted medicine for the condition in Europe and the US.

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Medicine Safety Side effects Patients 80

European Pharmaceutical Review

SEPTEMBER 21, 2022

Enjaymo (sutimlimab) for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease, a rare autoimmune disorder characterised by the premature destruction of red blood cells. As well as generic medicines Teriflunomide Accord and Teriflunomide Mylan (teriflunomide), indicated for the treatment of multiple sclerosis.

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Medicine Marketing Patients Safety 96

European Pharmaceutical Review

JULY 20, 2022

Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Six products were withdrawn or revoked for safety reasons during the study period.

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Medicine Safety Side effects Electronics 78

European Pharmaceutical Review

OCTOBER 20, 2022

Apogenix , a biopharmaceutical company developing next generation immunotherapeutics, announced that asunercept showed statistically significant benefits for hospitalised COVID-19 patients in the ASUNCTIS trial. The Phase II trial investigated efficacy and safety of asunercept in 435 patients with moderate to severe COVID-19 disease.

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PM360

JUNE 26, 2023

Access to medicines have persisting and systemic differences across the globe and within countries. It is estimated that nearly two billion people globally do not have access to essential medicines. Traditionally, pharmaceutical companies have not prioritized emerging markets as part of their access strategy.

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European Pharmaceutical Review

NOVEMBER 17, 2023

During the Phase III clinical trial , patients with migraine who could identify prodromal symptoms that led to headache at least 75 percent of the time. UBRELVY was well-tolerated with no new safety signals observed when administered during the prodrome, data from the clinical trial found.

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Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

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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.

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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.”

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Pharmaceutical Technology

NOVEMBER 1, 2022

Intrinsic Medicine has signed a definitive business combination agreement with special purpose acquisition (SPAC) firm Phoenix Biotech Acquisition to create a public company. To be named Intrinsic Medicine following closing, the combined company will be led by current Intrinsic CEO Alexander Martinez and president and COO Jason Ferrone.

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PM360

SEPTEMBER 7, 2023

The New England Journal of Medicine runs a weekly diagnostic challenge tasking physicians with correctly identifying a thorny case. AI and the Future Patient Experience Even though marketers should not forget about the people behind medical care, they still can’t ignore the potential of AI to transform the patient experience.

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Pharma Marketing Network

JULY 27, 2022

The patient care team supplies an abundance of information, although sifting through brochures and online resources can be daunting for the patient and their caregiver. 1 The marketer’s goal is to design easy-to-follow patient guidelines while conforming to med-legal language. Meeting Patients Where They Are.

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European Pharmaceutical Review

JUNE 29, 2022

How does that impact the safety of the biologics? Safety is key to the development of any medicine, but the safety considerations linked to bioproduction are more complex because biologics are more sophisticated medicines than small molecules. How are regulatory guidelines adapting to this trend? References.

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European Pharmaceutical Review

OCTOBER 20, 2022

City of Hope , one of the largest cancer research and treatment organisations in the US, announced that the first patient to receive novel cancer medicine AOH1996, is doing well. Its objective is to determine the maximum tolerated dose of the investigational pill, AOH1996, and to evaluate the medicine for preliminary efficacy.

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European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. They are vital to ensuring the safe and effective use of medicines, making them an integral part of healthcare in Europe. percent as EU average with some Member States as high as 25 percent).

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Healthcare Healthcare Electronics Safety 82

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). According to the MHRA, artificial intelligence offers “improved efficiencies”, enabling patients in the UK to safely access medical products earlier.

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European Pharmaceutical Review

OCTOBER 28, 2022

revealed the first patient to be dosed with OTX-2002, the first programmable mRNA therapeutic for c-Myc (MYC) oncogene overexpression, which targets cancer cells while sparing healthy cells. Most mRNA medicines code for natural proteins, although some have been modified. Biotech firm Omega Therapeutics, Inc.

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European Pharmaceutical Review

MAY 2, 2023

3 With greater scientific understanding of cancer, the industry has made significant progress in developing innovative medicines to help patients. However, access to these medicines is not close to meeting patient demand, creating inequalities in the health prospects of those diagnosed with cancer.

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European Pharmaceutical Review

APRIL 17, 2024

Roche’s twice-yearly, 10-minute subcutaneous injection of OCREVUS ® (ocrelizumab) has shown significant promise for patients with either with relapsing or primary progressive multiple sclerosis (RMS or PPMS). percent had no relapse) in patients through 48 weeks of the treatment. No new safety signals were identified for OCREVUS SC.

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Pharmaceutical Technology

JULY 7, 2022

But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. Cell and gene therapies are currently at the forefront of immunotherapy cancer research, and a few approved therapies are already making a difference to disease outcomes for patients.

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European Pharmaceutical Review

OCTOBER 6, 2022

The approval redefines the pool of patients to be optioned for Enhertu (fam-trastuzumab deruxtecan-nxki), a modified HER2-directed antibody drug conjugate (ADC). Now, they may be eligible for a HER2-targeted therapy, significantly increasing the number of patients who could have improved outcomes.”. Every year 2.3

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pharmaphorum

JANUARY 27, 2023

Having previously spoken with Dr Mullen three years ago when she was country medical director for the UK & Ireland at GSK – on the topic of patient centricity and embedding that focus within the core of a pharmaceutical company – our recent interview provided some interesting insights into the changing landscape of the industry.

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Clarivate

JUNE 29, 2023

We’re mindful of some challenges that life science and healthcare organizations must work through before this technology is mature enough for use in critical business decisions that may impact patient health. Our customers entrust our products and services to help them improve patient health, and we will not jeopardize that mission.

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European Pharmaceutical Review

DECEMBER 7, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Comirnaty ® , the Pfizer/BioNTech COVID-19 vaccine for infants and children aged six months to four years in Great Britain. Additional authorisations and recommendations of Comirnaty ®.

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Food and Drug Administration Patients Side effects Medicine 83

European Pharmaceutical Review

APRIL 26, 2024

The Phase IIIb/IV LEVEL UP study evaluated the efficacy and safety of these drugs in individuals 12 years old and older with moderate-to-severe atopic dermatitis. The trial assessed patients who had an inadequate response to systemic therapy or when using these therapies was inadvisable. percent vs 8.9 percent vs 22.5 percent vs 15.5

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Safety Medical Patients Medicine 82

European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The FDA noted that its decision for the biosimilars is based on clinical study data, which showed no clinically meaningful differences from the reference medicines.

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pharmaphorum

JANUARY 5, 2023

With the FDA due to deliver a decision of Eisai and Biogen’s new Alzheimer’s disease candidate lecanemab tomorrow, the safety of the drug has been thrust into the spotlight by a case report detailing a fatality in one of their clinical trials.

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European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. There were 381 Parkinson’s patients enrolled in the trial. and Joan A.

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European Pharmaceutical Review

JANUARY 30, 2024

The European Medicine Agency’s human medicines committee (CHMP) recommended marketing authorisations for the regulatory approval of three medicines at its January 2024 meeting last week. Additionally, a positive opinion for Niapelf (paliperidone), a generic medicine for schizophrenia was adopted in the meeting.

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pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

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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.

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Safety Side effects Medicine Patients 93

European Pharmaceutical Review

NOVEMBER 13, 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for GSK’s momelotinib, recommending marketing approval. It would be sold under the proposed trade name Omjjara.

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Safety Medicine Pharmaceutical Patients 85

European Pharmaceutical Review

SEPTEMBER 20, 2022

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have announced that biosimilar medicines authorised in the European Union (EU) can now be interchanged with their reference medicine or an equivalent biosimilar product. New regulatory guidance could lead to UK biosimilar boom.

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