Author: GMDP Academy Editorial Board

News from the EMA: Guidelines announced on bioequivalence for immediate release solid oral dosage forms

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The European Medicines Agency has published for public consultation an ICH Guideline M13A on bioequivalence for immediate release solid oral dosage forms.

This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post-approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.

News from FDA: CDER Continues to Advance Rare Disease Drug Development with New Efforts, Including the Accelerating Rare Disease Cures (ARC) Program

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A rare disease is any disease that affects fewer than 200,000 people in the U.S. There are approximately 25 to 30 million Americans living with a rare disease (about 1 in 10 people), and many rare diseases have few or no available treatment options. FDA’s goal for this year’s Rare Disease Day (February 28) is to explore ways to engage and collaborate with patients, patient advocates, and other stakeholders to support the development of safe and effective therapies.

Five reasons to get certified in Medicines Development

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Medicines Development is a complex and rapidly evolving field, with new drugs and therapies being developed all the time. As such, there is a growing need for professionals who are trained and certified in the various aspects of Medicines Development, including drug discovery, clinical trials, and regulatory affairs. Here are five reasons why becoming certified in Medicines Development can be a great career move.

Reported rates of all-cause serious adverse events following immunization with BNT-162b in 5-17-year-old children in the United States

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The development of the vaccines against Covid 19 was a significant achievement, and a collaborative effort among scientists, regulators and pharmaceutical companies. However, we are aware that several criticisms were raised, especially by non-specialized opinion leaders, questioning the safety of these vaccines. These warnings were particularly addressed to their use in the pediatric population. The publication below provides a solid answer to this important consideration.

News on artificial intelligence: How Nature readers are using ChatGPT

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Researchers are keen to experiment with using generative AI tools such as the advanced chatbot ChatGPT to help with their work, according to a survey of Nature readers. But they are also concerned about the potential for errors and false information.

Of 672 readers who responded to an online questionnaire, around 80% have used ChatGPT or a similar AI tool at least once. More than one-fifth use such tools regularly — 8% said they use them every day, and 14% several times per week. Around 38% of respondents know of other researchers who use the tools for research or teaching.

News from the EMA: addressing the ongoing antibiotic shortage

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EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met recently  to discuss the progress made and to agree on the next steps in the coordinated response to the ongoing shortages of antibiotic medicines containing amoxicillin (alone and in combination with clavulanic acid) in the EU. The MSSG is made up of representatives from EMA, the European Commission and the Heads of Medicines Agencies (HMA).

Why eConsent Primes Patients and Studies for Success

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According to a survey conducted by Florence Healthcare, 47% of research sites had adopted e-Consent by December 2020, just 8 months after the WHO declared an official pandemic. By July 2021, 75% of research sites had either used it or were looking into it. In conclusion – the decentralized consent process is here to stay.

Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension

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Arterial hypertension was the “school” of the methodology of clinical trials. All readers who started to work in Pharmaceutical Medicine/Medicines Development in the 70s and 80s will certainly remember the great enthusiasm caused by the discovery of the new classes of anti-hypertensive agents (beta-blockers, calcium antagonists, ACE-inhibitors and finally sartans), and the rigid methodology which was applied, for the first time, for their clinical development. These significant achievements contributed to a good control of arterial hypertension, saving millions of lives from cardiovascular events.

National crises and cancer control: challenges for Latin America

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The article below from the Lancet reflects Latin America’s fight to control cancer amidst a slew of regional political crises.

“2023 began with the emergence of chaotic and violent scenes from Brazil, as the country weathers a period of high political instability. In January, thousands of far-right supporters of former president Jair Bolsonaro stormed Congress, the Presidential Palace, and the Supreme Court in Brasilia in protest against the inauguration of the country’s new President, Luiz Inácio Lula da Silva, who was democratically elected in October, 2022. Bolsonaro’s most dedicated supporters refuse to accept the new presidency, claiming electoral fraud, and have led road blockades that have crippled major sectors of the economy, as well as street protests and violent attacks on police and civilians. The mounting tensions are just one indicator of the nation’s instability and unrest—a socio-political crisis that is not confined to Brazil but extends to many other Latin American countries. Against this tumultuous backdrop, how is health care, and cancer care in particular, faring across the region?

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