European Pharmaceutical Review

JANUARY 29, 2024

In the published in 2023, the process and requirements for toxicological risk assessment of medical device constituents is outlined. Also covered in the guideline are “the methods and criteria used to assess whether exposure to a constituent is without appreciable harm”.

Compounding 85

Compounding FDA 85

European Pharmaceutical Review

JULY 17, 2023

New research published in JAMA Health Forum has documented that the US National Institutes of Health (NIH) spent $8.1 billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. percent of total NIH spending for basic or applied research related to these products.

Documentation 88

Documentation FDA 88

European Pharmaceutical Review

JULY 28, 2023

Publication of results of the Phase III SKYLARK study “is a pinnacle moment in treating postpartum depression ( PDD ),” stated Dr Kristina M Deligiannidis, Professor at the Institute of Behavioral Science at the Feinstein Institutes, the trial’s principal investigator, lead author of the paper. At day 45, 61.9

FDA 92

FDA 92

Hospital Pharmacy Europe

MARCH 7, 2024

The findings of three trials published in 2018 ( ASPREE , ASCEND and ARRIVE ), which assessed the effects of starting aspirin therapy versus a placebo on ASCVD outcomes in aspirin-naive adults, resulted in guidelines no longer recommending low-dose aspirin for the primary prevention of ASCVD. for the ASPREE data and 1.21

Hospitals 52

Hospitals 52

European Pharmaceutical Review

NOVEMBER 8, 2023

A paper published by Research Square has described a rapid, simple, accurate and precise high-performance liquid chromatography with diode-array detection (HPLC-DAD) method for levofloxacin determination in liquid pharmaceutical formulations. percent trifluoroacetic acid (18:82 v/v) was used as a mobile phase with a rate of 1.5

Dosage 94

Dosage FDA 94

European Pharmaceutical Review

JANUARY 18, 2024

US researchers have reported promising outcomes from a Phase I/II trial in cancer patients treated with cord blood-derived CD19-targeted chimeric antigen receptor (CAR) natural killer (NK) cell therapy. Published in Nature Medicine , the findings revealed an overall response (OR) rate of 48.6 percent at 100 days post treatment.

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European Pharmaceutical Review

AUGUST 31, 2023

New research published in the New England Journal of Medicine has indicated that stem cell gene therapy could provide a curative treatment for sickle cell disease (SCD). Autologous stem cell therapy The autologous, hematopoietic stem and progenitor cell (HSPC) product OTQ92 incorporated gene-editing using CRISPR-Cas9 technology.

Hospitals 111

Hospitals FDA 111

European Pharmaceutical Review

FEBRUARY 15, 2023

The results suggest “that neoadjuvant nivolumab was safe in long-term follow-up,” commented Patrick Forde, MBBCh, an Associate Professor of oncology and Director of the Thoracic Oncology Clinical Research Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. It was successfully managed, the authors noted.

Chemotherapy 91

Chemotherapy Immunization FDA 91

European Pharmaceutical Review

JUNE 16, 2023

The authors argued that fundamentally, implementation of AI/ML for pharmacovigilance has been hindered by the associated legal framework processes and governance issues. Therefore, this suggests sub-optimal use of ML in pharmacovigilance. However, the paper highlighted the challenges these technologies hold for analytics. Bate et al.

Vaccines 93

Vaccines FDA 93

European Pharmaceutical Review

JANUARY 11, 2023

The findings, published in Nature Communications , show a wide imbalance in microbiome composition in people with Parkinson’s. The research reported Parkinson’s disease metagenome is indicative of a disease-promoting microbiome. “We Heersink School of Medicine Department of Neurology and senior author on the study.

Communication 101

Communication 101

European Pharmaceutical Review

APRIL 3, 2023

In the Phase I New Approaches to Neuroblastoma Therapy (NANT) trial, researchers found that lorlatinib given alone or in combination with chemotherapy was safe and tolerable in patients with relapsed/refractory anaplastic lymphoma kinase (ALK)-driven neuroblastoma. The data showed 63 percent of patients responded to the combined treatment.

Chemotherapy 80

Chemotherapy Hospitals FDA 80

Hospital Pharmacy Europe

JUNE 8, 2023

A lack of transparency The importance of setting the primary outcome prior to commencing a study and not deviating from the original protocol, was first highlighted in 1990 by Jay Siegel , a physician and research scientist working for the FDA in the US. This suspicion was confirmed in a 2004 analysis by researchers from Oxford.

Documentation 52

Documentation Communication Patient Care Hospitals 52

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA 96

FDA Documentation Packaging Labelling 96

European Pharmaceutical Review

MARCH 30, 2023

The first-in-human, Phase I/Ib study published in Nature Medicine , described the interim analyses of the novel delivery approach. Until recently there have been limited resources to develop clinical trials in this space,” commented corresponding author Dr Isabella Glitza Oliva, PhD, Associate Professor of Melanoma Medical Oncology. “We

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European Pharmaceutical Review

SEPTEMBER 29, 2022

According to a new report , implementing a Transferable Exclusivity Extension (TEE) system could solve the “broken economic model” for researching and developing new antibiotics in Europe. Table 2 : The cost to healthcare systems of extending the exclusivity of another product using the voucher for each of the six countries.

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pharmaphorum

SEPTEMBER 12, 2021

Deployment of digital health technologies during the pandemic improved patient satisfaction, expanded the delivery of care and augmented training of staff at a leading neurosurgery provider in the US, according to a new study. “Enough information could be elicited to make reliable clinical decisions,” according to the authors.

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Patient Care 132

pharmaphorum

JANUARY 27, 2022

Still, it can be challenging to acquire a complete picture of how this technology is used overall in medicine. “I “For many of the medications, for example, SSRIs, we get greater efficacy when we combine their use with concurrent cognitive behavioural therapy.”

Chemotherapy 142

Chemotherapy Pharmaceutical Companies Pharmaceutical Companies 142

European Pharmaceutical Review

AUGUST 11, 2022

Hospitalised patients on high-flow oxygen for severe COVID-19 pneumonia were nearly 50 percent less likely to die when treated with antiviral remdesivir in combination with steroid dexamethasone and baricitinib, according to research from Rutgers Ernest Mario School of Pharmacy in the US.

Hospitals 77

Hospitals FDA 77

pharmaphorum

NOVEMBER 12, 2021

Researchers in the US have developed an artificial intelligence-based tool that is able to predict COVID-19 symptoms and suggest which FDA-approved drugs might be used to treat patients. The tool meanwhile could also be applied to new outbreaks of other novel viral infections as they emerge, according to the scientists.

Immunization 135

Immunization FDA 135

European Pharmaceutical Review

JULY 20, 2022

Researchers have shown that ratio of nicotinic acid (NA) to nicotinamide (NAM) in cell cultures significantly increases with the presence of live microorganisms within 24 hours, acting as a useful biomarker for the detection of early-stage microbial contamination in cell therapies. coli -contaminated MSCs after 5.5 hours, respectively.

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Pharmaceutical Technology

MARCH 23, 2023

These changes come following a public consultation with the Healthcare Research Authority, to which a government response was published on March 21. Furthermore, the UK is now implementing a legislative requirement to publicly register clinical trials and share summary results with any research participants.

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The FDA Law Blog

MARCH 29, 2024

Richardson — While Covid is in the rear view for most of us, FDA has had a tough time shaking off the effects of the pandemic on its inspection output. More recently, GAO has published a new report on FDA inspections entitled “ FDA Should Evaluate Its Efforts to Recruit and Retain Its Inspection Workforce.” By John W.M.

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FDA Hospitals 59

pharmaphorum

APRIL 25, 2022

The meta-analysis by researchers in the US pooled the results of the studies to assess the impact of digital approaches like telemedicine, use of monitoring sensors, Internet-based interventions, smartphone apps, or text messaging/email interactions on all-cause mortality. with usual care to 8.5% versus 7.3%, respectively).

Hospitals 139

Hospitals 139

pharmaphorum

JANUARY 26, 2023

In March, the collaborative T2T consortium published the first complete telomere-to-telomere sequence of the human genome, filling in the last 8% of the 3 billion base pairs that make up our DNA. Moreover, research has shown that genetic testing can reduce adverse reactions to drugs by nearly one third.

Adverse Reactions 129

Adverse Reactions Vaccines 129

Hospital Pharmacy Europe

MAY 22, 2023

Spironolactone is a cheap, safe and effective for treating women with acne that can also be used in the longer term, a large UK study has shown. There did not seem to be a difference in effectiveness between women who had PCOS and those who did not, the researchers noted.

Hospitals 102

Hospitals 102

pharmaphorum

MARCH 29, 2021

Akili has published data backing the efficacy of its childhood attention-deficit hyperactivity disorder (ADHD) video game therapy EndeavorRx in the peer-review journal Nature Digital Medicine. . Boston, US-based Akili is one of a group of companies founded by UK group PureTech, which retains a 34% stake in the venture.

Labelling 110

Labelling 110

pharmaphorum

JULY 6, 2022

Yet, three of the 19 drugs given the go ahead in the US were later withdrawn, compared to just one in the EU, prompting some to ask if faster approval times merely represent “quantity over quality”. And how can regulators balance timely access with robust safety? Delayed access. The remaining 12 still have confirmatory trial results pending.

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FDA 98

European Pharmaceutical Review

SEPTEMBER 8, 2022

“The most exciting finding of the study is the robustness of the signal in the cluster-interval data,” noted co-author and Assistant Professor of Neurology at Harvard Medical School, US, Dr Jurriaan Peters. ” The results of the study were published in Epilepsia. . days in Period 1 (day 1-90) to 26.8

Medical Schools 91

Medical Schools 91

European Pharmaceutical Review

DECEMBER 21, 2022

Since then, there have been few breakthrough innovations in treating neuropsychiatric diseases such as anxiety, depression, substance use disorders (SUDs), and post-traumatic stress disorder (PTSD). Psychedelic research, in particular, is gaining momentum. . Up until recently, it took a prohibitive stance toward psychedelic research.

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Compounding Controlled Substances FDA Patient Care 112

pharmaphorum

APRIL 28, 2021

The primary way to uncover these targets is through searching and reviewing published scientific literature. Eric Gilbert explores how data science techniques like text mining are speeding up research into areas such as pancreatic cancer. Understanding more about the disease and what determines poor patient outcomes.

Immunization 105

Immunization 105

PharmaShots

MARCH 27, 2023

the US & EC Ref: Novartis | Image: Novartis Related News:- Novartis Published P-III (SUNSHINE) and (SUNRISE) Trials Results of Cosentyx (secukinumab) for Hidradenitis Suppurativa in The Lancet The therapy was approved in 99 countries globally, incl. The therapy was approved in 99 countries globally, incl.

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The People's Pharmacy

APRIL 27, 2023

Many of us don’t pay much attention to the parasympathetic nervous system. So does using a tilt table, which activates baroreceptors that are part of this nervous system. Dr. Porges has published more than 400 peer‐reviewed scientific papers across several disciplines that have been cited in more than 50,000 peer-reviewed papers.

Communication 110

Communication 110

pharmaphorum

JUNE 7, 2021

Researchers in the US have developed a wearable fabric that can sense, store and analyse data that could be used to measure physiological functions or detect illness. The fibres can be washed at least 10 times without breaking down, according to the scientists, who have published their work in Nature Communications.

Communication 145

Communication 145

European Pharmaceutical Review

JULY 29, 2022

Both the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have endorsed a statement calling for international collaboration on integrating real-world evidence (RWE) into regulatory decision-making. Interested parties also need to deal with various processes for data sharing and access.

FDA 86

FDA 86

pharmaphorum

FEBRUARY 10, 2022

The healthcare ecosystem may be the natural beneficiary of recent advances in data collection and analysis, but that’s no use without the staff to develop and implement solutions. In a report published last month, the Association of the British Pharmaceutical Industry (ABPI) noted significant skills gaps in several areas.

Compounding 105

Compounding 105

European Pharmaceutical Review

MARCH 11, 2024

In fact, a study published in 2023 in The Lancet HIV revealed that women and men with HIV at age 40 had an average of 39 and 37 years of life left, respectively – only a few years less than that of the general population – if they started antiretroviral therapy (ART) after 2015. 3 But that paradigm is rapidly changing.

Immunization 94

Immunization 94

The Honest Apothecary

MAY 4, 2023

In a new paper published in Science, Dana-Farber researchers outline the complexities of the disease and the research needed to map out a path toward understanding it.” Authorities swarmed the city’s midtown neighborhood shortly after noon in search of the shooter. by the year 2030. Does Chat GPT Really Outshine Docs?

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