European Pharmaceutical Review

JANUARY 9, 2024

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). 2019; 380(14):1347-1358. 2019; 16(9):1297-1299. 2023; 44(3):1384-1392.

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

Pharmaceutical Technology

JANUARY 16, 2023

In October last year, CARsgen submitted a new drug application (NDA) for CT053 to China’s National Medical Products Administration (NMPA). The US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations to the company’s zevor-cel in 2019.

Medicine 119

Medicine Food and Drug Administration Food Medical 119

European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects.

Patients 82

Patients Food and Drug Administration Side effects Safety 82

Pharmaceutical Technology

NOVEMBER 1, 2022

Karyopharm is currently assessing selinexor as a single agent in priorly treated MF patients and, along with ruxolitinibin, individuals who are naïve to treatment. . In May 2022, the US Food and Drug Administration (FDA) granted orphan drug designation for selinexor in MF indication.

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Food and Drug Administration FDA Medicine Food 52

PM360

MARCH 22, 2024

Amor Vegas stated, “T cells have the ability to develop memory and persist in your body for really long periods, which is very different from a chemical drug. Think about patients who need treatment multiple times per day versus you get an infusion and then you’re good to go for multiple years.” was approved by the U.S.

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Food and Drug Administration FDA Healthcare Healthcare 52

European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

Food and Drug Administration 84

Food and Drug Administration Manufacturing Food Medicine 84

European Pharmaceutical Review

OCTOBER 19, 2023

These diagnostics have significantly progressed based on rigorous Phase III trial designs and because of the impact these diagnostics have had on patient management. These diagnostics are also paired with therapeutics and act as an imaging biomarker to identify patients who may benefit from the paired therapies.

Food and Drug Administration 87

Food and Drug Administration Side effects Manufacturing Doctors 87

Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. FDA continues to approve the most NASs. N) = number of approvals.

Medicine 98

Medicine Food and Drug Administration FDA Healthcare 98

European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Management Food and Drug Administration Manufacturing Pharmaceutical manufacturing 75

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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Pharmaceutical Food and Drug Administration Medicine FDA 95

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics.

Food and Drug Administration 87

Food and Drug Administration Manufacturing Safety Pharmaceutical 87

European Pharmaceutical Review

JULY 13, 2023

However, even as science advances, there remain patients who still need new treatment options. By re-engineering existing approaches that have already shown clinical promise, there is potential to bring further benefit to the patient community in its fight against cancer.

Engineering 86

Engineering Food and Drug Administration Safety Patients 86

Pharmaceutical Technology

AUGUST 16, 2022

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn. months compared with patients treated with standard-of-care chemotherapy.

Food and Drug Administration 59

Food and Drug Administration Sales Patients Food 59

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. ECG leads).

Food and Drug Administration 84

Food and Drug Administration FDA Medical Food 84

European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. We’ve learnt that innovative therapies, like Zolgensma, require equally inventive access pathways so that as many patients as possible benefit from treatment.

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Food and Drug Administration Government Healthcare Healthcare 69

Pharmaceutical Technology

MARCH 22, 2023

Substance use disorders leave people with long-term negative mental and physical health implications and can lead to death. A recent study in the Journal of the American Medical Association found that between 2015 and 2019 as high as one in eight deaths in the US could be attributable to excessive alcohol consumption.

Food and Drug Administration 52

Food and Drug Administration Healthcare Healthcare Medical 52

Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). The InTandem name reflects both the synchronization inherent in the device’s mechanism of action and the partnership formed between patient and device. The burden on patient functioning is also profound. MedRhythms also unveiled the brand name for MR-001: InTandem.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

JANUARY 11, 2023

Micronoma , the first biotech company offering early cancer detection with a microbiome-driven liquid biopsy platform, announced that its OncobiotaLUNG assay received the Breakthrough Device Designation from the Food and Drug Administration (FDA). Early detection of lung cancer can lead to a higher survival rate.

FDA 52

FDA Food and Drug Administration Recruitment Patients 52

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 percent and 14.3

Food and Drug Administration 76

Food and Drug Administration Safety Patients Leads 76

Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors. However, there is still some use of remote patient monitoring technologies.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 52

Legacy MEDSearch

AUGUST 10, 2023

The Breakthrough Device application was supported by preliminary data of 281 patients from their 400-patient Swedish pilot study, which demonstrated a strong correlation to the invasive gold-standard measurements of pulmonary pressure. The designation is a testament to Acorai’s commitment to driving innovation in patient care.

Food and Drug Administration 52

Food and Drug Administration Management Recruitment Medical 52

European Pharmaceutical Review

JUNE 28, 2022

According to the World Health Organization (WHO), CVDs are the leading cause of death worldwide accounting for 32 percent of global deaths in 2019 (approximately 17.9 percent of patients taking empagliflozin for around 14 months were hospitalised for heart failure or died of cardiovascular causes, compared with 24.7 150 mg/dl [?

Food and Drug Administration 91

Food and Drug Administration Medicine Patients FDA 91

Legacy MEDSearch

FEBRUARY 16, 2023

a developer of medical devices to repair fractures in curved bones, announced the launch of its smaller-diameter, 7.5mm CurvaFix® IM Implant , designed to simplify surgery and provide strong, stable fixation in small-boned patients. patient who sustained a low energy fall two years prior, resulting in pelvic fragility fractures.

Food and Drug Administration 52

Food and Drug Administration Recruitment Patients Medical 52

Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. How can we better educate the patients? How has the field changed in recent years?

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Food and Drug Administration Engineering Patients Education 59

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 83

Manufacturing Pharma Food and Drug Administration Safety 83

Pharmaceutical Technology

SEPTEMBER 14, 2022

Positive data with checkpoint inhibitor combinations in particular garnered attention for their potential in broader patient groups. Early-stage cervical cancer patients achieve good recovery through surgery and concurrent chemotherapy, but treatment options are scarce for those with recurrent metastatic cervical cancer.

Food and Drug Administration 59

Food and Drug Administration Patients FDA Pharmaceutical 59

Evolve Your Success

FEBRUARY 7, 2023

The patients like that their copay is lower. Patients have a lower copay. The foods are put on the trays, then go up to the person who has a diabetic diet. It’s the first drug-eluting heart stent in the world. Do you want to go into healthcare administration? The staff loves to work there. It was April 23, 2002.

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Medical Sales Medical sales Doctors 52