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). 2018; 22(5):1589-1604. 2018; 15(141):20170387. Tuijin Jishu / Propuls.

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

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 85

Patients Food and Drug Administration Side effects Safety 85

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 87

Food and Drug Administration Manufacturing Food Medicine 87

European Pharmaceutical Review

OCTOBER 19, 2023

The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. 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 90

Food and Drug Administration Side effects Manufacturing Doctors 90

European Pharmaceutical Review

AUGUST 1, 2022

The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said. The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team.

Food and Drug Administration 110

Food and Drug Administration Medical Medicine Engineering 110

Pharmaceutical Technology

APRIL 4, 2023

of NSCLC patients with exon 19 and 21 mutations develop resistance mutations at C797S. While Scorpion will lead the development of STX-721, Pierre Fabre will handle STX-241. On April 3, the company said it selected the drug STX-241 as its next development candidate, and that it plans to present related preclinical data in H2 2023.

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Food and Drug Administration Biopharma FDA Pharmaceutical 52

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

Food and Drug Administration 79

Food and Drug Administration Manufacturing Safety Transportation 79

Legacy MEDSearch

DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

Food and Drug Administration 98

Food and Drug Administration Safety Recruitment Medical 98

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

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. Conversely, in the US, it has always been clear and regulated as a drug.

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Food and Drug Administration Manufacturing Medicine Pharma 99

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 for placebo.

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Food and Drug Administration Medicine Patients FDA 93

PM360

OCTOBER 28, 2022

Shepherding a new drug to market is a long, expensive, and uncertain process. billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. in 2010 to only 1.9%

Pharma 105

Pharma Food and Drug Administration Government Medicine 105

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.

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FDA Food and Drug Administration Recruitment Medical 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

Positive data with checkpoint inhibitor combinations in particular garnered attention for their potential in broader patient groups. In 2018, the World Health Organisation (WHO) reported that 570,000 women were diagnosed with cervical cancer, of which 311,000 died of the disease. Phase I/II Checkmate-358 trial. and 30.6%, respectively.

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Food and Drug Administration Patients FDA Pharmaceutical 59

Pharmaceutical Technology

APRIL 24, 2023

These attributes make some biologic drugs, especially monoclonal antibodies more specific and targeted in their treatment. With new drugs on the market, companies are now looking for ways to manufacture recently approved biologics, and countries are racing to claim their corner – or maintain their decades-old market share.

Manufacturing 52

Manufacturing Food and Drug Administration Biopharma Sales 52

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? Medicare and patients love it. Who loves that?

Medical 52

Medical Sales Medical sales Doctors 52