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). 2016; 85(4):2048-2050. 2016; 12(7):878. Tuijin Jishu / Propuls. cited 2023Dec].

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

Legacy MEDSearch

MARCH 15, 2023

Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring. HeartBeam AIMI and HeartBeam AIMIGo have not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies.

Food and Drug Administration 97

Food and Drug Administration FDA Recruitment Physicians 97

Clarivate

JUNE 26, 2023

Obtaining the preferences of patients and their caregivers is not a new concept in healthcare. Increasingly, however, industry guidance documents utilize the term ‘patient preference’ in relation to new drug development and benefit-risk assessment.

Food and Drug Administration 52

Food and Drug Administration Patients Side effects Medicine 52

European Pharmaceutical Review

NOVEMBER 4, 2022

Nevertheless, chemotherapy’s disadvantages, including substantial toxicities, combined with inconvenient hospital-based intravenous (IV) administration, impede patients’ ability to stay on treatment and their quality of life. tumour effects. The importance of taxanes in oncology.

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical FDA Patients 98

Legacy MEDSearch

NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. The BodyTom 64 brings the power of innovative imaging to patients’ bedsides safely and efficiently. About NeuroLogica. NeuroLogica Corp., the healthcare subsidiary of Samsung Electronics Co., For more information, please visit: www.NeuroLogica.com.

FDA 92

FDA Food and Drug Administration Electronics Recruitment 92

European Pharmaceutical Review

OCTOBER 19, 2022

1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. 4 The initial patents are usually filed during drug discovery. The patent will typically expire after 20 years.

Food and Drug Administration 96

Food and Drug Administration Pharmaceutical products Pharmaceutical FDA 96

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 105

Food and Drug Administration Manufacturing Safety Pharmaceutical 105

PM360

OCTOBER 25, 2023

Between May 1, 2016, and May 31, 2021, 42% of all U.S. Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. It is their prerogative to support and commercialize new innovation, providing new therapeutic options to patients. References: 1. Benjamin, Alexander Xu, Mark P.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Marketing Pharmaceutical manufacturing 105

Pharmaceutical Technology

NOVEMBER 3, 2022

The US Food and Drug Administration (FDA) has granted approval for the supplemental new drug application (sNDA) of Gilead Sciences ’ Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in paediatric patients.

Food and Drug Administration 52

Food and Drug Administration FDA Physicians Food 52

Pharmaceutical Technology

MARCH 29, 2023

The collaboration between the companies began in 2016, for the purpose of identifying modifying treatments for a wide range of neurodegenerative diseases. Together with our BMS colleagues, we are confident that we will deliver new medicines that matter to patients with neurodegenerative diseases.”

Food and Drug Administration 52

Food and Drug Administration Medicine Food FDA 52

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) granted Eli Lilly’s Lartruvo (olaratumab) accelerated approval in 2016 for soft tissue sarcoma (STS). But, following negative Phase III efficacy results, Lilly withdrew the drug from the market. After this, Telix licenced the drug for $5m.

Food and Drug Administration 52

Food and Drug Administration Food Safety FDA 52

Clarivate

MAY 24, 2023

Food and Drug Administration advisory committee’s narrow 8-6 vote in favor of recommending accelerated approval for a first-in-class gene transfer therapy was welcomed by Duchenne muscular dystrophy (DMD) patients and caregivers. Most patients must use a wheelchair by the time they are in their teens.

Patients 52

Patients Food and Drug Administration Biopharma FDA 52

Pharmaceutical Technology

SEPTEMBER 2, 2022

The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. increase over the 2016–2020 period average. De-risking drug launch.

Food and Drug Administration 52

Food and Drug Administration Pharma Medicine Distribution 52

European Pharmaceutical Review

AUGUST 14, 2023

The US Food and Drug Administration (FDA) has approved Janssen’s Akeega (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). ” In April 2016, Janssen Biotech, Inc. ” In April 2016, Janssen Biotech, Inc.

FDA 52

FDA Food and Drug Administration Medicine Prospecting 52

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

Patients 52

Patients Food and Drug Administration Marketing Pharma 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 months for lecanemab and 5.5

Food and Drug Administration 97

Food and Drug Administration Safety Patients Leads 97

pharmaphorum

SEPTEMBER 13, 2022

Over the past two centuries, researchers have identified more than 100 different types of blood cancer, while most patients may be familiar with the big three (leukaemia, lymphoma, and melanoma). In 39-year-old patient Sarah Newbury, Solly observed the appearance of fatigue and bone pain resulting from multiple fractures.

Food and Drug Administration 98

Food and Drug Administration Patients Engineering Physicians 98

Penrod

JUNE 6, 2024

Health Cloud was a version of Salesforce CRM tailored to healthcare providers, insurance companies, and other organizations’ unique needs with patient-focused business models. To some extent, this patient model fits the requirements of med dev and pharma pretty well, but it wasn’t one-size-fits-all.

CRM 52

CRM Food and Drug Administration Healthcare Provider Management 52

PM360

AUGUST 9, 2022

Following the annual American Society of Clinical Oncology (ASCO) conference, oncologists were asked how the data presented would impact their care of patients. Another 17% recommended mandating patient recruitment requirements and 14% would like to see the development of a diverse pool of investigators and staff.

Healthcare 52

Healthcare Healthcare Food and Drug Administration FDA 52

European Pharmaceutical Review

MARCH 8, 2023

She founded COMPASS Pathways with her husband George Goldsmith in 2016, having experienced at first hand the challenges in accessing evidence-based and effective mental health care for a family member. I used to prescribe antidepressants for patients but never considered psychiatry as a profession. I believe we can and must do better.

Leads 52

Leads Pharma Food and Drug Administration Medicine 52

Nixon Gwilt Law

OCTOBER 11, 2022

Food and Drug Administration (“FDA”) released the final version of its guidance to industry stakeholders for Clinical Decision Support software (“CDS Guidance”). On September 27, 2022, the U.S.

Medical 52

Medical FDA Food and Drug Administration Food 52

Legacy MEDSearch

JANUARY 3, 2023

Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

FDA 95

FDA Food and Drug Administration Recruitment Prospecting 95

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. N) = number of approvals. N) = number of approvals.

Medicine 98

Medicine Food and Drug Administration FDA Healthcare 98

Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations.

FDA 52

FDA Food and Drug Administration Recruitment Transportation 52

Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations. Leveraging real-world data to develop the clinical trials diversity plan.

FDA 52

FDA Food and Drug Administration Recruitment Transportation 52

PM360

AUGUST 26, 2024

Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. Over a decade ago, AstraZeneca identified and tested specific biomarkers to develop drug molecules. Let’s take cancer for example. Bright Spots.

Medicine 52

Medicine Food and Drug Administration Government Insurance 52

World of DTC Marketing

JANUARY 28, 2021

Not only did the public provide $1 billion to the company to bring the vaccine to market, but government scientists at the National Institutes of Health (NIH) also helped conduct the clinical trials that led to its authorization by the Food and Drug Administration. What about PBM’s?

Healthcare 180

Healthcare Healthcare Food and Drug Administration Insurance 180

Pharmaceutical Technology

MAY 17, 2023

The US Food and Drug Administration (FDA) has awarded an orphan drug designation to Intercept Pharmaceuticals’ fixed-dose combination of obeticholic acid and bezafibrate for the treatment of primary biliary cholangitis. Bezafibrate is a peroxisome proliferator-activated receptor agonist.

Food and Drug Administration 52

Food and Drug Administration FDA Pharmaceutical Prospecting 52

Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration approved Boehringer Ingelheim and Eli Lilly’s oral medicines Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) to manage blood sugar in children with type 2 diabetes (T2D) aged ten years or older. in the placebo group.

Medicine 59

Medicine FDA Food and Drug Administration Sales 59

Pharmaceutical Technology

APRIL 6, 2023

Verismo Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational new drug, SynKIR-110. The investigational drug has been developed for treating patients with mesothelioma, a rare type of cancer that impacts abdominal cavities or the chest lining.

FDA 52

FDA Food and Drug Administration Medical Food 52

Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The egress of the drug itself (a leakage) is also of critical importance.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical products Manufacturing Pharmaceutical 52

World of DTC Marketing

APRIL 7, 2022

Obesity costs our health care system $147 billion per year, yet there is a movement underway to tell HCPs not to weigh patients during routine visits. Launch prices of new cancer drugs in the U.S. Food and Drug Administration (FDA). adults aged 20 and older are either overweight or obese. billion in 1970.

Healthcare 215

Healthcare Healthcare Food and Drug Administration Government 215