Pharma Marketing Network

MARCH 25, 2022

Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. 2015-2017 Behavioral Risk Factor Surveillance System (BRFSS) Data from adults in 44 States, Puerto Rico, and the District of Columbia. Connect at linkedin.com/in/sunnywhite/ .

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Pharma Education Training Transportation 98

European Pharmaceutical Review

APRIL 11, 2024

Globally, the pharmaceutical sector emitted around 52 megatonnes of CO 2 in 2015, the most recent period for which detailed numbers are available. The pharmaceutical industry is becoming increasingly conscious of emissions and the importance of sustainable manufacturing. 1 That’s more than the automotive sector, which released 46.4

Manufacturing 105

Manufacturing Pharmaceutical Engineering Pharmaceutical manufacturing 105

European Pharmaceutical Review

MAY 26, 2023

For clinical trials, this is obviously even more complicated with the need for extra safety data. The administrative burden is not really something that the regulatory bodies make any effort in addressing, as they are solely interested in safety. But for this, we are more prepared and supported by the trial sponsors.

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Safety Management Patients Manufacturing 98

Infuse Medical

SEPTEMBER 9, 2024

billion from the 200 million seen in 2015. To guarantee their safety and effectiveness, AR gadgets applied in healthcare have to be tested rigorously and approved by authorities. By 2024 there will be an estimated 1.7 billion mobile augmented reality (AR) users worldwide, a rise of 1.5

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PM360

NOVEMBER 29, 2022

In 2015, the United Nations launched 17 Sustainable Development Goals (SDGs) as part of the 2023 Agenda for Sustainable Development. The effects of climate change represent an additional danger for the health, safety, and quality of life of people all over the world, as evidenced by the recent heat waves plaguing the northern hemisphere.

Healthcare 98

Healthcare Healthcare Manufacturing Pharmaceutical 98

Pharmaceutical Technology

APRIL 11, 2023

The FDA initially granted Orkambi approval in 2015 as the first medicine to treat the underlying cause of CF for individuals aged 12 or older with two copies of the F508del mutation. Health Canada previously approved Orkambi for CF patients ages two and above. This label expansion follows a similar label change in the US in September 2022.

Medicine 98

Medicine Patients Safety Prospecting 98

European Pharmaceutical Review

SEPTEMBER 20, 2023

The growing presence of these unintended amino acid sequences in recombinant proteins is a top concern for regulators and drug manufacturers due to the ability of these mutations to cause higher order structural problems, potentially affecting efficacy and safety. 2015; 7(5): 881-90. While SVs are typically present at less than 0.1

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Pharmaceutical Technology

MARCH 24, 2023

Until 2010, no regulatory approval pathway for biosimilars existed in the US and the first biosimilar was only approved in the US in 2015. Further, there remains scepticism on the efficacy and safety of biosimilars. Currently, 40 biosimilars are FDA-approved and 25 have launched, whereas the EMA has approved 86 biosimilars since 2006.

Competition 59

Competition Marketing FDA Physicians 59

Pharmaceutical Technology

OCTOBER 25, 2022

Between 2010 and the end of 2015, of the 655 New Drug Applications (NDAs) approved by the FDA, 63 were for FDCs. Improved convenience and safety. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 Of those 131 approved FDCs, 98 were oral dosage forms. new FDC products per year. One of these is convenience.

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Manufacturing Physicians Prescription Pharmaceutical 52

Legacy MEDSearch

MAY 23, 2022

2015) designs devices to set new operating-room standards for efficiency and patient safety. The company has raised more than $18 million to date from institutional investors, family offices, and more than 50 physician champions. The Cleveland-based company (est.

Food and Drug Administration 52

Food and Drug Administration Medicine Recruitment Physicians 52

Contrarian Sales Techniques

APRIL 21, 2022

They meet with health professionals to describe the safety, efficacy and access of the product, as well as the potential benefits and risks of each product. According to the latest figures from the Ministry of Health (MOH), the average annual salary of a doctor in Malaysia in 2015 was RM122,107.00.

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Medical sales Medical Sales Medical sales reps 52

Medgadget

MARCH 2, 2023

Some years later, in 2015, Alpha TAU was founded by Uzi Sofer, the company’s CEO, to give the technology another opportunity to prove itself. The technology had a chance when a company called Althera was founded, but due to an inability to fund clinical trials, the company ceased to exist just as things were getting interesting.

Manufacturing 82

Manufacturing Leads Patients Medicine 82

Clarivate

MAY 13, 2024

New York and Minnesota are the only two states to provide the Basic Health Plan through a Section 1132 State Innovation Waiver since 2015. This may also lead to gaps in care, reduced drug adherence, increased emergency room visits and a decline in chronic care management.

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Insurance Marketing Healthcare Healthcare 52

European Pharmaceutical Review

JULY 22, 2024

It is not accurate to use ‘sterile’ to describe surfaces, methodologies, or environments such as biological safety cabinets and isolators. 3, 2015, pp. This term is best applied to drug substance or product, or items rendered sterile using a validated process such as sterile filtration. Bain D, et al. Baseline Guide, Vol.

Manufacturing 52

Manufacturing Medicine Management Pharmaceutical 52

Clarify Health

JULY 13, 2020

At launch in 2015, Sanofi priced Praluent at $14,600 per year, and Amgen set Repatha’s price at $14,100 per year. Despite their efficacy and safety, the high cost and lifetime use made payers put up barriers to exclude the drug on formulary. total cost of care), comparative effectiveness, quality of life, etc.

Pharmaceutical 52

Pharmaceutical Pharma Patients Marketing 52

European Pharmaceutical Review

APRIL 10, 2024

Engaging in continuous dialogue with regulatory bodies in Europe and the US helps in designing clinical trials that follow the latest safety standards and international regulations. During the development of clinical trials that use faecal-derived material, the necessity of safety is paramount.

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Safety Patients Medical FDA 95

Pharmaceutical Technology

DECEMBER 22, 2022

Increased trafficking of illegal fentanyl represents a new threat to public health and safety. According to the National Institute of Drug Abuse, the total number of drug-involved overdose deaths in the US increased from 52,404 in 2015 to 91,799 in 2020. A lethal drug that creates its own demand.

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Safety Manufacturing Distribution Prescription 105

pharmaphorum

NOVEMBER 23, 2022

Qdenga isn’t the first dengue vaccine to reach the market, but is free of the severe restrictions that have held back its only predecessor, Sanofi’s Dengvaxia, which was first approved for marketing in 2015, but was found to have a serious safety issue.

FDA 122

FDA Marketing Leads Safety 122

European Pharmaceutical Review

JULY 5, 2022

7 In addition, the study supported the safety, tolerability and convenience of frequent low dosing, showing that Oncoral was well-tolerated and that the reported haematological toxicities were only mild to moderate (grade 1 or grade 2). 2015; 35(3):1437-45. J Clin Oncol, 2004; 22(14): 2849-2855. Kümler I, Sørensen PG, Palshof J, et al.

Patients 104

Patients Food and Drug Administration Side effects Safety 104

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. World Health Organization. The Global Health Observatory.

Medicine 98

Medicine Pharmacology Leads Healthcare 98

European Pharmaceutical Review

MAY 29, 2023

Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. For instance, the benefits of automation with robotics in Pharma are mainly related to HSE (health, safety and environment), quality, and production efficiency. Yet in 2021, 100 nanomedicines had been marketed.

Food and Drug Administration 95

Food and Drug Administration Manufacturing Pharma Pharmaceutical 95

pharmaphorum

DECEMBER 21, 2022

Kite has agreed to acquire all the shares it does not already own in Tmunity – a University of Pennsylvania (PENN) spinout founded in 2015 by CAR-T pioneers Carl June and Bruce Levine – for an undisclosed amount. Image by Anja from Pixabay . The post Gilead’s Kite takes control of CAR-T partner Tmunity appeared first on.

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Pharma Manufacturing Engineering Safety 52

Pharmaceutical Technology

OCTOBER 10, 2022

In 2015, the FDA approved Sprout Pharmaceuticals’s Addyi, also known under the generic name flibanserin, for use by pre-menopausal women with hypoactive sexual desire disorder (HSDD). Moreover, despite the buzz generated when Addyi was launched in 2015, only one other drug has since been marketed.

Pharmacology 59

Pharmacology Side effects FDA Safety 59

Pharma Marketing Network

MAY 3, 2023

This involves paying researchers and scientists to publish articles or conduct studies that support the use of a particular drug, while suppressing or ignoring research that casts doubt on the drug’s safety or efficacy. British medical journal, 344, e4348. Fugh-Berman, A. Industry-sponsored clinical research: a broken system.

Pharmaceutical 52

Pharmaceutical Medical Pharmaceutical research Prescription 52

PM360

OCTOBER 22, 2024

Patients and consumers need to believe in the efficacy and safety of the products they use. Just think back to 2015 when the FDA issued a warning regarding the Kim Kardashian Instagram endorsement of Diclegis, a morning sickness drug. Credibility and Trust In healthcare, trust is currency.

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Media Pharma Pharmaceutical Sales 52

European Pharmaceutical Review

JANUARY 16, 2023

The safety and efficacy of mRNA vaccines should be a game changer and is the likely solution to antibiotic-resistant microorganisms and emerging viral pathogens.” He is a member of the 2015‑2020 USP Microbiology Committee of Experts where he takes a leadership role in the area of modern microbiology methods. References.

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Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

World of DTC Marketing

SEPTEMBER 28, 2021

from 2015 to 2020. With a lower cost per visit than traditional office visits and more comfort and safety for patients and providers alike, using telemedicine for common colds, ailments, dermatology, and therapy, can save employers and employees time and money.

Pharma 37

Pharma Prescription Healthcare Healthcare 37

Clarivate

SEPTEMBER 1, 2022

While some high-profile issues related to women’s rights and safety make the news cycle, gender inequalities are firmly entrenched in every society, impacting the daily lives of women and girls in ways that are rarely reported on. Dataset: articles and reviews related to SDG 5: Gender Equality published between 2015-2021.

Education 124

Education Healthcare Healthcare Prospecting 124

European Pharmaceutical Review

DECEMBER 14, 2023

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. EMA/95098/2010. Internet] European Medicines Agency.

Medicine 116

Medicine Safety Competition Medical 116

European Pharmaceutical Review

SEPTEMBER 12, 2022

The approval was based on data from a 2015 NIH publication. “To NIAID’s trial of Jynneos will provide important information on the immunogenicity, safety and tolerability of alternative dosing approaches that would expand the current supply of vaccine.”. Data on the safety and efficacy of tecovirimat will be submitted to the FDA.

Food and Drug Administration 98

Food and Drug Administration Safety FDA Food 98

Clarivate

AUGUST 9, 2022

Using InCites Benchmarking & Analytics we identified 25,798 publications that map to SDG 16 between 2015 and 2021. SDG 16 calls for social justice, safety and equality. Promote and enforce non-discriminatory laws and policies for sustainable development. Criminology tops all other disciplines in SDG 16.

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Government Ethics Leads Media 98

World of DTC Marketing

FEBRUARY 4, 2021

million, his first big raise since 2015, thanks to incentive pay that jumped by about $1.2 million in 2020, more than double the number in 2015, according to health data company IQVIA. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S. ” Ouch.

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Pharma Food and Drug Administration Side effects Safety 180

European Pharmaceutical Review

APRIL 8, 2025

One element that project managers often forget or underestimate is the environmental, health and safety (EHS) tasks” Operating PAT from hardware to software, in a manufacturing suite, would not be successful without training and competency development to track training status in a learning management system for individuals.

Manufacturing 52

Manufacturing Food and Drug Administration Management Pharmaceutical 52

European Pharmaceutical Review

DECEMBER 23, 2024

14 This in turn has led to the introduction of safety-based limits, 15 eg, permitted daily exposures (PDEs), etc. ICH Q6A 1 states that specifications should focus on those characteristics found to be useful in ensuring the safety and efficacy of the drug substance and drug product. September 2015. 3 February 2023. 18 July 2023.

Safety 52

Safety Pharmaceutical Manufacturing Management 52

World of DTC Marketing

MAY 6, 2021

A study published in JAMA Internal Medicine examined the costs of developing 10 cancer drugs approved by the FDA from 2006 to 2015 and provided a strong contrast to the Tufts study from a year before. Big Pharma’s Go-To Defense of Soaring Drug Prices Doesn’t Add Up. After all, 90 percent of all drugs that enter human testing fail.

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Pharma Food and Drug Administration Government Insurance 185