European Pharmaceutical Review

JUNE 12, 2024

Since 2018, biotech company Mikrobiomik has been researching, development and producing innovative biological medicines based on the human microbiome. The study included 92 adult patients with confirmed CDI. Donor of stools for MBK-01 were screened for pathogens and viruses to ensure safety. percent compared to 61.54

Safety 111

Safety Patients Side effects Healthcare 111

Pharmaceutical Technology

JANUARY 23, 2023

The term LN refers to a major predictor of poor prognosis in SLE patients, with inflammation of the kidney that encompasses diverse patterns of renal disease, including glomerular and vascular pathology. in 2018 across the 7MM despite being an off-label therapy for lupus.

Marketing 111

Marketing Safety Patients Pharmaceutical 111

European Pharmaceutical Review

SEPTEMBER 29, 2023

The Phase III clinical trial demonstrated significant improvement in progression-free survival (PFS) in patients receiving Rybrevant with lazertinib compared to osimertinib. A planned interim overall survival (OS) analysis will determine the statistical and clinical significance of overall survival for these patients.

Pharmaceutical 111

Pharmaceutical Safety Patients 111

European Pharmaceutical Review

JANUARY 18, 2023

The first good manufacturing practice (GMP) registration of a UK pharmaceutical facility for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API) has been granted since the legalisation of medical cannabis in 2018. The firm’s medicinal cannabis product will be supplied in oil form as an API.

Manufacturing 119

Manufacturing Medical Medicine Pharmaceutical 119

Pharmaceutical Technology

JUNE 1, 2023

On 31 May, the FDA granted approval based on subgroup analysis of the Phase III PROpel trial (NCT03732820) in patients with BRCA mutations. Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines. Trials peaked at 115 in 2018 before declining to 91 last year.

Food and Drug Administration 97

Food and Drug Administration FDA Food Safety 97

Pharmaceutical Technology

JULY 4, 2022

The companies signed a partnership, option and license agreement in May 2018 under which Brii Bio gained the option for the acquisition of exclusive rights to some programmes of Vir in Greater China.

Safety 111

Safety Medical Marketing Sales 111

European Pharmaceutical Review

FEBRUARY 21, 2023

After the substance became legal in the UK in 2018, pharmaceutical companies have faced numerous obstacles to attain a fairer position in the industry. They are there to do a job and ultimately to keep patients safe. You’ve got to work with regulators in a very constructive way – that’s really the key lesson.”

Medicine 132

Medicine Manufacturing Specialization Pharmaceutical 132

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

European Pharmaceutical Review

APRIL 27, 2023

Investigating safety and efficiency of the immunotherapy Researchers of the international clinical trial studied the safety and effectiveness of blinatumomab in babies with ALL. Between 2018 and 2021, 30 children in nine countries were treated with blinatumomab.

Safety 105

Safety Medicine Leads Pharmaceutical 105

pharmaphorum

DECEMBER 8, 2022

Like Holmes, former president and chief operating officer Balwani was found guilty of wire fraud, but he was also convicted of defrauding patients who used Theranos’ tests in an attempt to diagnose illness, raising the maximum sentence he faced to 20 years. The company folded in 2018. He is also expected to appeal the sentence.

Doctors 111

Doctors Media Patients Safety 111

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 97

Food and Drug Administration Manufacturing Safety Transportation 97

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. As of October 2023, 62.93

Medicine 116

Medicine Safety Competition Medical 116

Referral MD

OCTOBER 23, 2024

Prior authorization is a crucial healthcare topic related to the relationship between a patient, their healthcare provider, and the insurance company. A patient’s physician or healthcare provider can decide what treatment the patient needs. Patient safety Patient safety is paramount.

Healthcare 104

Healthcare Healthcare Insurance Healthcare Provider 104

pharmaphorum

DECEMBER 22, 2022

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. We can now measure patient activity, steps, and movement continuously and in real time, which serves as a new potential indicator of treatment effectiveness.

FDA 97

FDA Patients Electronics Medical 97

Pharmaceutical Technology

JANUARY 8, 2023

While options like bronchodilator inhalers are available for COPD patients, these have limitations. Biologics have the potential to impact disease-driving processes if we hit the right target in the right patient,” Adcock continues. Still, patients require an individual-led approach. Biologics: From asthma to COPD?

Patients 119

Patients FDA Pharmaceutical Pharma 119

European Pharmaceutical Review

FEBRUARY 22, 2023

This ‘quick-approval, quick-withdrawal from the market’ utilised in accelerated approval can benefit both industry and patients alike. Furthermore, certain drugs awarded accelerated approval have subsequently been proven inefficacious or not safe in impacted patients. FDA; 2018 [cited 2023Jan]. 2019; 116(3): 168-169.

Food and Drug Administration 97

Food and Drug Administration FDA Safety Food 97

European Pharmaceutical Review

NOVEMBER 28, 2024

When the General Data Protection Regulation (GDPR) 1 came into effect in 2018, this appeared to accelerate the migration out of Europe for pharmaceutical clinical trials. However, in the meantime patients will be deprived access to the most innovative products and R&D will migrate out of Europe.

Government 105

Government Medical Safety Management 105

European Pharmaceutical Review

SEPTEMBER 21, 2023

Considerable progress has been made in other areas including enhancing safety, improving treatment administration and patient monitoring systems and implementing innovative pricing strategies – all with the goal of providing timely access to eligible patients who can benefit from these treatments.

Pharmaceutical 96

Pharmaceutical Food and Drug Administration Medicine Patients 96

pharmaphorum

SEPTEMBER 16, 2022

Atopic dermatitis (AD) is a highly prevalent chronic dermatological disease, with symptoms which include itching, dry skin, severe pain, and inflammation – all of which create considerable stress in the daily lives of patients and often negatively affect their day-to-day and long-term well-being. However, side effects do happen.

Management 100

Management Side effects Patients Safety 100

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

Clarivate

JULY 21, 2022

If the research is used to inform policy decisions around, food safety and public health, for example, then misleading and false research can risk people’s lives. Figure from the 2018 STM report showing the growth in the number of articles indexed from academic journals between 1975-2018 based on data from 4 different databases.

Ethics 105

Ethics Training Food Education 105

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. Unfortunately, such a chain of custody is not intended to provide patients with the ability to verify their own medicines. 2019; Available from: [link].

Medicine 98

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 98

PM360

OCTOBER 28, 2022

Likewise, it enables them to predict the effect of the compound on the target and the compound’s safety risks. Clinical trials: Evaluating the safety and efficacy of new drugs consumes up to half of the total cost of the drug development process. According to a Deloitte report , pharmaceutical investment ROI has declined from 10.1%

Pharma 105

Pharma Food and Drug Administration Medicine Government 105

European Pharmaceutical Review

OCTOBER 27, 2023

Benefits of The Future Clinical Trials Bill Chiefly, the Bill’s goal is to increase patient participation and overall, ensure clinical trials have the highest levels of safety while enabling greater regulatory pragmatism, the author explained. The UK’s approach has been regarded as “consistently slow”, Mansfield wrote.

Ethics 105

Ethics Medicine Education Competition 105

Pharmaceutical Technology

MAY 5, 2023

Following observations of an appetite-reducing effect using PBF-999, Palobiofarma designed a clinical trial to assess its efficacy and safety in reducing hyperphagia (excessive hunger) in PWS adults. In 2018, Palobiofarma commenced recruitment of participants for a Phase I clinical trial of PBF-999 in patients with solid tumours.

Safety 52

Safety Recruitment Patients 52

Referral MD

DECEMBER 9, 2024

Prior authorization is a pivotal component of healthcare, bridging the relationship between patients, healthcare providers, and insurance companies. Patient Safety Prior authorization protects patients by: Verifying that prescribed medications or treatments are safe. Identify more cost-effective alternatives.

Healthcare 52

Healthcare Healthcare Insurance Healthcare Provider 52

Healthcare Success

MAY 9, 2022

The QR code allows hospitals and healthcare providers to satisfy this need with immediate physician-patient interaction and engagement – all through smartphones and tablets. . In this blog post, you’ll learn: Why QR codes have made a comeback, When to use them, And, 8 ways to improve the patient experience and drive leads with QR codes. .

Leads 52

Leads Patients Healthcare Provider Healthcare 52

Clarivate

MARCH 17, 2022

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? The health of pregnant people and their fetuses can be compromised if the dose/dosing regimen, safety, and efficacy of treatments used during pregnancy are not established.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10

Pharma Marketing Network

MAY 15, 2023

One of the biggest opportunities presented by big data in the pharmaceutical industry is the ability to gain insights into patient needs and preferences. One of the biggest challenges is ensuring that patient privacy is protected. 8 (2018) 2. 79 (2018) *This article was produced with the assistance of artificial intelligence.

Pharmaceutical 59

Pharmaceutical Marketing Electronics Media 59

European Pharmaceutical Review

MARCH 4, 2024

Therefore, biologics identification and characterisation poses unparalleled challenges, as does their manufacturing processes and routes of administration while maintaining patient safety and clinical efficacy. However, balancing effectiveness, immunogenicity, cost as well as patient convenience and acceptance remains essential.

Food and Drug Administration 98

Food and Drug Administration Transportation FDA Medical 98

European Pharmaceutical Review

FEBRUARY 12, 2024

‘From bench to bedside’ is a well-known aphorism that merely hints at the arduous journey drug treatments must undergo from their position as a candidate molecule or soon to be explored pathway, to becoming a tablet, injection, or infusion administered to patients worldwide. How does it do this?

Manufacturing 98

Manufacturing Medicine Leads Patients 98

Pharmaceutical Technology

JANUARY 18, 2023

In June last year, Eli Lilly submitted a new drug application to the National Medical Products Administration (NMPA) of China for Galcanezumab to prevent episodic migraine in adult patients. In September 2018, the US Food and Drug Administration (FDA) approved Galcanezumab as the preventive treatment of migraine in adults.

Food and Drug Administration 52

Food and Drug Administration Distribution Food Safety 52

European Pharmaceutical Review

AUGUST 14, 2023

This data, together with a favourable safety profile, make C21 a potential game-changer for IPF patients, particularly those who are currently not treated due to the side effects of the available drugs, according to Dalsgaard. C21 was also trialled in a study for patients with COVID-19.

Pharma 98

Pharma Side effects Patients Manufacturing 98

pharmaphorum

SEPTEMBER 8, 2022

The problem with this form of treatment is that it is not targeted and, as a result, there are a number of short- and long-term side effects which can impact patients’ lives. billion acquisition of Endocyte in 2018 , with estimations that sales could reach $600 million in this first indication alone.

Manufacturing 105

Manufacturing Pharma Side effects Patients 105

Pharmaceutical Technology

JANUARY 12, 2023

Airsupra has been approved for the as-needed treatment or prevention of bronchoconstriction and for reducing the exacerbations risk in asthma patients aged 18 years and above. The drug is being developed by AstraZeneca and Avillion under a co-development agreement signed in March 2018.

Food and Drug Administration 52

Food and Drug Administration FDA Medical Physicians 52

European Pharmaceutical Review

MARCH 6, 2023

The application was accepted by the European Medicines Agency (EMA) on 26 January, signalling another significant breakthrough for both patients and experts working to address the disease. Building on these 4R’s, we designed the Phase III Clarity AD study in order to definitively assess the safety and efficacy of lecanemab.

Food and Drug Administration 96

Food and Drug Administration Safety Medicine Pharmaceutical 96

Pharma Marketing Network

MARCH 23, 2023

One of the biggest opportunities presented by big data in the pharmaceutical industry is the ability to gain insights into patient needs and preferences. One of the biggest challenges is ensuring that patient privacy is protected. 8 (2018) 2. 79 (2018) *This article was produced with the assistance of artificial intelligence.

Pharmaceutical 52

Pharmaceutical Marketing Electronics Media 52