European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). 2017; 8(43): 75712–26. Personalized medicine at FDA. Oral Presentation JGN-75414.

Food and Drug Administration 98

Food and Drug Administration Safety Patients Medicine 98

European Pharmaceutical Review

MAY 8, 2024

2 Driven by the success of FMTs with clinical efficacy in several indications 3-6 and the first two FDA-approved donor-derived products on the market for recurrent Clostridioides difficile infections, 7,8 a new and promising trend is emerging that combines the ‘whole ecosystem’ of FMTs with rational consortia design. Microbiome.

Manufacturing 98

Manufacturing Safety FDA Patients 98

Legacy MEDSearch

AUGUST 25, 2022

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. About Miracor Medical. Press Release by: Miracor Medical. Are you hiring?

Medical 52

Medical FDA Recruitment Pharmacology 52

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. Internet] FDA. cited 2023August].

Pharmaceutical 96

Pharmaceutical Food and Drug Administration Medicine Patients 96

pharmaphorum

AUGUST 18, 2022

Astellas remains on course to be the first drugmaker to bring a new non-hormonal therapy for symptoms of menopause to market, after the FDA started a review of its orally-active neurokinin-3 (NK3) receptor antagonist fezolinetant. billion yen ($97 million) charge as an R&D expense in its fiscal first quarter.

FDA 52

FDA Safety Marketing Pharma 52

pharmaphorum

SEPTEMBER 16, 2022

The week 16 data of lebrikizumab […] points towards a drug with robust efficacy with hardly any safety trade-offs. The FDA granted lebrikizumab Fast Track designation in December 2019. He explained just how promising the recent trial’s maintenance data compared to short-term data results are.

Management 100

Management Side effects Patients Safety 100

Pharma Marketing Network

MARCH 25, 2022

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. Additional concerns for the caregiver include a strain on physical and mental health.

Pharma 98

Pharma Education Training Transportation 98

Clarivate

NOVEMBER 10, 2022

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. In 2017, the Clarivate COA team began working with a sponsor to develop COAs for evaluating key clinical trial endpoints in alopecia areata clinical trials. The regulatory landscape around COAs is fast evolving.

Patients 52

Patients Food and Drug Administration FDA Safety 52

pharmaphorum

SEPTEMBER 14, 2022

SparingVision’s lead candidates are both targeting inherited retinal diseases (IRDs), a group which already has a gene therapy on the market in Novartis’ Luxturna (voretigene neparvovec), which was approved by the FDA in 2017 for biallelic RPE65 mutation-associated retinal dystrophy, a group which includes a small group of RP patients.

Safety 52

Safety Leads Patients FDA 52

pharmaphorum

JANUARY 5, 2023

The deal centres on reSET and reSET-O, Pear’s cognitive behavioural therapy (CBT) based programmes, for people living with substance and opioid use disorders, respectively, which have been approved by the FDA as an adjunct to outpatient treatment.

Prescription 52

Prescription Specialization FDA Networking 52

Pharmaceutical Technology

JANUARY 23, 2023

The few approvals within paediatrics can be seen to be contributing to the numerous challenges associated with these studies; the smaller patient population, in addition to special measures required to ensure the ethics and safety of these trials, which all leads to trial delays, extended studies, and higher costs.

Medical 59

Medical Ethics Specialization Physicians 59

Pharmaceutical Technology

JANUARY 27, 2023

The FDA’s recent approval of TG Therapeutics’s Briumvi (ublituximab) against relapsing forms of multiple sclerosis (MS) is welcome news for the company after suffering a major setback in 2022 when the FDA extended its review of Briumvi by three months. All three treatments are monoclonal antibodies.

Marketing 52

Marketing Side effects Safety Patients 52

Legacy MEDSearch

SEPTEMBER 27, 2023

Its flagship product, the Personal Cardiac Assistant (PCA 500) , is the only hospital-grade, resting 12-lead ECG device cleared by the FDA and CE marked for both professional and patient use. QT Medical aims to provide improved cardiac devices and services to revolutionize the care of patients with heart disease.

Medical 52

Medical Recruitment Leads Management 52

pharmaphorum

DECEMBER 6, 2022

We’re trying to register lifesaving therapies, but we have to collect the data manually, and often the FDA and EMA inspectors have to visit trial sites to validate the data. Live data is critical for patient safety and for good operations in clinical trials,” Peleg says. “It There’s no other industry where we capture data in this way.

Electronics 98

Electronics Patients Medical Marketing 98

Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). However, the French company will not be required to run a further efficacy study.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prospecting 52

Medgadget

MARCH 2, 2023

Moreover, due to the different nature of healthy and cancerous tissue, alpha radiation produced by Alpha DaRT sources diffuses about a millimeter into healthy tissue while penetrating at a diameter up to about five millimeters into tumors, providing an automatic safety mechanism. Results from initial clinical trials were quite impressive.

Manufacturing 82

Manufacturing Leads Patients Medicine 82

pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.

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FDA Doctors Patients Prescription 98

pharmaphorum

AUGUST 31, 2022

In recent years, gene therapy has transitioned from a promising idea to a reality for patients, with many of the severe safety issues that emerged in early iterations of the technology being overcome. FDA backing. from 2021 to 2029. billion in 2021.

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FDA Marketing Safety Patients 98

pharmaphorum

DECEMBER 20, 2022

Switzerland’s Idorsia has submitted a new drug application to the FDA for aprocitentan as a treatment for people whose blood pressure remains stubbornly high despite treatment and who are at increased risk of complications like kidney disease and stroke. The dual endothelin receptor antagonist (ERA) has been tipped as a potential $2.5

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Sales FDA Patients Safety 98

European Pharmaceutical Review

OCTOBER 21, 2022

At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs). A two-dose version of the vaccine was approved by the US Food and Drug Administration (FDA) in 2017. Volunteers were administered with additional doses four weeks and 24 weeks into the study.

Patients 96

Patients Food and Drug Administration Side effects Food 96

Pharmaceutical Technology

APRIL 18, 2023

The World Health Organization (WHO) designated carbapenem-resistant Acinetobacter baumannii as a priority pathogen for new antibiotic development in 2017. The drug had a favourable safety profile, including a statistically significant reduction in nephrotoxicity, based on the press release. Carbapenems are a class of antibiotics.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Food 52

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug.

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122

European Pharmaceutical Review

JANUARY 29, 2024

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. ng/day, compared to EMA which is 18 ng/day.

Pharmaceutical 111

Pharmaceutical Food and Drug Administration Medicine FDA 111

pharmaphorum

JANUARY 5, 2023

Bioethics International has developed a benchmarking tool for “fair inclusion” in clinical trials, drawing on pivotal trials submitted to the FDA in support of 59 new cancer therapeutics – submitted by 25 sponsors – that were approved by the regulator between 2012 and 2017.

Medicine 75

Medicine FDA Pharma Safety 75

Pharmaceutical Technology

FEBRUARY 10, 2023

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 Access to oncology medicines varies across countries, and their cost against safety/efficacy is generally perceived as being low, such as in the US.

Marketing 105

Marketing Medicine Leads Pharmaceutical 105

Clarivate

OCTOBER 7, 2024

Food and Administration (FDA) approval, a change long sought by animal welfare organizations. Since then, animal-based testing has been the gold standard for establishing a drug’s safety and efficacy. Drugs can be now cleared for human trials using non-animal technologies developed over the last 10-15 years. Works cited Anon.,

Food and Drug Administration 52

Food and Drug Administration Pharmacology Food Engineering 52

European Pharmaceutical Review

JUNE 8, 2023

2 The US Food and Drug Administration (FDA) has recently announced that it will control the quality of tobacco products, particularly e-cigarettes, more closely, to prevent avoidable contamination and help address “inconsistencies between product labelling and actual concentrations” in these products, potentially misleading customers.

Food and Drug Administration 59

Food and Drug Administration FDA Manufacturing Law & Regulation 59

Pharmaceutical Technology

JUNE 9, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of AstraZeneca’s and Sanofi’s respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) prophylactic nirsevimab for use in newborns and infants entering their first RSV season.

FDA 59

FDA Food and Drug Administration Patients Food 59

European Pharmaceutical Review

MAY 15, 2023

HARMONIE investigated the efficacy and safety of a single intramuscular dose of nirsevimab. Agreed in March 2017, AstraZeneca leads development and manufacturing activities, and Sanofi leads commercialisation activities. Throughout HARMONIE, nirsevimab maintained a favourable safety profile, consistent with the pivotal trial results.

Safety 104

Safety Leads Manufacturing Medicine 104

PM360

OCTOBER 22, 2024

Patients and consumers need to believe in the efficacy and safety of the products they use. While “Squatty Potty” may not be a top-tier pharma brand name, the consequences following controversy for their celeb spokesperson Kathy Griffin in 2017 were hefty. Credibility and Trust In healthcare, trust is currency.

Media 52

Media Pharma Pharmaceutical Sales 52

PM360

DECEMBER 20, 2023

From 2017 to 2022, the Chinese market witnessed a growth rate of 5.3%, compared to the average market growth of 6.6% Between 2017 and 2021, the median time difference between the first global approval and the approval in China was five years 1. Long Way to Go: Progress of Orphan Drug Accessibility in China from 2017 to 2022.”

Marketing 105

Marketing Insurance Medical Manufacturing 105

Cadensee

OCTOBER 19, 2021

In 2017, when we introduced the first version, nobody was willing to talk about it. By the way, with a very attractive safety profile so far. BrainQ was privileged to receive a Breakthrough Device designation by the FDA just a few months ago. The results of this pivotal study will be the base for an FDA approval.

Patients 52

Patients Medical Networking Marketing 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. 22 June 2017. EMA/CHMP/ICH/804273/2017.

Safety 52

Safety Pharmaceutical Manufacturing Management 52

PM360

SEPTEMBER 15, 2022

In many of the states where abortion is banned, strictly regulated, or soon to be restricted, the procedure is legal only in instances of a life-threatening situation, but no regulations define what such a situation may be, leaving 70% of physicians unclear about when to intervene for maternal safety. FDA Update. Drug Approvals.

Healthcare 52

Healthcare Healthcare Doctors Physicians 52