World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Do patients care?

Patients 200

Patients FDA Doctors Physicians 200

Pharmaceutical Technology

AUGUST 23, 2022

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Ocelot Bio’s OCE-205 to treat hepatorenal syndrome. A lead candidate of the company, OCE-205 is a peptide therapeutic. It will analyse the safety and efficacy of OCE-205 in adult HRS-AKI patients having cirrhosis with ascites.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

European Pharmaceutical Review

JULY 28, 2023

Publication of results of the Phase III SKYLARK study “is a pinnacle moment in treating postpartum depression ( PDD ),” stated Dr Kristina M Deligiannidis, Professor at the Institute of Behavioral Science at the Feinstein Institutes, the trial’s principal investigator, lead author of the paper.

Food and Drug Administration 94

Food and Drug Administration Food Safety FDA 94

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The reason for this review extension was undisclosed in the announcement. people per every 100,000 individuals in the US.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

European Pharmaceutical Review

AUGUST 11, 2023

This review started after results of a Phase III study (STAND) did not show a statistically significant difference between crizanlizumab and placebo in rates of pain crises leading to a healthcare visit over the first-year. However, the STAND results did not suggest new safety concerns with crizanlizumab.

Marketing 91

Marketing Food and Drug Administration Medicine FDA 91

Pharmaceutical Technology

APRIL 3, 2023

With eight marketed biosimilars, Sandoz is offering the broadest biosimilar portfolio and is the leading biosimilars company in Europe, with more than two decades of experience. The findings from the trial showed comparable pharmacokinetics and similar safety, as well as immunogenicity between the two concentrations.

Marketing 105

Marketing Food and Drug Administration Medicine Food 105

Pharmaceutical Technology

JANUARY 19, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1020 to treat facioscapulohumeral muscular dystrophy (FSHD). This DUX4 protein abnormal expression leads to modifications in gene expression in muscle cells which are associated with progressive muscle function loss in FSHD patients.

Food and Drug Administration 98

Food and Drug Administration FDA Food Safety 98

European Pharmaceutical Review

OCTOBER 2, 2023

has discontinued the Phase IIb clinical trial of its lead antibiotic candidate, ibezapolstat, for Clostridioides difficile infection (CDI). difficile infection, delivered high rates of clinical cure without any emerging safety concerns. Due to observed clinical success, Acurx Pharmaceuticals, Inc. Developing a front-line C.

Food and Drug Administration 104

Food and Drug Administration Pharmaceutical Food Safety 104

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

Marketing 97

Marketing FDA Food and Drug Administration Pharmaceutical 97

Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world.

Manufacturing 111

Manufacturing FDA Food Safety 111

Pharmaceutical Technology

APRIL 6, 2023

Leading with Nefecon as our anchor product, we are building a pipeline of promising renal drug candidates to address huge unmet medical needs.” In February 2023, Nefecon received a global innovative product on fast track (GIFT) designation from South Korea’s Ministry of Food and Drug Safety (MFDS).

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Food and Drug Administration Food Medicine Safety 52

Pharmaceutical Technology

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment.

Food and Drug Administration 52

Food and Drug Administration FDA Physicians Food 52

European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. The safety profile of SYFOVRE is well-demonstrated following ~12,000 injections. GA is an advanced form of age-related macular degeneration (AMD).

FDA 92

FDA Food and Drug Administration Food Leads 92

European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent. Through its longer half-life of 12.7

Food and Drug Administration 86

Food and Drug Administration Manufacturing Safety Transportation 86

World of DTC Marketing

APRIL 15, 2021

While patients have the right to full disclosure, misinformation and scare tactics could lead to more deaths from COVID. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. A big source of mistrust in the COVID-19 vaccine comes from the speed at which it was produced.

Food and Drug Administration 203

Food and Drug Administration Government Safety Side effects 203

Clarivate

MARCH 14, 2024

Over the past few years nitrosamines and nitrosamine impurities have been increasingly gaining the reputation of being high-risk containments in the food industry. The food sector has already initiated the publication of preliminary regulations aimed at restricting PFAS in packaging. [3].

Pharmaceutical 52

Pharmaceutical Manufacturing Food Healthcare Provider 52

European Pharmaceutical Review

AUGUST 22, 2023

The US Food and Drug Administration (FDA)-approved treatment, is the first RSV vaccine indicated for infants from birth to six months of age. Two studies investigated the safety of the RSV vaccine Abrysvo. It is approved for use at 32 through to 36 weeks pregnancy gestation. It reduced the risk of severe LRTD by 91.1

Food and Drug Administration 89

Food and Drug Administration FDA Government Food 89

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

Pharmaceutical Technology

APRIL 24, 2023

Such activation may lead to the onset and progression of many serious diseases. The two double-masked, multicentre, sham-controlled, randomised trials were designed to compare pegcetacoplan’s safety and efficacy with sham injections across GA patients secondary to AMD.

Marketing 52

Marketing Food and Drug Administration Food Safety 52

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

Food and Drug Administration 97

Food and Drug Administration Side effects Leads Patients 97

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].

Food and Drug Administration 97

Food and Drug Administration Side effects Leads Patients 97

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. It represents a key treatment option in patient care and patient choice. “As The company intends to launch the biosimilar in the US in July 2023.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

European Pharmaceutical Review

SEPTEMBER 25, 2023

Moreover, the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. The Phase III study demonstrated a statistically significant median overall survival rate of 8.6

Food and Drug Administration 96

Food and Drug Administration Manufacturing Safety Medicine 96

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. 16 Hydrazoic acid is a toxic, explosive gas and presents a significant worker-safety risk during manufacture of valsartan drug substance. However, there were some notable differences.

Pharmaceutical 104

Pharmaceutical Food and Drug Administration Medicine FDA 104

Pharmaceutical Technology

JUNE 16, 2023

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD). The company aims to run an interim analysis of the trial by mid-2024 at the very latest.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

pharmaphorum

JULY 4, 2022

Two weeks after reporting disappointing results for its lead coeliac disease therapy, 9 Meters Biopharma will draw some comfort from a mid-stage trial of its candidate for short bowel syndrome (SBS), although its share price remains under pressure. Some children are born with an abnormally short small intestine.

Biopharma 86

Biopharma Leads Food Safety 86

Pharmaceutical Technology

MARCH 27, 2023

The US Food and Drug Administration (FDA) has granted approval for Pharming Group’s Joenja (leniolisib) to treat adult and paediatric patients aged 12 years and above with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). Joenja is an oral, selective small molecule PI3Kẟ inhibitor.

Food and Drug Administration 52

Food and Drug Administration FDA Medicine Food 52

Pharmaceutical Technology

MARCH 30, 2023

The FDA’s proposed FY2024 Budget tops $7bn, to be shared between drug, food, and cosmetics tasks and overheads such as buildings; this is $372m higher than in FY 2023, a 10% increase. Postmarket Safety Collaborative: +$10.1m to enhance the safety surveillance of adverse events. for a total of $36.8m ACT for ALS : +$2.5m

Manufacturing 59

Manufacturing FDA Safety Pharma 59

Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Prospecting 52

Medgadget

AUGUST 18, 2022

The bioengineered cornea was created using highly purified collagen derived from pig skin, a byproduct of the food industry. “Safety and effectiveness of the bioengineered implants have been the core of our work,” said Mehrdad Rafat, another researcher involved in the study.

Food 115

Food Patients Safety Leads 115

European Pharmaceutical Review

MARCH 12, 2024

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Lack of proper training can lead to errors, omissions, or intentional data manipulation, which can compromise data. What is an effective solution?

Government 94

Government Pharma Ethics Training 94

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). 4, 5 Why was the data presented at ELCC 2023 on the bispecific monoclonal antibody significant?

Food and Drug Administration 96

Food and Drug Administration Safety Medicine Patients 96

Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.

Food and Drug Administration 105

Food and Drug Administration Engineering Patients Food 105

Pharmaceutical Technology

JUNE 9, 2023

Rocket Pharmaceuticals has received fast track and orphan drug designations for RP-A601 from the US Food and Drug Administration (FDA) to treat plakophilin-2-related arrhythmogenic cardiomyopathy (PKP2-ACM). In April 2023, the FDA approved the investigational new drug (IND) application for RP-A601 to begin a Phase I clinical trial.

Pharmaceutical 59

Pharmaceutical Food and Drug Administration FDA Food 59

Pharmaceutical Technology

SEPTEMBER 12, 2022

This dosage was chosen as the preferred dose in children aged under five years based on safety, tolerability and immunogenicity findings. Pfizer Canada mRNA Vaccines & Antiviral Portfolio lead Fabien Paquette said: “We know many parents in Canada have at heart to provide further protection for their children under five.

Food and Drug Administration 52

Food and Drug Administration Government Food Safety 52

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. It causes severe hepatitis B infection that can lead to progressive liver disease.

Patients 81

Patients Food and Drug Administration Side effects Food 81

Pharmaceutical Technology

MAY 12, 2023

Editas Medicine will release new efficacy and safety results of its gene therapy EDIT-301 in severe sickle disease as part of an oral presentation at the European Hematology Association’s (EHA) Hybrid Congress. Last month, the US Food and Drug Administration (FDA) granted the treatment an orphan drug designation for sickle cell disease.

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Food and Drug Administration Food Safety Patients 98