World of DTC Marketing

FEBRUARY 1, 2022

According to STAT News “after a double-digit decline in 2021, the sector has fallen another 20% in the new year, erasing billions in value and leading even the most seasoned investors to question whether biotech has further to fall. Meanwhile, the Food and Drug Administration has delayed several drug approvals, and Sen.

Food and Drug Administration 234

Food and Drug Administration FDA Pharmaceutical Food 234

Pharmaceutical Technology

OCTOBER 11, 2022

Swiss biotech company Stalicla has signed a licensing deal with Evgen Pharma for the latter’s lead asset, SFX-01, in neurodevelopmental disorders and schizophrenia. in milestone payments that include $5m upon receipt of the investigational new drug (IND) from the US Food and Drug Administration (FDA), which is expected late next year.

Leads 59

Leads Food and Drug Administration Food Medicine 59

Pharmaceutical Technology

JULY 12, 2022

The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration's (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands.

Leads 52

Leads Food and Drug Administration Marketing Sales 52

Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. This route of administration makes it a potential alternative, especially for migraine patients who suffer from migraine-related nausea.

Food and Drug Administration 98

Food and Drug Administration FDA Food Manufacturing 98

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

APRIL 28, 2023

Ocugen has received orphan drug designation from the US Food and Drug Administration for its OCU410ST (AAV5-hRORA) to treat ABCA4 – linked retinopathies. This condition leads to a gradual deterioration of vision in children.

Food and Drug Administration 52

Food and Drug Administration Transportation FDA Food 52

European Pharmaceutical Review

MARCH 8, 2023

Now working as a woman in pharma, Dr Ekaterina Malievskaia highlighted her female inspirations in the industry, two of which have held leading roles at Bristol Myers Squibb and the US Food and Drug Administration (FDA). I believe we can and must do better.

Leads 52

Leads Pharma Food and Drug Administration Medicine 52

Pharmaceutical Technology

JUNE 6, 2023

The therapy has also received orphan drug designation and breakthrough therapy designation from the US Food and Drug Administration. Alkeus Pharmaceuticals intends to submit a new drug application for gildeuretinol in 2024.

Food and Drug Administration 111

Food and Drug Administration Food Pharmaceutical Medicine 111

European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today?

Food and Drug Administration 85

Food and Drug Administration Manufacturing Pharma Patients 85

World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.

Pharma 210

Pharma Food and Drug Administration Marketing Prescription 210

World of DTC Marketing

JUNE 22, 2022

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). Then there is the cost of generic drugs. Generic drugs versus branded is also a considerable expense.

Healthcare 227

Healthcare Healthcare Food and Drug Administration FDA 227

European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

Food and Drug Administration 83

Food and Drug Administration Manufacturing Management Safety 83

Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for CRB-701.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical Food FDA 52

Legacy MEDSearch

OCTOBER 25, 2022

EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Recruitment 98

European Pharmaceutical Review

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. SpringWorks Therapeutics’ Ogsiveo (nirogacestat) tablets are authorised for adults with progressing desmoid tumours who require systemic treatment.

Food and Drug Administration 84

Food and Drug Administration Medicine FDA Food 84

European Pharmaceutical Review

MAY 12, 2023

Innovative therapies for rare diseases The acquisition will help to drive the growth of CTI’s lead product, kinase inhibitor VONJO ® (pacritinib) “in treating myeloproliferative disease,” stated Dr Adam Craig, President, Chief Executive Officer and Interim Chief Medical Officer of CTI BioPharma.

Food and Drug Administration 101

Food and Drug Administration Biopharma Medicine Food 101

European Pharmaceutical Review

APRIL 17, 2024

Roche multiple sclerosis subcutaneous injection: late-breaking data “Updated results from OCARINA II further underline the potential benefits of subcutaneous OCREVUS for patients with both relapsing and progressive forms of MS,” shared Scott Newsome , DO, lead author, Johns Hopkins University School of Medicine.

Food and Drug Administration 69

Food and Drug Administration Safety Medicine Food 69

European Pharmaceutical Review

DECEMBER 22, 2023

The deal includes Karuna’s lead asset KarXT (xanomeline-trospium), a potential first-in-class treatment for schizophrenia. Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024. per share in cash.

Food and Drug Administration 95

Food and Drug Administration Side effects Safety Food 95

Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.” mg tablet) to treat cardiovascular disease.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

Food and Drug Administration 91

Food and Drug Administration Transportation FDA Medical 91

World of DTC Marketing

NOVEMBER 1, 2020

Fauci, the country’s leading infectious-disease expert, said in a wide-ranging interview late Friday. Fauci, a leading member of the government’s coronavirus response, said the United States needed to make an “abrupt change” in public health practices and behaviors. We’re in for a whole lot of hurt.

Healthcare 188

Healthcare Healthcare Food and Drug Administration Distribution 188

European Pharmaceutical Review

FEBRUARY 2, 2024

ADUHELM was the “groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the [Alzheimer’s] field,” commented Christopher Viehbacher, President and Chief Executive Officer of Biogen. Eisai is leading development of LEQEMBI and regulatory submissions globally.

Food and Drug Administration 77

Food and Drug Administration FDA Food Marketing 77

Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has given orphan drug designation to SiSaf’s siRNA [a double-stranded RNA molecule that is non-coding] therapeutic, SIS-101-ADO, for the treatment of autosomal dominant osteopetrosis type 2 (ADO2), a rare and serious skeletal disorder in children.

Food and Drug Administration 52

Food and Drug Administration FDA Food Leads 52

European Pharmaceutical Review

NOVEMBER 27, 2023

This leads to a lipid build-up in vital organs such as the liver, blood vessels and other tissues, and is usually fatal for these individuals within their first twelve months of life, Alexion reported. This ultra-rare metabolic disease occurs due to lysosomal acid lipase (LAL) enzyme deficiency.

Food and Drug Administration 97

Food and Drug Administration Consulting Food Medicine 97

Pharmaceutical Technology

OCTOBER 7, 2022

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The agreement aids Provention in leveraging the capabilities and commercial resources of Sanofi to back teplizumab’s launch.

Food and Drug Administration 119

Food and Drug Administration FDA Healthcare Provider Prospecting 119

European Pharmaceutical Review

AUGUST 23, 2022

PTSD is a potentially chronic condition that disrupts lives and can lead to or exacerbate existing health issues such as depression, anxiety, eating disorders, and suicidal thoughts. Many people have PTSD, but there [are] few effective pharmacologic treatments and limited drug development for PTSD,” commented Gradus.

Food and Drug Administration 71

Food and Drug Administration Pharmacology Prospecting Medical 71

Pharmaceutical Technology

AUGUST 11, 2022

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation for Aro Biotherapeutics’ ABX1100 to treat Pompe disease. Due to the mutation, Pompe disease patients have increased glycogen levels which leads to the progression of the ailment. Gys1 is an enzyme that synthesises glycogen in muscle.

Food and Drug Administration 52

Food and Drug Administration FDA Food Pharmaceutical 52

Pharma Marketing Network

MARCH 23, 2023

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. This approval marks a major milestone in the fight against Alzheimer’s, which is the sixth leading cause of death in the United States and affects over 5 million people.

Food and Drug Administration 52

Food and Drug Administration FDA Consulting Food 52

Pharmaceutical Technology

APRIL 19, 2023

While the Clarksville, US-based company completed a Phase Ia study in healthy participants to eventually develop the drug for Alzheimer’s disease, it is likely that the company will now focus on Parkinson’s disease in its Phase II study first, said Kelleher-Andersson. Similarly, research collaborations are also a consideration.

Food and Drug Administration 52

Food and Drug Administration Recruitment Prospecting Food 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 90

Food and Drug Administration Food Safety FDA 90

European Pharmaceutical Review

JUNE 24, 2022

RECENTLY, there has been a spate of withdrawals caused by nitrosamine drug substance-related impurities (NDSRIs). These NDSRIs can form during manufacturing or subsequent storage of the drug product. It has also outlined the various issues impacting on the drug product.

Food and Drug Administration 52

Food and Drug Administration Manufacturing Food FDA 52

Pharma Leaders

MARCH 20, 2023

The US Food and Drug Administration (FDA) has granted fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 that helps to lower triglycerides in adult patients with familial chylomicronemia syndrome (FCS). Earlier, ARO-APOC3 received Orphan Drug designation from the FDA and the European Union.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical FDA Food 52

Pharmaceutical Technology

JUNE 2, 2023

AB Science has secured a Canadian patent for its lead compound masitinib to treat amyotrophic lateral sclerosis (ALS), a fatal motor neuron disorder. Under the notice of compliance with conditions (NOC/c) policy, AB Science received authorisation from Health Canada to file a new drug submission for masitinib to treat ALS.

Food and Drug Administration 52

Food and Drug Administration Food Competition Medicine 52

European Pharmaceutical Review

OCTOBER 30, 2023

According to Atamyo Therapeutics, the condition is characterised by progressive muscular weakness, leading to loss of the ability to walk independently. ATA-100 has received an Investigational New Drug (IND) clearance by the US Food and Drug Administration (FDA).

Food and Drug Administration 90

Food and Drug Administration Safety Food FDA 90

Pharmaceutical Technology

APRIL 6, 2023

The Singapore Health Sciences Authority (HSA) has accepted Everest Medicines’ new drug application (NDA) for Nefecon to treat adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. In November 2022, the Taiwan Food and Drug Administration granted accelerated approval designation (AAD) to Nefecon.

Food and Drug Administration 52

Food and Drug Administration Food Medicine Safety 52

European Pharmaceutical Review

DECEMBER 5, 2023

Currently, imetelstat is being reviewed by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for approval in transfusion dependent anaemia in patients with lower risk MDS who have failed to respond or have lost response to or are ineligible for ESAs, according to Geron.

Food and Drug Administration 98

Food and Drug Administration Patients Food Medicine 98

Pharmaceutical Technology

MAY 19, 2023

It received approval from the US Food and Drug Administration in October 2018. Alimera Sciences has acquired the US commercialisation rights for Yutiq (fluocinolone acetonide intravitreal implant) 0.18mg from EyePoint Pharmaceuticals.

Food and Drug Administration 52

Food and Drug Administration Food Pharmaceutical Sales 52