European Pharmaceutical Review

NOVEMBER 18, 2022

Tzield (teplizumab-mzwv), the first drug to help prolong the onset of stage 3 type 1 diabetes in adults and children over eight years old with stage 2 type 1 diabetes, has been approved by the US Food and Drug Administration (FDA). Tzield clinical trials that supported the US Food and Drug Administration approval.

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Food 98

European Pharmaceutical Review

MAY 7, 2024

A novel intravesical targeted drug delivery system for patients with bladder cancer has demonstrated positive data in updated results from a Phase I trial. Johnson & Johnson’s Phase I study is assessing the safety and efficacy of TAR-210 as a delivery method for sustained, local release of erdafitinib into the bladder.

Food and Drug Administration 97

Food and Drug Administration Patients Food Safety 97

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Manufacturing 98

European Pharmaceutical Review

NOVEMBER 25, 2022

The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5 The post Promising schizophrenia drug faces tough competition appeared first on European Pharmaceutical Review.

Competition 105

Competition Food and Drug Administration Pharma Food 105

European Pharmaceutical Review

OCTOBER 17, 2024

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). Approximately 40 million people in the US experience Type I allergic reactions due to food, venom or insect stings, 4 and the numbers are similar in Europe. What are the main advantages of EURneffy over similar treatments?

Food and Drug Administration 121

Food and Drug Administration Medicine Consulting Food 121

European Pharmaceutical Review

JUNE 29, 2023

The world’s first AI-generated anti-fibrotic small molecule inhibitor drug has been administered to the first human patients. Phase II clinical trials in the US and China are now underway for INS018_055, Insilico Medicine’s potentially first-in-class oral drug candidate. Patients will be divided into four parallel cohorts.

Food and Drug Administration 98

Food and Drug Administration Safety Recruitment FDA 98

European Pharmaceutical Review

FEBRUARY 22, 2023

The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising. billion, and rising.

Food and Drug Administration 97

Food and Drug Administration FDA Safety Food 97

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 drug is not currently approved in any markets globally.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

European Pharmaceutical Review

JANUARY 10, 2023

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023.

Food and Drug Administration 98

Food and Drug Administration FDA Food Medicine 98

World of DTC Marketing

NOVEMBER 1, 2020

According to The Washington Post “, the White House decision to set aside the mandatory safety controls put in place by the Food and Drug Administration fueled one of the most disputed initiatives in the administration’s response to the pandemic: the distribution of millions of ineffective, potentially dangerous pills from a federally controlled (..)

Healthcare 188

Healthcare Healthcare Food and Drug Administration Distribution 188

World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. standards for approving new drugs”.

FDA 207

FDA Food and Drug Administration Patients Biopharma 207

Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

Safety 59

Safety Food and Drug Administration FDA Side effects 59

European Pharmaceutical Review

JUNE 13, 2024

In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. Ocugen is currently enrolling patients in the Phase I/II ArMaDa clinical trial to assess the safety and efficacy of OCU410 for GA secondary to dAMD.

Manufacturing 145

Manufacturing Food and Drug Administration Engineering Safety 145

PM360

NOVEMBER 29, 2022

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

Pharmaceutical Technology

MAY 22, 2023

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile.

Food and Drug Administration 109

Food and Drug Administration Food Safety Medical 109

European Pharmaceutical Review

FEBRUARY 9, 2023

To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica.

Food and Drug Administration 97

Food and Drug Administration FDA Side effects Medicine 97

World of DTC Marketing

FEBRUARY 4, 2021

Merck’s old drugs are under more scrutiny, and anti-vaxxers are causing problems by cherry-picking unreliable information. regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label.

Pharma 180

Pharma Food and Drug Administration Side effects Safety 180

European Pharmaceutical Review

NOVEMBER 21, 2022

The first-in-human gene therapy trial for heart failure patients with preserved ejection fraction (HFpEF) has been approved by the US Food & Drug Administration (FDA). The first bioengineered HFpEF human heart models.

Food and Drug Administration 139

Food and Drug Administration Food Safety Patients 139

Pharmaceutical Technology

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). Furthermore, the favourable pharmacokinetic, safety and tolerability profile of REL-1017 was in line with data reported in prior Phase I trials.

Food and Drug Administration 119

Food and Drug Administration FDA Safety Food 119

European Pharmaceutical Review

JUNE 26, 2023

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. What recommendations are included in the draft guidance on psychedelic drugs? However, these are still investigational products.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Food 98

European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products.

Food and Drug Administration 105

Food and Drug Administration FDA Manufacturing Product sample 105

World of DTC Marketing

APRIL 15, 2021

Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. And while there’s concern that the Covid-19 vaccines were rushed and that that means they haven’t been properly vetted or that their safety is otherwise in question, it’s simply not the case.

Food and Drug Administration 203

Food and Drug Administration Government Safety Manufacturing 203

Pharmaceutical Technology

MAY 16, 2023

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. The trial has confirmed its safety and efficacy for the treatment of pain and fever in the targeted patients.

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Safety 98

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

European Pharmaceutical Review

AUGUST 29, 2023

Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes. This is compared to 30-60 minutes via intravenous (IV) administration. The safety and efficacy profile was consistent with the IV formulation.

Food and Drug Administration 98

Food and Drug Administration Safety Medicine Food 98

Pharmaceutical Technology

NOVEMBER 25, 2022

The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy and safety of Enhertu versus trastuzumab emtansine (T-DM1). In subjects who received Enhertu, the median progression-free survival (PFS) was not attained versus 6.8

Food and Drug Administration 105

Food and Drug Administration Safety Food Medicine 105

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults.

Food and Drug Administration 122

Food and Drug Administration FDA Competition Pharma 122

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

European Pharmaceutical Review

DECEMBER 5, 2022

PSMAfore, is a Phase III, open-label, multi-centre, 1:1 randomised study comparing the efficacy and safety of Pluvicto to a change in ARPI in 469 patients with PSMA–positive mCRPC. No unexpected safety findings were observed in PSMAfore. The data is consistent with the safety profile of Pluvicto. The PSMAfore study.

Food and Drug Administration 105

Food and Drug Administration Safety Food Medical 105

European Pharmaceutical Review

MAY 22, 2024

The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.

Medicine 93

Medicine Leads Food and Drug Administration Safety 93

Pharmaceutical Technology

MAY 2, 2023

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS).

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 98

European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

Food and Drug Administration 115

Food and Drug Administration Side effects Pharmaceutical Leads 115

European Pharmaceutical Review

OCTOBER 25, 2022

Phase III trial results found that three years post-treatment, 31 percent of patients given the drug combination were still alive. The US Food and Drug Administration’s (FDA) approval took data from the HIMALAYA Phase III trial into consideration. No new safety precautions were identified.

Food and Drug Administration 111

Food and Drug Administration Patients Safety Physicians 111

European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. The research paper comparing the two drug delivery methods was published in The Lancet Neurology.

Food and Drug Administration 98

Food and Drug Administration Medicine Physicians Food 98

Pharmaceutical Technology

OCTOBER 7, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Eli Lilly and Company ’s tirzepatide to treat adults with obesity or overweight with weight-associated comorbidities. .

Food and Drug Administration 104

Food and Drug Administration FDA Safety Food 104

Pharmaceutical Technology

DECEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above. Indicated for administration rectally, Rebyota is a single-dose 150ml microbiota suspension. .

Food and Drug Administration 105

Food and Drug Administration FDA Food Pharmaceutical 105

Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). dL) for the patients.

Food and Drug Administration 105

Food and Drug Administration FDA Safety Food 105