Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation.

Safety 52

Safety Food and Drug Administration Pharmaceutical Marketing 52

Pharmaceutical Technology

APRIL 26, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). This marks the first-ever designation for genetically modified gamma-delta T cell therapies.

Food and Drug Administration 52

Food and Drug Administration FDA Engineering Food 52

European Pharmaceutical Review

JANUARY 16, 2023

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. Regulation, particularly Annex 1, was identified as a key focus for 2022.

Pharmaceutical 127

Pharmaceutical Food and Drug Administration Manufacturing FDA 127

European Pharmaceutical Review

AUGUST 10, 2022

On 23 July 2022, the World Health Organization (WHO) Director-General, Dr Tedros Adhanom Ghebreyesus, declared the multi-country outbreak of monkeypox a public health emergency of international concern. As of 2 August 2022, the UK had 2,739 confirmed cases, 4 the majority occurring within London, England. Current case rates.

Food and Drug Administration 75

Food and Drug Administration Medicine Government FDA 75

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 89

Food and Drug Administration FDA Food Medicine 89

PM360

MAY 25, 2023

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. home health visits).

FDA 104

FDA Food and Drug Administration Safety Medicine 104

Pharmaceutical Technology

APRIL 5, 2023

Shionogi has obtained fast track designation from the US Food and Drug Administration (FDA) for its ensitrelvir fumaric acid, an investigational oral antiviral drug for the treatment of Covid-19. The firm also plans to initiate new studies to further assess the drug.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

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 90

Food and Drug Administration Transportation FDA Medical 90

European Pharmaceutical Review

JANUARY 5, 2023

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in all infants.

Food and Drug Administration 59

Food and Drug Administration FDA Safety Prescription 59

European Pharmaceutical Review

DECEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Gilead’s Sunlenca (lenacapavir), a capsid inhibitor for adults living with human immunodeficiency virus type 1 (HIV-1), who cannot be successfully treated with other available treatments. Sunlenca is given in combination with other antiretrovirals. In this group, 87.5

Food and Drug Administration 82

Food and Drug Administration FDA Patients Food 82

European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades.

Food and Drug Administration 109

Food and Drug Administration Medicine Food Government 109

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

MAY 9, 2023

The US Food and Drug Administration (FDA) has granted Vedanta Biosciences’ oral microbiome treatment VE303 a fast track designation for the treatment of recurrent Clostridioides difficile (C.diff) infection, as the company plans to start a Phase III trial later this year, based on a May 8 announcement.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

DECEMBER 11, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The vaccine is intended to prevent two respiratory ailments through a single injection.

FDA 115

FDA Food and Drug Administration Food Safety 115

Pharmaceutical Technology

APRIL 18, 2023

Members of the FDA’s Antimicrobial Drugs AdCom voted 12-0 for the drug’s potential approval based on a positive benefit-risk assessment. The agency accepted the drug’s new drug application (NDA) for priority review in November 2022. The application’s PDUFA date was set to 29 May 2023.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Food 52

European Pharmaceutical Review

DECEMBER 5, 2022

MOMENTUM was a randomised, double-blind Phase III clinical trial of momelotinib versus danazol in symptomatic and anaemic myelofibrosis patients treated with a US Food and Drug Administration (FDA)-approved JAK inhibitor.

Food and Drug Administration 77

Food and Drug Administration Marketing Food Medicine 77

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 Food Patients 59

European Pharmaceutical Review

NOVEMBER 29, 2023

Following the US Food and Drug Administration (FDA)’s approval of Ferring Pharmaceuticals’ gene therapy Adstiladrin ® (nadofaragene firadenovec-vncg) in December 2022, new long-term follow up data has been revealed. The KM-estimated median duration of HG recurrence-free survival was six months, with a 30.1

Food and Drug Administration 94

Food and Drug Administration FDA Pharmaceutical Food 94

European Pharmaceutical Review

DECEMBER 13, 2022

The following year, the US Congress passed the 1938 Federal Food, Drug and Cosmetic (FD&C) Act, which mandated safety assessments prior to the release of any new drug. There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007. 05 October 2022. References.

Food and Drug Administration 94

Food and Drug Administration Manufacturing Safety Food 94

Legacy MEDSearch

MARCH 13, 2023

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. and Europe. Are you hiring?

Medical 98

Medical FDA Food and Drug Administration Recruitment 98

European Pharmaceutical Review

JANUARY 26, 2024

The US Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) as a treatment for children patients aged one to 11 years, weighing at least 15kg with eosinophilic esophagitis (EoE). First medicine approved in EU for eosinophilic esophagitis What did the data from the Phase III Dupixent study show?

Medicine 83

Medicine Food and Drug Administration FDA Food 83

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

Pharmaceutical 98

Pharmaceutical Food and Drug Administration Medicine FDA 98

Legacy MEDSearch

SEPTEMBER 26, 2023

Food and Drug Administration (FDA) has approved MRI conditional labeling for the Evoke ® System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy powered by SmartLoop technology. Specific scan conditions and safety information are provided in the Evoke ® SCS System MRI Guidelines manual.

Medical 52

Medical FDA Food and Drug Administration Safety 52

European Pharmaceutical Review

JANUARY 26, 2023

The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices. These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products.

Food and Drug Administration 89

Food and Drug Administration Medicine Pharmaceutical products Pharmaceutical 89

Pharmaceutical Technology

AUGUST 25, 2022

The US Food and Drug Administration (FDA) has gra nted approval for AbbVie and Janssen Biotech’s Imbruvica (ibrutinib) to treat chronic graft versus host disease (cGVHD) in paediatric patients aged one year and above. Imbruvica is indicated for such patients following failure of one or more lines of systemic therapy.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

European Pharmaceutical Review

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Valneva SE’s IXCHIQ ® , the first chikungunya vaccine to be authorised in the world. In March 2022, Valneva reported final pivotal Phase III data for the vaccine showing a 98.9 percent seroresponse rate at 28 days with a single vaccination.

Food and Drug Administration 52

Food and Drug Administration FDA Medicine Food 52

European Pharmaceutical Review

MAY 4, 2023

Adjuvanted vaccine Arexvy has been approved by the US Food and Drug Administration (FDA). Approval of GSK’s RSV vaccine The FDA granted approval of Arexvy to GlaxoSmithKline Biologicals. Now, the FDA has granted this milestone to GSK’s Arexvy. Could GSK offer the first RSV older adult vaccine?

Food and Drug Administration 87

Food and Drug Administration Safety FDA Food 87

European Pharmaceutical Review

NOVEMBER 7, 2022

has announced its B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb) elranatamab for relapsed or refractory multiple myeloma (RRMM) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). The investigation noted elranatamab delivered a manageable safety profile.

Food and Drug Administration 96

Food and Drug Administration Medicine Safety FDA 96

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 98

Food and Drug Administration Patients Safety Physicians 98

European Pharmaceutical Review

OCTOBER 6, 2022

The US Food and Drug Administration (FDA) has approved Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY anti-HER2 (4B5) test), which identifies low HER2 expression in metastatic breast cancer.

Food and Drug Administration 78

Food and Drug Administration Patients Safety Food 78

European Pharmaceutical Review

JANUARY 25, 2023

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively. Costs and profits worldwide are shared with CRISPR Therapeutics.

Medicine 104

Medicine Food and Drug Administration FDA Pharmaceutical 104

Pharmaceutical Technology

MAY 10, 2023

In July 2022, Alvotech commenced a trial to compare AVT06 and Eylea for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD). The trial has been designed to assess the efficacy, safety and immunogenicity of the therapy combination in the targeted patients. “We

Food and Drug Administration 52

Food and Drug Administration Food Safety Marketing 52

European Pharmaceutical Review

AUGUST 30, 2022

The report, Clinical Trials – The Importance of Diversity in Clinical Trials , examined data from clinical trials initiated between 1 January 2013 and 16 June 2022. Earlier this year the US Food and Drug Administration (FDA) published draft guidance to support companies in enrolling more ethnically diverse trial populations.

Food and Drug Administration 79

Food and Drug Administration Food Safety Pharmaceutical 79

European Pharmaceutical Review

SEPTEMBER 12, 2022

A global outbreak of human monkeypox virus, first identified in May 2022, prompted public health emergency declarations from both the World Health Organization (WHO) and the US Department of Health and Human Services this past summer. The approval was based on data from a 2015 NIH publication. “To Exploring antiviral efficacy.

Food and Drug Administration 91

Food and Drug Administration Safety FDA Food 91

European Pharmaceutical Review

DECEMBER 6, 2023

The US Food and Drug Administration (FDA) has approved the first oral monotherapy treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH). Novartis’ Factor B inhibitor, Fabhalta ® (iptacopan) provides comprehensive control of red blood cell (RBC) destruction, according to the company.

Food and Drug Administration 85

Food and Drug Administration Patients Physicians Food 85

European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

Food and Drug Administration 87

Food and Drug Administration Manufacturing Food Medicine 87

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.

Food and Drug Administration 98

Food and Drug Administration Food Safety Patients 98