Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. BLA process (CBER). 510(k) process (CBER). NDA process (CBER).

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Development Production Immune Response Licensing 161

pharmaphorum

SEPTEMBER 14, 2020

Here he gives us a deeper look at how genomic medicine is evolving and the barriers that are preventing it from reaching its full potential. At that time, we thought this would be the holy grail for medicine. Now, however, the field is changing with respect to genomic medicine. Enhancing sequencing.

Genomics 119

Genomics Genome Medicine Gene 119

Pfizer

AUGUST 22, 2022

Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (containing benzyl alcohol), Due To The Potential Presence of Visible Particulates. It is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a Single Patient Use Glass Fliptop Vial.

Containment 97

Containment Production Vaccine Vaccination 97

Pharmaceutical Technology

AUGUST 3, 2022

The potential to use these scientific breakthroughs to make a real difference to patients’ lives is what drives many highly skilled scientists to the world of drug development. This is where the process development stage, which directly follows the drug discovery and early formulation work, can make or break a drug’s success.

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Pharmaceutical Technology

AUGUST 5, 2022

The development of therapeutics for transmissible spongiform encephalopathies (TSEs) continues to be challenged by the complex nature of these diseases. It is ultra-rare,” says Jesús Rodriguez Requena, PhD, associate professor in the Department of Medicine at the University of Santiago de Compostela.

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Drugs Protein Vaccine Vaccination 299

Pfizer

AUGUST 3, 2022

Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. deliesschef.

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Pharmaceutical Technology

MAY 25, 2023

A new vaccine developed by the Serum Institute of India to fight meningococcal disease could help eliminate meningitis across Africa. The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile.

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Vaccine Vaccination Immune Response Bacteria 195

Druggist

NOVEMBER 6, 2020

Patients commonly request over the counter medicines for a chesty cough. In today’s post, I will seek to find the best medicine for chesty cough by looking at over the counter and pharmacy-only products available in the UK. The best evidence for or against the effectiveness of medicines comes from well designed clinical trials.

Medicine 69

Medicine Containment Production Pharmacy 69

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Worldwide sourcing and drop-ship of orphan medicines, and. GDP and GMP advisory. Temperature control facilities and supply solutions.

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Packaging Packaging Compliance Manufacturing 130

Pharmaceutical Technology

JUNE 21, 2023

In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This followed positive results from CSL’s Phase III HOPE-B trial (NCT03569891).

Gene Therapy 246

Gene Therapy Gene Protein Sales 246

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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Gene Therapy Gene Trials Clinical Trials 264

Pharmaceutical Technology

SEPTEMBER 15, 2022

The list includes suppliers of a wide range of pharmaceutical packaging, containers and containment solutions, including plastic, glass and other customised packaging solutions, as well as labelling and printing solutions. Pharmaceutical packaging formats and materials. Trends in pharmaceutical contract packaging.

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Packaging Packaging Marketing Containment 100

Camargo

SEPTEMBER 14, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. INDs must contain full study reports of nonclinical and clinical (if available) studies.

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Clinical Trials Clinical Trials Medicine Production 144

pharmaphorum

SEPTEMBER 21, 2020

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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Pharmaceutical Technology

FEBRUARY 26, 2023

The idea behind these treatments relies on altering the gut microbiome by designing therapeutics that contain bacteria derived from donated stool samples. These safety concerns froze research, says Dr. Sarah McGill, associate professor of medicine at the University of North Carolina School of Medicine, Chapel Hill. “It

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Bacteria Trials Research Medicine 278

pharmaphorum

JUNE 14, 2022

The investment flowing into the sector is not limited to just the development of medicines, there has also been a focus on rapidly developing capability and capacity to manufacture both traditional pharmaceuticals and biologic medicines. Evolving regulatory landscape.

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Clinical Trials Clinical Trials Trials Development 98

Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. has a fever.

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Pfizer

SEPTEMBER 28, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer.

Vaccine 101

Vaccine Vaccination Medicine Clinical Trials 101

Pharmaceutical Technology

FEBRUARY 15, 2023

Innovation S-curve for the pharmaceutical industry CRISPR nuclease is a key innovation area in pharmaceutical development CRISPR, which refers to clustered regularly interspaced short palindromic repeats, are bacteriophage-derived DNA sequences that had previously infected the prokaryote and are found in the genomes of bacteria and archaea.

In-Vivo 162

In-Vivo Genomics Genome Gene Editing 162

XTalks

APRIL 25, 2024

Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace. The Carillon device, developed by Cardiac Dimensions Inc.

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Development Trials Clinical Trials Clinical Trials 111

Delveinsight

AUGUST 17, 2021

Food and Drug Administration gave a red flag to FibroGen’s anemia pill roxadustat, for the use in patients suffering from kidney diseases owing to safety concerns that arose after results, which in turn are concluded for the presentation of further clinical studies to assess safety for future medicinal use.

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FDA Approval Medicine Vaccine Vaccination 98

Pharmaceutical Technology

MAY 24, 2023

The ability to modify or introduce genetic material in human cells in such a precise and patient-centered manner clearly constitutes a breakthrough in personalized medicine. Allogeneic therapies begin with healthy donor samples to develop the eventual therapeutic product which can be administered to multiple patients.

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Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

Pharmaceutical Technology

SEPTEMBER 20, 2022

The information contained within the download document is intended for pharmaceutical manufacturers, wholesalers, retailers and distributors, pharmaceutical executives, medical representatives, business development managers, retail salesmen, sales managers, pharmacy executives, and any other individual involved in pharmaceutical marketing.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

The expert services rendered by them help in improving patient outcomes, minimising costs of the healthcare system, improving medicinal adherence and persistency and saving clinicians’ time. The emergence of expensive new speciality medicines are also expected to impact business models in future.

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XTalks

SEPTEMBER 6, 2022

Gastric ulcers may also be caused by an overuse of NSAIDs like ibuprofen or aspirin, especially if these anti-inflammatory medicines were taken at high doses or for a long time. Other factors like frequently consuming alcohol or using steroids often may also increase the chance of developing a gastric ulcer.

FDA Approval 98

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Pharmaceutical Technology

SEPTEMBER 8, 2022

Test method development. The information contained within the download document is intended for pharmacists, pharmaceutical executives, sales managers, manufacturers, business development managers, pharmaceutical sales representatives, and any other individual involved in the pharmaceutical compounding sector. . · Refilling.

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The Pharma Data

DECEMBER 12, 2020

We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients.” ” Ludwig Hantson , Ph.D., Strategic rationale.

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JAMA Internal Medicine

JUNE 2, 2024

In this issue of JAMA Internal Medicine, Ji and colleagues randomized patients with impaired glucose tolerance and multiple metabolic abnormalities to receive either a traditional Chinese medicine preparation, Jinlida (JLD) granules, 9 g 3 times/d, or placebo.

Medicine 40

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Victoza, Copaxone, Lupron, Zoladex, Sandostatin, and Somatuline are some of the popularly marketed peptide API therapeutic drugs while more than 600 peptide-based pharmacological leads are being investigated worldwide, across various phases of development. Technologies in the delivery of peptides and proteins.

Protein 100

Protein Marketing Manufacturing Reagent 100

XTalks

NOVEMBER 10, 2020

” A rare disease diagnosis can also influence family planning options, as well as lead to better development tools, support for patients, and improved patient outcomes. HS: Well, a definitive diagnosis opens the door to personalized medicine, potentially leading to reduced morbidity and mortality.

Genomics 98

Genomics Genome Medicine Genetic Disease 98

pharmaphorum

OCTOBER 2, 2020

UK-based Compass Pathways and its potential magic mushroom depression drug went public last month – and just a week later psychedelic therapy firm Mind Medicine announced it would be up-listing its shares on the Nasdaq. Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

Medicine 122

Medicine Life Science FDA Approval Development 122

pharmaphorum

SEPTEMBER 29, 2021

The 10 startups – all from the US – will now embark on a four-week programme of assessment, training and development to ensure their technologies are ready for widespread deployment in the Amazon Web Services (AWS) cloud. The finalists are: AIVA , a startup that has developed a voice operating system for patient care.

FDA Approval 138

FDA Approval Pharmacy Development Containment 138

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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Manufacturing Vaccine Vaccination Packaging 130

Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

Bioequivalency 130

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Pharmaceutical Technology

MAY 24, 2023

The RMAT designation programme is intended to accelerate the drug’s development and review processes for products, including gene therapies. It also provides the ability for early FDA interactions, support accelerated approvals and priority review of biologics licensing applications.

Gene Therapy 130

Gene Therapy Gene Licensing Licensing 130

Scienmag

SEPTEMBER 27, 2021

28, 2021) – The microbiota in the nose and upper throat likely contains biomarkers for assessing how sick an individual infected with SARS-CoV-2 may get and for developing new treatment strategies to improve their outcome, researchers say. AUGUSTA, Ga. Credit: Michael Holahan, Augusta University AUGUSTA, Ga.

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