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. CGT trials operate with much lower volumes of manufactured final product. CGT have highly unique and specialized manufacturing processes.

Clinical Trials 246

Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

Pfizer

JULY 13, 2022

Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), Due To The Potential Presence of Visible Particulate. It is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a single patient use fliptop vial.

Containment 98

Containment Production Vaccination Vaccine 98

Pharmaceutical Technology

DECEMBER 27, 2022

Indian pharmaceutical company Hetero has received the World Health Organization Prequalification of Medicines Program (WHO PQ) approval for its Nirmacom (nirmatrelvir). Hetero’s Nirmacom combi-pack will contain nirmatrelvir 150 mg (two tablets) and ritonavir 100mg (one tablet).

Licensing 195

Licensing Licensing Containment Medicine 195

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. Discover the top pharmaceutical wholesalers. GDP and GMP advisory.

Packaging 130

Packaging Packaging Compliance Manufacturing 130

FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

Manufacturing 105

Manufacturing Drugs Compliance Pharmacy 105

Pfizer

JANUARY 17, 2023

Pfizer to Acquire Sanford, North Carolina Manufacturing Site from Abzena. Pfizer to Acquire Sanford, North Carolina Manufacturing Site from Abzena. NYSE: PFE) and Abzena today announced that the companies have entered into an agreement under which Pfizer will acquire Abzena’s manufacturing facility in Sanford, North Carolina.

Manufacturing 85

Manufacturing Containment Development Medicine 85

Pharmaceutical Technology

JUNE 8, 2023

Arexvy contains a combination of recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3) and GSK’s AS01E adjuvant. The EC approval follows a positive opinion from the European Medicines Agency’s committee on medicinal products for human use (CHMP) in April 2023.

Vaccination 147

Vaccination Vaccine Marketing Manufacturing 147

Roots Analysis

JANUARY 27, 2025

It is worth mentioning that the past few decades have witnessed several advances in this domain, particularly in the cell therapy manufacturing process. However, even the latest and the most promising advances in modern medicine have their own set of challenges and risks, which need to be addressed to ensure continued growth.

Manufacturing 40

Manufacturing Contamination Production Gene Therapy 40

Pharmaceutical Technology

AUGUST 15, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. 1 variant as well as the original 2020 strain.”.

Vaccination 214

Vaccination Vaccine Immune Response Clinical Trials 214

Pharmacy Checkers

MAY 22, 2020

One of our more popular Ask PharmacyChecker posts is called “ How can I determine where a drug is manufactured? ” But here’s something different to chew on: Even drugs that our research categorized as manufactured in the U.S. The longer-term goal: bring back drug manufacturing to America for greater national self-sufficiency.

Manufacturing 98

Manufacturing Drugs Generic Drugs Branding 98

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.

Packaging 100

Packaging Packaging Marketing Containment 100

Pharmaceutical Technology

JUNE 24, 2022

The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 5, there may be enough overlap for the bivalent vaccine to offer protection against all the subvariants, says Dr Prathit Kulkarni, assistant professor of medicine in infectious diseases at Baylor College of Medicine.

Vaccination 264

Vaccination Vaccine Antibody Medicine 264

Pharmaceutical Technology

DECEMBER 13, 2022

Using sensors to monitor shipments of temperature-sensitive medicines has been standard for years. Based on insight gained from downloading all metrics from all containers in Envirotainer’s fleet, there are some excellent examples of how specific measurements have sparked improvements. The insights speak for themselves.

Containment 130

Containment Big Data Manufacturing Medicine 130

XTalks

SEPTEMBER 8, 2020

Albany Molecular Research Inc (AMRI), a global provider of advanced drug development and manufacturing solutions, announced that they have signed a supply agreement with AstraZeneca. The company has signed on to help manufacture AstraZeneca’s COVID-19 vaccine candidate, AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus.

Manufacturing 83

Manufacturing Vaccination Vaccine Allergies 83

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.

Marketing 100

Marketing Drug Delivery Systems Production Containment 100

XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Each module contains six standard sized containers, which measure 2.6

Vaccination 105

Vaccination Vaccine Production Manufacturing 105

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. Payer and/or manufacturer reporting. The emergence of expensive new speciality medicines are also expected to impact business models in future.

Pharmacy 113

Pharmacy Containment Manufacturing Business Development 113

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 is immunocompromised or are on a medicine that affects the immune system. The information contained in this release is as of July 19, 2022.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

Pharmaceutical Technology

MARCH 10, 2023

In Lebanon, the battle for access to medicines rages on and is further heightened by dramatic decreases to the healthcare budget last year. Consequentially, the five-year average price trend in Lebanon for all medicines has increased to 1,123%. GlobalData reviews the key events leading up to these current price trends in Lebanon.

Marketing 130

Marketing Branding Medicine Manufacturing 130

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 1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted

Vaccination 101

Vaccination Vaccine Medicine Clinical Trials 101

Pharmaceutical Technology

AUGUST 31, 2022

Decreasing product life cycle time, varying customer demands and niche products, as well as increasing the cost of manufacturing and shipment, all contribute to constraints on the supply chain. This launch expands upon ILC Dover’s integrated solution set across the entire biopharmaceutical manufacturing workflow.

Packaging 130

Packaging Packaging Production Containment 130

Roots Analysis

AUGUST 16, 2023

mRNA has completely revolutionized the field of medicine and significantly influenced the study and treatment of human diseases. However, synthesis and manufacturing of mRNA is fraught with several challenges as the production of such biomolecules is complex, cost intensive, requires specialized expertise and dedicated equipment.

Contract Manufacturing 52

Contract Manufacturing Manufacturing Marketing RNA 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

The increasing demand for API peptide products is in turn increasing the demand for peptide API manufacturers who also offer contract marketing services. The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision.

Protein 100

Protein Marketing Manufacturing Reagent 100

Pharmaceutical Technology

MAY 25, 2023

With a network of more than 134 local pharmaceutical companies, Adalvo supplies more than 110 different medicines in over 100 countries across the world. Mellozzan contains the sleep hormone melatonin and is indicated for use in children with attention deficit hyperactivity disorder (ADHD) and sleep difficulties.

Hormones 130

Hormones Engineer Containment Licensing 130

Pharmaceutical Technology

SEPTEMBER 8, 2022

Large-scale manufacturing. 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. Packaging. •

Marketing 100

Marketing Pharmacy Containment Sales 100

Camargo

SEPTEMBER 14, 2021

An IND submission serves as a request to start clinical studies, containing a summary of information known about the drug, including nonclinical studies; chemistry, manufacturing and controls (CMC); and a proposed clinical plan. INDs must contain full study reports of nonclinical and clinical (if available) studies.

Clinical Trials 144

Clinical Trials Clinical Trials Medicine Production 144

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. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

pharmaphorum

MAY 11, 2021

Called eRNA for short, this class of medicines is programmable and can continuously express therapeutic proteins inside the body. This makes the body into a “drug factory”, allowing for long-lasting medicines that allow for repeat redosing and can be administered easily by several routes.

RNA 98

RNA Drugs Protein Immune Response 98

The Pharma Data

MARCH 5, 2021

Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. The company is separately supporting COVID-19-related clinical investigations of several Novartis medicines.

Manufacturing 52

Manufacturing Vaccination Vaccine Production 52

pharmaphorum

JANUARY 30, 2023

The current shortages have been spurred by a number of issues, some short-term and many long-term, that have plagued the manufacture and development of antibiotics. For its part, the US Food and Drug Administration (FDA) posted its drug shortage list , which contains various formulations of amoxicillin that are limited in supply.

Medicine 104

Medicine Production Manufacturing Regulation 104

Camargo

NOVEMBER 29, 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. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms.

Development 180

Development Protein Production Hormones 180

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. Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines.

FDA Approval 98

FDA Approval Containment Pharmacy Medicine 98

The Pharma Data

JANUARY 10, 2021

11, 2021 (GLOBE NEWSWIRE) — Editas Medicine, Inc. EDIT-301 is an experimental, ex vivo gene editing cell medicine in development for the treatment of sickle cell disease. EDIT-301 is the first experimental medicine in development generated using CRISPR/Cas12a gene editing. CAMBRIDGE, Mass.,

Medicine 52

Medicine Development Clinical Trials Clinical Trials 52

Pharmaceutical Technology

AUGUST 3, 2022

During this stage, a team of lab technicians must identify the best way to manufacture the active pharmaceutical ingredient (API) into a suitable dosage form for pilot production. If clinical trials prove successful, that same process should then be scaled to commercial manufacturing.

Development 130

Development Production Manufacturing Bioavailability 130

The Pharma Data

DECEMBER 4, 2021

company (NASDAQ: AMZN), announced that it is working with Pfizer to create innovative, cloud-based solutions with the potential to improve how new medicines are developed, manufactured, and distributed for testing in clinical trials. (AWS), an Amazon.com, Inc.

Manufacturing 52

Manufacturing Development Drugs Clinical Supply Chain 52

Pharmaceutical Technology

FEBRUARY 8, 2023

This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development. Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264

pharmaphorum

MARCH 26, 2021

Medicinal products are mentioned only in passing. This applies equally to medicinal products and medical devices as to any other type of goods. This general rule on exporting and importing goods free of tax, duty and tariff is significant in enabling the continuing flow of medicines and medical devices between the EU and the UK.

Production 119

Production Medicine Marketing Regulation 119