Pharmaceutical Technology

MARCH 29, 2023

With the new version of EU GMP Annex 1 coming into effect on 25 August this year, big changes to the way the pharmaceutical industry approaches container closure integrity testing (CCIT) are in motion. In addition, 100% testing is now required for fusion-sealed containers such as ampoules and IV bags.

Containment 130

Containment Production Packaging Packaging 130

Pharmaceutical Technology

SEPTEMBER 8, 2022

A first-in-human drug product, ARDS-003 contains the active pharmaceutical agent, Onternabez. We look forward to working jointly with Cellvera to bring this combination drug product forward to improve treatment options for patients worldwide.”. Onternabez is a selective full agonist of the type 2 cannabinoid receptor (CB2R).

Development 331

Development RNA Containment Drugs 331

Pharmaceutical Technology

MARCH 22, 2023

Process intensification can loosely be described as making more product with the same or fewer resources. The appeal of process intensification continues to grow in the biopharma industry as a means of not only increasing the productivity, but also improving sustainability. Existing technologies could also be run in a different way.

Production 130

Production Manufacturing Engineer Containment 130

Pharmaceutical Technology

FEBRUARY 9, 2023

Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. On a regular basis, pharmaceutical manufacturers are performing CCIT during commercial production to ensure that packaging processes are operating as they should.

Production 130

Production Containment Packaging Packaging 130

Bio Pharma Dive

MARCH 20, 2023

Speeding up the drug development process through a less optimized containment and delivery system may have been an option in the past, but both expectations and the competitive environment are changing.

Production 130

Production Containment Development Drugs 130

Camargo

MARCH 25, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications : Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation.

Production 130

Production Drugs In-Vitro Containment 130

Medical Xpress

DECEMBER 27, 2024

Food and Drug Administration (FDA) has proposed a new rule to require standardized testing of talc-containing cosmetics for asbestos, a known carcinogen linked to serious illnesses such as lung and ovarian cancers.

Cosmetics 104

Cosmetics Production Containment Drugs 104

Camargo

FEBRUARY 16, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Definition of a Rare Disease or Condition.

Production 130

Production Drugs Marketing In-Vitro 130

Camargo

MAY 19, 2021

The Camargo Blog has published a four-part blog series highlighting those designation programs available specifically for products with rare disease indications. The HUD designation program is designed for medical devices and is similar to the Orphan Drug Designation (ODD) program for drugs and biological products.

Production 142

Production FDA Approval Marketing Drugs 142

STAT News

FEBRUARY 3, 2023

The dietary supplement industry has been begging for federal oversight of products containing cannabidiol (CBD), a non-psychoactive compound found in the cannabis plant that is being incorporated into a bewildering range of oils, tinctures, edibles, and other products. Read the rest…

Regulation 98

Regulation Production Containment Marketing 98

Medical Xpress

MAY 11, 2023

Tens of millions of Americans use menstrual products, and while manufacturers contend they are safe, most disclose little about the chemicals they contain. Now, amid calls for more disclosure and research into the health effects of these products, some states require more transparency.

Production 92

Production Packaging Packaging Containment 92

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. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.

Vaccine 105

Vaccine Vaccination Production Manufacturing 105

NPR Health - Shots

NOVEMBER 28, 2022

The bottom base of some Green Sprouts products can break off, exposing a solder dot that contains the toxic metal, a federal regulator said. Consumer Product Safety Commission) No injuries have been reported from such incidents. Image credit: U.S.

Containment 145

Containment Regulation Production 145

World of DTC Marketing

OCTOBER 25, 2021

In addition to immediate access to a physician, they offer on-site labs to analyze blood, MRI and CAT scan machines, pharmacies, and a full range of OTC products. The most important touchpoint for pharma continues to be product websites, but there is no indication that pharma understands this. Patients have wanted this for a long time.

Containment 257

Containment Branding Pharmacy Drugs 257

World of DTC Marketing

JUNE 6, 2021

Wegovy also contains warnings for pancreatitis, gallbladder problems including gallstones, low blood sugar, acute kidney injury, eye retina damage, increased heart rate, and suicidal behavior or thinking. And, like any medication, there is a risk of side effects, some serious. appeared first on World of DTC Marketing.com.

Drugs 318

Drugs Cosmetics Production FDA Approval 318

XTalks

SEPTEMBER 19, 2023

The US Food and Drug Administration (FDA) has issued warning letters to eight companies manufacturing or marketing unapproved eye products that violate federal law. The FDA said the warning letters are part of the agency’s ongoing effort to protect Americans from potentially harmful ophthalmic products.

Production 105

Production Pharmacy Drugs Sales 105

Pharmaceutical Technology

SEPTEMBER 15, 2022

Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. Adding to these factors is that oncology accounts for the majority of marketed, contained drugs. Containment challenges.

Containment 130

Containment Manufacturing Production Contract Manufacturing 130

Fierce Pharma

SEPTEMBER 13, 2023

For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. | For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter.

Containment 126

Containment Production Drugs 126

Pharmaceutical Technology

SEPTEMBER 14, 2022

As an autologous cell therapy, manufacturing the infusion product is a highly specialised process involving tumour harvest and the extraction and large-scale ex vivo expansion of TILs. Improvement to the TIL product itself is an area of intense research. Once infused, TILs are further stimulated by IL-2 treatment. to more than 10%.

Immune Response 246

Immune Response In-Vivo Production Manufacturing 246

Pharmaceutical Technology

DECEMBER 11, 2023

Thousands of over-the-counter (OTC) and prescription healthcare products contain antimicrobial agents. Here’s what you need to know when working with these ingredients.

Containment 130

Containment Production 130

Pharmaceutical Technology

DECEMBER 12, 2022

An investigational late-stage product candidate, CART-ddBCMA is being analysed in the Phase II iMMagine-1 clinical trial at present. It leverages the new D-Domain binder of Arcellx and contains autologous T cells genetically modified for targeting multiple myeloma.

Development 264

Development Gene Therapy Clinical Trials Clinical Trials 264

Drug Patent Watch

MARCH 12, 2025

Behind the scenes, generic drug manufacturers are working tirelessly to ensure that their products are safe, effective, and identical to their branded counterparts. It helps them to identify potential issues early on, make adjustments as needed, and ultimately bring a high-quality product to market.

Generic Drugs 96

Generic Drugs Drugs Manufacturing Branding 96

Pharmaceutical Technology

AUGUST 1, 2022

The mRNA-1273.222 vaccine containing the BA.4/5 In June, the company and the European Commission (EC) signed an agreement to amend their previously agreed contractual supply schedules for the former’s Covid-19 vaccine booster product (Spikevax, mRNA-1273) or updated booster vaccine candidate.

Vaccine 289

Vaccine Vaccination Gene Therapy RNA 289

Pharmaceutical Technology

MAY 24, 2023

Allogeneic therapies begin with healthy donor samples to develop the eventual therapeutic product which can be administered to multiple patients. CGT trials operate with much lower volumes of manufactured final product. The labeling process of the final product is earlier than that for traditional trials.

Clinical Trials 246

Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

Pharmaceutical Technology

FEBRUARY 3, 2023

There are a number of reasons why OSD forms dominate the market, not least because they are simple to administer, and it is easy to differentiate one OSD product from another. This heightens the risk of cross contamination, requiring effective containment solutions, especially when handling highly potent powders.

Contamination 130

Contamination Manufacturing Containment Production 130

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.

Development 242

Development Bioequivalency Generic Drugs Production 242

World of DTC Marketing

OCTOBER 4, 2021

SUMMARY: The Facebook whistleblower lawsuit can be summed up in one sentence: Facebook prioritizes engagement above all else because it leads to more profits even if that engagement containing inflammatory information. Mt recommendation was no and was based on the amount of health misinformation I found on the site.

Branding 224

Branding Marketing Pharmacy Pharma Companies 224

Pharmaceutical Technology

OCTOBER 6, 2022

According to Adam Bradbury, GlobalData PharmSource analyst “[…] evidence indicates that containment facilities are in high demand and will be increasingly so in future as the oncology pipeline and the use of cytotoxic drugs continues to grow.” The processes and subsequent installation must be adapted to the product,” says Housh.

Engineer 130

Engineer Containment Production Manufacturing 130

Pharmaceutical Technology

SEPTEMBER 5, 2022

The list includes companies that provide a range of services, including but not limited to: · New product/health plan innovation research. The document contains detailed information on the suppliers and their product offerings, alongside their contact details to aid your purchasing or hiring decision. Concept evaluation testing.

Production 147

Production Branding Scientist Compliance 147

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies hold permission to market their products directly to consumers. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing decision. Product claim advertising is allowed with a summary of the product risks included.

Marketing 130

Marketing Compliance Production Doctor 130

Drug Patent Watch

MARCH 22, 2022

Drugs contain ingredients with therapeutic activity, so-called “active ingredients” as well as inactive ingredients. These inactive ingredients, called excipients, are included in oral products for various reasons, such as to….

Drugs 115

Drugs Containment Production 115

STAT News

OCTOBER 7, 2022

The FDA has announced the set of rules it proposes to enforce for manufacturers to claim that a food product is “healthy.” They are about selling food products. ” The proposed rules are a lot better than the labeling anarchy that currently exists. Read the rest…

Packaging 98

Packaging Packaging Containment Production 98

Pharmaceutical Technology

MARCH 21, 2023

So far, the FDA has approved just one CBD product, a prescription drug designed to treat seizures associated with Lennox Gastaut syndrome (LGS) [i]. Just before the Covid-19 pandemic, there were 60 ongoing clinical trials with cannabis-based products, with the majority being tested for pain or psychosis.

Production 243

Production Bioavailability Pharmacy Clinical Trials 243

Pharmaceutical Technology

SEPTEMBER 5, 2022

Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs. Wholesalers can be either full-line wholesalers, who purchase the complete product line of a company, or specialised companies, which purchase speciality drugs to sell to clinics and hospitals. GDP and GMP advisory.

Packaging 130

Packaging Packaging Compliance Manufacturing 130

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. The download contains detailed information on commercial pharmaceutical packaging contractors, and their product and service lines, alongside contact details to aid your hiring decision.

Packaging 100

Packaging Packaging Marketing Containment 100

Pharmaceutical Technology

AUGUST 17, 2022

RANKINGS 2022 Excellence Innovation Commended Excellence Product Launch Commended Excellence Safety Commended. The company is ranked in the 2022 Excellence Rankings in the INNOVATION , PRODUCT LAUNCH and SAFETY categories. The Verdict. Northgate Technologies Inc.

Contamination 245

Contamination Containment Production Branding 245

XTalks

JANUARY 30, 2025

In 2020, the US Food and Drug Administration (FDA) issued a Guidance for Industry recommending that sponsors include plans for developing age-appropriate formulations of drug products in instances where adult formulations may not be suitable for paediatric patients. One of the most significant benefits of PDFs is their ease of administration.

Manufacturing 52

Manufacturing Development Compliance Production 52