Camargo

OCTOBER 14, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Continued development of the use of complex innovative trial designs. Continue development of the use of Real-World Evidence.

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Camargo

DECEMBER 10, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. What is the answer, then, for those who need an inspection as a requirement for obtaining a drug product application approval?

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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.

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Camargo

JANUARY 14, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Issues Advice on Combination Products. The guidance could also serve as a good regulatory primer for those new to combination products.

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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. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Development Production Immune Response Licensing 161

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.

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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. For generic drug manufacturers, stability testing is a critical step in the development process. Container Closure System : How will the drug interact with its packaging?

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Camargo

JUNE 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Because of the significant public health need, FDA granted this 505(b)(2) pathway product a fast track designation in late 2017.

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XTalks

AUGUST 27, 2021

General Mills appears to be exploring and developing an animal-free dairy cheese brand called Renegade Creamery. This technique results in the same taste and texture as dairy cheese, is a sustainable product and reduces greenhouse gases by being animal-free. What is an Animal-Free Product? The jury is still out.

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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.

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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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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.

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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. Sources.

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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. Propofol Injectable Emulsion is a terminally sterilized (TS) product. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

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Containment Production Vaccination Vaccine 97

Camargo

DECEMBER 9, 2020

Camargo is currently involved with no less than three product applications that are stalled because the FDA is requiring inspections before the application can be approved (assuming a satisfactory outcome). Biopharma and manufacturing company Alkermes was recently able to participate in a remote document review for its ALKS 3831 product.

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Camargo

APRIL 20, 2021

This trend progressively reduces the attractiveness of engaging in the early stages of oncology therapy development in the eyes of Big Pharma and opens the space for small pharma and biotech players. Become Fluent in the Drug Development “Languages.”. The language of accounting, to optimally allocate capital to maximize results.

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Druggist

MARCH 11, 2021

Saliva production is primarily driven by mechanical and gustatory (taste) stimulation (Dodds et al., In today’s post, I will review the best dry mouth lozenges for saliva production. I will also list products which can be may be available to buy from the pharmacy. Alternatives products to manage dry mouth.

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Production Containment Pharmacy Sales 97

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.

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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.

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Pharmaceutical Technology

AUGUST 1, 2022

The mRNA-1273.222 vaccine containing the BA.4/5 4/5 Omicron strain is being developed in line with the latest recommendations from the Food and Drug Administration (FDA). Last month, the company announced the advancement of two bivalent candidates based on various population health security approaches in different countries.

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Pharmaceutical Technology

MAY 24, 2023

Every major pharma company is now involved in CGT development which has resulted in the approval of 28 therapies by the FDA thereby making CGT no longer a niche category of therapies. Allogeneic therapies begin with healthy donor samples to develop the eventual therapeutic product which can be administered to multiple patients.

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XTalks

FEBRUARY 25, 2022

EverGrain Ingredients, a barley protein and fiber solutions company, recently received certification from the Upcycled Food Association (UFA) for its entire portfolio of products. The brand saw a unique opportunity to extract the excess barley to meet the global demand for sustainable, plant-based products. Barley Milk.

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Production Protein Branding Bioavailability 98

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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Pharmaceutical Technology

SEPTEMBER 6, 2022

Hospitals, clinics, pharmacies, wholesalers of medical products and other health centres are catered by pharmaceutical logistics that include handling activities such as procurement, warehousing, and inventory management, as well as transportation, and management of the supply chain for diverse products.

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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%.

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Immune Response In-Vivo Production Manufacturing 246

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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XTalks

JULY 15, 2021

University of Newcastle researchers in Australia have developed a saliva test to evaluate glucose levels in diabetic patients. The test involves the use of testing strips that contain a glucose biosensor with electronic elements in the test’s transistor, like inks, that allow for mass printing of the test strips at low cost.

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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).

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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.

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Pharma Marketing Network

JULY 13, 2023

Your website is your online storefront, so it’s important to choose the best web development company to create it. In the pharmaceutical industry, where trust and credibility are essential, it’s especially important to choose a web development company that understands the specific needs of your business. Trust your gut.

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XTalks

APRIL 10, 2023

As the first OTC naloxone product approved by the FDA, Narcan is expected to be sold directly to consumers without a prescription as an emergency life-saving medication to reverse opioid overdose. Narcan nasal spray contains a single 4 mg dose of naloxone hydrochloride, which is administered intranasally.

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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.

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Packaging Packaging Compliance Manufacturing 130

Pharmaceutical Technology

MARCH 10, 2023

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state. The process eliminates the disadvantages of conventional drying methods or freezing.

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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.

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Production Branding Scientist Compliance 147

World of DTC Marketing

MARCH 10, 2021

A creative management platform contains a range of products, features, and tools that assist and aid different areas of campaign production. Instead, they need digital marketing talent to use cloud-based cloud-based software to develop and make changes based on the brand manager and M L R team’s needs.

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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. has been manufacturing, designing, and innovating since 1984.

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Contamination Containment Production Branding 245

Pharma Mirror

SEPTEMBER 1, 2023

A key option offered with the company’s automated cleaning and disinfecting wash systems, the custom wash rack services were developed to help pharmaceutical and nutritional product manufacturers ensure complete cleaning and disinfection of laboratory glassware, tableting tools, containers, valves, machine parts, and other supplies and equipment (..)

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