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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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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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.

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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.

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XTalks

AUGUST 27, 2021

This technique results in the same taste and texture as dairy cheese, is a sustainable product and reduces greenhouse gases by being animal-free. In the past, General Mills hasn’t developed its own stand-alone plant-based brand but has launched some vegan products within existing brands. What is an Animal-Free Product?

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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 is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Mon, 08/22/2022 - 13:22.

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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….

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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. Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. deliesschef. NEW YORK, NY.,

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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.

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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.

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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…

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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.

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Pharmaceutical Technology

MAY 24, 2023

This promise and growth are expected to continue as CGT, which have the potential to cover 70% of oncology drugs, are being developed to treat further disease types such as solid tumors. CGT drugs fall into two major categories: autologous and allogeneic. CGT trials operate with much lower volumes of manufactured final product.

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XTalks

NOVEMBER 25, 2021

is recalling four lots of its injectable seizure medication levetiracetam over concerns of container closure integrity on vials of the drug product. Administration of a product that is not sterile may cause serious systemic infections that could pose to be life-threatening. Sagent Pharmaceuticals Inc.

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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.

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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.

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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

MAY 9, 2023

In February, the FDA issued an alert restricting the import of the veterinary sedative xylazine or tranq and the ingredients used to make the drug. This followed in the wake of a Drug Enforcement Agency (DEA) Joint Intelligence Report in October 2022, which stated that xylazine is widely available from Chinese suppliers on the internet.

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pharmaphorum

JANUARY 20, 2022

Gilead has also reportedly received a limited number of reports of bottles labelled as Gilead medication that did not contain the HIV treatment or prevention medication listed on the label. This works to ensure the safety and efficacy of the drugs received by patients.

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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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Camargo

NOVEMBER 15, 2021

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements.

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XTalks

APRIL 10, 2023

The US Food and Drug Administration (FDA) has recently approved the company’s naloxone hydrochloride nasal spray called Narcan for over-the-counter (OTC), non-prescription use. Narcan nasal spray contains a single 4 mg dose of naloxone hydrochloride, which is administered intranasally.

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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. Definition of Biologic Products. These products can be derived from humans, animals, or microorganisms with biotechnology.

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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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Containment Pharmacy Life Science Production 147

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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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.

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XTalks

NOVEMBER 5, 2024

per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 Proceeds from the IPO will fund preclinical and clinical development for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D).

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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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XTalks

JANUARY 24, 2022

Gilead Sciences has been seizing counterfeit versions of its HIV drugs Biktarvy and Descovy since last year and is now suing distributors who have been behind selling the illicit medications. The counterfeit drugs were being sold across several states in the US over the past two years. While Biktarvy brought in $7.3

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Camargo

OCTOBER 14, 2021

The expanded use of the INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting : INTERACT meetings are intended to facilitate IND-enabling efforts where a sponsor is facing a novel, challenging issue that might delay the progress of the product towards entry into the clinic in the absence of this early FDA input.

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Drug Channels

FEBRUARY 14, 2023

This Valentine's Day, what could be more romantic than a deep dive into the relationships between manufacturers of specialty drugs and the pharmacies they choose for their limited and exclusive specialty pharmacy networks. As you’ll see, a typical network contains only five specialty pharmacies. d/b/a Drug Channels Institute.

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Pharmacy Manufacturing Drugs Containment 97

Drug Patent Watch

JUNE 18, 2024

Branded generics are generic drugs that are marketed under a brand name by the manufacturer. These products contain the same active ingredients as their brand-name counterparts but are typically sold at a lower price point.

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XTalks

OCTOBER 24, 2024

Meanwhile, Innovent Biologics recently saw its New Drug Application (NDA) for picankibart, an IL-23p19 inhibitor, accepted by the Chinese National Medical Products Administration (NMPA). This drug may significantly improve psoriasis care by offering effective long-term control with fewer side effects.

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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. Documentation for a faster drug authorisation process. . Documentation for a faster drug authorisation process. Concept evaluation testing. Competitive intelligence studies. Media habits.

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Pharmaceutical Technology

FEBRUARY 8, 2023

The recent town hall, titled “Clinical Development of Gene Therapy Products for Rare Diseases”, was meant to further that dialogue with those in pharmaceutical industry developing new gene therapies for underserved patient groups. Therefore, the good news is we have flexibilities that can be offered to see drug development for these diseases.”

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Gene Therapy Gene Trials Clinical Trials 264

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.” These turnkey solutions cover every process through the drug manufacturing life cycle.

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