pharmaphorum

JANUARY 18, 2022

The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience. Drug developers.

Drug Delivery 52

Drug Delivery Production Drug Delivery Systems Packaging 52

Roots Analysis

OCTOBER 5, 2023

Driven by the increasing need for safe and efficient medical devices and drug delivery systems, the pharmaceutical polymers / medical grade polymers domain is advancing significantly. Vaccine Adjuvants: Polymers often serve as carriers for releasing the antigen and thereby regulating the immunological responses.

Manufacturing 40

Manufacturing Drug Delivery Systems Drug Delivery Packaging 40

FDA Law Blog

MARCH 12, 2024

As Abbvie wrote: “While your letter refers to ‘sham’ patents and concerns about ‘abusing the patent system,’ the FTC’s letter makes no assertions that these patents were ill-gotten or are otherwise illegitimate. In fact, federal law and regulation appear to require AbbVie to list these patents.”

Drugs 59

Drugs Drug Delivery Systems Regulation Production 59

Pharmaceutical Technology

FEBRUARY 3, 2023

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.

Contamination 130

Contamination Manufacturing Containment Production 130

XTalks

AUGUST 24, 2022

By the end of this year, the EPA plans to propose an air pollution regulation to address EtO emissions at commercial sterilizers and to protect public health. As a result, the EPA is providing new information on specific facilities where lifetime risk levels are the largest to nearby communities.

Drug Delivery Systems 98

Drug Delivery Systems Drug Delivery Regulation Packaging 98

XTalks

AUGUST 30, 2022

One of the biggest challenges with developing therapies to treat CNS disorders is the delivery of systemically administered investigational products (IPs) to the brain, which is limited by the blood-brain barrier. Some methods of direct CNS administration include intrathecal, intraparenchymal and intracerebroventricular (ICV) delivery.

Trials 83

Trials Drug Delivery Drugs Gene 83

FDA Law Blog

SEPTEMBER 19, 2023

It merely says that “[t]he Hatch-Waxman Act and FDA regulations set forth the criteria for listing patents in the Orange Book” and that “Brand manufacturers are responsible for ensuring their patents are properly listed.” But it is not always clear which types of patents are eligible for listing in the Orange Book.

Drugs 105

Drugs Branding Drug Delivery Systems Generic Drugs 105

Roots Analysis

MARCH 24, 2022

However, research related to metabolites is essential to increase the understanding of molecular level interactions, functions, modifications and regulations in cells, therefore, the field of metabolomics plays a vital role in biomarker discovery for early disease diagnosis and prognosis as well as for drug discovery and development processes.

Clinical Research 52

Clinical Research Development Research Drug Delivery Systems 52

The Pharma Data

APRIL 27, 2021

A Minipump Continuous Drug Infusion Dog Model System to Identify Candidate Drugs and Drug Delivery Rates for Intracameral IOP-lowering Implants. A Retrospective Analysis: Visual Field Progression and Visual Acuity following Administration of Brimonidine Drug Delivery System. Sunday, May 2.

Research 40

Research Drug Delivery Systems Drug Delivery Production 40