article thumbnail

Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

FDA 72
article thumbnail

Patents: a necessary evil?

European Pharmaceutical Review

Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. Letter to FDA, 06 July 2022.

FDA 69
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

IoT innovation: Leading companies in nanoparticles for drug delivery

Pharmaceutical Technology

GlobalData’s analysis also uncovers the companies at the forefront of each innovation area and assesses the potential reach and impact of their patenting activity across different applications and geographies. Bristol-Myers Squibb is the leading patent filer in nanoparticles for drug delivery.

article thumbnail

A history of AstraZeneca

pharmaphorum

But although it was dubbed a “dangerous game”, some companies came out on top… On 6th April 1999, two companies with similar science-based cultures and a shared vision of the pharmaceutical industry came together to form what’s now considered as one of the top ten pharma companies in the world: AstraZeneca.

Vaccines 116
article thumbnail

An Annex 1 and Pharma 4.0 perspective on water quality

European Pharmaceutical Review

The US Food and Drug Administration (FDA) defines eight different types of water: non-potable, potable (drinkable), purified, water for injection (WFI), sterile water for injection, sterile water for inhalation, bacteriostatic water for injection and sterile water for irrigation. Chemometrics and Intelligent Laboratory Systems , 2005, Årg.

article thumbnail

Top 20 Cell and Gene Therapy Companies Based on 2022 Total Revenue

PharmaShots

The company first received the US FDA approval for its gene therapy Zynteglo in Aug 2022 for treating adult and pediatric patients with ß-thalassemia. Amongst the pipeline of gene therapy being evaluated, In Nov 2022, the company received approval for Hemgenix from the US FDA to treat Hemophilia B.

FDA 58
article thumbnail

Biogen’s $900 million settlement signals scrutiny on speaker fees

Pharmaceutical Technology

Ferry describes a popular solution among pharmaceutical companies. Some companies try to separate the clinical educational programs from their sales programs, and the speaker programs are run through the clinical education programs. Biogen’s activity in multiple sclerosis. 4 integrins, which play a key role in MS pathology.