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Pharma companies continue to be among the most profitable industries, even outperforming tech companies. The Pharma Spin. Pharma continues to spin the lie about the high development costs of drugs but an analysis tells us the truth. This is an industry that doesn’t care about what people think of them.
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Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety.
Chrys Kokino has been involved in the biosimilars market prior to the first biosimilar being approved in Europe in 2006. The entire premise was that because biosimilars were so new, and there was not a lot of information on the safety and efficacy of those products, customers should be a bit leery prior to jumping on the biosimilar bandwagon.
3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. For this reason, a unique ‘abridged’ procedure was introduced to provide a specific regulatory pathway for biosimilars in the EU.
The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. In this article, we share how a sponsor partnered with Clarivate to incorporate COAs into clinical trials for alopecia areata. The regulatory landscape around COAs is fast evolving.
Currently, 40 biosimilars are FDA-approved and 25 have launched, whereas the EMA has approved 86 biosimilars since 2006. Many pharma companies hold extensive patent protections and have ongoing patent litigation cases. Further, there remains scepticism on the efficacy and safety of biosimilars.
The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. Data and insights gleaned from these projects have most recently been presented at industry conferences and events, including ISPOR.
But the recent acquisition by Japanese pharmaceutical provider Shionogi of US-based rival Sciele Pharma, worth $1,276m, is just the latest in a spree of big and bold outbound deals. “Local generic companies such as Ranbaxy and DRL have expanded through acquisition in Western markets aggressively in 2006.”
Furthermore, by simulating real-life scenarios, AR offers the chance for staff in the pharma industry to practice complex operations without the associated risks. The pandemic raised the sector’s profile and has helped establish pharma as a desirable career path for several reasons, including job security, innovation, and societal value.
However, a wave of exciting monoclonal antibody products was being developed, and these were quickly partnered with big pharma which demonstrated the increasing commercial opportunity for biotechnology. “There have been doubts about the extent to which the high prices paid by big pharmaceuticals were justified in the short term.”
The Biden administration’s decision to support a temporary waiver of Covid-19 vaccine patents prompted instant outrage in the pharma sector, which argues that the move rides roughshod over their intellectual property rights and will discourage US innovation while sending jobs abroad. The post Pharma panics over patent wavers.
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