There is perpetual tension between competition and exclusivity. Competition supports multisource supply. Exclusivity requires protection for a single source. Both have bearing on access to medicines. Competition ensures access, while exclusivity denies access. This tension was heightened during the negotiations on the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs), as developed countries, egged on by Big Pharma, pushed for higher intellectual property rights protection.
New York City has long aspired to become a life sciences hub, but while the city seems to have all the elements necessary to foster such industry growth, it has continually fallen short of this goal. New York currently ranks a distant third behind both Greater Boston and the San Francisco Bay Area, and there’s some work to do if it hopes to catch up.
Generic drug prices are falling. For confirmation, look no further than the recent earnings reports from generic manufacturers and pharmaceutical wholesalers whose profits from distributing generic pharmaceuticals are also declining.
Clinical research is becoming more and more complex due to many factors, including increased regulations, competition for patients, and cost of conducting clinical trials. Most of the smaller pharmaceutical and biotech companies (sponsors) do not have the workforce to provide proper oversight of a clinical trial. This forces companies to outsource much, if not all, of the trial oversight to contract research organizations (CROs) and service providers (vendors).
In a presentation at the 2017 World Biosimilars Congress, Asif Mahmood, disease area safety and strategy lead at Pfizer, shed some light on global risk management strategies and the challenges of launching these programs.
In this final installment of a three-part series, managing directors Jonathan Kfoury and Ricardo Brau of L.E.K. Consulting share their perspectives on six biosimilar company archetypes, emerging biosimilar development and business strategies (as well as mistakes to avoid), and the market’s future.
In a recent article, I discussed the market opportunities and reimbursement system in Russia. But in addition to this snapshot of the market, my conversation with BIOCAD's Roman Ivanov highlighted how the Russian biosimilar regulatory system was established, as well as the challenges BIOCAD has faced during it evolution.
There have been considerable updates in the Brexit situation since April 2017, including, the surprising result of the U.K. general election. If anything, news regarding Brexit and the biopharma industry has started to heat up in recent months, and there have been a number of relevant developments that manufacturers must keep their eye on.
Real-world evidence is a hot topic in clinical research right now. But too often, the massive amounts of data now available from electronic medical records used in routine medical practice are being considered to be clinical evidence to support medical decision making. However, the process of transforming these large data sources into actionable evidence that can change clinical practice is a complicated but important endeavor.
In the Amgen v. Hospira decision, issued on Aug. 10, 2017, the U.S. Court of Appeals for the Federal Circuit gave a little more ammunition back to the biologics manufacturers (though on its face, it was a loss for Amgen), opining that the “could reasonably be asserted” language in the statute allows a biologics sponsor to initially include in the list any patent that it believes in good faith “could” reasonably be asserted, even if the belief is mistaken.
This handbook gives a general introduction to the principles and applications of cross flow filtration using systems and filters from GE.
This poster focuses on how the resin selection and architecture of a bioprocess film can be optimized to maintain critical performance attributes, such as container integrity and gas barrier properties, under the significant forces during bulk liquid transportation and WAVE Bioreactor™ system applications.
Considerations when choosing a contract manufacturer for drug substance development or finished dosage forms.
Apart from the potentially tragic impact on patients, the economic consequences of a batch failure are enormous. For the mAb blockbusters, a month production stop can result in lost revenues of up to 1 billion dollars and a typical QA investigation could cost $20,000. Thankfully, there are solutions for decreasing the risks. Download this Infographic on the financial impact of a bioburden incident and ways to reduce said impact.
This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.
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