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FDA reaches over 100 Competitive Generic Therapy approvals
The FDA reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation.
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Drug Markets
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Six major disruptors for the generics and biosimilars market
In this article, EPR's Hannah Balfour outlines six factors that could significantly challenge the generics and biosimilars market in the next decade.
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UK life sciences sector: do you have the Vision for innovation?
Here, EPR explores some highlights of the UK’s new Life Sciences Vision for the pharma, biopharma and biotech industries, covering topics from funding to regulatory reviews and clinical trial innovation.
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-300x278.jpg)
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-e1629795881701.jpg)
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Pfizer-BioNTech becomes the first FDA-approved COVID-19 vaccine
Pfizer and BioNTech's vaccine is the first to be approved by the FDA for the prevention of COVID-19 in people aged 16 years and older.
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Drug price reduction could have no impact on future approvals, study finds
New research shows that drug price reductions under the US's H.R. 3 policy could have no impact on innovation in the pharmaceutical industry.
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Parkinson’s disease market sales to reach $11.5 billion in 2029
The Parkinson’s disease market is set to triple in sales by 2029 driven by novel biologics and delivery systems, reports GlobalData.
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LBPs may offer hope to IBS patients in the near future, says report
Live biotherapeutic products (LBPs) are expected to help patients with IBS who currently have no US- or EMA-approved treatments.
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Over £100mn in fines for pharma firms hiking prices of crucial thyroid drug
The Competition and Markets Authority fines Advanz and two others for hiking prices of liothyronine tablets by 1,110 percent in eight years.
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EMA’s human medicine committee (CHMP) meeting highlights, July 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended two medicines for approval and provided a negative opinion on Nouryant.
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Has the threat of waiving COVID-19 vaccine intellectual property rights had its desired effect?
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
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‘Marketplace’ launched to speed up global access to COVID-19 vaccine
CEPI has launched COVAX Marketplace to accelerate the global production of COVID-19 vaccines, increasing access to doses.
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AI and big data will continue to disrupt pharma sector, says survey
A GlobalData report has revealed the extent to which companies will be using AI and big data in drug discovery and development processes.
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Biopharma and the life sciences ecosystem: putting the foundations in place for a productive partnership
Even now 65 percent of drugs being approved come from biopharma companies and within a decade that is expected to rise to 85 percent. This is great news for a world hungry for new breakthrough treatments. As growth in pre-clinical and clinical work intensifies globally, Ahmed Bouzidi, Vice President of…
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EMA human medicines committee meeting highlights, June 2021
Drugs recommended for approval by the European Medicines Agency’s human medicines committee included a gene therapy and two generics, among five others.
![The GlaxoSmithKline headquarters building in Brentford, west London, June 2018 [Credit: Willy Barton / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/GSK-3-300x278.jpg)
![The GlaxoSmithKline headquarters building in Brentford, west London, June 2018 [Credit: Willy Barton / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/GSK-3-e1624534468322.jpg)
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GSK to focus on vaccines and specialty medicines in next decade
In an investor update, GlaxoSmithKline (GSK) revealed its plan to promote growth and performance over next ten years.
