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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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Generics
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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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European Pharmaceutical Review Issue 4 2021
In our latest issue, features explore the use of nano formulations to improve skin and nail drug delivery, how to take cell and gene therapies from concept to commercialisation and what strategies you can use to overcome interfering factors in LAL bacterial endotoxin testing. Also in this journal, find out…
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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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British generics manufacturers call for Northern Ireland supply to be sorted
Mark Samuels, Chief Executive of the British Generic Manufacturers Association (BGMA), urges EU and UK to put patients above politics in solving medicine supply challenges for Northern Ireland.
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ICH M13: Bioequivalence guidelines
Dave Elder outlines how bioequivalence data supports numerous processes at various stages of drug development as well as when establishing generic drug substitution, and reflects on its differing interpretations across the globe.
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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.
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Supply of biosimilars and generics with Adrian van den Hoven, Medicines for Europe
In this interview, Adrian van den Hoven, Director General of Medicines for Europe, discusses all things supply of generic and biosimilar medicines for the continent. Also, in a bonus video, Adrian discusses challenges disrupting access to biosimilars and generics in Europe.
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Six major risks facing pharmaceutical manufacturers in 2021
In this article, Shannon Flynn outlines six of the key risks threatening pharmaceutical manufacturers’ recovery from COVID-19 in 2021.
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What is on the horizon for the pharmaceutical packaging equipment market?
European Pharmaceutical Review’s Hannah Balfour outlines the findings of market research reports exploring the challenges and drivers for the pharmaceutical packaging equipment market between 2020 and 2025.
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Launch of generic oncology medications to improve treatment access in India
GlobalData suggests the recent approval of new generics in oncology should enhance access and adherence to cancer treatment by reducing costs borne by patients.
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EMA recommends six medications for approval in February meeting
The EMA’s committee adopted positive opinions of six medications, including two orphan drugs, and concluded its review of the use of REGN-COV2 – an investigational antibody therapy for COVID-19.
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Bioanalytical testing services market to become a $4.5 billion industry
A report found the rise in outsourcing, growing popularity of biologics and expanding acceptance of quality-by-design approaches would drive the market expansion.
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Generic remdesivir may put pricing pressure on Indian pharma, says analyst
According to an expert, Indian pharmaceutical companies will have to price remdesivir cautiously to ward off generic competition in the near future.
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An alternative to pharmaceutical pay-for-delay deals
A new paper has suggested that pay-for-delay deals could be replaced with a challenger-based system to improve access to generic drugs.