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On-demand webinar: ICH stability testing and method development
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
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Biologics
whitepaper
Whitepaper: Establishing the proper PH range for aqueous simulating solvents used in extractables profiling
This whitepaper considers the chemical properties of commonly encountered acidic and basic extractables and uses these properties to address questions about establishing the proper pH (or proper pH range).
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Biosimilars: the future of competition
Earlier this year, the British Biosimilars Association (BBA), the trade body representing the interests of biosimilar manufacturers, welcomed Dr Andrew Ellis as its new Chair. In this interview, Nikki Withers asks why biosimilars are so important for pharma and how he foresees the market evolving in the coming years.
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Expert view: Sterility testing of challenging samples
While membrane filtration is often straightforward, some sample types can be challenging. These include difficult-to-filter viscous oils, water-in-oil emulsions and fatty base ointments as well as samples containing substances that inhibit microbial growth.
news
4D pharma to initiate Phase II study of MRx-4DP0004 to treat COVID-19
The UK MHRA granted expedited acceptance for the Phase II trial of MRx-4DP0004, a live biotherapy product and targeted immunomodulatory therapy.
news
FDA transitions to new regulatory pathway for biosimilars
The US FDA will now approve biosimilars via a new regulatory pathway to help grow the competition between biologic products.
news
Second patient cured of HIV using stem cell therapy
Researchers report that a patient who underwent stem-cell transplantation and a chemotherapy drug regimen has been cured of HIV.
news
Coronavirus update: clinical trials and antibody manufacture
The US NIH has initiated a clinical trial for remdesivir and two pharmaceutical companies will work together to manufacture antibody treatments to tackle the coronavirus.
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How will the rise of biosimilars impact biologics?
Once patents expire for biologic medicines, a market opportunity opens up for biosimilars, a cheaper alternative. With more patents due to expire soon, what will the future look like for biologic medicines?
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The FDA and FTC team up to prevent anti-competitive practices
The two agencies have signed a statement of their intent to combat anti-competitive practices which are preventing the adoption of biosimilars in the US drug market.
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Biologics patent expiry to positively impact US pharma, says report
New research has suggested that the expiration of biologics patents will be the factor that positively impacts US pharma the most this year.
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Drug delivery and packaging trends for 2020 revealed
Pharmaceutical industry experts have highlighted the key trends for the coming year for drug delivery and packaging.
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The intricacies of rising drug prices in the US
Following 250 US drug price increases in 2020 already, this article explores why costs are rising, what changes could ensure brand reputations remain intact and what manufacturers can do to ensure they get their share.
news
First company awarded market authorisation under new Chinese drug law
The mAb tislelizumab has been granted approval from Chinese authorities, making Boehringer Ingelheim Biopharmaceuticals the first MAH under the new system.
whitepaper
Whitepaper: Complex Generic APIs: A Primer
The US Food and Drug Administration (US FDA) defines complex generics as products having intricacy associated with an active pharmaceutical ingredient(s) (API), formulation process, route of delivery, or drug-device combination.
