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NICE approves cost-comparison fast-track appraisal pilot
A new approach to the cost-comparison fast-track appraisal process is being piloted this summer for the review of low-risk appraisals.
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FDA approves emergency use of REGEN-COVTM for COVID-19 prevention
The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
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FDARA implementation guidance for paediatric studies of molecularly targeted oncology drugs
This article addresses early planning for paediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original New Drug Application (NDAs) and Biological License Application (BLAs) are expected to be submitted to FDA, in accordance with The FDA Reauthorization Act (FDARA).
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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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Biden Administration to support resilience of US pharma supply chain
US President announces $60 million in funding to support domestic API production and a consortium to onshore essential medicine manufacturing.
![Pfizer logo on a sign in New York city, US [Credit: Molly Woodward / Shutterstock.com]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-4-300x278.jpg)
![Pfizer logo on a sign in New York city, US [Credit: Molly Woodward / Shutterstock.com]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-4-e1627904909506.jpg)
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Pfizer reports 92 percent increase in revenues for Q2
The company’s second quarter (Q2) results reveal a $9.1 billion increase in revenues from Q2 2020 and significant operational growth.
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Camostat cuts recovery time in half for mild COVID-19 patients
Phase II trial results suggest Daewoong Pharmaceutical’s Foistar (Camostat mesilate) may significantly expedite recovery from mild COVID-19 symptoms.
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Project worth £3.1mn to develop advanced controls for biopharma manufacturing
A collaborative project will develop automated manufacturing controls for biologics such as antibodies, viral vectors and vaccines.
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Roche’s Evrysdi significantly improves lives of babies with SMA
The Phase II study of Evrysdi showed significant improvements in survival and motor milestones in babies with type 1 spinal muscular atrophy (SMA).
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FDA approves first interchangeable biosimilar insulin product
The first interchangeable biosimilar insulin product will help increase access and affordability of insulin for diabetics.
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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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Alzheimer’s treatment lowers tau by nearly 50 percent in Phase I trials
Biogen and Ionis announced positive topline data on investigational Alzheimer’s treatment, indicating 50 percent tau protein reduction.
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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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Regulators call for clinical research to include pregnant and breastfeeding women
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
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J&J to pay up to $5bn in US opioid settlement
Johnson & Johnson has signed a nationwide opioid settlement agreement and will pay billions to settle opioid-related claims and litigation in the US.
