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How can biopharma strengthen its resilience?
A recent report has found that since 2021, biopharma resilience has decreased, affecting areas such as supply chain, strength of the R&D ecosystem and manufacturing agility.
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Small molecule treatment reduces risk of death by half in NSCLC
Astrazeneca’s small molecule tyrosine kinase inhibitor reduced the risk of death by 51 percent in non-small cell lung cancer (NSCLC), a major Phase III study has shown.
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Study identifies key contamination source during ATMP manufacture
Researchers say they are the first to demonstrate contamination of over 40 percent of lipoaspirate samples for adipose tissue-derived stem cell (ADSC)-based advanced therapy medicinal product (ATMP) manufacture.
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Analysis reports nitrosamine prevalence in small molecule drugs
Data from a paper on small molecule drugs has indicated nitrosamines in pharmaceuticals is likely more prevalent than originally expected.
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Nivolumab plus chemo provides one-year PFS in 94 percent lymphoma patients
A PD-1 checkpoint inhibitor plus chemotherapy is expected to become new standard of care for advanced Hodgkin lymphoma, based on Phase III trial data.
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Novel PAT system could enable adaptive process control
A paper has demonstrated a novel refractometry-based process analytical technology (PAT) system has potential for enabling adaptive process control in CGT manufacturing.
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NICE recommends oral migraine treatment for first time
An oral small molecule CGRP antagonist has been recommended for episodic migraines in National Institute for Health and Care Excellence (NICE) final draft guidance.
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Microfluidic device detects bacteria concentration from small sample volumes
A novel ultrasonic nanosieve enabled concentration of bacteria into a 1µL highly concentrated solution suitable for plate counting and PCR, according to research.
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Big Pharma inventory management trends revealed
Rapid growth of Big Pharma manufacturer inventories fail to prevent medicine shortages, a 2022 report has highlighted.
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European Commission approves haematology biosimilar
A marketing authorisation for a biosimilar to eculizumab has been granted by the European Commission for paroxysmal nocturnal haemoglobinuria.
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CHMP meeting highlights – May 2023
The Committee for Medicinal Products for Human Use (CHMP) recommended two new medicines for approval in its May meeting, including a neurosteroid for epileptic seizures.
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Nanoparticle HIV vaccine shows potential in trial
Positive first-in-human trial results have highlighted potential of a nanoparticle vaccine towards broadly neutralising against HIV.
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Benefits of blockchain in limiting counterfeit drug distribution
Smart contracts on blockchain could help prevent distribution of counterfeit drugs in the pharmaceutical supply chain, a review shows.
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First NICE-recommended treatment for chronic heart failure
In final draft guidance, the National Institute for Health and Care Excellence (NICE) has recommended dapagliflozin (Forxiga) for patients with heart failure regardless of ejection fraction.
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Digitalisation to boost quality management systems market
Pharma has been implementing process digitalisation and automated quality management systems to improve efficiency in drug manufacturing, a report says.
