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US invests over $240 million into seven new COVID-19 diagnostic tests
The National Institutes of Health in the US has awarded contracts to seven biomedical companies to develop and manufacture COVID-19 diagnostics.
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US Food and Drug Administration (FDA)
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FDA proposes four APIs for bulk substances list for outsourcing facilities
Four APIs are being considered by the FDA for its bulk drug substances list for potential use by outsourcing facilities when compounding if there is a clinical need.
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Why pharma firms would benefit from a modular approach to working with product labelling
According to David Bennett, securing and building trust in the label, brand and process of a highly regulated industry player in a complex age will demand a new approach.
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Top 10 biopharma workplaces in the US
A Fortune report reveals the best 10 places to work in the US biopharmaceutical industry.
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Pfizer and BioNTech COVID-19 vaccine candidate enters Phase II/III trials
The BNT162b2 mRNA-based vaccine produced by Pfizer and BioNTech will enter Phase have II/III clinical trials to test its safety and efficacy against COVID-19.
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FDA orders update of label change for opioid pain medications
The FDA is requiring that labels for opioid pain medicine and medicines to treat opioid use disorder recommend healthcare professionals discuss the availability of naloxone with patients to reduce overdoses.
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Study suggests some excipients in common drugs are biologically active
Preliminary research has revealed that some excipients used in common medications may interact with important human enzymes and receptors.
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New MET ONE 3400+ air particle counter automates routine environmental monitoring for GMP cleanroom compliance
Integrated electronic SOPs and maps are “all in the box” to help reduce errors.
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FDA grants Fast Track designation to two COVID-19 vaccines
Two investigational SARS-CoV-2 vaccine candidates, BNT162b1 and BNT162b2, currently in clinical trials have been granted Fast Track designation by the FDA.
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Global distribution partnership established for Strontium89
Q Biomed entered into a Named Patient Programme distribution agreement for Strontium89, a non-opioid metastatic bone cancer pain drug.
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India approves remdesivir for restricted emergency use in COVID-19 patients
The Drug Controller General of India (DCGI) approved remdesivir lyophilised powder for emergency use in patients hospitalised with severe COVID-19.
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Expanded access for compassionate use of remestemcel-L in COVID-19 infected children
US expands access to remestemcel-L for compassionate use in COVID-19 infected children with complications of multisystem inflammatory syndrome.
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How to start up an ATMP clinical trial
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues or cells. They offer revolutionary opportunities for the treatment of disease and injury; however, developers face a complex regulatory and developmental landscape to bring ATMPs to market. Here Magdalena Czarnecka offers guidance and advice on effectively initiating an ATMP…
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FDA approves new heart rhythm devices featuring Bluetooth connectivity and continuous remote monitoring
Abbott’s Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices are given approval.
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FDA approves new administration route for Phesgo to treat breast cancer
The FDA has given approval to Phesgo for injection under the skin to treat HER2-positive breast cancer, meaning it can be administered at home by a healthcare professional.
