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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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US Food and Drug Administration (FDA)
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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.
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Five patent issues that European biosimilar developers should consider before entering the US market
As patents on originator biologic medicines begin to expire, there are growing opportunities for biosimilars to enter the market at lower prices. Joshua Whitehill, Natasha Daughtrey and Grace Truong discuss key aspects of US patent law that European developers should consider before entering the American market.
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The many advantages of repurposing existing drugs
Repurposing existing drugs can be attractive as the process is often less risky, more cost effective and can be undertaken in less time. This article discusses the logic behind drug repurposing and the approaches that are currently being explored.
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Life sciences M&A activity during the global pandemic
COVID-19 has severely disrupted the lives of many people around the world. In this article, corporate partner Theo Godfrey and competition partner Russell Hoare from the life sciences team at law firm CMS Cameron McKenna Nabarro Olswang LLP consider some issues related to COVID-19 that have impacted life sciences merger…
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Collaborating in the fight against COVID-19
The founder of Apple Steve Jobs once said, “Great things in business are never done by one person; they’re done by a team of people.” This is true now more than ever as medical device manufacturers and companies from a range of industries work together in the fight against COVID-19.…
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GSK recalls three lots of children’s cough medicine in US
GlaxoSmithKline has voluntarily recalled two lots of Children's Robitussin® Honey Cough and Chest Congestion DM and one lot of Children's Dimetapp® Cold and Cough in the US.
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Radical innovation occurs when pharma looks outside its own world
Pharma executives are committed to bringing drugs to market to improve the lives of patients but is the industry too introspective to be truly innovative?
