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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…
Abbott’s Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices are given approval.
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.
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.
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.
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…
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.…
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.
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?
Following ongoing analysis and emerging scientific data, the FDA has taken away its emergency use authorisation for chloroquine and hydroxychloroquine, finding they are unlikely to be effective as COVID-19 treatments.
The FDA has approved Tivicay (dolutegravir) and Tivicay PD (dolutegravir) dispersible tablets to treat HIV in children at least four weeks old and weighing at least 3kg.
A newly released paper has revealed that the shortages of medications in the US at present will be increased further due to the COVID-19 outbreak.
Recarbrio (imipenem-cilastatin and relebactam) was approved for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).
The voluntary recall of Metformin Hydrochloride Extended Release Tablets, 500mg and 750mg is due to unacceptable levels of NDMA impurities.
Interim results showed Auxora plus standard of care improved time to recovery and reduced ventilator use in patients compared to standard of care alone.
