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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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US Food and Drug Administration (FDA)
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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?
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FDA revokes emergency use authorisation for chloroquine and hydroxychloroquine as COVID-19 treatments
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.
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New HIV drug formulation approved by FDA to treat paediatric patients
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.
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Study suggests current drug shortages in US will be worsened by COVID-19 pandemic
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.
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FDA approves Recarbrio for treatment of bacterial pneumonias
Recarbrio (imipenem-cilastatin and relebactam) was approved for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).
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Amneal recalls Metformin Hydrochloride Extended Release Tablets to consumer level
The voluntary recall of Metformin Hydrochloride Extended Release Tablets, 500mg and 750mg is due to unacceptable levels of NDMA impurities.
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Interim analysis indicates Auxora™ is effective in severe COVID-19 pneumonia patients
Interim results showed Auxora plus standard of care improved time to recovery and reduced ventilator use in patients compared to standard of care alone.
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Global regulatory authorities COVID-19 policy and regulations meeting
Global pharma regulators met to discuss measures to ensure supply continuity, flexible regulatory policies and their expectations for COVID-19 clinical trials.
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COVID-19 convalescent plasma therapy shown to be safe and effective
Scientists reveal 76 percent of critically ill trial participants treated with convalescent plasma are recovering, with almost half now discharged from hospital.
