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Apellis attempts to clear the air around Syfovre safety as eye drug launch gains steam

Fierce Pharma

For Apellis Pharmaceuticals, the emergence of rare but serious side effects has cast a pall over the launch of the company’s geographic atrophy med Syfovre. While touting the “strong commercial execution” of Syfovre’s launch, Apellis’ CEO Cedric Francois, M.D.,

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UK agency pilots biobank to study links between genetics and drug side effects

Pharmaceutical Technology

The biobank will work in parallel with the MHRA’s Yellow Card website, which is used for reporting adverse events and side effects caused by medicines and medical devices, per the 25 May announcement. According to the press release, the MHRA will be the first drug safety regulator in the world to pilot such a biobank.

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Navigating the Regulatory Environment of Pharmaceutical Marketing: Balancing Patient Safety and Industry Innovation

Pharma Marketing Network

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

Safety 52
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US FDA approves Acadia Pharmaceuticals’ Rett syndrome therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Acadia Pharmaceuticals CEO Steve Davis said: “Today marks an important milestone for the Rett community and Acadia.

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Cerner Enviza and FDA partner to develop AI drug safety tools

Pharmaceutical Technology

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies. During the two-year project, the companies will assess the mental health side effects of the asthma drug, montelukast.

Safety 59
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UK MHRA approves Pfizer-BioNTech’s bivalent Covid-19 booster

Pharmaceutical Technology

The approval came after the vaccine was found to satisfy the standards of safety, quality and effectiveness of the medicines regulator in the UK. This comprises wide-ranging data on the safety and effectiveness of the initial vaccine, clinical findings from the bivalent original/omicron BA.1

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mRNA therapy could provide intracellular protein replacement for rare disease

European Pharmaceutical Review

These interim data indicate early signs of potential clinical benefit with mRNA-3927, and importantly also demonstrate that mRNA-3927 has infrequent treatment-limiting side effects. The post mRNA therapy could provide intracellular protein replacement for rare disease appeared first on European Pharmaceutical Review.