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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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EMA’s PRAC confirms recommendation to withdraw amfepramones

European Pharmaceutical Review

The Pharmacovigilance Risk Assessment Committee (PRAC) , the European Medicines Agency (EMA)’s safety board, has confirmed it recommends the withdrawal of Marketing Authorisation Application (MAA) for amfepramone obesity medicines, to prevent more patients being at risk of serious side effects. Risks of amfepramones.

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Teva touts safety profile of once monthly schizophrenia therapy

Pharmaceutical Technology

New safety data shows an absence of post-injection syndrome, a rare and serious side effect of long-acting olanzapine.

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Cell therapies might revolutionise treatment for multiple sclerosis patients

Pharmaceutical Technology

While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections.

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FDA gives go-ahead on labelling for Cumberland’s therapy for fever and pain in infants

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. The trial has confirmed its safety and efficacy for the treatment of pain and fever in the targeted patients. All but one patient in the trial received a single dose of Caldolor.

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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.