regulatory

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Close up view of young woman holding ginseng vitamins and minerals pills in hand with capsule bottle on table. High angle view

Pfizer and Flynn appeal £70m epilepsy drug fines in UK

Drugmakers Pfizer and Flynn Pharma have formally launched an appeal against a £70 million ($84 million) fine levied by the UK Competition and Markets Authority (CMA) for overcharging the NH

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Ipsen faces yet another delay for rare disease drug in US

Less than a week before Ipsen's palovarotene was due to go in front of an FDA advisory committee, the meeting has been called off following a request by the regulator for more data.

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Takeda dengue vaccine receives positive CHMP opinion

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Takeda GmbH’s live, attenuated dengue tetravalent vaccine, Qdenga

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US clears Omicron shots from Pfizer, Moderna for children

The US authorities have authorised use of two bivalent COVID-19 booster vaccines from Pfizer/BioNTech and Moderna – targeting the BA.4 and BA.5 subvariants of Omicron – for use in children

Views & Analysis

The criticality of compliance

Remaining compliant is imperative to the life sciences industry, so adhering to regulatory requirements is mandatory.

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Why research into the mental health impact of a rare disease diagnosis is long overdue

Wellcome funds work on regulating digital mental health tool...

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy?

Pfizer and Flynn appeal £70m epilepsy drug fines in UK

Ipsen faces yet another delay for rare disease drug in US

Takeda dengue vaccine receives positive CHMP opinion

US clears Omicron shots from Pfizer, Moderna for children

The criticality of compliance

Wellcome funds work on regulating digital mental health tool...

The long-delayed promise of the microbiome, with Sam Possemi...

How to meet your physicians where they are online

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