International – ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5

Historically, the regulatory requirements for the assessment of the carcinogenic potential of pharmaceuticals in the three regions (E.U., Japan, U.S.) provided for the conduct of...

Europe – EMA grants Bavarian Nordic access to PRIME scheme for RSV vaccine candidate

The EMA launched its PRIME scheme to enhance support and enable accelerated assessment for the development of medicines that target an unmet medical need....
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

USA – FDA warns pharmacy benefit company for distributing unapproved foreign drugs

The US Food and Drug Administration (FDA) recently warned pharmacy benefit firm ElectRx for substituting prescription drugs ordered by its customers with drugs sourced...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – UK’s MHRA approves first drug under international recognition procedure

The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently approved Amgen’s bone cancer drug Xgeva (denosumab), the first drug submitted through the international...

UK – BMS’ Sotyktu gets NICE green light for NHS use

The therapy becomes an option for moderate-to-severe plaque psoriasis in certain adults Bristol Myers Squibb (BMS) has announced that the National Institute for Health and...

Europe – Global regulators agree on way forward to adapt COVID-19 vaccines to emerging...

International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and the need for and strategy to update their composition...

USA – Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry

This guidance provides recommendations to assist industry and other parties involved in the development of antibody-drug conjugates (ADCs) with a cytotoxic small-molecule drug or...

USA – Patients with incurable cancer should be included in trials for new therapies

The US Food and Drug Administration (FDA) has issued final guidance on the inclusion of patients with incurable cancers in clinical trials for investigational...

Europe – New features further strengthen Priority Medicines scheme (PRIME)

EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of...

USA – FDA finalizes umbrella trial guidance for cell and gene therapies

The US Food and Drug Administration (FDA) laid out its recommendations for sponsors to study multiple versions of a cellular or gene therapy in...