Four new medicines approved by EMA

The European Medicines Agency (EMA) has approved four new medicines at its January meeting, getting 2023 off to a low-key start. The Agency’s key human medicines committee (CHMP) recommended granting a marketing authorisation for Sotyktu (deucravacitinib) – a medicine for the treatment of moderate to severe plaque psoriasis in adults, a skin disease causing red, scaly patches. The committee adopted positive opinions […]

EMA sets up expert group on medicine innovation

The European Medicines Agency (EMA) has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of patients in the EU. These include new technologies, digitalisation, novel materials and novel devices. The role of the QIG is to ensure that the European medicines regulatory network keeps pace with innovation, […]

European Medicines Agency steps up effort on superbugs

The number of people in Europe dying because of antimicrobial resistant (AMR) infections has hit an all time high, according to new EU data. An estimated 35,000 Europeans die every year, while drug-resistant infections are responsible for €1.5 billion extra healthcare costs and productivity losses. The European Medicines Agency (EMA), the EU’s medicines watchdog, says it is playing its part […]

CHMP recommends Opdivo for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma – BMS

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression greater than 1% who are at a high risk of recurrence after undergoing radical resection. The European Commission (EC), […]

Boost for global access to diabetes treatments

Two established diabetes medicines have been given the green light for use outside the EU – even when stored at higher temperatures – under the EU Medicines for All (EU-M4All) scheme. This procedure allows the European Medicines Agency (EMA) to assess the quality, safety and efficacy of medicines that address an unmet medical need or a public health concern outside […]

EU experts cautious on fourth dose of COVID-19

It is ‘too early’ to consider using a fourth dose of mRNA COVID-19 vaccines in the general population, according to the European Medicines Agency (EMA) and the European Centre for Disease Prevention & Control (ECDC). However, experts from both agencies agreed that a fourth dose – or second booster shot – can be given to adults 80 years of age. […]

EMA gives green light for six new medicines

A total of 67 new medicines have been approved by the European Medicines Agency (EMA) in 2021. This includes six new products backed by the watchdog’s key advisory body, the Committee on Human Medicinal Products (CHMP). The newly approved products are: Trodelvy (sacituzumab govitecan) for the treatment of unresectable or metastatic triple-negative breast cancer. Rybrevant (amivantamab), conditionally approved for the treatment of […]

EMA boost for COVID-19 vaccine production

The European Medicines Agency has approved additional manufacturing capacity for two companies producing vaccines against COVID-19. The news comes as European countries continue to roll out vaccines amid rising rates of the delta variant of the virus. The medicines watchdog, which has played a leading role in approving vaccines and inspecting manufacturing facilities, gave the green light to a site […]

EMA gives green light for 8 new medicines

The European Medicine Agency’s key decision-making committee on human medicines (CHMP), has recommended eight medicines for approval at its June meeting.  The Committee recommended granting a conditional marketing authorisation for Abecma (idecabtagene vicleucel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three previous therapies, and whose cancer has worsened since receiving the last treatment. […]

EMA reports big wins for small pharma

The success rate for marketing authorisation applications for small and medium-sized enterprises (SMEs) has doubled between 2016 and 2020, according to the European Medicines Agency (EMA). In 2016, 40% of medicines with an SME applicant received a positive opinion. In 2020, the number had increased to 89%. In 2020 alone, SMEs were behind 16 recommendations for approval of a new […]