Tower Mains Weekly Newsletter
EC approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for endometrial cancer
The European Commission (EC) has granted conditional marketing authorisation for GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer.
FDA and CDC lift recommended pause on Janssen COVID-19 vaccine use following thorough safety review
On 23rd April, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) voted to resume the use of the Johnson & Johnson (Janssen) COVID-19 vaccine in persons 18 years of age and older in the U.S. This follows a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunisation Practices.
FDA authorises marketing of device to facilitate muscle rehabilitation in stroke patients
On 23rd April, the FDA authorised the marketing of a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. The Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) is a Brain-Computer-Interface (BCI) device that assists in rehabilitation for stroke patients with upper extremity — or hand, wrist, and arm — disability.
Increase in manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna
On 23rd April, the EMA’s (European Medicines Agency) Human Medicines Committee (CHMP) announced it has adopted two important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. These are the approval of the increase in batch size and associated process scale-up at Pfizer’s vaccine manufacturing site in Belgium, and the approval of a new filling line at Moderna’s finished product manufacturing site in Spain.
Selumetinib recommended for approval as first medicine for paediatric patients with neurofibromatosis type 1
On 26th April 2021, it was announced that AstraZeneca and MSD’s selumetinib has been recommended for conditional marketing authorisation in the European Union (EU) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged three years and above.
FDA issues guidance on submitting Veterinary Adverse Event Reports
The FDA issued guidance on filling out Form FDA 1932, “Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.” As required by FDA regulations, an applicant must report adverse drug experiences (ADEs) and product/manufacturing defects on Form FDA 1932. Firms named on the label as a manufacturer, packer, or distributor may also use this form.
EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in EU
On 26th April 2021, the EMA and the European Centre for Disease Prevention and Control (ECDC) kicked off a new initiative aimed at strengthening post-marketing monitoring of the safety, effectiveness, and impact of COVID-19 vaccines in the European Union (EU) and the European Economic Area (EEA). With the ongoing authorisation and rollout of several COVID-19 vaccines in the EU, jointly coordinated, large-scale, EU-wide effectiveness and safety studies will closely monitor how these vaccines perform.
Issue Number: WN0008