Tower Mains Weekly Newsletter
Regulatory Updates
MHRA extends consultation on how it communicates with healthcare professionals to improve medicines and medical devices’ safety
On 6th January, the Medicines and Healthcare products Regulatory Agency (MHRA) extended the deadline for the consultation on how the agency communicates with healthcare professionals. It will now close at 11:45pm on 31st January 2023.
MHRA updates guidance on GCP for clinical trials
On 11th January, the MHRA updated its guidance on how to show MHRA you’re meeting good clinical practice (GCP) standards and what to expect from an inspection
FDA issues final guidance on non-clinical testing, clinical studies, and labelling to support premarket submissions for PBM devices
On 12th January, the US Food and Drug Administration (FDA) issued draft guidance providing the agency’s recommendations on non-clinical testing, clinical studies, and labelling to support premarket submissions for photobiomodulation (PBM) devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of PBM device submissions.
Industry Updates
EMA publishes agenda for upcoming CTIS event
On 6th January, the European Medicines Agency (EMA) published the agenda for the upcoming virtual public CTIS event “CTIS Event on Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023.” The event will be held on the 20th of January at 10am (CET).
FDA grants accelerated approval for Alzheimer’s treatment
On 6th January, the FDA approved Leqembi via the Accelerated Approval pathway for the treatment of Alzheimer’s. Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease. These medications represent an important advancement in the ongoing fight to effectively treat the disease.
AstraZeneca enters agreement to acquire CinCor Pharma
On 9th January, AstraZeneca announced it has entered into a definitive agreement to acquire CinCor Pharma, Inc., a US-based clinical-stage biopharmaceutical company, focused on developing innovative treatments for resistant and uncontrolled hypertension as well as chronic kidney disease. The acquisition will boost AstraZeneca’s cardiorenal pipeline by adding CinCor’s candidate drug, baxdrostat (CIN-107), an aldosterone synthase inhibitor (ASI) for blood pressure lowering in treatment-resistant hypertension.
FDA issues two warning letters to leading manufacturer of endoscopes
On 10th January, the FDA’s Center for Devices and Radiological Health (CDRH) announced it has issued two warning letters to a leading manufacturer of endoscopes and one of its subsidiaries following facility inspections. The warning letters concern violations related to medical device reporting (MDR) requirements and quality system regulations for endoscopes and endoscope accessories, including surgical and gastrointestinal endoscopes and automated endoscope reprocessors.
FDA and Health Canada announce joint eSTAR pilot
On 10th January, the FDA and Health Canada (HC) announced a joint pilot to evaluate the use of a single eSTAR, an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. The pilot will test the use of a single eSTAR submitted for the following medical device submissions:
- HC applications:
- Class III and Class IV
- FDA submissions:
- 510(k)
- De Novo
- Premarket Approval (PMA)
Pheno Therapeutics announces worldwide license with UCB for preclinical program for neurodegenerative disease
On 11th January, Pheno Therapeutics Limited, a biotechnology company focused on the discovery and development of small molecule therapeutics that promote remyelination for the treatment of neurological diseases such as multiple sclerosis, announced it has entered into an exclusive worldwide license agreement with UCB. The agreement grants the company access and rights to develop, manufacture, and market a preclinical-stage program of novel small molecules designed to promote remyelination.
EMA issues latest Human Medicines Highlights newsletter
On 11th January, the EMA published the January issue of its Human Medicines Highlights newsletter.
Issue Number: WN00094
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