Tower Mains Weekly Newsletter
Company Updates
Do you want to further your knowledge in conducting laboratory investigations or understand more about the processes for planning, conducting, and reporting audits and inspections? With spaces available, it’s not too late to book one of our June courses…
? 12th June: Conducting Laboratory Investigations, led by Erin Bell and Anna Lothian
? 13th-14th June: Research Audit and Inspection, led by Andrew Waddell
All our training Is led by an expert in the field, who use their experience and expertise to bring their topic alive with information, and real-life examples.
Each course can be booked on an individual or group basis. Find further information on each course on our website, or if you are interested in discussing your specific training requirements or if you wish to book for your group or organisation, please don’t hesitate to contact training@towermains.com.
Regulatory Updates
EMA publishes latest CTIS newsflash
On 5th May, the European Medicines Agency (EMA), published the latest Clinical Trials Information System (CTIS) newsflash providing key updates on CTIS and links to useful reference materials. The data refers to the period from 25th April to 1st May 2023.
MHRA guidance updates
- Apply for manufacturer or wholesaler of medicines licences: On 5th May, the Medicines and Healthcare products Regulatory Agency (MHRA) updated fee information in its guidance on applying for manufacturer or wholesaler of medicines licences. Click to view source
FDA guidance updates
- Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other HighRisk Drug Components for Diethylene Glycol and Ethylene Glycol. On 8th May, final guidance was published to alert pharmaceutical manufacturers, compounders, re-packers, and suppliers to the potential public health hazard of glycerin and other high-risk drug components contaminated with diethylene glycol (DEG) or ethylene glycol (EG). The FDA has received and continues to receive reports about fatal poisonings of consumers who ingested drug products in a liquid dosage form (such as cough, allergy, analgesic, and antiemetic drug products) that were manufactured with DEG- or EG-contaminated components. Click to view source
Industry Updates
Kry launches digital care pathways to support people with chronic respiratory conditions
On 3rd May, Kry, a leading digital healthcare provider, announced it is launching several digital-first pathways to transform approaches for early diagnosis, prevention and management for people living with chronic respiratory diseases (CRDs) such as asthma, COPD, and lung cancer. The new solutions will improve access and continuity of care for millions of people across Europe living with chronic conditions.
EMA’s Emer Cooke issues statement on COVID-19 pandemic following WHO declaration
On 8th May, following the declaration of the end of the COVID-19 pandemic by the World Health Organisation (WHO), the Executive Director of the European Medicines Agency (EMA), Emer Cooke, issued a statement on the end of the pandemic. She said: “It was science that brought us the vaccine breakthroughs, it was science that freed us from the lockdowns, and it was scientists who provided factual information when it mattered most.” To read more, click here.
Spikevax COVID-19 vaccine is authorised for individuals aged 6 months to 5 years
On 9th May, the MHRA announced it had authorised Spikevax, the COVID-19 vaccine from Moderna, for use in children aged 6 months to 5 years. The vaccine was authorised in this new age group after it has been found to meet the agency’s standards of safety, quality, and effectiveness, with no new safety concerns identified. This followed advice from the Commission on Human Medicines, which carefully reviewed the evidence.
AstraZeneca’s Farxiga approved in the US for heart failure
On 9th May, AstraZeneca announced the FDA has approved Farxiga to reduce the risk of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) visits in adults with HF following positive results from the DELIVER Phase III trial. Farxiga is a first-in-class, oral, once-daily SGLT2 inhibitor and was previously approved in the US for adults with HF with reduced ejection fraction (HFrEF).
Patients asked to return Emerade 300 and 500 microgram adrenaline pens
On 9th May, the MHRA announced that patients, or carers of patients, who carry Emerade 300 or 500 microgram adrenaline auto-injector pens should return them to their local pharmacy and contact their GP to obtain a prescription for an alternative brand.
EMA and European medicines regulatory network lift COVID-19 business continuity status
On 10th May, the EMA and the European medicines regulatory network announced they are ending their respective COVID-19 business continuity measures after successfully handling the operational challenges posed by the pandemic. The EMA is gradually resuming activities that were suspended or reduced, including the planned restart of clinical data publication for all new active substances later this year. EMA’s workplan for 2023 to 2025 outlines its focus over the next two years.
AstraZeneca’s Ultomiris approved in the EU for NMOSD
On 10th May, AstraZeneca announced its Ultomiris has been approved in the EU as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the CHAMPION-NMOSD Phase III trial.
Issue Number: WN00111
Would you like a personal copy of the Tower Mains Weekly Newsletter directly to your mailbox each month? Just send an email to info@tower mains.com with the subject “Weekly Newsletter Please.”