Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.

Company Updates

Tower Mains: Quality Assurance Services

If you’re looking for flexible, pragmatic, and cost-effective Quality Assurance services… look no further!

With over 200 years of combined experience, our team is on hand to provide you with Quality Assurance services when and where you need them – from short ad hoc projects to long-term QA collaborations across the regulatory and non-regulatory fields.

We are renowned for providing a tailored service designed to meet your requirements.

Our services include:

✔️ Audit: We have the expertise and capability to support your entire regulatory audit programme from early development to post-market surveillance, whether it’s a single audit or a global programme of audits.

✔️ Consultancy: Our team is ready to assist you with assessing your current state of compliance, identifying gaps, and developing effective strategies to address any areas of concern.

✔️ Quality Assurance support: We can help you establish and maintain robust quality management systems. By implementing best practices and quality control procedures, your organisation can effectively demonstrate compliance and inspection readiness.

✔️ Training: We offer training covering a wide range of topics relating to the regulatory industry.

If you would like to find out more or have any questions, please do not hesitate to contact us at info@towermains.com.

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Regulatory Updates

FDA Guidance Updates

Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics On 14th June, the US Food and Drug Administration (FDA) issued final guidance providing recommendations to assist industry in the development of oligonucleotide therapeutics under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and 21 CFR parts 312 and 314.

Diabetic Foot Infections: Developing Drugs for Treatment On 17th June, the FDA issued final guidance to assist sponsors in the clinical development of drugs for the treatment of diabetic foot infections without concomitant bone and joint involvement.

Facility Readiness: Goal Date Decisions Under GDUFA On 18th June, the FDA issued final guidance providing information to applicants on how FDA intends to assign a goal date based on a facility’s readiness for inspection as certified on Form FDA 356h, submitted as part of an original abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).

Enhancing Clinical Study Diversity On 18th June, the FDA issued the report from the Public Workshop to Enhance Clinical Study Diversity held in collaboration with the Clinical Trials Transformation Initiative (CTTI), which discussed strategies to increase broader representation in clinical trials.

MHRA Updates

MHRA performance data for assessment of clinical trials and established medicines On 14th June, the Medicines and Healthcare products Regulatory Agency (MHRA) issued updated performance metrics for assessment of marketing authorisations.

Field Safety Notices: 27 to 31 May 2024 On 14th June, the MHRA issued an updated list of field safety notices.

Class 3 Medicines Recall: Teva UK Limited, GoResp Digihaler, EL (24)A/23  On 18th June, the MHRA announced the recall alert, following notification from Teva UK Limited of its plans to withdraw from further sale all batches of GoResp Digihaler (budesonide and formoterol fumarate dihydrate) and the linked Digihaler App for commercial reasons.

Warfarin: be alert to the risk of drug interactions with tramadol On 20th June, the MHRA published advice, risks and details on reporting of adverse reactions to warfarin. Click to view source

Drug Safety Update: monthly PDF newsletter On 20th June, the MHRA issued the latest edition of the Drug Safety Update newsletter.

EMA Updates

EMA Management Board: highlights of June 2024 meeting On 14th June, the European Medicines Agency (EMA) issued the meeting highlights which included assessment of 2023 activities, fee updates, progress on shortages and challenges. Click to view source

Faster access to clinical trial information in Europe On 18th June, the EMA announced that revised rules for the Clinical Trials Information System (CTIS) become applicable. Key changes include earlier availability of information on authorised clinical trials, approximately 4,000 clinical trials with issued decisions are now publicly accessible through the CTIS search. The CTIS portal will add approximately 500 newly authorised clinical trials per month. The updated rules strike a balance between the transparency of information and the protection of commercially confidential information. Click to view source

Industry Updates

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Carboplatin and Paclitaxel as Treatment for Adult Patients with Primary Advanced or Recurrent Endometrial Carcinoma

On 17th June, Merck announced the FDA approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. This approval marks the third endometrial carcinoma indication and the 40th indication overall for KEYTRUDA in the U.S. The approval is based on data from the Phase III NRG-GY018 trial, data showed that the treatment regimen reduced the risk of disease progression or death by 40% in individuals who were mismatch repair. The treatment minimised this risk by 70 percent in patients.

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Cessation Therapeutics Announces Oral Presentation of Preliminary Findings from First-in-Human Study of Anti-Fentanyl Monoclonal Antibody, CSX-1004

On 19th June, Cessation Therapeutics, Inc., a clinical-stage biotechnology company advancing biologics that target substances of abuse, announced the presentation of preliminary data from its Phase 1a first-in-human study of CSX-1004, an investigational monoclonal antibody for prophylaxis against fentanyl-related overdose. Preliminary results indicate that CSX-1004 was generally well-tolerated across the dose range tested, with no dose-limiting toxicities.

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Neurotech Receives Priority Review of Biologics License Application (BLA) for NT-501 (revakinagene taroretcel) as a Treatment for Macular Telangiectasia Type 2 (MacTel)

On 20th June, Neurotech Pharmaceuticals, Inc., an innovator in sustained drug delivery for chronic retinal diseases, announced that the FDA determined that the Biologic License Application (BLA) for NT-501, an investigational encapsulated cell therapy for the treatment of MacTel, is sufficiently complete to permit a substantive review. The application has a prescription drug user fee act (PDUFA) goal date of December 17, 2024.

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Silence Therapeutics Announces Positive Topline 48-Week Data from Phase 2 Study of Zerlasiran in Patients with Elevated Lipoprotein(a)

On 20th June, Silence Therapeutics plc, a biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines, announced positive topline 48-week data from the ALPACAR-360 phase 2 study of Zerlasiran (SLN360) in 178 subjects with baseline lipoprotein(a), or Lp(a), levels at or over 125 nmol/L at high risk of atherosclerotic cardiovascular disease (ASCVD) events. Zerlasiran is a siRNA (short interfering RNA) designed to lower the body’s production of Lp(a), a key genetic risk factor for cardiovascular disease affecting up to 20% of the world’s population.

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Issue Number: WN00167

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