Regulations, Notices & Guidance

• June 10, 2024: The FDA announced the “Emerging Drug Safety Technology Meetings; Program Announcement.” The Center for Drug Evaluation and Research (CDER) introduced the Emerging Drug Safety Technology Meeting (EDSTM) program, managed by the newly formed CDER Emerging Drug Safety Technology Program (EDSTP). This program offers approved applicants and other relevant parties involved in industry pharmacovigilance (PV) activities the chance to discuss their use of Artificial Intelligence (AI) and other emerging technologies in PV with CDER staff. The initial phase aims to promote mutual learning and discussion on the application of these technologies, including validation and verification of models. The EDSTP is focused on using AI in PV for postmarket activities, contributing to CDER’s broader efforts to enhance the use of innovations like AI throughout the drug product lifecycle.
  
• June 11, 2024: The FDA issued a notice titled “Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under the Federal Food, Drug, and Cosmetic Act; Notice; Request for Information and Comments; Reopening of the Comment Period.” This notice seeks to gather information on the status of trading partners’ systems for enhanced drug distribution security, as mandated by the FD&C Act. The comment period for the notice initially published on November 20, 2023, has been reopened to allow for additional input.
  
• June 11, 2024: The Department of Health and Human Services (HHS) released a notice titled “Development of Public Health Vaccine and Prevention Educational Campaigns Involving Community Health Workers.” The Office of Minority Health (OMH) is requesting feedback on involving community health workers to improve cultural competency in educational campaigns on public health vaccines and prevention, including for influenza and COVID-19.
  
• June 14, 2024: The FDA proposed an exemption titled “Requirements for Additional Traceability Records for Certain Foods; Proposed Exemption for Cottage Cheese Regulated by the National Conference on Interstate Milk Shipments Grade ‘A’ Pasteurized Milk Ordinance.” This exemption, in accordance with the FDA Food Safety Modernization Act, would apply to certain cottage cheese products.
  
• June 14, 2024: The FDA issued final guidance titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.” This guidance provides recommendations for developing oligonucleotide therapeutics, addressing clinical pharmacology considerations such as QT interval prolongation, immunogenicity risk assessment, the impact of hepatic and renal impairment, and drug-drug interaction assessments. It finalizes the draft guidance issued on June 27, 2022.
  
• June 14, 2024: The Food and Drug Administration (FDA) has released the final guidance for industry titled “Diabetic Foot Infections: Developing Drugs for Treatment.” This guidance aims to support sponsors in the clinical development of drugs specifically for treating diabetic foot infections (DFI) that do not involve bone and joint complications. This final guidance supersedes the draft version issued on October 17, 2023.
  
• June 18, 2024: Revised rules for Clinical Trials Information System (CTIS) become applicable for Faster access to clinical trial information in Europe. The European Medicines Agency (EMA) has updated the CTIS public portal in line with the update to its transparency rules. Under the new rules, approximately 4,000 clinical trials with issued decisions are now publicly accessible through the Clinical Trials Information System (CTIS).
  
• June 20, 2024: The Food and Drug Administration (FDA or Agency) announced the availability of a draft guidance for industry entitled “Considerations for Demonstrating Interchangeability with a Reference Product: Update.” This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. FDA issued the guidance for industry Considerations in Demonstrating Interchangeability With a Reference Product (May 2019) (Interchangeability Guidance) before receiving and reviewing any biologics license applications (BLAs) submitted under section 351(k) of the Public Health Service Act (PHS Act) for a proposed interchangeable biosimilar.  As described in this draft guidance, applicants for proposed interchangeable products may choose to provide an assessment of why the comparative analytical and clinical data provided in the application or supplement support a showing that the switching standard set forth in section 351(k)(4)(B) of the PHS Act has been met.
  

FDA Promotes Clinical Trial Innovation

The FDA is highlighting significant advancements in clinical trial innovation driven by breakthroughs in science and technology. These innovations are paving the way for novel treatment options and are rooted in a deeper understanding of disease, human biology, and the potential of new technologies. In celebration of Clinical Trials Day, the FDA reflects on the progress made in enhancing clinical research design and execution. This progress is a collective achievement made possible by clinical trial participants and their families, healthcare professionals, medical product developers, federal partners, and the broader clinical research community. Read more.

Two new advice pilots to improve clinical trials in Europe

The Accelerating Clinical Trials in the EU (ACT EU) initiative is today launching two advice pilots aimed at improving the quality of applications for clinical trials, the foundation for the development of safe and effective medicines in Europe. Read more.

U.S. clinical trials begin for twice-yearly HIV prevention injection

Two clinical trials have launched to examine a novel long-acting form of HIV pre-exposure prophylaxis (PrEP) in cisgender women and people who inject drugs. The mid-stage studies will assess the safety, acceptability, and pharmacokinetics (how a drug moves through the body) of lenacapavir, an antiretroviral drug administered by injection every six months. Read more.

Nurix Therapeutics Presents Positive Results from Ongoing Clinical Trial of NX-5948 in Patients with Relapsed Refractory CLL at the EHA2024

Nurix Therapeutics, Inc., a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the presentation of updated clinical data for NX-5948, an orally bioavailable degrader of Bruton’s tyrosine kinase (BTK), being evaluated in an ongoing Phase 1a/b clinical trial in adults with relapsed or refractory B-cell malignancies, including CLL and non-Hodgkin lymphoma (NHL). Read more.

FDA Approves Pneumococcal Vaccine Designed Specifically for Adults

FDA approved the vaccine, Capvaxive, for the following indications and use:

• for the prevention of invasive disease caused by 22 different serotypes of Streptococcus pneumoniae covered by the vaccine for individuals 18 years of age and older.
• for the prevention of pneumonia caused by 21 different serotypes of Streptococcus pneumoniae covered by the vaccine for individuals 18 years of age and older.

Streptococcus pneumoniae, also known as pneumococcus, are bacteria that can infect the lungs causing pneumonia, but when they infect the blood (bacteremia) or the coverings of the brain or spinal cord (meningitis) it is called invasive pneumococcal disease. It can be a very serious disease. The vaccine is manufactured by Merck Sharp & Dohme LLC. Read more.

FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma

The FDA approved pembrolizumab (Keytruda, Merck) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma. Adverse reactions associated with pembrolizumab and chemotherapy were generally similar to those previously reported for pembrolizumab or chemotherapy with the exception of a higher incidence of rash. Read more.

FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer

The Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) with carboplatin plus paclitaxel followed by single-agent durvalumab for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). Read More.

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Lambda Therapeutic Research

Lambda Therapeutic Research stands at the forefront of the global Clinical Research Organization (CRO) landscape, headquartered in Ahmedabad, India, and extending its impact across Mehsana (India), Warsaw (Poland), London (UK), Toronto (Canada), Pittsburgh (USA), and Las Vegas (USA).

Our unwavering mission revolves around providing comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. Lambda has consistently raised the bar in the Clinical Research sector, achieving milestones through both organic growth and strategic acquisitions. In 2019, we strategically bolstered our North American presence by acquiring Novum Pharmaceutical Research Services, a distinguished 50-year-old CRO. Operating under the unified brand of Novum Pharmaceutical Research Services in North America, Lambda reinforces its position as a key player in the global CRO market.

Prioritizing secure IT infrastructure and automation, Lambda ensures timely project delivery, adhering to global regulatory standards. Our outstanding regulatory track record is underscored by over 60 successful international inspections and audits conducted by esteemed authorities, including the USFDA, EMEA, MHRA, EU member states, and other global bodies over the past five years.

Lambda’s dedication to excellence has garnered widespread recognition, with accolades such as the distinction of ‘Best Indian CRO’ by Frost & Sullivan (USA) and the prestigious title of ‘Great Indian Workplace’ by UBS Transformance. In the latest achievements, Lambda Therapeutic Research proudly received the ‘Regulatory Excellence’ Award at the CPhI Awards 2023 and the ‘Industry Partner of the Year’ Award at the Global Generics & Biosimilar Awards 2023. These honors reflect our ongoing commitment to regulatory compliance, industry leadership, and impactful collaborations within the pharmaceutical and clinical research sectors.