The US Food and Drug Administration (FDA) has granted the first approval of an Epstein–Barr virus-related mRNA therapeutic cancer vaccine. authorisation of the [mRNA therapeutic cancer vaccine by] the FDA represents a significant advance in cancer treatment” Biotech company WestGene has received the investigational new drug (IND) approval for its mRNA vaccine, WGc-043. This authorisation of the immunotherapy from the FDA “represents a significant advance in cancer treatment”, stated WestGene. The FDA’s decision means that patients with advanced Epstein–Barr virus-related cancers will be giv ..read more

A paper investigating spectroscopy challenges in biosimilar analysis has suggested a method for preparing aqueous protein solutions that “yields reproducible circular dichroism spectra”. The paper noted that it is important to understand the interaction between surfactants and proteins, to ensure “protein formulations are stable during storage and transportation”. The authors explained that while circular dichroism spectroscopy is used to determine different characteristics of proteins in biosimilars, such as its structure and folding sequence, “protein aggregation due to its interaction with ..read more

the success of CGT depends on a robust and reliable supply chain” Cell and gene therapies (CGT) offer a revolutionary approach to the treatment, prevention and potential cure of diseases. These advanced medical treatments provide hope for patients suffering from conditions that have historically been poorly understood and widely considered incurable, including genetic diseases and cancers. A recent survey1 of healthcare industry professionals showed that CGT is expected to have the most significant impact on the pharmaceutical industry in 2024. However, the success of CGT depends on a ..read more

A study has reported the application of light-assisted drying (LAD) to large-volume samples (250 μL) that are closer to those used for doses of vaccines and therapeutics. According to the authors of the paper, this is “a five-fold increase in volume compared to previous studies”. While lyophilisation (freeze drying) is most widely adopted method for storing proteins, temperature-controlled storage can be time-consuming and costly, especially considering the thermal sensitivity of some biologics, the authors noted. While previous studies have demonstrated that LAD can prepare small-volume ..read more

Withdrawal of the marketing authorisation for the COVID-19 vaccine (ChAdOx1-S [recombinant]) Vaxzevria (SRD) by the European Medicines Agency on 7 May, follows a request by AstraZeneca. “Global demand for all COVID vaccines is now much lower and overall supply exceeds demand. This is in marked contrast to the early part of the pandemic when supply was limited and distribution very limited, especially in poorer countries. Case for withdrawing the AstraZeneca vaccine there is probably no commercial case for continuing to manufacture and distribute the vaccine and I think this is like ..read more

Regulatory agencies in the US across three sectors: agriculture and environmental, have produced a joint plan to “update, streamline, and clarify” regulations and oversight mechanisms for biotechnology products. The plan, developed by the US Environmental Protection Agency (EPA), the US Food and Drug Administration (FDA), and the US Department of Agriculture (USDA), helps to address US President Biden’s related goals, including and improving the “transparency, predictability, coordination, and efficiency” of the biotechnology regulatory system, as detailed in the Executive Order 14081 ..read more

What is dissolution? Dissolution tests determine the rate and extent of release of the drug substance from a drug product under specific conditions and specific times. Dissolution tests help to evaluate bioavailability of drug substances and are part of release criteria during quality control testing. Dissolution tests are also undertaken during product development to study batch-to-batch consistency, evaluate stability of the product and to assure compliance with regulations. The regulatory agencies use the dissolution test to provide a quality connection from a pivotal bio batch to the comme ..read more

New data from a Phase IIa trial in moderate-to-severe atopic dermatitis has demonstrated that a novel monoclonal antibody (mAb) could facilitate dosing every 12 weeks for induction therapy. This is due to a 31-day half-life at anticipated therapeutic dose levels, Inmagene Biopharmaceuticals confirmed. Humanised anti-OX40 IgG1 mAb IMG-007 works via a silenced antibody-dependent cellular cytotoxicity (ADCC) function, Inmagene explained. What did the interim data for IMG-007 demonstrate? The clinical trial is evaluating the mAb IMG-007 in adults with moderate-to-severe atopic dermatitis who have ..read more

Although we have yet to understand the human microbiome and its role in disease fully, the scientific evidence on the efficacy of complex live biotherapeutic products (LBPs) in modulating the microbiome is striking, as evidenced by the approval of the first two commercial donor-derived products, Rebyota and VOWST, in 2022 and 2023, respectively. What are the top three trends in microbiome-based therapeutic development? Bacterial LBPs have demonstrated the potential to modulate the human microbiome and positively alter this highly complex and interactive community.1 Today’s advances in pr ..read more

Two new formulations cabotegravir (cabotegravir extended-release injectable suspension and tablets) have been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). The treatment consists of Apretude 30mg film-coated tablets and Apretude 600mg prolonged-release suspension for injection. These treatments are indicated for the prevention of sexually transmitted HIV-1 infection — pre-exposure prophylaxis (PrEP) in adults and adolescents weighing at least 35kg with a higher infection risk, MHRA confirmed. About cabotegravir Cabotegravir long-acting (LA) for PrEP is ..read more