New trial results for GSK’s oral gepotidacin, a potential first-in-class oral antibiotic, has shown that it was non-inferior with 92.6 percent success rates in patients with uncomplicated urogenital gonorrhoea (GC). “These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide” In the pivotal EAGLE-1 Phase III trial, comparatively, intramuscular ceftriaxone (500mg) plus oral azithromycin (1,000mg) combined therapy, a leading combination treatment regimen for gonorrhoea, provided success rates of 91.2 percent. Gepotida ..read more

Researchers have proposed a “promising” UV spectroscopic approach for quantifying both formoterol and beclomethasone formulations in pressurised metered dose inhalers. The team worked to develop an analytical method that is “viable and user-friendly”.  Musale et al. acknowledged that there are analytical techniques for assessing formoterol fumarate and beclomethasone dipropionate in combination dry powder inhalers. However, the study presented in the paper focused on developing and validating a UV spectrophotometric method for quantifying the corticosteroid in pressurised metered dose in ..read more

In investigating formulations of the hypothyroidism drug levothyroxine, researchers have developed a new non-targeted approach using ultra-high-performance liquid chromatography with a data-independent acquisition high-resolution mass spectrometry (UHPLC-DIA-HRMS). The authors explained that the analytical technique is not commonly utilised in pharmaceutical quality control analysis.  Levothyroxine is a low-dose API where formulations consist predominantly of excipients. It is sensitive to external factors such as light, oxygen, humidity, the paper explained. “[A] small change in its con ..read more

Roche’s twice-yearly, 10-minute subcutaneous injection of OCREVUS ® (ocrelizumab) has shown significant promise for patients with either with relapsing or primary progressive multiple sclerosis (RMS or PPMS). One-year data from the Phase III OCARINA II trial demonstrated a near-complete suppression of relapse activity (97.2 percent had no relapse) in patients through 48 weeks of the treatment. About OCREVUS The monoclonal antibody is designed to target CD20-positive B cells. Roche stated that the subcutaneous formulation of the treatment facilitated “rapid and sustained B-cell depletion in th ..read more

A report by Market Research Future has predicted that the rapid sterility testing market will increase in value from $2.3 billion in 2023 to $4.3 billion by 2032. It is expected hold a compound annual growth rate (CAGR) of 8.20 percent between 2023 and 2032. Factors supporting expansion of the rapid sterility testing market Concerns around the safety of biological medicinal products is rising and will contribute to expansion of the sterility testing sector in the subsequent years, according to the report. Another driving factor for its growth is more efficient sterility testing due to technol ..read more

Novartis has released new data from the first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with the rare kidney disease IgA nephropathy (IgAN). Pre-specified interim analysis results from the Phase III APPLAUSE-IgAN clinical trial were presented at the 2024 World Congress of Nephrology (WCN). Fabhalta ® (iptacopan) is a Factor B inhibitor of the alternative complement pathway. It was investigated as a twice-daily oral treatment in the trial. The small molecule treatment enabled a 38.3 percent proteinuri ..read more

A new global licensing agreement is set to advance development of an oncology biosimilar candidate. Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. and Spain-based biopharmaceutical company mAbxience, have entered into a strategic deal for a drug candidate that is in development for treating multiple indications in the oncology space. Initiation of the licensing agreement will help Teva to grow its biosimilar pipeline. mAbxience will be able to further its global expansion strategy. The deal covers several drug markets worldwide, including in Europ ..read more

Positive data from MaaT Pharma’s Microbiome Ecosystem TherapyTM (MET) MaaT013 as a treatment for acute graft-versus-host disease (aGvHD), is set to be presented at the 2024 European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting. Based on the long-term survival data, at 18 months MaaT013 enabled 42 percent overall survival in all patients and 58 percent in responder patients. “MaaT013 shows remarkable efficacy at 18 months, yielding more complete responses in aGvHD patients who have shown resistance to current treatments, as compared to other available therapies. This effe ..read more

FUJIFILM Corporation is planning to invest $1.2 billion to expand the planned FUJIFILM Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina, US. This news follows the organisation’s announcement of a $2 billion investment in the facility in March 2021. This additional financial boost totals the investment to over $3.2 billion, FUJIFILM confirmed. Benefits of the manufacturing expansion “This investment is an important step to further accelerate the growth of our biopharmaceutical CDMO business,” stated Teiichi Goto, President and Chief Executive Officer, Repre ..read more

Researchers investigating environmental microbial contamination found “no seasonal climatic influences were observed” in bacteria and fungi counts present in Grade D (ISO 8) Brazilian pharmaceutical cleanrooms.  Samples were obtained via surface and air monitoring over a one-year period. While microbial levels were predicted to be higher during rainy periods compared to dry spells, “no statistically significant differences in bacteria and fungi counts were found between months or seasonal periods… Only slight variation, especially for fungi [was observed]”.  external factors such a ..read more