The “accurate, precise, and robust” data obtained via the dew point chilled mirror method, means it is an “outstanding” approach for quantifying water activity status in tablets and capsules, according to a paper published in RPS Pharmacy and Pharmacology Reports. It has value for direct assessment to determine microbiological bioburden, stated Prada-Ramírez et al. The researchers aimed to find out whether the method’s entire performance met “USP 1225 requirements for naproxen, amoxicillin, ciprofloxacin, chlorpheniramine, prednisolone, flunarizine, and methocarbamol as representatives of tab ..read more

The first adjuvant treatment for tumour-resected early-stage anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) has been approved by the US Food and Drug Administration (FDA). This authorisation was granted to Genentech’s (a member of the Roche Group) small molecule treatment Alecensa ® (alectinib). “Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” summarised Dr Levi Garraway, Chief Medical Officer and Head of Global Product Development, Roche. According to Genentech, Alecensa is a kinase inhib ..read more

Conclusions from the meeting of the special European Council (17-18 April 2024) have recognised a need for new European competitiveness deal “anchored in a fully integrated Single Market”. Collaboration was highlighted by the Council as an essential factor to “close growth, productivity and innovation gaps between the Union and its international partners and main competitors… [therefore] policy action must be better put at the service of enhancing Europe’s economic, manufacturing, industrial and technological base”. On industry research and innovation, the Council Conclusions called for “a mo ..read more

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

What are the three main challenges of monitoring pharmaceuticals in the environment? Andreas Häner (AH): Roche, along with other pharmaceutical companies, acknowledges concerns about pharmaceuticals in the environment (PiE). While pharmaceutical manufacturing’s overall contribution is small compared to patient use and inappropriate disposal of pharmaceuticals, inadequately managed manufacturing emissions can impact local environments and receiving waters. Environmental monitoring (EM) relies on mass balances to estimate losses and chemical analysis of waste stream samples to determine the ..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