Explore the vast range of titles available.

Ranjit Ranbhor,1 Priyanka Kulkarni2 1Business Development, Portfolio and Patents, Odin Pharmaceuticals LLC, Somerset, NJ, USA; 2Feliciano School of Business, Montclair State University, Montclair, NJ, USACorrespondence: Ranjit Ranbhor, Business Development, Portfolio and Patents, Odin Pharmaceuticals LLC, 300 Franklin Square Drive, Somerset, NJ, 08873, USA, Email ranjitranbhor@gmail.comBackground: The FDA’s October 2025 guidance proposes waiving Phase 3 comparative efficacy studies for biosimilars when analytical and pharmacokinetic similarity are demonstrated.Methods: We conducted a net present value (NPV) analysis comparing traditional biosimilar development pathways (with Phase 3 comparative efficacy studies) to streamlined pathways utilizing FDA’s Phase 3 waiver framework. The model incorporates industry-benchmarked cost data (Phase 3 studies: $20– 28M), development timelines (Phase 3 duration: 1– 3 years). Economic outcomes were evaluated across three monoclonal antibody biosimilar programs representing high-, moderate-, and lower-complexity scenarios. Sensitivity analysis evaluated parameter variation across realistic ranges.Results: Waiving Phase 3 studies reduces development costs by $25 million per program (18% reduction) and shortens timelines by 1.5 years (21% reduction). Risk-adjusted NPV improves by $25 million (29%), and minimum viable peak sales threshold decreases from $300 million to $250 million.Conclusion: Phase 3 waivers can substantially reduce development costs ( $25M average), accelerate timelines ( 1.5 years), and improve NPV ( 25– 29%) for well-characterized monoclonal antibody biosimilars meeting FDA’s analytical similarity and pharmacokinetic equivalence criteria. Economic benefits are conditional on robust analytical data, regulatory approval of waiver requests, and appropriate product selection (Tier 1/2/3 classification). Real-world realization requires post-implementation surveillance of FDA approval patterns, achieved cost reductions, and timeline compression beginning 2026– 2027.Keywords: biosimilar NPV, antibody cost reduction, phase 3 waiver

This work aims at the economic evaluation of a semi-underground pumped hydro storage power plant erected in an abandoned open-pit mine. For the exploratory model-based analysis, we develop and apply both a simple deterministic and a stochastic net present value (NPV) approach, the latter of which uses a Monte Carlo simulation to account for revenue uncertainty from electricity price fluctuations. The analytical framework developed is applied to two promising sites in the Rheinland region in Germany, Hambach and Inden, making reasonable parameter value assumptions and considering and ignoring the lengthy duration of lower reservoir flooding. The investor’s value-at-risk is computed for alternative performance indicators (NPV, net cash recovery, profit-to-investment ratio, and specific production costs) to compare the different outcomes in terms of the project’s financial risk distribution. Calculations show that a semi-underground pumped hydro storage power plant in an abandoned open-pit mine can be constructed at reasonably low investment costs and operated at low specific production costs. However, because the investment has to be made long before the pit lake is (naturally) flooded—a process that for realistic flow rates may take up to 20 years—the project is highly uneconomical and would require substantial subsidies, as compared to a situation where flooding happens immediately.

Control of Spodoptera litura in the tropical sugar beet is a critical issue for sustainable agriculture. The purpose of this field experiment was to assess the efficacy of botanical and non-chemical techniques against S. litura to identify ecologically viable management alternatives. Spodoptera litura responded best to a neem oil solution at a concentration of 3.0 mL/L. In terms of insect infestation, the plot treated with neem oil outperformed the untreated control plot. The infection rates for plants, leaves, and beets were 5.66/plot, 5.33/plant, and 11.00/plot, respectively. In terms of larvae decrease over control, the plot treated with neem oil had the greatest effectiveness (84.33%), followed by pheromones, which had an efficiency of 80%. Plants treated with neem oil showed the highest Brix and Pol values (17.61% and 12.62%, respectively). Weight per beet was lowest in the control plot (690.33 g), and highest in the best treatment (791.33 g). It clearly shows that when insect infestation grows, beet yield falls. The control plot was unable to effectively resist S. litura, resulting in unhealthy sugar beet output. In contrast, eco-friendly techniques such as NPV spraying, Bio Neem Plus®, Tracer 45SC (spinosad), hand picking, light trap, and polythene mulching trap outperformed the control plot.

Poly(methyl methacrylate) (PMMA) is a versatile polymer with a forecast market of 4 Mtons/y by 2025, and 6 USD billion by 2027. Each year, 10% of the produced cast sheets, extrusion sheets, or granules PMMA end up as post-production waste, accounting for approximately 30 000 tons/y in Europe only. To guide the future recycling efforts, we investigated the risks of depolymerization process economics for different PMMA scraps feedstock, capital expenditure (CAPEX), and regenerated MMA (r-MMA) prices via a Monte-Carlo simulation. An analysis of plastic recycling plants operating with similar technologies confirmed how a maximum 10 M USD plant (median cost) is what a company should aim for, based on our hypothesis. The capital investment and the r-MMA quality have the main impacts on the profitability. Depending on the pursued outcome, we identified three most suitable scenarios. Lower capital-intensive plants (Scenarios 4 and 8) provide the fastest payback time, but this generates a lower quality monomer, and therefore lower appeal on the long term. On 10 or 20 years of operation, companies should target the very best r-MMA quality, to achieve the highest net present value (Scenario 6). Product quality comes from the feedstock choice, depolymerization, and purification technologies. Counterintuitively, a plant processing low quality scraps available for free (Scenario 7), and therefore producing low purity r-MMA, has the highest probability of negative net present value after 10 years of operation, making it a high-risk scenario. Western countries (especially Europe), call for more and more pure r-MMA, hopefully comparable to the virgin material. With legislations on recycled products becoming more stringent, low quality product might not find a market in the future. To convince shareholders and government bodies, companies should demonstrate how funds and subsidies directly translate into higher quality products (more attractive to costumers), more economically viable, and with a wider market.

Widespread use of synthetic chemical insecticides causes growing concern regarding the risks to human health and negative impacts on the environment. At the same time, many insects have become resistant toward synthetic chemical insecticides. Baculoviruses bring many benefits and allow reduced use of synthetic insecticides when included in integrated pest management (IPM). They are specific to their target pest and thus do not have any negative effects on plants, mammals, and non-target insects including natural enemies and pollinators. In addition, their unique mode of action makes them suitable for resistance management. We provide examples of how baculoviruses can be applied in IPM strategies for open field and protected vegetable crops. In field trials, baculovirus products were applied in rotations and tankmixes with chlorantraniliprole, Bacillus thuringiensis products, and spinosad and provided promising control of target pests. The conducted trials in open field and protected vegetables show that baculoviruses can offer an effective solution to control pests in open field and protected vegetable production. Including baculoviruses gave results as good as other application strategies tested while conferring important benefits in reducing residues and improving the resistance management strategy.

PurposeThe aim of this Education Briefing is to comment on the problematic issues that sometimes arise when using the internal rate of return (IRR) and/or the net present value (NPV) as a measure of expected investment performance. The briefing looks at the sometimes conflicting signposts that each benchmark presents and highlights ways that decision-makers can overcome or mitigate the effects of those problematic issues.Design/methodology/approachAfter a short review of the IRR and NPV techniques, this Education Briefing provides numerous examples of problematic issues that arise with certain cash flow profiles and suggests how to address them.FindingsBoth the IRR and NPV provide simple benchmarks that can mislead the decision-maker who is not familiar with the nuances of both techniques.Practical implicationsThis review should heighten the reader’s ability to spot characteristics of proposed investments that may signal that a quick decision based on performance metrics may lead to disappointing results. These characteristics include: scale effects, unusual cash flow patterns and/or investments with dissimilar expected lives. Mutually exclusive investments merit special attention.Originality/valueThis is a review of existing performance measurement models.

Rewetting drained peatlands is crucial in mitigating climate change, but special monitoring schemes are required to track rewetting effects. Species distribution and condition may give indications on water level and hence rewetting success. We mapped the fractions of seven peatland related and four non-peatland vegetation classes, as well as their dynamics in condition from five 30 m EnMAP images. We used neural network regression with synthetic training data augmentation to predict peatland vegetation fractions (e.g., Phragmites australis, Typha spp. and Carex spp.) from the hyperspectral EnMAP stack, as well as NPV (non-photosynthetically active vegetation), GV (green vegetation), and water fractions from the single-dates to derive intra-annual dynamics. Patterns of species fractions matched field observations at varying accuracies with the highest agreement for Typha and Phragmites (MAE = 16% and 22%, respectively). The changes in vegetation condition similarly matched field observations (GV: MAE = 12%, Water: MAE = 14%, NPV = 21%), and in combination with species fractions revealed class-specific trends, such as differences in timing of the green peak (maximum GV fractions). Intraspecific variations in green peak could be observed for the class Phragmites, indicating differences in water level. Further, dynamics in the extent of open water areas were apparent, highlighting the necessity of multi-temporal information. Increasing availability of spaceborne imaging spectroscopy will enable long-term monitoring of peatland rewetting, accounting for intra-annual variations in vegetation and water dynamics.

Healthcare databases can be a valuable source of epidemiological research regarding postoperative venous thromboembolism (VTE), ie, deep vein thrombosis (DVT) and pulmonary embolism (PE), following orthopedic procedures, but only if the diagnoses are valid. We examined the validity of VTE diagnosis codes in the Danish National Patient Registry (DNPR) by calculating their positive predictive value (PPV) and negative predictive value (NPV) versus actual medical records. We identified patients who had undergone lower limb surgery during the period 2009-2019 at a hospital in the North Denmark Region. Of these, 420 patients had at least one VTE diagnosis registered in the DNPR within 180 days after lower limb surgery. Each patient with a VTE diagnosis was matched with two patients on age and sex, as well as type, location and period of surgery. The entire medical record and diagnostic imaging were reviewed to confirm VTE diagnosis. The overall PPVs was 85.2% (95% CI: 81.5-88.5%) for first time VTE diagnosis following lower limb surgery, 82.6% (95% CI: 77.5-82.8%) for DVT, and 90.3% (95% CI: 84.3-94.6%) for PE. We found improvement in PPV during the study period when stratifying for three periods of the whole period. There were no significant differences when stratifying for sex, age, or surgery site. All negative predictive values were higher than 99%. A total of 113 additional VTE diagnoses were registered among 88 VTE patients during follow-up. Only four of the suspected recurrent VTEs were confirmed to be true recurrent VTEs. The VTE diagnosis codes in the DNPR after lower limb orthopedic surgery were highly valid against the actual medical records, and we observed better PPV over recent years.

The paper proposes an optimal siting and sizing methodology to design an energy storage system (ESS) for railway lines. The scope is to maximize the economic benefits. The problem of the optimal siting and sizing of an ESS is addressed and solved by a software developed by the authors using the particle swarm algorithm, whose objective function is based on the net present value (NPV). The railway line, using a standard working day timetable, has been simulated in order to estimate the power flow between the trains finding the siting and sizing of electrical substations and storage systems suitable for the railway network. Numerical simulations have been performed to test the methodology by assuming a new-generation of high-performance trains on a 3 kV direct current (d.c.) railway line. The solution found represents the best choice from an economic point of view and which allows less energy to be taken from the primary network.