Regulatory policy and pharmaceutical innovation in the United Kingdom after Brexit: initial insights

Brexit was presented as an opportunity to promote innovation by breaking free from the European Union regulatory framework. Since the beginning of 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) has operated as the independent regulatory agency for the United Kingdom. The MHRA's regulatory activity in 2021 was analyzed and compared to that of other international regulatory bodies. The MHRA remained reliant on EU regulatory decision-making for novel medicines and there were significant regulatory delays for a small number of novel medicines in the UK, the reasons being so far unclear. In addition, the MHRA introduced innovation initiatives, which show early promise for quicker authorization of innovative medicines for cancer and other areas of unmet need. Longer-term observation and analysis is needed to show the full impact of post-Brexit pharmaceutical regulatory policy

Vibrations of a Complex System with a Viscoelastic Inertial Interlayer

The paper presents an analytical method for solving problems of free and forced vibrations with damping of complex systems whose loaded layers are made of homogeneous elastic inertial materials, and the middle one is made of viscoelastic inertial material. Small lateral vibrations of the complex systems are caused by distributed and movable loads. A dynamic analysis of laminated structures for a wide range of variation of the geometrical and mechanical characteristics of a layer from viscoelastic inertial material was performed.Предложен аналитический метод решения задач о затухании свободных и вынужденных колебаний сложных систем, несущие слои которых выполнены из однородного упругого, а средний - из вязкоупругого инерционного материала. Малые поперечные колебания сложных систем обусловлены распределенной и подвижной нагрузкой. Выполнен динамический анализ слоистых конструкций в широком диапазоне изменения геометрических и механических характеристик слоя из вязкоупругого инерционного материала.Запропоновано аналітичний метод розв’язку задач щодо згасання вільних та вимушених коливань складних систем, несучі шари яких виконано з однорідного пружного, а середній - з в’язкопружного інерційного матеріалу. Малі поперечні коливання складних систем зумовлені розподіленим і рухомим навантаженням. Виконано динамічний аналіз шаруватих конструкцій у широкому діапазоні зміни геометричних і механічних характеристик шару з в’язкопружного інерційного матеріалу

Dual networking : how collaborators network in their quest for innovation

Organizations typically employ a division of labor between specialist creator roles and generalist business roles in a bid to orchestrate innovation. We seek to determine the extent to which individuals dividing the work across roles can also benefit from dividing their network. We argue that collaborating individuals benefit from connecting to the same groups but different individuals within those groups—an approach we label dual networking—rather than from a pure divide-and-conquer approach. To test this argument, we study a dual career-ladder setting in a large multinational in which R&D managers and technologists partner up in their quest for innovation. We find that collaborators who engage in dual networking attain an innovation performance advantage over those who connect to distinct groups. This advantage stems from the opportunity to engage in the dual interpretation of input the partners receive, as well as from dual influencing that helps them to gain momentum for their proposed innovations, and it leads to more effective elaboration and championing of their ideas. In demonstrating these effects, we advance understanding of how collaborators organize their networking activities to best achieve innovative outcomes

Serum potassium levels and outcome in acute heart failure (data from the PROTECT and COACH trials)

Serum potassium is routinely measured at admission for acute heart failure (AHF), but information on association with clinical variables and prognosis is limited. Potassium measurements at admission were available in 1,867 patients with AHF in the original cohort of 2,033 patients included in the Patients Hospitalized with acute heart failure and Volume Overload to Assess Treatment Effect on Congestion and Renal FuncTion trial. Patients were grouped according to low potassium (<3.5 mEq/l), normal potassium (3.5 to 5.0 mEq/l), and high potassium (>5.0 mEq/l) levels. Results were verified in a validation cohort of 1,023 patients. Mean age of patients was 71 – 11 years, and 66% were men. Low potassium was present in 115 patients (6%), normal potassium in 1,576 (84%), and high potassium in 176 (9%). Potassium levels increased during hospitalization (0.18 – 0.69 mEq/l). Patients with high potassium more often used angiotensin-converting enzyme inhibitors and mineralocorticoid receptor antagonists before admission, had impaired baseline renal function and a better diuretic response (p [ 0.005), independent of mineralocorticoid receptor antagonist usage. During 180-day follow-up, a total of 330 patients (18%) died. Potassium levels at admission showed a univariate linear association with mortality (hazard ratio [log] 2.36, 95% confidence interval 1.07 to 5.23; p [ 0.034) but not after multivariate adjustment. Changes of potassium levels during hospitalization or potassium levels at discharge were not associated with outcome after multivariate analysis. Results in the validation cohort were similar to the index cohort. In conclusion, high potassium levels at admission are associated with an impaired renal function but a better diuretic response. Changes in potassium levels are common, and overall levels increase during hospitalization. In conclusion, potassium levels at admission or its change during hospitalization are not associated with mortality after multivariate adjustment

Optimized Trigger for Ultra-High-Energy Cosmic-Ray and Neutrino Observations with the Low Frequency Radio Array

When an ultra-high energy neutrino or cosmic ray strikes the Lunar surface a radio-frequency pulse is emitted. We plan to use the LOFAR radio telescope to detect these pulses. In this work we propose an efficient trigger implementation for LOFAR optimized for the observation of short radio pulses.Comment: Submitted to Nuclear Instruments and Methods in Physics Research Section

The influence of atrial fibrillation on the levels of NT-proBNP versus GDF-15 in patients with heart failure

In heart failure (HF), levels of NT-proBNP are influenced by the presence of concomitant atrial fibrillation (AF), making it difficult to distinguish between HF versus AF in patients with raised NT-proBNP. It is unknown whether levels of GDF-15 are also influenced by AF in patients with HF. In this study we compared the plasma levels of NT-proBNP versus GDF-15 in patients with HF in AF versus sinus rhythm (SR)