Market Access
Regenxbio is riding a wave these days, with all three of its clinical-stage programs set to reach critical milestones this year and recent positive news on its DMD gene therapy, just as Sarepta suffered a setback with a death related to its DMD treatment. In Vivo spoke with CEO Curran Simpson about the company’s plans and strategic decisions.
In the pharma and cosmetic sectors, innovation often arises from new uses for known compounds. While the compounds may not be patentable, their new applications can be. European law allows patents on substances used in medical methods, but not on the methods themselves.
In the wake of a series of unprecedented executive orders from US President Trump, the EU medtech industry faces significant political, regulatory and business challenges. Swift and strategic action is essential to ensure stability and safeguard patient safety.
Germany’s Union parties may have little alternative than to bring the SPD into a new four-year coalition, says Clifford Chance partner and life sciences legal expert Gunnar Sachs. Health policy will likely see both textural and structural changes.
Looking at a recent McKinsey report alongside our Evaluate data, the below infographic provides insight into the investment scene of pharma and raises questions as to how the industry is seemingly yet to seize the opportunity in women's health.
Nonprofits are finding new ways to address market gaps and develop treatments for rare diseases with little commercial attraction.
Improving reimbursement and integrating digital process across health care should be two priorities for the incoming German coalition, says Martin Walger, chief executive of the IVD industry association, the VDGH, in part two of his interview with In Vivo.
Lawmaking in Germany came to a halt after the federal election was called, meaning cardiovascular detection and pharmacy legislation were put on hold. In part one of a two-part interview on key themes for industry, Martin Walger, chief executive of the IVDs industry association, the VDGH, lays out the hopes and fears of IVD companies in the run up to the late February vote.
Takeda’s head of gastroenterology talked to In Vivo about the major’s plans for finding biomarkers for Crohn’s disease as part of a Euro-wide prevention and interception trial.
Despite significant investments in weight loss treatments, pharmaceutical companies face criticism for neglecting to study their drugs in obese patients, possibly leading to incomplete labeling and patient risks, prompting calls for the FDA to enforce more inclusive clinical trials and updated drug information.
ZS principal Brian Chapman tells In Vivo what is troubling the global medtech industry at the turn of 2025, and takes the opportunity to chide the EU for its persistent fixation on taking on the “problem that did not need to be solved.”
As India prepares to commercialize its first advanced therapies it must engage key stakeholders to ensure successful implementation. Learning from global best practices and managing pricing strategies will be crucial to maximize access, deliver high-quality outcomes, and sustain innovation through reinvestment in R&D.
As pharmaceutical companies face a crowded and competitive landscape, the debate between being first-in-class or best-in-class is evergreen. This strategic choice impacts new product launches, with first-to-market therapies offering market share and brand recognition advantages, while best-in-class options can capture value through product differentiation and commercial execution. In Vivo talked to L.E.K. Consulting on how to make a product stand out from the crowd.
Pharmaceutical manufacturers face unique challenges, particularly when it comes to managing thousands of complex rebate contracts and connecting the dots between contract agreements and business performance.
As the US biosimilars market approaches the end of its first decade, it has seen another busy year, with Amgen’s surprise launch of a rival to Eylea shaking up expectations as other first-time approvals rolled in throughout 2024. Meanwhile, competition to Stelara is waiting in the wings from the start of 2025.
The pharma industry arguably suffered none of the downside risks that were possible during the first Trump administration, and their relationship with Biden could not have gone much worse. And while they may hope a Trump return could help their fortunes, having RFK Jr. supervising the FDA is likely not the prescription they want.
Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?
As the pharmaceutical industry readies itself to navigate the complexities of 2025, US pricing trends reveal a landscape shaped by regulatory and legislative changes, innovative pricing models, and the ongoing impact of inflation.
As talks continue on the EU pharmaceutical legislative reform proposals, drug firms may have to wait some time before they find out what the future periods of regulatory data protection and orphan market exclusivity will be.
The five-year roadmap aims to expand support for AI research and development in essential health care and new drug development, as well as advance medical data usage systems and enable its safe use.