An Indian court has ruled against Bayer in a case concerning certain key aspects of the country’s Bolar provision - the experimental use or early working exception – with respect to the German multinational’s Nexavar and Xarelto. The court held that the meaning of “selling” under the provision cannot be construed to “exclude therefrom selling by way of exporting”.
German multinational Bayer Corp. suffered a setback in India, after the Delhi High Court failed to find merit in its contention on key aspects pertaining to Section 107A of India’s Patents Act - the Bolar Provision – in a case against the Indian firms Natco Pharma Ltd. and Alembic Pharmaceuticals Ltd.
Natco and Alembic have been permitted to export the active ingredients in Nexavar (sorafenib tosylate) and Xarelto (rivaroxaban) respectively under...
Merck’s immuno-oncology blockbuster was the world’s best-selling drugs by revenues for the second year in a row, with an almost $12bn lead over its closest rival, Novo Nordisk’s GLP-1 drug Ozempic.
MSN Laboratories will be unable to move forward – for now – with any potential ‘at-risk’ launch for its generic version of Novartis’ Entresto blockbuster in the US after the originator won a stay on the firm’s ANDA pending appeal from the US Court of Appeals for the District of Columbia Circuit.
The UK group remains confident that the scale of the US opioid epidemic, driven by misuse of fentanyl, still represents a considerable opportunity but investors have reacted nervously to lower revenues coming from Sublocade.
The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits.
Companies stand a better chance of securing public reimbursement in Mexico for innovative medicines if they understand changing approaches to healthcare. The shift means the emergence of managed entry agreements and a focus on economic impact, explains AMIIF, Mexico's research-based pharmaceutical industry association.
Novartis’s APMA chief outlines the company’s tailored approach to deliver long-term outcomes, novel access solutions via innovative financing options and shape the CVD disease ecosystem in the extraordinarily diverse region. Partnering to build AI infrastructure is another key prong.
A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.
