LONDON – The National Health Service (NHS) in the U.K. has agreed to reimburse Zolgensma, the one-off gene therapy treatment for spinal muscular atrophy billed as the most expensive drug in the world, after a confidential deal was struck with Novartis Gene Therapies.
The voluminous American Rescue Plan – the second largest stimulus package in U.S. history – has something for everyone. Almost. The $1.9 trillion package that passed the Senate over the weekend and is expected to be passed by the House March 9 failed to extend the current moratorium, set to expire April 1, on the 2% Medicare sequestration.
More than a decade after first approving Actemra (tocilizumab) for the treatment of rheumatoid arthritis, the FDA has added a sixth use to its label: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease.
China’s most important annual government meetings, known as the “Two Sessions,” kicked off March 4 and biopharma executives that were also delegates to the National People's Congress (NPC) suggested that approval for trials should be stricter to avoid repetitive R&D and called for innovative drugs to get into the state insurance list – and to patients – faster.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Betta, Kintor, Moderna, Ocular, Roche, Seqirus, Sigilon, Turnsole.
The European Commission (EC) is investigating whether Teva Pharmaceutical Industries Ltd., of Petah Tikva, Israel, illegally delayed the launch and uptake of competitors to its blockbuster multiple sclerosis (MS) drug, Copaxone (glatiramer acetate).
From the time it paused inspections of drug manufacturing sites a year ago due to the COVID-19 pandemic, the FDA conducted only three foreign “mission-critical” inspections in fiscal 2020. Those were in Canada, Germany and India, according to a new U.S. Government Accountability Office report.
The so-called pharma bro Martin Shkreli’s trials are far from over. The former hedge fund manager, biopharma CEO and now convicted felon is facing a class action lawsuit led by Blue Cross and Blue Shield.
The latest global regulatory news, changes and updates affecting biopharma, including: Australia eases substitution requirements; Guidance details fast-tracking modified vaccines.
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