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.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kronos, Nervgen, Nicox, Novadip, Ocumension, Pfizer, RDIF, Regeneron, Sanofi.

As the World Trade Organization (WTO) debate intensified this week over a demand to waive patent protections for COVID-19 vaccines and therapies, the group’s new director-general, Ngozi Okonjo-Iweala, urged members to “walk and chew gum” at the same time by working with “companies to open up and license more viable manufacturing sites now in emerging markets and developing countries. We must get them to work with us on know-how and technology transfer now.”

The latest global regulatory news, changes and updates affecting biopharma.