Mar 5, 2021 11:20am
Roche s Actemra has become the first biologic that the FDA approved for patients with systemic sclerosis-associated interstitial lung disease. (Roche/Genentech)
Missed the primary endpoint of a clinical trial? No problem. We’ll pick the study apart and approve your drug based on a post-hoc subgroup analysis.
That’s what the FDA did in granting Roche’s Actemra a go-ahead in patients with interstitial lung disease (ILD) associated with the rare autoimmune disease systemic sclerosis (SSc).
The approval makes Actemra the first biologic drug cleared by the FDA to slow the decline in pulmonary function in patients with SSc-ILD, Roche’s Genentech said Thursday.
Mar 5, 2021 11:23am
Novartis Kymriah is ready for new CAR-T competition from Bristol Myers Squibb, an exec said. (Novartis)
With the FDA’s recent approval for Bristol Myers Squibb’s Breyanzi, a new pharma giant is entering the CAR-T lymphoma fray. But with new, impressive real-world data and a global manufacturing expansion under its belt, rival Novartis says it s ready to rumble.
Novartis last year opened CAR-T production sites in Switzerland and France, while a partner opened a facility in Japan. Another partner, Cell Therapies, has since opened the first CAR-T manufacturing site in Australia. Now, the Swiss drugmaker can call on seven CAR-T manufacturing sites on four continents.
Mar 3, 2021 9:55am
Novartis presented positive study data at the sixth annual Americas Committee for Treatment and Research in Multiple Sclerosis Forum from nurses and patients using its Kesimpta auto-injector pen for MS. (Novartis)
Novartis nabbed FDA approval for Kesimpta to treat multiple sclerosis last year, but now it’s getting the thumbs-up from MS patients and nurses.
Novartis presented study data at the sixth annual Americas Committee for Treatment and Research in Multiple Sclerosis Forum in late February showing 84% preferred Kesimpta’s self-administration injector pen over rival administration methods.
The kudos from a small, 130-participant study come as Novartis bids to make Kesimpta a first-treatment option. Kesimpta’s chief rival Roche’s Ocrevus, which also works by targeting CD20-expressing B-cells is an infusion treatment.
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As the U.S. locks up supplies to make Pfizer's COVID-19 vaccine, Serum Institute of India and WHO are raising flags about global supply bottlenecks and raw materials shortfalls, Bloomberg reports. The supply disruption comes after the Biden administration tapped the Defense Production Act to increase deliveries of Pfizer's shot in the U.S.