Phase III
The FDA has two PDUFA dates on its calendar this week, with two extra days slotted for an advisory committee meeting to evaluate drug applications from three companies.
AstraZeneca’s rare disease subsidiary Alexion posted positive late-stage results from a potential complementary treatment for paroxysmal nocturnal hemoglobinuria.
The U.S. FDA approved Mallinckrodt’s Terlivaz in adults with hepatorenal syndrome and is the only FDA-approved drug for that indication.
There’s a new collaboration in the Parkinson’s disease development space, Cardiff Oncology kicks off a mid-phase study in colorectal cancer and Ocugen published a new review of COVAXIN.
Pfizer is leveraging its funding and experience with vaccines, developing its meningococcal, flu, and RSV vaccines. It also announced its venture investment in Nimbus Therapeutics.
NSCLC At ESMO: Pollution does indeed cause lung cancer; Tecentriq shows promise in poor prognosis patients, Amgen makes progress in KRAS G12-mutated disease and an update on a Daiichi Sankyo ADC.
BMS validated LAG-3 as the newest checkpoint in immuno-oncology in March. Regeneron, Merck and Immutep S.A. have been working hard to develop the next successful LAG-3 inhibitor.
Amgen presented data from its Phase III CodeBreaK 200 trial of Lumakras showing the drug improved progression-free survival and objective response rate over intravenous chemotherapy.
Novartis has had a busy few days, announcing plans to shutter a Sandoz plant, a $300 million infrastructure investment, and Cosentyx, Kisqali and Tislelizumab readouts.
AstraZeneca presented data showing Imfinzi and Tagrisso boosted survival chances for patients in different forms of lung cancer at ESMO on Monday.
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