Taking an unconventional path to market for its targeted therapies for RAS-addicted cancers, Revolution Medicines Inc. secured access to $2 billion in capital to build its own global commercial infrastructure, instead of partnering outside the U.S. as it had originally intended. “We’ve concluded that the best way for us to achieve our goals with our rich pipeline is to direct our own global development and commercial strategies and to operationalize these both inside and outside the U.S. through our own organization,” Mark Goldsmith, president and CEO of Revolution Medicines (Revmed), told investors June 24.
The U.S. FDA granted Abbvie Inc. accelerated approval for antibody-drug conjugate (ADC) Teliso-V (telisotuzumab vedotin), newly branded Emrelis, making it the first treatment for previously treated advanced non-small-cell lung cancer with high c-Met protein overexpression.
The U.S. FDA granted breakthrough therapy designation to Abbisko Therapeutics Co. Ltd.’s pimicotinib for patients with tenosynovial giant cell tumors who are not able to have surgery.
The U.S. FDA granted breakthrough therapy designation to Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor (CSF-1R) inhibitor, pimicotinib, for patients with tenosynovial giant cell tumors who are not able to have surgery.
The new year kicked off with good news from the U.S. FDA for Onconano Medicine Inc. The agency granted the company’s pH-sensitive fluorescent nanoprobe, pegsitacianine, breakthrough therapy designation for use as an adjunct for visualization of metastases in the peritoneal cavity.
China’s National Medical Products Administration (NMPA) awarded Akeso Inc. breakthrough therapy designation for its PD-1 checkpoint inhibitor/VEGF bispecific antibody, ivonescimab (AK-112), combined with docetaxel for locally advanced or metastatic non-small-cell lung cancer (NSCLC) in patients who failed to respond to prior PD-(L)1 inhibitors combined with chemotherapy.
It’s been one thing after another for rusfertide from Protagonist Therapeutics Inc. for the past year. Now the U.S. FDA has told the company it wants to rescind the breakthrough designation, a relatively rare occurrence, based on observed malignancies in a follow-up to September’s clinical hold.
New FDA breakthrough therapy designations awarded for two investigational Alzheimer's disease (AD) candidates, Eli Lilly and Co.'s donanemab and the Bioarctic AB-Eisai Co. Ltd.-developed asset lecanemab (BAN-2401) underline ongoing willingness at the U.S. regulator to invest deeper attention in the potential of amyloid plaque reduction to slow progress of the disease, a critical and costly challenge estimated to affect more than 6 million Americans.
