HONG KONG – China biopharma pioneer Chia Tai Tianqing Pharmaceutical Holdings Co. Ltd. said its self-developed chemical oncology, Focus V (anlotinib hydrochloride capsules), is now approved for a second indication to treat soft tissue sarcoma, becoming the only approved therapy for this rare cancer in China.
Revolution Medicines Inc., a California-based company developing a small-molecule inhibitor of SHP2 in partnership with Sanofi SA and other programs targeting mutant forms of the key signaling protein RAS, has raised a $100 million series C equity financing led by Boxer Capital LLC, an investment firm funded by British businessman Joe Lewis' Tavistock Group, which has backed financings of companies including G1 Therapeutics Inc., Kura Oncology Inc. and, more recently, Encoded Therapeutics Inc.
Merck & Co. Inc. has tapped Skyhawk Therapeutics Inc. for its expertise in the discovery and development of small molecules that modulate RNA splicing, agreeing to pay it up to $600 million per program target plus royalties on sales of any commercialized products of the collaboration. The deal, focused on potential treatments for certain neurological diseases and cancer, was accompanied by news of an expansion of Skyhawk's collaboration with Biogen Inc., which originally signed on with the Waltham, Mass-based company in January.
Despite a February adcom meeting urging the agency to wait for more data, the FDA has approved Karyopharm Therapeutics Inc.'s selinexor, in combination with dexamethasone (dex), as a new treatment for certain adults with relapsed refractory multiple myeloma (MM). The approval covers patients who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents and an anti-CD38 monoclonal antibody.
The FDA placed a clinical hold Wednesday on a phase I trial by Unum Therapeutics Inc. after a patient experienced serious adverse events that included grade 3 neurotoxicity and cytomegalovirus infection, and grade 4 respiratory distress.
HONG KONG - Incyte Corp. entered a collaboration and licensing deal to flip its greater China rights to an investigational anti-PD-1 monoclonal antibody to Zai Lab Ltd., of Shanghai. The candidate, INCMGA-0012, is currently being evaluated as a monotherapy in registration-directed trials for patients with MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer.
Boston Biomedical Inc. shuttered phase III study Canstem111P of napabucasin for patients with metastatic pancreatic ductal adenocarcinoma, adding to the list of studies that have fallen in pancreatic cancer.
The Warburg effect – the marked preference of tumors for fueling themselves via anaerobic metabolism – was described more than 90 years ago. Otto Warburg won the Nobel Prize for his discovery in 1931, and research into the phenomenon long dominated the field of tumor metabolism. Over the past decade, however, there has been increased attention to the fact that tumor metabolism is deregulated in multiple ways beyond the Warburg effect.
Japanese biopharma Carna Biosciences Inc. and Gilead Sciences Inc., of Foster City, Calif., have signed a $470 million R&D collaboration to develop and commercialize small-molecule compounds in immuno-oncology. Under the agreement, Gilead will license worldwide rights to develop and commercialize inhibitors against an undisclosed immuno-oncology target from Kobe, Japan-based Carna. Additionally, Gilead will have access to Carna's lipid kinase drug discovery platform.
Since being diagnosed with cancer a few months ago, I have been in an unwanted crash course on the patient perspective of everything I’ve been writing about biopharma for the past several years. It’s an eye-opener. Genetic testing, lack of research, unmet medical need, off-label use, drug shortages, adverse events, informed consent, clinical trial data that don’t represent real-world practice, drug-drug interactions, co-morbidities, labeling precautions, reimbursement, data-sharing vs. privacy issues. ... Up until now, these were all topics I wrote about or discussed with my colleagues during our news meetings. Now, they’re personal. They impact my daily life and could...