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treatments for liver diseases. The research of San Francisco-based Surrozen focuses on Wnt, a protein that plays a role in stem cell maintenance and tissue regeneration.
—-Celgene filed for European approval of multiple sclerosis drug ozanimod. The company also says it is on track to refile its FDA application for the drug by the end of March.
—Zafgen (NASDAQ: ZFGN) suspended plans to begin human testing of its experimental drug ZGN-1258 due to worrisome safety signs in preclinical tests. The disclosure marks another setback for Zafgen, which scrapped one drug due to safety problems and saw the FDA temporarily halt testing of another. Shares fell more than 34 percent.
—The European Medicines Agency approved a regimen of the Merck (NYSE: MRK) immunotherapy pembrolizumab (Keytruda) alongside chemotherapy for patients with newly diagnosed, advanced non-small cell lung cancer.
—The FDA approved a combination regimen of the Celgene drug nab-paclitaxel (Abraxane) and the Roche immunotherapy atezolizumab (Tecentriq) for certain patients with triple-negative breast cancer.
—Celgene reported the failure of a Phase 3 study testing nab-paclitaxel and chemotherapy gemcitabine against chemo alone in pancreatic cancer patients.
—The FDA cleared dupilumab (Dupixent), from Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi, for adolescents with moderate-to-severe atopic dermatitis. Dupilumab is already approved for adults with the condition.
—AbbVie (NYSE: ABBV) and Principia Biopharma (NASDAQ: PRNB) are winding down a partnership begun in 2017 to develop treatments for inflammation and autoimmune disorders. South San Francisco, CA-based Principia will regain rights to the preclinical program.
—Axovant (NASDAQ: AXGT) reported positive interim results from a mid-stage study of a gene therapy it’s testing in patients with Parkinson’s disease. Axovant will now test the gene therapy—a rival to a program from Voyager Therapeutics (NASDAQ: VYGR)—at higher doses.
— Ramucirumab (Cyramza), an Eli Lilly (NYSE: LLY) drug already approved for treating gastric and colorectal cancers, succeeded in a Phase 3 study in non-small cell lung cancer. Lilly tested its drug in combination with erlotinib, a lung cancer drug for patients whose tumors have an EGFR mutation.
—The first immunotherapy for breast cancer is here. The FDA approved a combination of Roche’s atezolizumab and Celgene’s nab-paclitaxel for locally advanced or metastatic triple-negative breast cancer, which accounts for about 15 percent of breast cancer cases. The approval is only for patients whose cancer expresses the protein PD-L1, which must be detected by a companion diagnostic from Roche’s Ventana division that was also approved by the FDA.
—The FDA decision date for Karyopharm Therapeutics (NASDAQ: KPTI) multiple myeloma drug selinexor was pushed out three months to July 6 to give the regulator time to review additional information submitted by the company. Last month, an FDA advisory committee voted against recommending accelerated approval of selinexor, a vote that followed a blistering review from the agency’s staff that questioned the drug’s safety and efficacy.
TRIALS AND TRIBULATIONS
—In the first major lawsuit against companies charged with fueling the opioid abuse crisis, Oklahoma’s attorney general is pressing for the public release of confidential documents implicating Johnson & Johnson (NYSE: JNJ). Axios has the scoop.
PEOPLE ON THE MOVE
—Adam Crystal left the Novartis Institutes for BioMedical Research to become chief medical officer of C4 Therapeutics.
—Tenaya Therapeutics hired Whittemore Tingley away from Cytokinetics (NASDAQ: CYTK) to become its chief medical officer.
Ben Fidler and Alex Lash contributed to this report.