The conditional marketing approval for Ocaliva (obeticholic acid) has been revoked with immediate effect, following a standoff between the EMA and Advanz Pharma Ltd., the company that markets the primary biliary cholangitis (PBC) therapy in Europe. On Sept. 5, London-based Advanz won a short reprieve after challenging the EMA’s June 28 ruling that the marketing authorization for Ocaliva should be revoked, when the General Court of the EU granted a temporary suspension of EMA’s decision. However, on Nov. 27, Advanz announced the court had said it would not be extending the suspension.
Empyrean Therapeutics Inc. has acquired a first-in-class TLR2 antagonist molecule from Eos Therapies Inc. with the aim of treating brain, pancreatic, breast and other hard-to-treat cancers.
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
Kura Oncology Inc. and Kyowa Kirin Co. Ltd. have joined hands in a global strategic collaboration worth $1.49 billion to develop and commercialize ziftomenib, Kura’s selective oral menin inhibitor for treating patients with acute myeloid leukemia (AML) and other hematologic malignancies.
The Alzheimer’s disease (AD) space took another blow along with the shares of Cassava Sciences Inc. (NASDAQ:SAVA), which plummeted by 83.8%, or $22.19, to end Nov. 25 at $4.30 after the firm unveiled top-line data from the phase III Rethink-Alz study with simufilam. The study tested simufilam in mild to moderate AD, where results fell short of each of the prespecified co-primary, secondary and exploratory biomarker endpoints.
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
Kura Oncology Inc. and Kyowa Kirin Co. Ltd. have joined hands in a global strategic collaboration worth $1.49 billion to develop and commercialize ziftomenib, Kura’s selective oral menin inhibitor for treating patients with acute myeloid leukemia (AML) and other hematologic malignancies.
The bad news keeps piling up for Sage Therapeutics Inc. Having absorbed other study stumbles in the past few months, the company now has halted development of dalzanemdor in treating Huntington’s disease after top-line phase II data showed it missed a statistically significant difference compared to placebo on the primary endpoint.
“It all comes down to outcomes,” said Michael Davidson, CEO of Newamsterdam Pharma Co. NV, which hailed “robust” and “consistent” data from its phase III study testing a fixed-dose combination of CETP inhibitor obicetrapib plus established anti-cholesterol drug ezetimibe, even as investors focused on a couple of findings that turned up lower than expected, sending shares of the company (NASDAQ:NAMS) down 15.5% to close Nov. 20 at $20.01.
Vitalli Bio Inc. terminated a potential $477 million licensing deal for autoimmune disease drug, DWP-213388, signed a year ago with Daewoong Pharmaceutical Co. Ltd., although Vitalli still retains option rights to two more dual inhibitor candidates that could fetch up to $941 million.
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