HONG KONG – Chugai Pharmaceutical Co. Ltd., of Tokyo, said its Alecensa (alectinib), an anaplastic lymphoma kinase (ALK) inhibitor, gained expanded approved as a first-line treatment for ALK-positive non-small-cell lung cancer (NSCLC) in Taiwan. Read More
Maxcyte Inc., of Gaithersburg, Md., said it presented preclinical data at the American Society of Gene & Cell Therapy meeting in Chicago, describing how nonviral cell engineering technology was used for CRISPR-mediated gene correction of a mutation within the hemoglobin gene of cells from a sickle cell disease (SCD) patient. Read More
Contravir Pharmaceuticals Inc., of Edison, N.J., has filed to raise up to $20 million in a sale of series C convertible shares. The company said it anticipates using the net proceeds from the sale primarily to fund R&D and for working capital and general corporate purposes. Read More
Acknowledging "constructive" trade consultations between China and the U.S., the Trump administration over the weekend stepped back from calling for tariffs on a long list of imports from China, including drugs and medical devices. While it made no specific mention of drugs and devices, a joint statement issued by the trade delegations from China and the U.S. said they have reached a consensus on taking effective measures to "substantially reduce" the U.S. trade deficit in goods with China. Read More
Precipio Inc. has launched its pancreatic cancer liquid biopsy kit for pancreatic cancer. The kit is intended to enable a cost of only $100 per specimen, which would be just a fraction of the cost of other tests. That price point could prove reasonable enough to better enable routine monitoring for cancer patients by making it more economically feasible for patients. Read More
The FDA and the Office for Human Research Protections (OHRP) finalized the August 2016 draft guidance for written procedures for institutional review boards (IRBs), and the final guidance includes a clear warning to them. The agencies said in the final that some IRBs have developed written procedures "that simply restate the regulations" in question, but that approach won't work anymore because a working set of procedures will have to provide at a minimum "a comprehensive and critical assessment" of that IRB's responsibilities, functions and organizational structure. Read More
Rain Therapeutics Inc., a startup planning a phase II test of an experimental small-molecule drug for people with EGFR and ErbB exon 20 insertion mutations in non-small-cell lung cancer, has closed a tranched $18.4 million series A round. The financing was led by Biotechnology Value Fund (BVF) and followed by Perceptive Advisors, Auckland Uniservices Ltd.'s Inventors Fund and other private investors. The series A round follows a $1 million convertible note financing the company completed in late-2017. Read More
HONG KONG – South Korea's Samsung Biologics Co. Ltd., one of the world's biggest biologic drug manufacturers, has seen its stock price fall 20 percent this month as allegations of accounting fraud remain in play after a year of investigation. Read More
Like David against Goliath, Roswell Park Cancer Institute (RPCI) spinout Mimivax LLC is seeking to take down one of the most common and aggressive forms of primary brain cancer, and interim findings from its U.S. multicenter phase II study suggest the Buffalo, N.Y.-based company may have a shot. Key Interim results of Survaxm, its survivin peptide mimic immunotherapeutic vaccine, showed that 91 percent of patients with newly diagnosed glioblastoma multiforme (nGBM) who received the treatment in combination with standard of care achieved 12-month overall survival (OS) compared to 61 percent historical standard of care. In addition, 96 percent achieved six-month progression-free survival (PFS) on the Survaxm regimen compared to 54 percent historical standard of care. Read More
Heading toward the May 21 PDUFA date for its thrombocytopenia drug, avatrombopag, Dova Pharmaceuticals Inc. was determined to have its sales and marketing team ready to go for a June launch, optimism that appeared justified Monday afternoon when the FDA gave the nod to the second-generation, once-daily, oral thrombopoietin (TPO) receptor agonist following a priority review. Read More
Astrazeneca plc's long-time-coming approval of Lokelma (sodium zirconium cyclosilicate) oral suspension for adults with hyperkalemia puts another weapon in the hands of doctors, and there's more coming down the pike, albeit far off. Read More
