Protocols

NIH, Fox Foundation allies with biopharmas on $24M Parkinson’s project; FDA accepts Theravance/Mylan NDA for COPD drug

→ The NIH is teaming up with The Michael J. Fox Foundation and a group of life sciences companies on a $24 million initiative to develop new biomarkers for the progression of Parkinson’s disease. “These technologies could allow us to tease out microscopic differences in people with Parkinson’s, which we may use to develop objective measures of the disease and treatments to slow or stop the Parkinson’s process,” said MJFF CEO Todd Sherer. “Leveraging existing studies and partnering with the NIH and industry can move us faster toward these goals.”

→ Theravance Biopharma and its partner Mylan got FDA acceptance of its NDA for revefenacin (TD-4208), their once-daily, nebulized long-acting muscarinic antagonist for COPD. The PDUFA data is November 13, 2018. “Today, patients with moderate to severe COPD do not have access to a nebulized LAMA as a treatment option yet,” said Mylan president Rajiv Malik in a statement. “We believe revefenacin, when approved, represents an important advancement in respiratory care by offering a convenient once-daily option for patients, and further strengthens Mylan’s robust and growing respiratory portfolio.” The two companies previously reported that in two Phase III efficacy studies, revefenacin demonstrated statistically significant and clinically meaningful improvements as compared to placebo in trough forced expiratory volume in one second (FEV1) and in overall treatment effect on trough FEV1 (OTE FEV1) after 12 weeks of dosing.

→ Cambridge, MA-based Syros Pharmaceuticals $SYRS is raising $40 million through a public offering of its stock, with an additional $6 million available to underwriters. The money will go toward the company’s R&D expenses, among other corporate uses, according to a company statement. The company’s platform identifies alterations in gene expression that cause diseases, and Syros is developing medicines that control the expression of genes. The company’s lead drug candidates are SY-1425, a selective RARα agonist in a Phase II study for “genomically defined” subsets of acute myeloid leukemia and myelodysplastic syndrome patients, and SY-1365, a selective CDK7 inhibitor in a Phase I clinical trial for patients with advanced solid tumors.

 

 


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Biotech Primer Boston 2018

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