Qiagen NV, of Venlo, the Netherlands, said a clinical development program is underway with Novartis AG, of Basel, Switzerland, to develop a companion diagnostic to guide the use of BYL-719 (alpelisib) in combination with fulvestrant to treat men and postmenopausal women with PIK3CA-mutated hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Qiagen expects the test to be available for clinical labs upon potential regulatory approval of BYL-719, which has completed the phase III SOLAR trial in individuals with HR+/HER2- advanced breast cancer. Read More
Impel Neuropharma Inc., of Seattle, said it completed a series D financing raising $67.5 million. The investment was co-led by KKR and Norwest Venture Partners, with participation from existing investors Vivo Capital, 5AM Ventures and Venbio Partners. The funding will enable the company to accelerate its existing clinical development portfolio in CNS disorders. Read More
This year, about 55,440 people (29,200 men and 26,240 women) will be diagnosed with pancreatic cancer, according to the American Cancer Society, and about 44,330 people (23,020 men and 21,310 women) will die of this particularly virulent tumor type. For men, the average lifetime risk is about one in 63; for women, about one in 65. But risk factors – tobacco use, obesity, exposure to certain chemicals – play a role. Read More
TOKYO – Defying the non-litigious nature of Japanese companies, makers of drugs and biosimilars are increasingly willing to file lawsuits to protect patents or clear the way to market biosimilars. Read More
With U.S. drug prices attracting the lion's share of public condemnation these days, perhaps it's no surprise to see the brakes applied to drug spending. Read More
More than a year after legal wrangling derailed a $2 billion deal to hasten development of its antibody drug conjugate (ADC) IMMU-132 (sacituzumab govitecan) for breast cancer, Immunomedics Inc. is racing toward new regulatory milestones. The company submitted updated phase II data on the ADC in metastatic triple-negative breast cancer (mTNBC) to support an ongoing FDA priority review while also reaching an accord with the agency on the design of a registration-enabling trial for the drug in HR+/HER2- metastatic breast cancer (mBC), it said. Read More
Four years out from opening its doors, Xylocor Therapeutics Inc. closed a $17 million series A as it prepared to move lead candidate XC-001, a cardiovascular angiogenic gene therapy, into phase I in individuals with refractory angina who have no other treatment options. The round was co-led by Sofinnova Ventures and LSP (Life Sciences Partners). Read More
In attention deficit hyperactivity disorder (ADHD), doctors are "starving for something new, something refreshing, something that can really add value and is not only a formulation of an existing amphetamine or methylphenidate," said Supernus Pharmaceuticals Inc. CEO Jack Khattar – and in fast-onset SPN-812, they just might have it. Read More
The U.S. House and Senate Thursday passed a two-week extension of a continuing resolution that's been keeping the FDA and several other federal agencies and departments running since Oct. 1. President Donald Trump is expected to sign the extension Friday before the continuing resolution expires at midnight. The extension will give the lame duck Congress until Dec. 21 to reach agreement on seven outstanding fiscal 2019 spending bills, including one for the Department of Agriculture and the FDA. Read More
