Drug company officials were a no-show at Tuesday's Senate hearing on drug prices, and they weren't on the witness list for a House Oversight hearing. In rejecting an invitation to testify before the Senate Finance Committee, they yielded the microphone to patients and policy experts and denied themselves a seat at the table in what proved to be a productive, even-handed discussion of the drivers of prescription drug prices and ways to realign government reimbursement schemes and do away with perverse incentives. Read More
Neurocrine Biosciences Inc. has agreed to pay Voyager Therapeutics Inc. $165 million up front and up to $1.7 billion in milestone payments for rights to develop and commercialize four experimental adeno-associated virus-based gene therapies, starting with one for Parkinson's disease and another for Friedreich's ataxia (FA). The complex agreement, which includes co-commercialization options for Voyager, broadens Neurocrine's pipeline of movement disorder drugs while simultaneously extending Voyager's cash runway into 2022, advancing each company's goals "beyond what we could have done apart from one another," Neurocrine CEO Kevin Gorman said. Read More
Toronto-based Triphase Accelerator Corp. and its majority shareholder, Fight Against Cancer Innovation Trust (FACIT), disclosed a new epigenetics deal with Celgene Corp. for what's described as a first-in-class preclinical therapeutic targeting the WDR5 protein for the treatment of blood cancers, including leukemia. Read More
Following up on its 2017 $23.5 million series A financing, Lyndra Therapeutics Inc. secured $55 million in a series B round to support the development of its long-acting therapies. All of the previous investors resubscribed, while Hopu Investments, Gilead Sciences Inc., Invus, the Bill & Melinda Gates Foundation and Orient Life joined their ranks. (See BioWorld Today, April 14, 2017.) Read More
HONG KONG – Roughly half a year after starting phase I development, Chinese biosimilars maker Bio-Thera Solutions Ltd. moved BAT-1806, its biosimilar referencing Genentech Inc.'s Roactemra (tocilizumab) for rheumatoid arthritis, into a global phase III trial. Read More
The latest FDA guidance for cybersecurity is still dry-docked in draft form, but device makers and software vendors now have yet another set of mandates to deal with where cybersecurity is concerned. A public-private partnership dubbed the Healthcare and Public Health Sector Coordinating Council (HSCC) has issued a cybersecurity plan that goes beyond the mandates of the Quality Systems Regulations, giving device makers even more requirements to keep track of as they attempt to navigate the turbulent seas of digital health. Read More
Arch Biopartners Inc., of Toronto, said it closed the nonbrokered, unsecured convertible note financing for gross proceeds of CA$500,000 (US$376,779). The company will primarily use proceeds to fund final preclinical tasks for Metablok and the initial costs of the phase I trial. Read More
Biogen Inc., of Cambridge, Mass., reported full-year revenues totaling $13.5 billion, up 10 percent over 2017, driven primarily by the continued global launch of spinal muscular atrophy drug Spinraza (nusinersen), which contributed $1.7 billion in revenues in 2018 vs. $884 million for the prior year. Read More
Trovagene Inc., of San Diego, said it reached an agreement with Poc Capital LLC, to fund clinical development of onvansertib, its first-in-class, third-generation oral and highly selective Polo-like kinase 1 inhibitor in a phase Ib/II trial in patients with metastatic colorectal cancer. Read More