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Home » Newsletters » BioWorld

BioWorld

Jan. 30, 2019

View Archived Issues

Biopharma voices missing during congressional hearings on drug prices

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 taps Voyager's gene therapy expertise

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

Many-FACITed effort has Triphase, Celgene, OICR in $980M leukemia play

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

Lyndra nabs $55M series B to support long-acting therapies

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

Bio-Thera launches global phase III trial for biosimilar of RA drug tocilizumab

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

Joint cybersecurity plan inked as FDA draft sits in docket

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

Financings

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

Earnings

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

Other news to note

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

Clinical data for Jan. 29, 2019

Read More

Regulatory actions for Jan. 29, 2019

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