DUBLIN – European biotechnology firms engaged in drug development scaled new heights in 2018, raising $7.715 billion in equity funding, a massive 37 percent increase in a like-for-like comparison with the 2017 total of $5.75 billion. Although the European sector, like its American counterpart, slowed significantly in the final quarter of the year, the momentum built up during the first three quarters enabled it to push up to a new high-water mark. Read More
Real-world data could provide some perspective on the results from a required postmarket cardiovascular outcomes trial that once again raised safety concerns about Takeda Pharmaceutical Co. Ltd.'s gout drug, Uloric. Read More
SAN FRANCISCO – Following a year in which, for the first time ever, the FDA approved more orphan drugs than non-orphans and the number of big pharma approvals fell, panelists at Biotech Showcase highlighted a litany of reasons the space is continuing to prove attractive, despite challenges. Citing cooperative regulators and compelling cost structures, they underscored some of the most convincing reasons to pursue orphan status and the growing interest from bigger companies in the space, most evident in Takeda Pharmaceutical Co. Ltd.'s recent acquisition of Shire plc. Read More
What Oppenheimer analyst Leland Gershell a few months ago called "the shift toward non-opioid/locally delivered treatment strategies [in pain], driven by increasing regulatory/payer/institutional hurdles" has brought a handful of players to the fore. Read More
HONG KONG – Clinical-stage biotech firm Athenex Inc. out-licensed to Chongqing Jingdong Junzhuo Pharmaceutical Co. Ltd. the rights to commercialize an ointment known as KX2-391 for treating actinic keratosis and oncology indications in China. Under the terms, Athenex will receive an up-front payment of $14.5 million and up to $15 million for development milestones. The company is also entitled to tiered royalties based on annual net sales starting at 15 percent, and with incremental increases of royalties with growing sales. Read More
Napajen Pharma Inc., of Burlingame, Calif., closed a series C financing of $12.4 million, led by existing investor INCJ Ltd. with participation by existing investor Mitsui & Co. Global Investment and new investor P&D Directions Inc. Napajen plans to use the funds to complete an ongoing phase I study of NJA-730, an anti-CD40 small interfering RNA delivered using the company's beta-glucan technology. Read More
The FDA issued a five-year strategic plan for its Sentinel electronic safety surveillance system. The plan is intended to serve as a roadmap to guide the development of Sentinel through 2023. Read More
Oramed Pharmaceuticals Inc., of Jerusalem, received a $3 million milestone payment from Hefei Tianhui Incubator of Technologies Co. Ltd., of Hefei, China, in association with the licensing deal for Oramed's orally ingestible insulin capsule (ORMD-0801) in greater China. Read More
Genevant Sciences Ltd., of Cambridge, Mass., appointed Margrit Schwarz chief scientific officer and head of R&D and Pete Zorn chief operating officer. Read More
The past 48 hours "have been pretty emotional and overwhelming," Bluebird Bio Inc. CEO Nick Leschly told BioWorld, and he wasn't talking about navigating the street crowd at the 37th Annual J.P. Morgan (JPM) Healthcare Conference. Between meetings in San Francisco, Leschly had fielded dozens of calls from biopharma CEOs, payer representatives, key opinion leaders, patient advocacy organizations, government officials around the world – even employees and board members – reacting to the presentation at JPM where Leschly made the case for capped, at-risk, term-limited, installment-plan payments for potentially curative gene therapy and other one-time treatments. The response across stakeholders was uniformly heartening. Read More
