The FDA has removed a clinical hold on Cel-Sci Corp.'s primary clinical program, a global phase III test of its immunotherapy candidate Multikine (leukocyte interleukin injection) in advanced primary head and neck cancer. The 928-patient study had been in limbo ever since the agency expressed concerns about matters of risk communication and trial design in late 2016.
Drug repositioning specialist Biovista Inc. has tapped Hewlett Packard Enterprise Co. (HPE) to add greater computing power to Project Prodigy, a personalized medicine platform that leverages artificial intelligence (AI) to help doctors identify novel drugs for hard-to-treat patients. HPE, a spin-off of HP Inc. focused on data analysis and security, is also providing financial and commercial support to help Biovista explore new applications for the system beyond health care, president and co-founder Aris Persidis told BioWorld.
Galapagos NV's autotaxin inhibitor, GLPG-1690, halted worsening lung function in adults with idiopathic pulmonary fibrosis (IPF) during the 12 weeks of a small phase IIa trial, setting the stage for it to quickly move on to late-stage testing. Top-line results of the trial, called Flora, suggest '1690 might eventually challenge Roche Holding AG's Esbriet (pirfenidone) and Boehringer Ingelheim GmbH's Ofev (nintedanib).
Roivant Sciences Inc., an umbrella for five biopharma companies and a new tech-focused venture, has secured biopharma's biggest-ever private financing, a $1.1 billion equity investment led by Softbank Vision Fund. The investment is expected to accelerate its launch of new subsidiaries within and beyond drug development, starting with the newco Datavant. CEO Vivek Ramaswamy told BioWorld that the new venture aspires to apply artificial intelligence and machine learning to "shelved data sets" in hopes of yielding insights that can speed drug development.
Dermira Inc. agreed to pay Roche Group up to $1.4 billion for global rights to the midstage interleukin-13 antagonist lebrikizumab for atopic dermatitis (AD) and other indications in hopes it will prove more effective than existing therapies, even with less frequent dosing. Dermira will record a $135 million charge related to the deal.
Zynerba Pharmaceuticals Inc. shares (NASDAQ:ZYNE) plunged more than 55 percent Monday to $6.67 on news that its lead candidate, the cannabidiol (CBD) gel ZYN-002, missed the primary endpoint of a phase II trial, failing to help adult epilepsy patients with focal seizures achieve a statistically significant reduction in seizures during the 12-week treatment period of the trial, called Star 1.
Mallinckrodt plc said it plans to acquire Infacare Pharmaceutical Corp., the developer of a late-stage severe jaundice treatment, for $80 million up front plus up to $345 million in potential milestone payments. If approved, the FDA fast-tracked candidate, stannsoporfin, could potentially be used to reduce or prevent the need for phototherapy, risky exchange transfusions and the incidence of pricey hospital readmissions.
Jazz Pharmaceuticals plc is seeing the first concrete dividend of its $1.5 billion buyout of Celator Pharmaceuticals Inc. with FDA approval for Vyxeos (daunorubicin and cytarabine) for the treatment of adults with two types of high-risk acute myeloid leukemia (AML). It's the second new AML therapy approved this week, following Tuesday's approval of Idhifa (enasidenib) for certain adults with relapsed or refractory AML.
