Wellstat Therapeutics Corp. gained a rare pediatric disease priority review voucher (PRV) from the FDA with the agency's approval of Xuriden (uridine triacetate), a pyrimidine analogue for uridine replacement for the treatment of hereditary orotic aciduria (HOA), a potentially life-threatening disease known to impact fewer than 22 children worldwide.
A risk-defraying pact between Amgen Inc. and Novartis AG will align the companies' early stage efforts to fight Alzheimer's disease (AD) behind Novartis' phase I/II oral beta-site APP-cleaving enzyme-1 (BACE) inhibitor, CNP-520, while also enlisting Novartis as a co-developer and eventual co-seller of Amgen's two migraine candidates in markets beyond North America and Japan.
Takeda Pharmaceutical Co. Ltd. and Nanotherapeutics Inc. have struck an agreement providing the Osaka, Japan-based pharma firm with expanded commercialization and technology rights to Nanotherapeutics’ Vero cell technology, a manufacturing platform that’s key to Takeda’s flu vaccines and its aspirations to further develop its global vaccines business in other markets.
Heat Biologics Inc. is winding down a phase II study of its injectable adenocarcinoma cell vaccine, HS-110 (viagenpumatucel-L), in combination with low-dose cyclophosphamide, to focus instead on the potential benefits of combining the vaccine with Opdivo (nivolumab, Bristol-Myers Squibb Co.) to battle non-small-cell lung cancer (NSCLC).
Bristol-Myers Squibb Co. will pay up to $1.3 billion, including a $150 million up-front payment, for an exclusive right to acquire Promedior Inc. and worldwide rights to the company's lead asset, a recombinant form of human pentraxin-2 protein, called PRM-151, that is in development for the treatment of IPF and myelofibrosis.
Takeda Pharmaceutical Co. Ltd. and Nanotherapeutics Inc. have struck an agreement providing Takeda with expanded commercialization and technology rights to Nanotherapeutics' Vero cell technology, a manufacturing platform that's key to Takeda's flu vaccines and its aspirations to further develop its global vaccines business in other markets.
Merus BV, a Dutch developer of bispecific antibodies for cancer immunotherapy, claimed the first tranche of a €72.8 million (US$80.5 million) series financing led by Sofinnova Ventures and Novo A/S, with additional backing from RA Capital Healthcare Fund, Rock Springs Capital, Tekla Capital Management, an unnamed U.S. investor and earlier supporters.
Flugen Inc., a Madison, Wis.-based company working on a universal flu vaccine, completed a $12.6 million series A financing to advance its plans to file an FDA investigational new drug application in the first half of next year, followed by a phase Ia study to look at safety and immune response in healthy adults.
Medivation Inc. will pay a hefty $410 million up front for global rights to Biomarin Pharmaceutical Inc.'s BMN-673 (talazoparib), a phase III poly ADP ribose polymerase (PARP) inhibitor intended to battle BRCA-mutated breast cancer and other malignancies.
An exclusive new tie-up between Boston-based Janus Biotherapeutics Inc. and Roche AG will advance what could become the first oral Toll-like receptor (TLR) inhibitor to enter the clinic with the potential to address autoimmune diseases.
