The lessons learned in developing companion diagnostics (CDx) for cancer – which accounts for all but one FDA-approved in vitro CDx device – are beginning to resonate in other fields, including autoimmune, cardiovascular (CVD), central nervous system and infectious diseases. But the peculiarities of cancer, where many causative genetic alterations are known, don't easily translate to complex indications such as Alzheimer's disease (AD), which doesn't yet have a defined culprit.
Eagle Pharmaceuticals Inc. said the FDA issued a complete response letter (CRL) for Kangio (bivalirudin injection), which the company is advancing through the 505(b)(2) pathway as a ready-to-use, stable liquid intravenous formulation of 5 mg/mL bivalirudin, a new version of the anticoagulant Angiomax (bivalirudin, The Medicines Co.).
Sanofi SA put the power of its Sunrise Initiative behind start-up Dice Molecules SV LLC with the goal of creating a next-generation approach to small-molecule drug discovery. The partners rolled directly into a five-year global collaboration to discover therapeutics for up to 12 discrete targets encompassing an eclectic array of indications of strategic interest to the Paris-based pharma, which Kathy Bowdish, head of Sanofi Sunrise, cited as oncology, cardiovascular disease, rare diseases and diabetes.
Blueprint Medicines Corp. inked a potential $1 billion deal with Roche AG units F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. covering the discovery, development and commercialization of up to five small-molecule drugs targeting kinases deemed important in cancer immunotherapy – both as monotherapy and, potentially, in combination with drugs in Roche’s portfolio.
Based, in part, on the perseverance of founder Andrew Ritter, Ritter Pharmaceuticals Inc. has gutted out development of its only disclosed asset, RP-G28, for the treatment of lactose intolerance.
Tyg Oncology Ltd. and Oncoqr ML GmbH are relative newcomers to the field of cancer immunotherapy but their platforms are not. What's different now is that Tyg's lead vaccine candidate, TYG100, which targets gastrin (G17) for the treatment of pancreatic and other gastrointestinal (GI) cancers, is powered by the S-TIR technology platform – originally developed by S-target Therapeutics GmbH to treat severe allergic diseases and out-licensed for oncology uses to Oncoqr.
Targeting Alzheimer's disease (AD) patients based on their apolipoprotein E (ApoE) genotype could provide the path forward for ALZ-801, a prodrug of tramiprosate that developer Alzheon Inc. is preparing to move into a phase III program.
The Centers for Medicare & Medicaid Services (CMS) waded into the growing debate over the use of value-based pricing of prescription drugs by proposing to test a new model to deliver Medicare Part B drugs – infused cancer therapies, injectable antibiotics, eye care treatments and other treatments administered in a physician's office or hospital outpatient setting.
After quietly huddling in 2015 while it filled out its C-suite and lined up a manufacturing deal, Tizona Therapeutics Inc. went on the offense with a fast break into immunotherapy, scoring a $43 million series B round. The financing was co-led by Abingworth and Canaan Partners with investments from Lightstone Ventures and existing series A investors, including MPM Capital, Amgen Ventures, Astellas Venture Management and Interwest Partners.
Two years after inking an agreement to provide manufacturing services and clinical development assistance for GT038, the lead program at Genable Technologies Ltd., Spark Therapeutics Inc. is acquiring the Dublin-based company and its technology, now known as Rhonova.
