Congress doesn't need a planet-scale array of radio telescopes to generate evidence of the black hole in prescription drug pricing. U.S. lawmakers know the hole exists, and they know where to find it. But piercing the darkness to get at the truth of the inner workings of price-setting for a drug is a matter of relativity. Right now, that truth depends on the perspective of who's explaining what's going on. Read More
Clovis Oncology Inc. called a halt late Friday to its phase II open-label monotherapy trial evaluating Rubraca (rucaparib) in recurrent metastatic bladder cancer (Atlas), based on a data monitoring committee recommendation that had reviewed the preliminary efficacy data. Read More
Shares of Fibrocell Science Inc. (NASDAQ:FCSC) climbed 42.7% to $2.54 Monday on news that Castle Creek Pharmaceuticals LLC has agreed to support the development and commercialization of FCX-007, Fibrocell's lead gene therapy candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Read More
Looking to join the 12 drug companies that have gone public this year, Cortexyme Inc., Milestone Pharmaceuticals Inc., Applied Therapeutics Inc. and Nextcure Inc. all filed preliminary prospectuses with the SEC on Friday. Read More
VIENNA – Interim phase IIa data of hepatitis B core protein inhibitor ABI-H0731, from Assembly Biosciences Inc., used in combination with nucleos(t)ide (Nuc) analogues, indicate deep declines of hepatitis B virus (HBV) RNA and DNA to significantly low levels, suggesting potentially curative abilities. Read More
VIENNA – Phase II data presented at The International Liver Congress on Saturday paved the way for Lille, France-based Genfit SA to move into another phase III trial sometime this year for its lead drug, elafibranor, this time for primary biliary cholangitis (PBC). Read More
TORONTO – Triumf Innovations Inc., the business arm of Canada's national particle accelerator center, and Vancouver, British Columbia's Center for Drug Research and Development (CDRD) have joined forces in a worldwide "renaissance" using targeted alpha-particle therapy to fight cancer. Read More
The U.S. Office of Management and Budget (OMB) has published a new memo that takes more full aim at regulatory activity by executive branch agencies by redefining the activities subject to review by the Office of Information and Regulatory Affairs (OIRA). The new memo says that any rule, which is defined "expansively" to include guidances, must undergo review at OIRA, a requirement that could significantly delay the issuance of guidances by the U.S. FDA. Read More
EIP Pharma Inc., of Cambridge, Mass., said it completed a new private funding round of $11.2 million to support the use of the investigational drug neflamapimod as a treatment for dementia with Lewy bodies and for the cognitive deficits in Huntington's disease. Phase II studies in those indications are expected to start in the second quarter. Read More
The EMA is restricting the use of Sanofi SA's multiple sclerosis (MS) drug, Lemtrada (alemtuzumab), while it reviews new reports of immune-mediated conditions and problems with the heart and blood vessels, including fatal cases, that may be associated with the monoclonal antibody. Read More
Trillium Therapeutics Inc., of Toronto, said data demonstrating that TTI-621 triggers macrophage-mediated phagocytosis of Sezary cells and reduces tumor load in Sezary syndrome patients following intravenous administration were published in Blood Advances. Read More
