Recognizing the conundrum that is the Biologics Price Competition and Innovation Act (BPCIA), the U.S. Supreme Court heard extended arguments Wednesday on fundamental questions entangling the biosimilar pathway. Read More
DUBLIN – Kiadis Pharma NV filed a marketing authorization application (MAA) with the EMA for ATIR-101, an adjunctive treatment for patients with hematological malignancies undergoing haploidentical (partially matched) allogeneic hematopoietic stem cell transplantation (HSCT). Read More
BOSTON – Typically, watching videos of other people's children doing unremarkable things such as sitting unassisted, toddling aimlessly and sticking things into their mouths is an exercise in smiling politely and hoping there is not too, too much footage. Read More
Despite a tepid response from payers to first approvals in the protein convertase subtilisin/kexin type 9 (PCSK9) drug class, The Medicines Co. (MDCO) plans to move aggressively into a pivotal phase III program for its candidate, inclisiran (formerly PCSK9si and ALN-PCSsc), after reaching agreement with the FDA on a study design to support submission of a new drug application (NDA), expected around year-end 2019. Read More
Arsanis Inc., an infectious disease specialist developing a targeted monoclonal antibody to prevent Staphylococcus aureus pneumonia, has closed on a $45.5 million series D financing that will help it complete a phase II trial of candidate ASN-100 in high-risk mechanically ventilated patients. The new funds will also support the advancement of preclinical gram-negative programs, as well as a respiratory syncytial virus (RSV) program. Read More
HONG KONG – A deal inked between Carlsbad, Calif.-based Ionis Pharmaceuticals Inc. and Kunshan, China-based Suzhou Ribo Life Science Co. Ltd. will ease the U.S. company's entry into the Chinese innovative drug market, while Ribo picks up a license for two antisense drugs – and an option for a third – aimed at treating metabolic diseases and cancer. Read More
The Senate Committee on Health, Education, Labor and Pensions (HELP) met Wednesday morning and swiftly postponed, for 24 hours, its vote on the nomination of Scott Gottlieb to serve as commissioner of the FDA. Read More
Neurocrine Biosciences Inc., of San Diego, said it intends to offer, subject to market and other conditions, $450 million aggregate principal amount of convertible senior notes due 2024 in a private offering to qualified institutional buyers. Read More
United Therapeutics Corp., of Silver Spring, Md., reported revenues totaling $370 million for the third quarter, missing consensus estimates of $401 million, due to flagging sales of its pulmonary arterial hypertension (PAH) drugs. Read More
Shire plc, of Dublin, said the European Commission has granted conditional marketing authorization for Natpar (rhPTH[1-84]), the first recombinant human protein with the full length 84-amino acid sequence of endogenous parathyroid hormone. Read More
Arca Biopharma Inc., of Westminster, Colo., said the 200th patient has been randomized into Genetic-AF, an adaptive, seamless design phase IIb/III trial evaluating Gencaro (bucindolol hydrochloride) as potentially the first genetically targeted treatment for atrial fibrillation (AF). Read More
