Amgen Inc. again set analysts and investors abuzz with phase II/III data on its protein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab, now dubbed Repatha, presented at the American College of Cardiology's (ACC) annual scientific session in San Diego.
If Alzheimer's disease (AD) has been a graveyard for drug development over the past 10 years, Parkinson's disease (PD) has been on life support, limping along with mostly lackluster reformulations and extended-release versions of levodopa (L-dopa). The dopamine precursor became a clinically relevant treatment in the late 1960s based on research conducted by George Cotzias and colleagues, garnering Cotzias the 1969 Lasker Prize.
Phasebio Pharmaceuticals Inc. landed Astrazeneca plc as the lead investor in its $40 million series C round, designed to advance its biopolymer-based drug pipeline in metabolic and specialty cardiopulmonary indications.
United Therapeutics Corp. punched a golden ticket with Unituxin (dinutuximab, formerly ch14.18), which the FDA green-lighted to treat children with high-risk neuroblastoma, along with the award of a rare pediatric disease priority review voucher.
Calithera Biosciences Inc. didn't have to dig deep to expand its pipeline of cancer drugs, taking an exclusive global license to a portfolio of hexokinase II inhibitors developed by Transtech Pharma LLC (TTP) and affiliate High Point Pharmaceuticals LLC for a mere $600,000 up front. Calithera, of South San Francisco, will owe development and regulatory milestone payments of up to $30.5 million for the first licensed product, and Transtech is eligible for up to $77 million in sales-based milestones, plus mid-single-digit royalty payments, on tiered sales of the first commercialized product.
Mallinckrodt plc plans to amp up its hospital-based drug portfolio with the acquisition of privately held Ikaria Inc. in a transaction valued at approximately $2.3 billion. Hampton, N.J.-based Ikaria, which is focused on therapies and delivery systems for critically ill infants in hospital neonatal intensive care unit (NICU) settings, markets Inomax, a continuous flow version of inhaled nitric oxide.
In 2012, the Agency for Healthcare Research and Quality (AHRQ) set out to develop the Registry of Patient Registries (RoPR) as a one-stop repository of information about patient registries focused on, but not exclusive to, U.S.-based registries. The goals, in a nutshell, were to increase collaboration, reduce redundancy and improve transparency during drug and medical device development.
The FDA approved Avycaz (ceftazidime/avibactam) to treat adults with complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs), offering a promising option to fight drug-resistant superbugs. Avycaz, which combines a cephalosporin that demonstrated in vitro activity against certain gram-negative and gram-positive bacteria and a non-beta-lactam beta-lactamase inhibitor, will be marketed in North America by developer Actavis plc, of Dublin, and elsewhere by partner Astrazeneca plc, of London.
Sunovion Pharmaceuticals Inc. moved its nebulized long-acting muscarinic antagonist (LAMA) into phase III development by opening the final two studies in a pivotal program that will collectively enroll approximately 2,340 adults with moderate to very severe chronic obstructive pulmonary disease (COPD).
