Rep. Upton updates 21st Century Cures timeline
Rep. Fred Upton (R-Mich.) said he plans to release a discussion draft in mid-January 2015 of legislation based on the 21st Century Cures initiative he and Rep. Diana DeGette (D-Colo.) launched in May.
CHMP gives nod to AbbVie's HCV therapies
EMA's CHMP recommended approval of Exviera dasabuvir and Viekirax, which is a two direct-acting-antiviral (2-DAA) combination of ombitasvir and paritaprevir (ABT-450) plus the booster Norvir ritonavir from AbbVie Inc. (NYSE:ABBV) to treat chronic HCV infection.
CHMP backs psoriasis treatments from Novartis, Celgene
EMA's CHMP recommended marketing authorization for Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) as a first-line treatment for adults with moderate to severe plaque psoriasis and Otezla apremilast from Celgene Corp. (NASDAQ:CELG) to treat active psoriatic arthritis and moderate to severe chronic plaque psoriasis in adults. CHMP said marketing authorization for both products would include a pharmacovigilance plan.
CHMP supports Boehringer's nintedanib for IPF
EMA's CHMP recommended marketing authorization of Ofev nintedanib from Boehringer Ingelheim GmbH (Ingelheim, Germany) for the treatment of idiopathic pulmonary fibrosis (IPF). The compound is under accelerated assessment in the EU.
Genzyme's Cerdelga gets CHMP nod for Gaucher's
EMA's CHMP recommended marketing authorization of Cerdelga eliglustat tartrate from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) to treat Type I Gaucher's disease.
Boehringer, WellPoint studying outcomes in AF
Boehringer Ingelheim GmbH (Ingelheim, Germany) and the HealthCore Inc. unit of WellPoint Inc. (NYSE:WLP) have identified non-valvular atrial fibrillation (NVAF) as the first project under their July deal to collaborate on the collection of real world health economic and outcomes data.
G-BA: No additional benefit for Tecfidera in MS
Germany's Federal Joint Committee (G-BA) has concurred with the Institute for Quality and Efficiency in Healthcare (IQWiG) that Tecfidera dimethyl fumarate from Biogen Idec Inc. (NASDAQ:BIIB) offers no additional benefit over interferon beta-1a to treat relapsing-remitting multiple sclerosis (RRMS).
Lexicon raises $130M in follow-on and notes
Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) raised $80 million through the sale of senior convertible notes and $50 million in a follow-on through the sale of 49.8 million shares at $1. JP Morgan; Goldman Sachs; Needham; and Stifel, Nicolaus are underwriters.
Dresner Partners hired Robert Friedman as managing director, healthcare. Friedman was most recently managing director at Northeast Securities, and previously co-head of healthcare investment banking for Burnham Securities.
POLITICS & POLICY
Woodcock: Breakthrough designation mostly about efficacy
FDA awards or denies breakthrough designation requests primarily based on convincing clinical evidence of substantial efficacy or lack thereof, Janet Woodcock said Friday at a conference organized by Friends of Cancer Research and the Brookings Institution. Woodcock is director of the agency's Center for Drug Evaluation and Research.
CMS issues final guidance on CED program
The Centers for Medicare & Medicaid Services (CMS) issued final guidance on its coverage with evidence development (CED) program that clarifies the program's stopping rules.
FDA to hold workshop on LDT guidance
FDA will hold a public workshop on Jan. 8 and 9 in Bethesda, Md., to discuss its proposal for a risk-based framework to address regulatory oversight of laboratory developed tests (LDTs). The agency plans to discuss with stakeholders how to balance patient safety and access to LDTs.
FDA workshop on therapies for rare patient subsets
FDA will hold a public workshop on Dec. 12 to discuss approaches to evaluate precision therapies targeting subsets of patients with rare molecular characteristics. The Center for Translational and Regulatory Sciences at the University of Virginia will co-sponsor the workshop, entitled "Developing and Using Precision Therapies in the 'Omics' Era: Generating and Interpreting Evidence for Rare Subsets."