Archive for October 2017
AstraZeneca Plots Crucial IDO Phase III Combo Trial With Incyte
Astra and Incyte are pushing forward on the development of immunotherapy combination treatments. Source: BioSpace
Read MoreStemline Therapeutics Announces that Pivotal Trial of SL-401 in Blastic Plasmacytoid Dendritic Ce…
Based on feedback from the FDA, Stemline remains on track to begin submission of its BLA in the 4Q17-1Q18 timeframe. Source: BioSpace
Read MoreVoyager Sinks as Sanofi Genzyme Opts Out of Parkinson's Gene Therapy Program
Shares of Voyager have fallen more than 12 percent in premarket trading after Sanofi Genzyme walked away from its $845M gene therapy treatment for Parkinson’s disease. Source: BioSpace
Read MoreSanofi: Dupilumab Significantly Reduced Steroid Use, Asthma Attacks, and Improved Lung Function i…
Dupilumab added to standard therapies significantly reduced the use of maintenance oral corticosteroids (OCS) by 70% on average. Source: BioSpace
Read More3 Biotechs Bloodied Celgene Could Take Out
Investors and analysts are wondering if the company should buy a biotech to bolster its pipeline and bottom line. Source: BioSpace
Read MoreCancer Biotech Apellis Pharma Sets Terms for $150M IPO
The Crestwood, KY-based company plans to raise $150M by offering 10.7 million shares at a price range of $13 to $15. Source: BioSpace
Read MoreEndo Subsidiaries Sue FDA to Have Agency’s Compounding Decree Declared Illegal
Two Endo International subsidiaries sued the FDA last week to have the agency’s bulk drug compounding decree on compounding operations declared illegal and to halt compounding involving the API vasopressin. Source: Drug Industry Daily
Read MoreEMA Drops Requirement for Testing Untreated Hemophilia Patients in Draft Guidelines
The European Medicines Agency revised two guidelines on the development and labeling of factor VIII products used to treat hemophilia A, removing requirements for sponsors to conduct clinical trials in previously untreated patients. Source: Drug Industry Daily
Read MoreEMA Issues New Guideline on RSV Products
The European Medicines Agency published a new draft guideline on developing medicines and vaccines against respiratory syncytial virus infections, including monoclonal antibodies and direct-acting antivirals. Source: Drug Industry Daily
Read MoreFDA to Adopt ICH E9 Addendum on Clinical Trials Analyses
The FDA is seeking public comments on an ICH addendum to a 1998 clinical trials statistics guideline focused on the use of sensitivity analyses and targets for estimation and measurement. Source: Drug Industry Daily
Read More