FDA Greenlights New Treatment for Multi-Drug Resistant HIV-1
The U.S. Food and Drug Administration has approved Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1. Source: BioSpace
Roivant Licenses Diabetes Drug From Ligand Pharma
Ligand Pharmaceuticals is licensing LGD-6972, a glucagon receptor antagonist (GRA), to Roivant Sciences for $20 million. Source: BioSpace
Seattle Genetics Commences Dosing in Early-Stage Multiple Myeloma Trial
Seattle Genetics dosed its first patient with an early-stage treatment for patients with relapsed or refractory multiple myeloma (MM). Source: BioSpace
Moderna's Vaccines Boss Leaves Company
Giuseppe Ciaramella, formerly chief scientific officer of Moderna Therapeutics’ Valera unit, has left for an unidentified stealth-mode biotech startup. Source: BioSpace
FDA Approves 23andMe’s Direct-to-Consumer Genetic Test for Cancer
The U.S. Food and Drug Administration (FDA) approved the first-ever direct-to-consumer genetic test for cancer risk. Source: BioSpace
Chinese Drugmaker Warned for Testing Deficiencies
The FDA hit Chinese firm Zhejiang Ludao Technology with a warning letter after an August inspection revealed significant testing issues at its Taizhou, Zhejiang facility. Source: Drug Industry Daily
CBER Faults Drugmaker for Implying Hemophilia Drug Allows Patients to Engage in High-Risk Activity
CBER’s advertising and promotional labeling branch sent an untitled letter to a drugmaker in Pennsylvania saying the company overpromised the impact of its hemophilia treatment. Source: Drug Industry Daily
FDA: Opioid Sales Increased to $8 Billion From 1992 to 2015
Opioid sales increased more than eightfold between 1992 and 2015, according to a new analysis by the FDA that found no clear links between price and volume. Source: Drug Industry…
DEA to Divulge Opioid Sales Data Under Confidentiality Order
The Drug Enforcement Administration told an Ohio federal judge it would divulge nearly a decade’s worth of data on opioid sales after long resisting the disclosure, but only under a…
Martin Shkreli Ordered to Forfeit $7.36 Million in Assets Ahead of Sentencing
Days before his sentencing for a criminal fraud conviction disgraced pharma entrepreneur Martin Shkreli has been ordered to forfeit $7.36 million. Source: BioSpace
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