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Home » Newsletters » BioWorld

BioWorld

April 2, 2018

View Archived Issues

Regulatory actions for March 30, 2018

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Clinical data for March 30, 2018

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Regulatory front

U.S. Health and Human Services (HHS) Secretary Alex Azar Thursday named Daniel Best, a veteran of both the pharma and payer landscapes, as his senior adviser for drug pricing reform. Read More

Financings

Diamedica Therapeutics Inc., of Minneapolis, said it completed the second and final tranche of its previously announced offering of units for additional gross proceeds of about $2.5 million. Read More

Other news to note

Ligand Pharmaceuticals Inc., of San Diego, said it entered an agreement with Venbio Partners, a venture capital group, permitting Venbio's portfolio companies to enter pre-agreed worldwide Omniab platform license agreements.  Read More

Appointments & advancements

Cytodyn Inc., of Vancouver, Wash., appointed David Hinrichs, Patrick Iversen, Daniel Lindner, Richard Pestell, David L. Porter, Jonah Sacha to its new scientific advisory board. Read More

Bench Press: BioWorld looks at translational medicine

Immune responses to gut bacteria may initiate systemic lupus erythematosus (lupus) in susceptible individuals. Individuals who go on to develop lupus have autoantibodies years before the onset of symptoms, and the earliest detectable antibodies are often those to the RNA-binding protein Ro60. Scientists from Yale University and the NIH investigated potential sources of Ro60 antigen, and they showed that several species of commensal bacteria express bacterial versions of Ro60.  Read More

Pfizer's tafamidis ATTR-ACTs new attention with transthyretin cardiomyopathy data

A top-line win for Pfizer Inc.'s tafamidis, a small-molecule drug in phase III testing to treat a rare and fatal condition associated with progressive heart failure, has shaken up competitive outlooks for Alnylam Pharmaceuticals Inc. and Ionis Pharmaceuticals Inc., both of which are developing alternate therapies in the space. The ATTR-ACT trial, in transthyretin cardiomyopathy, found tafamidis provided a statistically significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations vs. placebo at 30 months. It was the first pivotal trial to test a pharmacological treatment for the condition. Read More

Accounting mandates in flux via tax reform, new revenue standards

Compliance with life sciences accounting standards has never been a simple task, but a new report by Deloitte says that public business entities in the life sciences must be aware of the impact of tax reform and recent changes to reporting standards for revenues associated with several activities if they want to maximize profits and stay out of the crosshairs of federal regulators. Read More

No red light for roxa(nne), Fibrogen success-dressed to sting CKD anemia space

With Fibrogen Inc. and U.S. partner Astrazeneca plc, of London, set to roll out data in the fourth quarter on roxadustat (roxa) for anemia associated with chronic kidney disease (CKD) – and with a filing for approval possible in the first half of next year – speculation has begun about the oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor's odds for success. Read More

Autophagy role in memory may yield anxiety treatments

The discovery that autophagy can enhance erasure of memory suggests that autophagy inducers could represent a useful new therapeutic tool for treating common chronic anxiety-associated conditions in individuals with post-traumatic stress disorder (PTSD). Read More

'The spring of biotech' as HKEX gets ready to be the Nasdaq of the East

SHANGHAI – This year's China Healthcare Investment Conference (CHIC) event, where investors and entrepreneurs gathered between the mirrored walls of the Ritz-Carlton, was especially supercharged, thanks to the recent decision by the Hong Kong Stock Exchange to open its doors to pre-revenue biotech companies, a move that has the potential to usher in a new era of wealth and opportunity for many of the attendees.  Read More

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