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Home » Newsletters » BioWorld

BioWorld

May 31, 2018

View Archived Issues

Regulatory front

The FDA announced an innovation challenge for the development of diagnostics and medical devices, including digital devices, that would provide "novel solutions to detecting, treating and preventing addiction, addressing diversion and treating pain." Read More

Other news to note

Frequency Therapeutics Inc., of Woburn, Mass., was awarded a $2 million grant from the U.S. Department of Defense to support the development of its small-molecule drugs to treat hearing dysfunction that are designed to awaken dormant progenitor cells in the ear that can induce the regeneration of hair cells and neuronal connections. Read More

Appointments and advancements

Imara Inc., of Cambridge, Mass., appointed Joe Datt senior vice president, clinical development, and Siddharth Parulkar head, global clinical operations. Read More

Clinical data for May 30, 2018

Read More

Financings

Provention Bio Inc., of Oldwick, N.J., aims to raise between $40 million and $50 million in a best-efforts IPO. The company said its mission is to in-license, transform and develop clinical-stage, or nearly clinical-stage, therapeutic candidates targeting type 1 diabetes, Crohn's disease, ulcerative colitis, lupus and life-threating viral diseases. Read More

CNDA Town Hall: New drug commissioner Hong promises continued innovation support

BEIJING – Freshly installed Commissioner Jiao Hong of the China National Drug Administration, formerly the CFDA, voiced the agency's plans to streamline review and approval of new drugs, encourage innovation, improve capacity to take a science-based approach, deepen industry's quality control efforts and step up monitoring of adverse events. Read More

Atox Bio targeting severe infections with reltecimod; trials in AKI, NSTI ongoing

HONG KONG –Israeli biotech firm Atox Bio Inc., of Ness Ziona, is moving ahead with its lead product, reltecimod (AB-103), with two clinical trials ongoing in parallel in the U.S. The funds from the financing round last December will help speed up the development of the drug candidate, pushing it closer to approval in two year's time. Read More

WHO finalizing protocol for testing five therapies in current Ebola outbreak

LONDON – The World Health Organization (WHO) is to test five experimental Ebola therapies in patients infected with the virus in the current outbreak in the Democratic Republic of Congo (DRC). Read More

Digital health trailblazers provide examples of technology in action

The digitization of health is very much a work in progress, but there are now many and varied initial deployments that give a sense of the benefits that will flow from the comprehensive and integrated application of digital technologies in health care. Read More

F-star, Denali forge ahead with antibody collaboration

A collaboration between Denali Therapeutics Inc. and F-star Ltd. aimed at enhancing the delivery of new therapies for neurodegenerative diseases across the blood-brain barrier gained new momentum Thursday. Denali exercised an option to acquire the first target of the partnership for $24 million up front and potential milestone payments of up to $447 million, composed of preclinical, clinical, regulatory and commercial milestones. Read More

President promises a historic first – a 'massive' drop in U.S. drug prices

As the Senate Health, Education, Labor and Pensions (HELP) Committee gets set to examine President Donald Trump's blueprint to bring down drug prices, the president promised action, saying that in two weeks, major drug companies will announce "massive" drops in their drug prices. Read More

Regulatory actions for May 30, 2018

Read More

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