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Home » Newsletters » BioWorld

BioWorld

Nov. 27, 2018

View Archived Issues

Claim of first gene edited babies draws outrage, skepticism, calls for regulation

LONDON – There has been widespread condemnation following the claim by a Chinese scientist that he has used CRISPR/Cas9 technology to create the world's first genetically edited babies. The two girls, born a few weeks ago, are said to be healthy. Their genomes have been edited to express a modified version CCR5, a chemokine receptor that is the route by which the HIV virus infects white blood cells. Read More

Zafgen, haunted by past setback, sees shares tumble on FDA clinical hold

Cardiovascular safety concerns about Zafgen Inc.'s midstage type 2 diabetes (T2D) candidate, ZGN-1061, moved the FDA to push pause on the company's planned U.S.-based trial of the drug with a clinical hold. The setback triggered memories of a death tied to an earlier and now-discontinued candidate Zafgen had advanced from the same class, MetAP2 inhibitors, sending company shares (NASDAQ:ZFGN) down 40.6 percent to $5.41 on Monday. Read More

Back from the Edge post aSAH fizzle, PDS merger makes for renewal in I-O

Edge Therapeutics Inc.'s hunt for a "strategic alternative" after the failure of its flagship candidate, EG-1962 (nimodipine microparticles), ended with a stock-for-stock merger deal with privately held immuno-oncology (I-O) specialist Protein Delivery Sciences Biotechnology Corp. (PDS). Read More

Drugmakers embracing AI's utility to uncover hidden opportunities in discovery

For anyone not hip-deep in the hot field of artificial intelligence (AI), its role in drug discovery — or in any endeavor, for that matter — can feel vague, especially relative to the concrete problems drugmakers face daily. The very definition of AI can seem fuzzy, touted at times as capable of doing everything from organizing your photos to driving your car. Yet, in the biopharma space, as dollars flow in and candidates rise up, clarity is surfacing, too, program by program, bringing with it a more down-to-earth explanation of how the technology is reshaping the discovery enterprise. Read More

Omass applying gas mass spec tech to human health with $18M series A round

LONDON – Omass Therapeutics Ltd. has closed a £14 million (US$18 million) series A round, equipping it to commence commercialization of a new gas phase mass spectrometry technology with which it is possible to study the binding of small molecules to intact protein assemblies. Read More

Japan cuts review lag for priority new drugs: report

HONG KONG – Reviews for priority new drugs in Japan in 2017 took the shortest time in five years, amid the drug watchdog's efforts to cut review lag. The review time for priority new drugs in 2017 was 8.9 months, the shortest since 2013, according to a recent report by the Pharmaceuticals and Medical Devices Agency (PMDA). Read More

Other news to note

Cobra Biologics Ltd., of Kelle, U.K., Pall Corp., of Port Washington, N.Y., and the Cell and Gene Therapy Catapult, of London, were jointly awarded a £1.5 million (US$1.92 million) grant from Innovate UK to investigate continuous manufacturing of adeno-associated virus for gene therapy applications. The parties have been working together on the project since September. Read More

Financings

Tiziana Life Sciences plc, of London, raised gross proceeds of about £3.42 million (US$4.8 million) from its now-closed underwritten, registered public offering of 442,910 American depositary shares (ADSs). The company granted its sole bookrunner, Laidlaw & Co. Ltd., a 30-day option to purchase up to an additional 66,437 ADSs.  Read More

Clinical data for Nov. 26, 2018

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Regulatory actions for Nov. 26, 2018

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