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Home » Newsletters » BioWorld

BioWorld

Dec. 17, 2018

View Archived Issues

Amyloid beta seeds have decades-long staying power

LONDON – Vials of cadaver-derived human growth hormone in storage for more than 30 years were contaminated with amyloid beta seeds that promoted development of Alzheimer's-related amyloid beta pathology in mice. Read More

DoJ memos seen as having modest impact on federal prosecutors

WASHINGTON – Several memos directed toward U.S. federal prosecutors have surfaced during the current year, including one that spells out a seemingly novel policy regarding whistleblower lawsuits. A panel at a meeting of the Food and Drug Law Institute indicated that while the defense bar sees those memos as hopeful signs, the memos largely reflect the mainstream of federal prosecutor practice rather than represent a sea change in policy, leaving life sciences companies with more or less the same set of legal hazards as existed before 2018. Read More

Validated ECM platform helps Engitix draw series A round to expand into drug development

LONDON – Engitix Ltd. has raised £5 million (US$6.4 million) in a series A to flip the business model from drug discovery services to drug development and to finance preclinical testing of novel drugs discovered with its extracellular matrix (ECM) technology. Read More

Other news to note

Bioarctic AB, of Stockholm, said partner Abbvie Inc., of North Chicago, received U.S. Federal Trade Commission clearance to license Bioarctic's alpha-synuclein antibody portfolio for Parkinson's disease and other potential indications. (See BioWorld, Nov. 5, 2018.) Read More

Regulatory front

The United States-Mexico-Canada Agreement (USMCA) has been signed by the chief executives of each of the participating nations, but it has not been ratified by the U.S. Senate despite the passage of two weeks since the ceremonial signing Nov. 30. The agreement, which would overwrite the North American Free Trade Agreement, includes a concession from Canada regarding biotech exclusivity, currently set at eight years but scheduled to increase to 10 years upon enactment.  Read More

Financings

Axovant Sciences Ltd., of Basel, Switzerland, said it priced its underwritten public offering of 30 million of its common shares at $1 each with gross proceeds expected to be approximately $30 million. The underwriters have been granted a 30-day option to purchase up to an additional 4.5 million shares on the same terms and conditions. Read More

Clinical data for Dec. 14, 2018

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Regulatory actions for Dec. 14, 2018

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Bench Press: BioWorld looks at translational medicine

In looking for ways to culture gut bacteria, researchers at Northeastern University have discovered that multiple species of gut bacteria are able to either produce or consume gamma-aminobutyric acid (GABA), the major inhibitory nervous system of the mammalian nervous system.  Read More

When health care meets tech: Panelists offer advice for building blended syndicates

LONDON – The rise of digital health and the application of artificial intelligence and big data, to preserves such as drug discovery, real-world patient monitoring and the analysis of medical images, is forcing investors in traditional life sciences startups out of their comfort zone and propelling them to form syndicates with tech venture capitalists. Read More

Innovent's Avastin biosimilar clears hurdle in China trials

HONG KONG – HKEX-listed Innovent Biologics Inc. said its IBI-305 referencing Roche Holding AG's Avastin (bevacizumab) has met primary endpoints in two randomized, head-to-head trials, putting the company one step closer to bringing to market one of the first Avastin biosimilars approved in China. Read More

Toll bridge: Idera phase II results could presage win in later-stage combo trial

Wall Street didn't seem much enthused about Idera Pharmaceuticals Inc.'s data from the ongoing phase II trial called Illuminate-204 testing the intratumorally delivered Toll-like receptor 9 (TLR9) agonist tilsotolimod in combination with Yervoy (ipilimumab, Bristol-Myers Squibb Co.) against melanoma, but lead investigator Adi Diab from MD Anderson Cancer Center said that "to see such a durable response for these patients really creates hope. This is clearly an effective combination." Read More

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