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Home » Newsletters » BioWorld

BioWorld

Oct. 7, 2019

View Archived Issues

Gilead's Descovy becomes second FDA-approved drug to prevent HIV infection

WASHINGTON – Since 2012, Americans at risk of HIV-1 infection from sex have had just a single option for reducing their odds of acquiring it: a daily dose of Gilead Sciences Inc.'s Truvada (emtricitabine and tenofovir disoproxil fumarate). Now, about a year before Truvada goes generic, at least some of them have a second option in Gilead's Descovy (emtricitabine and tenofovir alafenamide). On Thursday, the FDA approved Descovy for HIV-1 pre-exposure prophylaxis, or PrEP, to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex. Read More

Arbutus halts hep B study after volunteers develop hepatitis

Rough times continued Friday at Arbutus Biopharma Corp. as it discontinued clinical development of AB-506, an oral capsid inhibitor, which is in a clinical trial for treating chronic hepatitis B. The decision was made when two healthy volunteers were found to have acute hepatitis. Read More

Stealing fire in GI, subsets effort by Prometheus lures Takeda to $420M IBD pact

CEO Mark McKenna told BioWorld that San Diego-based Prometheus Biosciences Inc. has "cracked the code" in inflammatory bowel disease (IBD) – progress underscored by the firm's deal with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, which brings an undisclosed up-front payment and as much as $420 million more if development, regulatory and commercial milestones are reached in three programs. Read More

U.K. bans certain exports to preserve drug stockpiles in case of no-deal Brexit

LONDON – The U.K. government has placed an immediate ban on the export of certain drugs in a bid to prevent wholesalers taking advantage of the fall in the value of the pound against the euro by selling off U.K. stockpiles that have been built up to protect against an interruption in supplies in event of a no-deal Brexit. Read More

South Korea's Bioleaders and Israel's Weizmann found JV to advance p53-targeted R&D

HONG KONG – South Korean biotech Bioleaders Co. Ltd., headquartered in Yong-in city, Gyeonggi-do, and Israel's Weizmann Institute of Science, based in Rehovot, recently founded a joint venture in Israel. With the new entity, they will accelerate the R&D of a Weizmann-developed approach targeting p53, a strong tumor suppressor that has proved difficult to drug. Read More

Chong Kun Dang receives Japan's approval for NESP biosimilar to treat anemia

HONG KONG – South Korea's Chong Kun Dang (CKD) Pharmaceutical Corp. received approval for its novel erythropoiesis stimulating protein (NESP) biosimilar from Japan's Ministry of Health, Labour and Welfare (MHLW). The drug (CKD-11101) is world's first NESP biosimilar to treat anemia. Read More

Other news to note

Evotec SE, of Hamburg, Germany, reached a milestone as part of its 2017 partnership with Aeovian Pharmaceuticals Inc., of San Francisco, which triggered an undisclosed payment to Evotec. Read More

Financings

Adaptive Phage Therapeutics Inc., of Gaithersburg, Md., said it closed an oversubscribed, nonbrokered financing of about $7 million.  Read More

Clinical data for Oct. 4, 2019

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Regulatory actions for Oct. 4, 2019

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Bench Press: BioWorld looks at translational medicine

Researchers at Princeton University have used a combination of artificial intelligence and synthetic biology to identify and produce biologically active small molecules produced by members of the human microbiome.  Read More

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