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BioWorld - Wednesday, June 17, 2026
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FDA approves Beovu for wet age-related macular degeneration

Oct. 8, 2019

Cybersecurity may be next front in False Claims Act litigation

Oct. 8, 2019
By Mark McCarty
The device industry is quite familiar with whistleblower lawsuits, but Cisco Systems Inc., of San Jose, Calif., was recently forced to pay more than $8 million in connection with a qui tam lawsuit over cybersecurity lapses for video surveillance equipment sold to state and federal government agencies. The case suggests device makers will have to be up to speed on cybersecurity if they wish to avoid suffering a similar fate, particularly given a recent warning the FDA posted regarding a widespread cybersecurity vulnerability.
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FDA approves Aklief cream for topical treatment of acne

Oct. 7, 2019

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

Oct. 7, 2019
By Jihyun Kim
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.
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Gilead's Descovy becomes second FDA-approved drug to prevent HIV infection

Oct. 7, 2019
By Michael Fitzhugh
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.
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Arbutus halts hep B study after volunteers develop hepatitis

Oct. 7, 2019
By Lee Landenberger
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.
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U.K. bans certain exports to preserve drug stockpiles in case of no-deal Brexit

Oct. 7, 2019
By Nuala Moran
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.
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FDA approves Descovy for HIV-1 PrEP

Oct. 4, 2019

FDA approves Entresto for pediatric heart failure

Oct. 4, 2019

Trump promises quicker Medicare coverage for breakthrough technologies

Oct. 4, 2019
By Mari Serebrov
Following a speech that seemed more campaign rhetoric than policy, President Donald Trump signed an executive order Thursday that's his answer to the Democrats' proposed Medicare for All Act.
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