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BioWorld - Wednesday, March 4, 2026
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
Home » Topics » BioWorld Asia, Regulatory

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Mosquito

Takeda files long-term dengue vaccine data to support EU, other applications

May 25, 2021
By Michael Fitzhugh
New three-year safety and efficacy data on Takeda Pharmaceutical Co. Ltd.'s dengue vaccine candidate, TAK-003, showed it to be 62% more effective than placebo in preventing virologically confirmed infections with the virus and 83.6% more effective than placebo in preventing hospitalizations caused by the mosquito-borne viral disease and due to any of the four dengue virus serotypes in patients ages 4 to 16.
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Failure to disclose Chinese research ties lands prison sentence

May 18, 2021
Song Guo Zheng, a rheumatology professor and researcher at Ohio State University (OSU), was sentenced May 14 to 37 months in prison for lying on U.S. NIH grant applications about his ties to at least five Chinese research institutes.
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Ovarian cancer illustration

Beigene’s PARP inhibitor approved for recurrent ovarian cancer in China

May 11, 2021
By Elise Mak
Beigene Ltd.’s PARP inhibitor, pamiparib, won conditional approval from China’s National Medical Products Administration for treating patients with germline BRCA mutation-associated recurrent advanced ovarian, fallopian tube or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.
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World trade illustration

Déjà vu sets in with Special 301 Report

May 11, 2021
By Mari Serebrov
The 2021 Special 301 Report recently released by the U.S. Trade Representative is mostly déjà vu for the 32 countries included on the Priority Watch and Watch Lists, as all of them have appeared before on the lists that call out U.S. trading partners for unfair IP practices that disadvantage foreign companies.
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regulatory-washington-white-house-president.png

U.S. change of course on IP waiver facing backlash

May 11, 2021
By Mari Serebrov
The Biden administration’s May 5 about-face on the proposed TRIPS waiver of intellectual property (IP) protections for COVID-19-related medical products is not playing well with U.S. industry, EU trading partners and others concerned about the long-term unintended consequences.
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Vaccine and data illustration

U.S. switches stance on IP waiver, sponsors promise revision

May 11, 2021
By Mari Serebrov
Once again, the World Trade Organization postponed a decision on a temporary IP waiver for COVID-19 vaccines and other related medical products.
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China accelerates drug approvals, development since joining ICH

May 11, 2021
By Elise Mak
Since joining the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use in 2017, China has approved clinical trials and marketing of drugs a lot faster with simultaneous clinical development at home and abroad.
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COVID-19 vaccine vial on ice

U.S.-supported patent waiver meets with skepticism in Asia

May 11, 2021
By David Ho, Gina Lee, and Elise Mak
HONG KONG – The Biden administration’s support for a TRIPS waiver of COVID-19 vaccine patents has already met a chorus of resistance from Western companies. In Asia, skepticism about how it would be achieved and what it will cover, is widespread.
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Gavel and block with Chinese flag

China overhauls patent law to stay competitive in biotech innovation

May 4, 2021
By Elise Mak
To honor its part for phase one of the U.S.-China trade deal, China has revised its patent law to establish a drug patent linkage system and provide compensation for lost patent terms.
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Chinese flag and pills

China’s new policy gives innovative drugs direct access to hospitals in Hainan province

April 20, 2021
By Elise Mak
Now drugmakers can gain instant access to hospitals in Hainan province right after their innovative drugs are approved by China’s National Medical Products Administration to skip market entry hurdles.
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