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BioWorld - Friday, July 3, 2026
Home » Topics » Regulatory

Regulatory
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Amyloid plaque on nerve cell

Yes we aducanumab? Biogen/Eisai AD bid gains traction, outlook still divided

Aug. 11, 2020
By Randy Osborne
News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz.
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Ascletis’ all-oral HCV treatment approved for marketing in China

Aug. 11, 2020
By Bryan Wong
HONG KONG – The recent approval of all-oral hepatitis C virus (HCV) drug RDV/DNV, a combination of Asclevir (ravidasvir) and Ganovo (danoprevir), helped boost shares of Ascletis Pharma Inc. (HK:1672), which ended July with a 10% jump to HK$3.36 (US43 cents), as the Hangzhou, China-based company continues to push its pipeline of treatments forward and improve its outlook.
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Pakistan flag-map

Import bans hit Pakistan’s pharma industry

Aug. 11, 2020
By Khawar Khan
KARACHI, Pakistan – Geopolitics and a fraught relationship with its neighbors are hurting Pakistan’s pharmaceutical industry and the ability of people to access active pharmaceutical ingredients (APIs) and modern drugs.
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Fennec's Pedmark lands CRL over manufacturing issues

Aug. 11, 2020
By Michael Fitzhugh
Manufacturing deficiencies triggered an FDA complete response letter for Fennec Pharmaceuticals Inc.'s Pedmark, a medicine intended to prevent ototoxicity associated with cisplatin use in children with certain solid tumors.
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COVID-19 vaccine vials

From Russia with flub? Safety jitters ripple after quick COVID-19 vaccine approval

Aug. 11, 2020
By Randy Osborne
Reports out of Russia that the country approved a COVID-19 vaccine came with more questions than answers, as some in the rest of the world fretted over the apparently paltry degree of testing. Though the product has not completed phase III trials – human research thus far has involved only two groups of volunteers of 38 people each – Russia President Vladimir Putin is said to have declared Gam-COVID-Vac adequately studied.
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Financial chart, downward arrow

Mesoblast sees stock tumble 31% ahead of FDA adcom meeting

Aug. 11, 2020
By Tamra Sami
PERTH, Australia – Australian regenerative medicine company Mesoblast Ltd. saw its stock tumble more than 30% following the release of briefing documents from the FDA ahead of an Aug. 13 advisory committee meeting to review the company’s BLA for Ryoncil (remestemcel-L) for steroid-refractory acute graft versus host disease (SR-aGVHD) in children.
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U.S. Capitol building

Domestic Rx, device supply chain a tall order

Aug. 11, 2020
By Mari Serebrov
“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines.
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Regulatory front for Aug. 11, 2020

Aug. 11, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Allergan, BTL Industries, Spartan Bioscience, Zimmer Medizinsysteme.
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Regulatory actions for Aug. 11, 2020

Aug. 11, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Life Spine, Magventure, United Imaging.
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Regulatory front for Aug. 11, 2020

Aug. 11, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Kodak, Moderna.
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