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Regulatory
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Chinese flag, pills

China approves Beigene’s PD-1, tislelizumab, as companies look to differentiate

Dec. 31, 2019
By Elise Mak
BEIJING – Chinese regulators granted the marketing nod to Beijing-based Beigene Ltd.‘s PD-1 antibody, tislelizumab, for treating patients with classical Hodgkin lymphoma (cHL) who have received at least two prior therapies. To be sold under the Chinese trade name Baize’an, tislelizumab is Beigene’s first drug to win approval in China, following an FDA approval for its BTK inhibitor, Brukinsa (zanubrutinib), last month. “We are preparing the commercialization of tislelizumab, and we will start supplying the drug soon,” Beigene’s media relations officer, Min Xiao, told BioWorld Asia.
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Brexit pencil illustration

Year in Review: Drawn-out Brexit takes toll as industry hopes for stability in 2020

Dec. 30, 2019
By Nuala Moran
LONDON – Following 3.5 years of uncertainty, the U.K. will be leaving the EU at 11 pm Jan. 31, after the newly elected Conservative government finally got the withdrawal agreement bill voted through Parliament Dec. 20, by a majority of 124.
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FDA approves Lynparza as first-line maintenance treatment for gBRCAm metastatic pancreatic cancer

Dec. 30, 2019

Tislelizumab approved in China for classical Hodgkin's lymphoma

Dec. 30, 2019

Remimazolam tosylate obtains first approval in China

Dec. 30, 2019

China NMPA approves Sinovac's varicella vaccine

Dec. 30, 2019

Regulatory front for Dec. 27, 2019

Dec. 27, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Thumbs up

Medical IP wins green light from FDA for its medical 3D printing software Medip

Dec. 27, 2019
By Jihyun Kim
HONG KONG – South Korea’s Medical IP Co. Ltd., an artificial intelligence (AI)-based medical 3D printing and software company, has won the FDA’s nod for its medical imaging analysis solution Medical Image Processing (Medip).
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FDA Approved stamp

FDA grants accelerated approval for Padcev to treat urothelial cancer

Dec. 24, 2019
By Lee Landenberger
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer.
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FDA sign

Advamed argues device-specific guidances suffer from overly narrow scope

Dec. 24, 2019
By Mark McCarty
The U.S. FDA’s attempt to use objective performance criteria for class II devices offers several advantages for device makers. However, the Advanced Medical Technology Association (Advamed) said in comments to the docket for two such sub-guidances that the documents are too narrowly scoped to be of much use in many instances.
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